Our Medications

Table of Contents

1. Viagra
2. Cialis

 

Viagra^®

What Should You Know Before Taking Viagra?

Disclaimer: The information provided on this page is not a substitute for professional medical advice, diagnosis, or treatment. If you have any questions or concerns about your health, please talk to a doctor.

Contraindications

Do not take Viagra® or generic Viagra® if you:

• take medicines called "nitrates" (such as nitroglycerin)

• use street drugs called "poppers" such as amyl nitrate or amyl nitrite, and butyl nitrate

• take any medicines called guanylate cyclase stimulators such as riociguat (Adempas)

• are allergic to sildenafil, as contained in Viagra® and Revatio, or any of the ingredients in Viagra®. See the end of this leaflet for a complete list of ingredients in Viagra®.

What should I tell my healthcare provider before taking Viagra® or generic Viagra®?

To make sure Viagra® is safe for you, tell your healthcare provider if you have any of the following before you take Viagra® or generic Viagra®:

• Have or have had heart problems such as a heart attack,irregular heartbeat, angina, chest pain, narrowing of the aortic valve, or heart failure

• Have had heart surgery within the last 6 months

• Have pulmonary hypertension

• Have had a stroke

• Have low blood pressure, or high blood pressure that is not controlled

• Have a deformed penis shape

• Have had an erection that lasted for more than 4 hours

• Have problems with your blood cells such as sickle cell anemia, multiple myeloma, or leukemia

• Have retinitis pigmentosa, a rare genetic (runs in families) eye disease

• Have ever had severe vision loss, including an eye problem called NAION

• Have bleeding problems

• Have or have had stomach or intestinal ulcers

• Have liver problems

• Have kidney problems or are having kidney dialysis

• Have any other medical conditions

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Viagra® and generic Viagra® may affect the way other medicines work, and other medicines may affect the way Viagra® and generic Viagra® works, causing side effects.

Drug Interactions

Tell your healthcare provider if you take any of the following because these drugs interact with Viagra® and generic Viagra®:

• Medicines called "nitrates"

• Medicines called guanylate cyclase stimulators such as Adempas® (riociguat)

• Medicines called alpha-blockers such as Hytrin® (terazosin HCl), Flomax® (tamsulosin HCl), Cardura® (doxazosin mesylate), Minipress® (prazosin HCl), Uroxatral® (alfuzosin HCl), Jalyn® (dutasteride and tamsulosin HCl), or Rapaflo® (silodosin). Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. In some patients, the use of VIAGRA® or generic VIAGRA® with alpha-blockers can lead to a drop in blood pressure or to fainting

• Medicines called HIV protease inhibitors, such as ritonavir (Norvir®), indinavir sulfate (Crixivan®), saquinavir (Fortovase® or Invirase®), or atazanavir sulfate (Reyataz®)

• Oral antifungal medicines, such as ketoconazole (Nizoral®) and itraconazole (Sporanox®)

• Antibiotics, such as clarithromycin (Biaxin®), telithromycin (Ketek®), or erythromycin

• Other medicines that treat high blood pressure

• Other medicines or treatments for ED

• Viagra® and generic Viagra® contain sildenafil, which is the same medicine found in another drug called Revatio®. Revatio® is used to treat a rare disease called pulmonary arterial hypertension (PAH). Viagra® and generic Viagra® should not be used with Revatio® or with other PAH treatments containing sildenafil or any other PDE5 inhibitors (such as Adcirca [tadalafil])

Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.

Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

Viagra Side Effects

What are the possible side effects of Viagra® and generic Viagra®?

Viagra® and generic Viagra® can cause serious side effects. Rarely reported side effects include:

• an erection that will not go away (priapism). If you have an erection that lasts more than 4 hours, get medical help right away. If it is not treated right away, priapism can permanently damage your penis.

• sudden vision loss in one or both eyes. Sudden vision loss in one or both eyes can be a sign of a serious eye problem called non-arteritic anterior ischemic optic neuropathy (NAION). It is uncertain whether PDE5 inhibitors directly cause the vision loss. Stop taking Viagra® and call your healthcare provider right away if you have sudden vision loss in one or both eyes.

• sudden hearing decrease or hearing loss. Some people may also have ringing in their ears (tinnitus) or dizziness. If you have these symptoms, stop taking Viagra® or generic Viagra® and contact a doctor right away.

The most common side effects of Viagra® and generic Viagra® are:

• headache

• flushing

• upset stomach

• abnormal vision, such as changes in color vision (such as having a blue color tinge) and blurred vision

• stuffy or runny nose

• back pain

• muscle pain

• nausea

• dizziness

• Rash

In addition, heart attack, stroke, irregular heartbeats and death have happened rarely in men taking Viagra®. Most, but not all, of these men had heart problems before taking Viagra®. It is not known if Viagra® caused these problems.

Tell your healthcare provider if you have any side effect that bothers you or does not go away.

These are not all the possible side effects of Viagra® and generic Viagra®. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

 

Cialis^®

What Should You Know Before Taking Cialis

Disclaimer: The information provided on this page is not a substitute for professional medical advice, diagnosis, or treatment. If you have any questions or concerns about your health, please talk to a doctor.

Contraindications

Who should not take Cialis® or generic Cialis®? Do not take Cialis® or generic Cialis® if you:

• take medicines called nitrates (such as nitroglycerin)

• use street drugs called "poppers" such as amyl nitrate or amyl nitrite, and butyl nitrate

• take any medicines called guanylate cyclase stimulators such as riociguat (Adempas)

• are allergic to Cialis® or any of the ingredients in Cialis®. See the end of this section for a complete list of ingredients in Cialis®.

What should I tell my healthcare provider before taking Cialis® or generic Cialis®?

To make sure Cialis® is safe for you, tell your healthcare provider if you have any of the following before you take Cialis® or generic Cialis®?:

• Have or have had heart problems such as a heart attack,irregular heartbeat, angina, chest pain, narrowing of the aortic valve, or heart failure

• Have had heart surgery within the last 6 months

• Have pulmonary hypertension

• Have had a stroke

• Have low blood pressure, or high blood pressure that is not controlled

• Have a deformed penis shape

• Have had an erection that lasted for more than 4 hours

• Have problems with your blood cells such as sickle cell anemia, multiple myeloma, or leukemia

• Have retinitis pigmentosa, a rare genetic (runs in families) eye disease

• Have ever had severe vision loss, including an eye problem called NAION

• Have bleeding problems

• Have or have had stomach or intestinal ulcers

• Have liver problems

• Have kidney problems or are having kidney dialysis

• Have any other medical conditions

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Cialis® and generic Cialis® may affect the way other medicines work, and other medicines may affect the way Cialis® and generic Cialis® works, causing side effects.

Drug Interactions

Tell your healthcare provider if you take any of the following because these drugs interact with Cialis® and generic Cialis®:

• Medicines called nitrates

• Medicines called guanylate cyclase stimulators such as Adempas® (riociguat)

• Medicines called alpha-blockers such as Hytrin® (terazosin HCl), Flomax® (tamsulosin HCl), Cardura® (doxazosin mesylate), Minipress® (prazosin HCl), Uroxatral® (alfuzosin HCl), Jalyn® (dutasteride and tamsulosin HCl), or Rapaflo® (silodosin). Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. In some patients, the use of Cialis® or generic Cialis® with alpha-blockers can lead to a drop in blood pressure or to fainting

• Medicines called HIV protease inhibitors, such as ritonavir (Norvir®), indinavir sulfate (Crixivan®), saquinavir (Fortovase® or Invirase®), or atazanavir sulfate (Reyataz®)

• Oral antifungal medicines, such as ketoconazole (Nizoral®) and itraconazole (Sporanox®)

• Antibiotics, such as clarithromycin (Biaxin®), telithromycin (Ketek®), or erythromycin

• Other medicines that treat high blood pressure

• Other medicines or treatments for ED

• Adcirca® (tadalafil) is used to treat a rare disease called pulmonary arterial hypertension (PAH) and has the same active ingredient as Cialis®. Cialis® and generic Cialis® should not be used with Adcirca® or with other PAH treatments containing sildenafil or any other PDE5 inhibitors (such as Revatio® [sildenafil citrate])

Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.

Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

Cialis Side Effects

What are the possible side effects of Cialis® and generic Cialis®?

Cialis® and generic Cialis® can cause serious side effects. Rarely reported side effects include:

• an erection that will not go away (priapism). If you have an erection that lasts more than 4 hours, get medical help right away. If it is not treated right away, priapism can permanently damage your penis.

• sudden vision loss in one or both eyes. Sudden vision loss in one or both eyes can be a sign of a serious eye problem called non-arteritic anterior ischemic optic neuropathy (NAION). It is uncertain whether PDE5 inhibitors directly cause the vision loss. Stop taking Cialis® and call your healthcare provider right away if you have sudden vision loss in one or both eyes.

• sudden hearing decrease or hearing loss. Some people may also have ringing in their ears (tinnitus) or dizziness. If you have these symptoms, stop taking Cialis® or generic Cialis® and contact a doctor right away.

The most common side effects of Cialis® and generic Cialis® are:

• headache

• flushing

• upset stomach

• abnormal vision, such as changes in color vision (such as having a blue color tinge) and blurred vision

• stuffy or runny nose

• back pain

• muscle pain

• nausea

• dizziness

• Rash

In addition, heart attack, stroke, irregular heartbeats and death have happened rarely in men taking Cialis®. Most, but not all, of these men had heart problems before taking Cialis®. It is not known if Cialis® caused these problems.

Tell your healthcare provider if you have any side effect that bothers you or does not go away.

These are not all the possible side effects of Cialis® and generic Cialis®. For more information, ask your healthcare provider or pharmacist.

Talk to your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What Happens if I Overdose?

Taking more than the recommended amount of Cialis® or generic Cialis® greatly increases your risk of side effects, including severe ones that can be dangerous, such as severe low blood pressure or an erection that won’t go away even after 4 or more hours (priapism). Never take more than the amount prescribed to you by your doctor. If you have any severe side effects after taking more than the recommended amount, or even after taking the amount of medicine prescribed to you, seek out emergency medical attention immediately.

Table of Contents

1. Wegovy
2. Rybelsus
3. Sexanda
4. Ozempic
5. Victoza
6. Trulicity
7. Zepbound
8. Mounjaro
9. Semaglutide
10. Tirzepatide
11. Orlistat
12. Contrave
13. Metformin

 

Wegovy^®

Important Safety Information

What is the most important information I should know about Wegovy^®?

Wegovy^® may cause serious side effects, including:

• Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, Wegovy^® and medicines that work like Wegovy^® caused thyroid tumors, including thyroid cancer. It is not known if Wegovy^® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people

• Do not use Wegovy^® if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

Do not use Wegovy^® if:

• you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

• you have had a serious allergic reaction to semaglutide or any of the ingredients in Wegovy^®

Before using Wegovy^®, tell your healthcare provider if you have any other medical conditions, including if you:

• have or have had problems with your pancreas or kidneys

• have type 2 diabetes and a history of diabetic retinopathy

• have or have had depression, suicidal thoughts, or mental health issues

• are pregnant or plan to become pregnant. Wegovy^® may harm your unborn baby. You should stop using Wegovy^® 2 months before you plan to become pregnant

• are breastfeeding or plan to breastfeed. It is not known if Wegovy^® passes into your breast milk

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Wegovy^® may affect the way some medicines work and some medicines may affect the way Wegovy^® works. Tell your healthcare provider if you are taking other medicines to treat diabetes, including sulfonylureas or insulin. Wegovy^® slows stomach emptying and can affect medicines that need to pass through the stomach quickly. 

What are the possible side effects of Wegovy^®?

Wegovy^® may cause serious side effects, including:

• inflammation of your pancreas (pancreatitis). Stop using Wegovy^® and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back

• gallbladder problems. Wegovy^® may cause gallbladder problems, including gallstones. Some gallstones may need surgery. Call your healthcare provider if you have symptoms, such as pain in your upper stomach (abdomen), fever, yellowing of the skin or eyes (jaundice), or clay-colored stools

• increased risk of low blood sugar (hypoglycemia) in patients with type 2 diabetes, especially those who also take medicines for type 2 diabetes such as sulfonylureas or insulin. This can be both a serious and common side effect. Talk to your healthcare provider about how to recognize and treat low blood sugar and check your blood sugar before you start and while you take Wegovy^®. Signs and symptoms of low blood sugar may include dizziness or light-headedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, or feeling jittery

• kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration

• serious allergic reactions. Stop using Wegovy^® and get medical help right away, if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat

• change in vision in people with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Wegovy^®

• increased heart rate. Wegovy^® can increase your heart rate while you are at rest. Tell your healthcare provider if you feel your heart racing or pounding in your chest and it lasts for several minutes

• depression or thoughts of suicide. You should pay attention to any mental changes, especially sudden changes in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you

The most common side effects of Wegovy^® may include: nausea, diarrhea, vomiting, constipation, stomach (abdomen) pain, headache, tiredness (fatigue), upset stomach, dizziness, feeling bloated, belching, gas, stomach flu, heartburn, and runny nose or sore throat.

Please click here for Prescribing Information and Medication Guide for Wegovy^®.

Wegovy^® is a prescription medication.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

 

RYBELSUS^®

RYBELSUS® (semaglutide) tablets 7 mg or 14 mg is a prescription medicine used along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes.

• It is not known if RYBELSUS® can be used in people who have had pancreatitis

• RYBELSUS® is not for use in people with type 1 diabetes

• It is not known if RYBELSUS® is safe and effective for use in children under 18 years of age

Important Safety Information

What is the most important information I should know about RYBELSUS®?

RYBELSUS® may cause serious side effects, including:

• Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, RYBELSUS® and medicines that work like RYBELSUS® caused thyroid tumors, including thyroid cancer. It is not known if RYBELSUS® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people

Do not use RYBELSUS® if:

• you or any of your family have ever had MTC, or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

• you have had a serious allergic reaction to semaglutide or any of the ingredients in RYBELSUS®. See symptoms of serious allergic reaction in "What are the possible side effects of RYBELSUS®?"

Before using RYBELSUS®, tell your healthcare provider if you have any other medical conditions, including if you:

• have or have had problems with your pancreas or kidneys

• have a history of vision problems related to your diabetes

• are pregnant or plan to become pregnant. It is not known if RYBELSUS® will harm your unborn baby. You should stop using RYBELSUS® 2 months before you plan to become pregnant. Talk to your healthcare provider about the best way to control your blood sugar if you plan to become pregnant or while you are pregnant

• are breastfeeding or plan to breastfeed. Breastfeeding is not recommended during treatment with RYBELSUS®

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. RYBELSUS® may affect the way some medicines work and some medicines may affect the way RYBELSUS® works.

How should I take RYBELSUS®?

• Take RYBELSUS® exactly as your healthcare provider tells you to

• Take RYBELSUS® by mouth on an empty stomach when you first wake up with a sip of plain water (no more than 4 ounces)

• Do not split, crush, or chew. Swallow RYBELSUS® whole

• After 30 minutes, you can eat, drink, or take other oral medicines

• If you miss a dose of RYBELSUS®, skip the missed dose and go back to your regular schedule

What are the possible side effects of RYBELSUS®?

RYBELSUS® may cause serious side effects, including:

• inflammation of your pancreas (pancreatitis). Stop using RYBELSUS® and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back

• changes in vision. Tell your healthcare provider if you have changes in vision during treatment with RYBELSUS®  

• low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use RYBELSUS® with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include: dizziness or lightheadedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, and feeling jittery

• kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration

• serious allergic reactions. Stop using RYBELSUS® and get medical help right away, if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat

• gallbladder problems. Gallbladder problems have happened in some people who take RYBELSUS®. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include: pain in your upper stomach (abdomen), yellowing of skin or eyes (jaundice), fever, and clay-colored stools

The most common side effects of RYBELSUS® may include nausea, stomach (abdominal) pain, diarrhea, decreased appetite, vomiting, and constipation. Nausea, vomiting, and diarrhea are most common when you first start RYBELSUS®.

Please see Prescribing Information and Medication Guide for RYBELSUS®.

RYBELSUS® is a prescription medication.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

 

Saxenda^®

Saxenda® (liraglutide) injection 3 mg is an injectable prescription medicine used for adults with excess weight (BMI ≥27) who also have weight-related medical problems or obesity (BMI ≥30), and children aged 12-17 years with a body weight above 132 pounds (60 kg) and obesity to help them lose weight and keep the weight off. Saxenda® should be used with a reduced calorie diet and increased physical activity. 

• Saxenda® and Victoza® have the same active ingredient, liraglutide, and should not be used together or with other GLP-1 receptor agonist medicines

• It is not known if Saxenda® is safe and effective when taken with other prescription, over-the-counter medicines, or herbal weight-loss products

• It is not known if Saxenda® is safe and effective in children under 12 years of age

• It is not known if Saxenda® is safe and effective in children aged 12 to 17 years with type 2 diabetes

Do not share your Saxenda® pen with others even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.

What is the most important information I should know about Saxenda®?

Serious side effects may happen in people who take Saxenda®, including:

Possible thyroid tumors, including cancer. Tell your health care professional if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rats and mice, Saxenda® and medicines that work like Saxenda® caused thyroid tumors, including thyroid cancer. It is not known if Saxenda® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.

Do not use Saxenda® if you or any of your family have ever had MTC, or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Who should not use Saxenda®?

Do not use Saxenda® if:

• you or any of your family have ever had MTC or if you have MEN 2

• you have had a serious allergic reaction to liraglutide or any of the ingredients in Saxenda®. See symptoms of serious allergic reactions in "What are the possible side effects of Saxenda®?"

• you are pregnant or plan to become pregnant. Saxenda® may harm your unborn baby

Before taking Saxenda®, tell your health care provider about all of your medical conditions, including if you:

• are taking certain medicines called GLP-1 receptor agonists

• have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food

• have or have had problems with your pancreas, kidneys or liver

• have or have had depression or suicidal thoughts, or mental health issues

• are breastfeeding or plan to breastfeed. It is not known if Saxenda® passes into your breast milk. You and your health care provider should decide if you will use Saxenda® or breastfeed

Tell your health care provider about all the medicines you take, including prescription, over-the-counter medicines, vitamins, and herbal supplements. Saxenda® slows stomach emptying and can affect medicines that need to pass through the stomach quickly. Saxenda® may affect the way some medicines work and some other medicines may affect the way Saxenda® works. Tell your health care provider if you take diabetes medicines, especially insulin and sulfonylurea medicines.

How should I use Saxenda®?

• Read the Instructions for Use that comes with Saxenda®

• Inject your dose of Saxenda® under the skin (subcutaneously) in your stomach area (abdomen), upper leg (thigh), or upper arm, as instructed by your health care provider. Do not inject into a vein or muscle

• Change (rotate) your injection site within the area you choose with each injection to reduce your risk of getting lumps under the skin (cutaneous amyloidosis). Do not use the same site for each injection

What are the possible side effects of Saxenda®?

Saxenda® may cause serious side effects, including:

• inflammation of the pancreas (pancreatitis). Stop using Saxenda® and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your stomach area (abdomen) to your back

• gallbladder problems. Saxenda® may cause gallbladder problems, including gallstones. Some gallbladder problems need surgery. Call your health care provider if you have any of the following symptoms: pain in your upper stomach (abdomen), fever, yellowing of your skin or eyes (jaundice), or clay-colored stools

• increased risk of low blood sugar (hypoglycemia) in adults with type 2 diabetes who also take medicines to treat type 2 diabetes such as sulfonylureas or insulin

• risk of low blood sugar (hypoglycemia) in children who are 12 years of age and older without type 2 diabetes

• Signs and symptoms of low blood sugar may include: shakiness, sweating, headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, and feeling jittery. You should check your blood sugar before you start taking Saxenda® and while you take Saxenda®

• increased heart rate. Saxenda® can increase your heart rate while you are at rest. Your health care provider should check your heart rate while you take Saxenda®. Tell your health care professional if you feel your heart racing or pounding in your chest and it lasts for several minutes

• kidney problems (kidney failure). Saxenda® may cause nausea, vomiting, or diarrhea leading to loss of fluids (dehydration). Dehydration may cause kidney failure, which can lead to the need for dialysis. This can happen in people who have never had kidney problems before. Drinking plenty of fluids may reduce your chance of dehydration. Call your health care provider right away if you have nausea, vomiting, or diarrhea that does not go away, or if you cannot drink liquids by mouth

• serious allergic reactions. Stop using Saxenda® and get medical help right away if you have any symptoms of a serious allergic reaction including swelling of your face, lips, tongue, or throat, fainting or feeling dizzy, very rapid heartbeat, problems breathing or swallowing, or severe rash or itching

• depression or thoughts of suicide. You should pay attention to any mental changes, especially sudden changes, in your mood, behaviors, thoughts, or feelings. Call your health care provider right away if you have any mental changes that are new, worse, or worry you

The most common side effects of Saxenda® in adults include nausea, diarrhea, constipation, vomiting, injection site reaction, low blood sugar (hypoglycemia), headache, tiredness (fatigue), dizziness, stomach pain, and change in enzyme (lipase) levels in your blood. Additional common side effects in children are fever and gastroenteritis.

Please click here for Prescribing Information and Medication Guide for Saxenda®. 

Saxenda® is a prescription medication.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

 

Ozempic^®

Ozempic® may cause serious side effects, including:

• Possible thyroid tumors, including cancer. Tell your health care provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, Ozempic® and medicines that work like Ozempic® caused thyroid tumors, including thyroid cancer. It is not known if Ozempic® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people. 

• Do not use Ozempic® if you or any of your family have ever had MTC, or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Do not use Ozempic® if:

• you or any of your family have ever had MTC or if you have MEN 2.

• you are allergic to semaglutide or any of the ingredients in Ozempic®. See symptoms of serious allergic reaction in "What are the possible side effects of Ozempic®?".

Before using Ozempic®, tell your health care provider if you have any other medical conditions, including if you:

• have or have had problems with your pancreas or kidneys. 

• have a history of diabetic retinopathy.

• are pregnant or breastfeeding or plan to become pregnant or breastfeed. It is not known if Ozempic® will harm your unborn baby or passes into your breast milk. You should stop using Ozempic® 2 months before you plan to become pregnant.

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and other medicines to treat diabetes, including insulin or sulfonylureas.

What are the possible side effects of Ozempic®?

Ozempic® may cause serious side effects, including:

• inflammation of your pancreas (pancreatitis). Stop using Ozempic® and call your health care provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.

• changes in vision. Tell your health care provider if you have changes in vision during treatment with Ozempic®.

• low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Ozempic® with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include: dizziness or Iightheadedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, and feeling jittery.

• kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration.

• serious allergic reactions. Stop using Ozempic® and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat.

• gallbladder problems. Gallbladder problems have happened in some people who take Ozempic®. Tell your healthcare provider right away if you get symptoms which may include: pain in your upper stomach (abdomen), fever, yellowing of the skin or eyes (jaundice), or clay-colored stools.

The most common side effects of Ozempic® may include nausea, vomiting, diarrhea, stomach (abdominal) pain, and constipation.

Please click here for Prescribing Information and Medication Guide.

Ozempic® is a prescription medication.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

 

Victoza^®

Victoza^® may cause serious side effects, including:

• Possible thyroid tumors, including cancer. Tell your health care provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rats and mice, Victoza^® and medicines that work like Victoza^® caused thyroid tumors, including thyroid cancer. It is not known if Victoza^® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.

Who should not use Victoza^®?

Do not use Victoza^® if:

• you or any of your family have ever had MTC or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

• you are allergic to liraglutide or any of the ingredients in Victoza^®. See symptoms of serious allergic reaction in “What are the possible side effects of Victoza^®?”.

What is Victoza^®?

Victoza^® (liraglutide) injection 1.2 mg or 1.8 mg is an injectable prescription medicine used:

• along with diet and exercise to lower blood sugar (glucose) in adults and children who are 10 years of age and older with type 2 diabetes mellitus.

• to reduce the risk of major cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes mellitus with known heart disease.

Victoza^® is not for use in people with type 1 diabetes. It should not be used with other medicines that contain liraglutide. It is not known if Victoza^® is safe and effective to lower blood sugar in children under 10 years of age.

Important Safety Information 
What should I tell my healthcare provider before using Victoza^®?

Before using Victoza^®, tell your health care provider if you:

• have or have had problems with your pancreas, kidneys, or liver.

• have any other medical conditions or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food.

• are pregnant or breastfeeding or plan to become pregnant or breastfeed.

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and other medicines to treat diabetes, including insulin or sulfonylureas.

How should I use Victoza^®?

• Inject under the skin of your stomach (abdomen), thigh, or upper arm. Do not inject Victoza^® into a muscle or vein.

• Change (rotate) your injection site within the area you choose with each injection to reduce your risk of getting lumps under the skin (cutaneous amyloidosis). Do not use the same site for each injection.

• Do not mix insulin and Victoza^® together in the same injection.

• You may give an injection of Victoza^® and insulin in the same body area (such as your stomach area), but not right next to each other.

• Do not share your Victoza^® pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.

What are the possible side effects of Victoza^®?
Victoza^® may cause serious side effects, including:

• inflammation of your pancreas (pancreatitis). Stop using Victoza^® and call your health care provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.

• low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Victoza^® with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. In children who are 10 years of age and older, the risk for low blood sugar may be higher with Victoza^® regardless of use with another medicine that can also lower blood sugar. Signs and symptoms of low blood sugar may include: dizziness or lightheadedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, and feeling jittery.

• kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse.

• serious allergic reactions. Stop using Victoza^® and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or a very rapid heartbeat.

• gallbladder problems. Gallbladder problems have happened in some people who take Victoza^®. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in the upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools.

The most common side effects of Victoza^® may include nausea, diarrhea, vomiting, decreased appetite, indigestion, and constipation.

Please click here for Prescribing Information and Medication Guide.

Victoza^® is a prescription medication.

 

Trulicity^®

Trulicity^®  is for adults and children 10 years of age and older with type 2 diabetes used along with diet and exercise to improve blood sugar (glucose). Trulicity^® is also used in adults with type 2 diabetes to reduce the risk of major cardiovascular events (problems having to do with the heart and blood vessels) such as death, heart attack, or stroke in people who have heart disease or multiple cardiovascular risk factors.

• It is not known if TRULICITY^® can be used in people who have had inflammation of the pancreas (pancreatitis). TRULICITY^® is not for use in people with type 1 diabetes and is not recommended for use in people with severe stomach or intestinal problems. It is not known if TRULICITY^® is safe and effective in children under 10 years of age.

• Trulicity^® is given through an injection (needle). You take it once a week by injecting it under the skin of your stomach, thigh, or upper arm.

Warnings: Trulicity^® may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, trouble swallowing, hoarseness, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.

• Do not use Trulicity^® if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).

• Do not use Trulicity^® if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

• Do not use Trulicity^® if you are allergic to dulaglutide or other ingredients in Trulicity^®.

Ask your healthcare provider how to recognize possible serious side effects and what to do :

Inflamed pancreas (pancreatitis). Stop using Trulicity^® and call your healthcare provider right away if you have severe pain in your stomach area (abdomen), with or without vomiting, that will not go away. You may feel the pain from your abdomen to your back.

Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use TRULICITY^® with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin.

Signs and symptoms of low blood sugar may include dizziness or light-headedness, confusion or drowsiness, headache, blurred vision, slurred speech, fast heartbeat, sweating, hunger, shakiness, feeling jittery, weakness, anxiety, irritability, or mood changes.

Serious allergic reactions. Stop using Trulicity^® and get medical help right away if you have any symptoms of a serious allergic reaction which may include swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting, or feeling dizzy, or very rapid heartbeat.

Acute kidney injury. In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration). This may cause kidney problems to get worse.

Severe stomach problems. Trulicity^® may cause stomach problems, which could be severe.

Changes in vision. Tell your healthcare provider if you have changes in your eyesight (vision) during treatment with Trulicity^®.

Gallbladder problems. Gallbladder problems have happened in some people who take Trulicity^®. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), clay-colored stools.

Common side effects

The most common side effects of Trulicity^® include nausea, diarrhea, vomiting, abdominal pain and decreased appetite, indigestion, and fatigue.

These are not all the possible side effects of Trulicity^®.

Tell your healthcare provider if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before using

• Your healthcare provider should show you how to use Trulicity^® before you use it for the first time.

• Before you use Trulicity^®, talk to your healthcare provider about low blood sugar and how to manage it.

Review these questions with your healthcare provider:

• Do you have other medical conditions, including problems with your pancreas, kidneys, liver, or stomach, or have a history of diabetic retinopathy (vision problems related to diabetes)?

• Do you take other diabetes medicines, such as insulin or sulfonylureas?

• Are you pregnant or plan to become pregnant or breastfeeding or plan to breastfeed?

• Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements?

How to take

• Read the Instructions for Use that come with Trulicity^®.

• Use Trulicity^® exactly as your healthcare provider says.

• Do not share your Trulicity^® pen, syringe, or needles with another person.

• Do not give Trulicity^® to other people.

• If you take too much Trulicity^®, call your healthcare provider or seek medical advice promptly.

Trulicity^® is a prescription medicine. For more information, call 1-844-TRU-INFO (1-844-878-4636) or go to www.TRULICITY^®.com.

This summary provides basic information about Trulicity^® but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Trulicity^® and how to take it. Your healthcare provider is the best person to help you decide if Trulicity^® is right for you.

 

Zepbound^®

Warnings:  Zepbound may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.

• Do not use Zepbound if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).

• Do not use Zepbound Do not use Zepbound if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

• Do not use Zepbound if you have had a serious allergic reaction to tirzepatide or any of the ingredients in Zepbound.

Zepbound may cause serious side effects, including:

Severe stomach problems.  Stomach problems, sometimes severe, have been reported in people who use Zepbound. Tell your healthcare provider if you have stomach problems that are severe or will not go away.

Kidney problems (kidney failure). Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration.

Gallbladder problems.  Gallbladder problems have happened in some people who use Zepbound. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools.

Inflammation of the pancreas (pancreatitis).  Stop using Zepbound and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.

Serious allergic reactions.  Stop using Zepbound and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat.

Low blood sugar (hypoglycemia).  Your risk for getting low blood sugar may be higher if you use Zepbound with medicines that can cause low blood sugar, such as a sulfonylurea or insulin.

Signs and symptoms of low blood sugar may include  dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness or feeling jittery.

Changes in vision in patients with type 2 diabetes.  Tell your healthcare provider if you have changes in vision during treatment with Zepbound.

Depression or thoughts of suicide.  You should pay attention to changes in your mood, behaviors, feelings or thoughts. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you.

Common side effects

The most common side effects of Zepbound include nausea, diarrhea, vomiting, constipation, stomach (abdominal) pain, indigestion, injection site reactions, feeling tired, allergic reactions, belching, hair loss, and heartburn. These are not all the possible side effects of Zepbound. Talk to your healthcare provider about any side effect that bothers you or doesn’t go away.

Tell your healthcare provider if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before using Zepbound

• Your healthcare provider should show you how to use Zepbound before you use it for the first time.

• Tell your healthcare provider if you are taking medicines to treat diabetes including insulin or sulfonylureas which could increase your risk of low blood sugar. Talk to your healthcare provider about low blood sugar levels and how to manage them.

• If you take birth control pills by mouth, talk to your healthcare provider before you use Zepbound. Birth control pills may not work as well while using Zepbound.  Your healthcare provider may recommend another type of birth control for 4 weeks after you start Zepbound and for 4 weeks after each increase in your dose of Zepbound.

Review these questions with your healthcare provider:

• Do you have other medical conditions, including problems with your pancreas or kidneys, or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food?

• Do you take other diabetes medicines, such as insulin or sulfonylureas?

• Do you have a history of diabetic retinopathy?

• Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements?

• Are you pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed? Zepbound may harm your unborn baby. Tell your healthcare provider if you become pregnant while using Zepbound. It is not known if Zepbound passes into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using Zepbound.

How to take

• Read the Instructions for Use that come with Zepbound.

• Use Zepbound exactly as your healthcare provider says.

• Zepbound is injected under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm.

• Use Zepbound 1 time each week, at any time of the day.

• Change (rotate) your injection site with each weekly injection. Do not use the same site for each injection.

• If you take too much Zepbound, call your healthcare provider, seek medical advice promptly, or contact a Poison Center expert right away at 1-800-222-1222.

Learn more

Zepbound is a prescription medicine. For more information, call 1-800-LillyRx (1-800-545-5979) or go to  www.zepbound.lilly.com.

 

Mounjaro^®

Warnings: Mounjaro® may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.

• Do not use Mounjaro if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).

• Do not use Mounjaro if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

• Do not use Mounjaro if you are allergic to it or any of the ingredients in Mounjaro.

Mounjaro may cause serious side effects, including:

Inflammation of the pancreas (pancreatitis). Stop using Mounjaro and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.

Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Mounjaro with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may includedizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, or mood changes, hunger, weakness and feeling jittery.

Serious allergic reactions. Stop using Mounjaro and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, and very rapid heartbeat.

Kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration.

Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Mounjaro. Tell your healthcare provider if you have stomach problems that are severe or will not go away.

Changes in vision. Tell your healthcare provider if you have changes in vision during treatment with Mounjaro.

Gallbladder problems. Gallbladder problems have happened in some people who use Mounjaro. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), and clay-colored stools.

Common side effects
The most common side effects of Mounjaro include nausea, diarrhea, decreased appetite, vomiting, constipation, indigestion, and stomach (abdominal) pain. These are not all the possible side effects of Mounjaro. Talk to your healthcare provider about any side effect that bothers you or doesn’t go away.

Tell your healthcare provider if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before using Mounjaro

• Your healthcare provider should show you how to use Mounjaro before you use it for the first time.

• Talk to your healthcare provider about low blood sugar and how to manage it.

• If you take birth control pills by mouth, talk to your healthcare provider before you use Mounjaro. Birth control pills may not work as well while using Mounjaro. Your healthcare provider may recommend another type of birth control for 4 weeks after you start Mounjaro and for 4 weeks after each increase in your dose of Mounjaro.

Review these questions with your healthcare provider:

• Do you have other medical conditions, including problems with your pancreas or kidneys, or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food?

• Do you take other diabetes medicines, such as insulin or sulfonylureas?

• Do you have a history of diabetic retinopathy?

• Are you pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed? It is not known if Mounjaro will harm your unborn baby or pass into your breast milk.

• Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements?

How to take

• Read the Instructions for Use that come with Mounjaro.

• Use Mounjaro exactly as your healthcare provider says.

• Mounjaro is injected under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm.

• Use Mounjaro 1 time each week, at any time of the day.

• Do not mix insulin and Mounjaro together in the same injection.

• You may give an injection of Mounjaro and insulin in the same body area (such as your stomach area), but not right next to each other.

• Change (rotate) your injection site with each weekly injection. Do not use the same site for each injection.

• If you take too much Mounjaro, call your healthcare provider or seek medical advice promptly.

Learn more
Mounjaro is a prescription medicine. For more information, call 1-833-807-MJRO (833-807-6576) or go to www.mounjaro.com.

 

Semaglutide

Important Safety Information

What is the most important information I should know about Semaglutide?

Semaglutide may cause serious side effects, including:

• Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, Semaglutide and medicines that work like Semaglutide caused thyroid tumors, including thyroid cancer. It is not known if Semaglutide will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people

• Do not use Semaglutide if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

Do not use Semaglutide if:

• you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

• you have had a serious allergic reaction to semaglutide or any of the ingredients in Semaglutide

Before using Semaglutide, tell your healthcare provider if you have any other medical conditions, including if you:

• have or have had problems with your pancreas or kidneys

• have type 2 diabetes and a history of diabetic retinopathy

• have or have had depression, suicidal thoughts, or mental health issues

• are pregnant or plan to become pregnant. Semaglutide may harm your unborn baby. You should stop using Semaglutide 2 months before you plan to become pregnant

• are breastfeeding or plan to breastfeed. It is not known if Semaglutide passes into your breast milk

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Semaglutide may affect the way some medicines work and some medicines may affect the way Semaglutide works. Tell your healthcare provider if you are taking other medicines to treat diabetes, including sulfonylureas or insulin. Semaglutide slows stomach emptying and can affect medicines that need to pass through the stomach quickly.

What are the possible side effects of Semaglutide?

Semaglutide may cause serious side effects, including:

• inflammation of your pancreas (pancreatitis). Stop using Semaglutide and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back

• gallbladder problems. Semaglutide may cause gallbladder problems, including gallstones. Some gallstones may need surgery. Call your healthcare provider if you have symptoms, such as pain in your upper stomach (abdomen), fever, yellowing of the skin or eyes (jaundice), or clay-colored stools

• increased risk of low blood sugar (hypoglycemia) in patients with type 2 diabetes, especially those who also take medicines for type 2 diabetes such as sulfonylureas or insulin. This can be both a serious and common side effect. Talk to your healthcare provider about how to recognize and treat low blood sugar and check your blood sugar before you start and while you take Semaglutide. Signs and symptoms of low blood sugar may include dizziness or light-headedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, or feeling jittery

• kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration

• serious allergic reactions. Stop using Semaglutide and get medical help right away, if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat

• change in vision in people with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Semaglutide

• increased heart rate. Semaglutide can increase your heart rate while you are at rest. Tell your healthcare provider if you feel your heart racing or pounding in your chest and it lasts for several minutes

• depression or thoughts of suicide. You should pay attention to any mental changes, especially sudden changes in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you

The most common side effects of Semaglutide may include: nausea, diarrhea, vomiting, constipation, stomach (abdomen) pain, headache, tiredness (fatigue), upset stomach, dizziness, feeling bloated, belching, gas, stomach flu, heartburn, and runny nose or sore throat.

Semaglutide is a prescription medication.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

 

Tirzepatide

What is the most important information I should know about Tirzepatide? Tirzepatide may cause serious side effects, including:

Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rats, Tirzepatide and medicines that work like Tirzepatide caused thyroid tumors, including thyroid cancer. It is not known if Tirzepatide will cause thyroid tumors, or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people. Do not use Tirzepatide if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC), or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Tirzepatide may cause serious side effects, including:

Inflammation of the pancreas (pancreatitis). Stop using Tirzepatide and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.

Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Tirzepatide with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, or mood changes, hunger, weakness and feeling jittery.

Serious allergic reactions. Stop using Tirzepatide and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, and very rapid heartbeat.

Kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration.

Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Tirzepatide. Tell your healthcare provider if you have stomach problems that are severe or will not go away.

Changes in vision. Tell your healthcare provider if you have changes in vision during treatment with Tirzepatide.

Gallbladder problems. Gallbladder problems have happened in some people who use Tirzepatide. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), and clay-colored stools.

Common side effects
The most common side effects of Tirzepatide include nausea, diarrhea, decreased appetite, vomiting, constipation, indigestion, and stomach (abdominal) pain. These are not all the possible side effects of Tirzepatide. Talk to your healthcare provider about any side effect that bothers you or doesn’t go away.

Tell your healthcare provider if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

This summary provides basic information about Tirzepatide but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Tirzepatide and how to take it. Your healthcare provider is the best person to help you decide if Tirzepatide is right for you.

 

Orlistat

Important Safety Information

Orlistat is contraindicated in patients:

• who are pregnant. Weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. A minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese, due to the obligatory weight gain that occurs in maternal tissues during pregnancy

• with chronic malabsorption syndrome

• with cholestasis

• with known hypersensitivity to Orlistat or to any component of this product

Warnings and Precautions:

• Orlistat may interact with concomitant drugs including cyclosporine, levothyroxine, warfarin, amiodarone, antiepileptic drugs, and antiretroviral drugs

• Orlistat can decrease cyclosporine exposure. Orlistat and cyclosporine should not be simultaneously co-administered

• Patients should be strongly encouraged to take a multivitamin supplement that contains fat-soluble vitamins to ensure adequate nutrition because Orlistat has been shown to reduce the absorption of some fat-soluble vitamins and beta-carotene

• Rare cases of severe liver injury with hepatocellular necrosis or acute hepatic failure have been reported, with some of these cases resulting in liver transplant or death

• Patients may develop increased levels of urinary oxalate following treatment with Orlistat. Monitor renal function in patients at risk for renal insufficiency.

• Substantial weight loss can increase the risk of cholelithiasis

• Exclude organic causes of obesity (e.g., hypothyroidism) before prescribing Orlistat

• Patients should be advised to adhere to dietary guidelines. Gastrointestinal events may increase when Orlistat is taken with a diet high in fat (>30% total daily calories from fat)

It is not known if Orlistat is present in human milk. Caution should be exercised when Orlistat is administered to a nursing woman.

The most commonly observed adverse events (incidence of ≥5% and twice that of placebo) were oily spotting, flatus with discharge, fecal urgency, fatty/oily stool, oily evacuation, increased defecation and fecal incontinence. In general, the first occurrence of these events was within 3 months of starting therapy.

Overall, approximately 50% of all episodes of GI adverse events associated with Orlistat treatment lasted for less than 1 week, and a majority lasted for no more than 4 weeks. However, GI adverse events may occur in some individuals over a period of 6 months or longer.

Report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.

 

Contrave

Important Safety Information

CONTRAVE can cause serious side effects including:

Suicidal thoughts or actions: One of the ingredients in CONTRAVE is bupropion. Bupropion has caused some people to have suicidal thoughts or actions or unusual changes in behavior, whether or not they are taking medicines used to treat depression. Bupropion may increase the risk of suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. If you already have depression or other mental illnesses, taking bupropion may cause it to get worse, especially within the first few months of treatment.

While taking CONTRAVE, you or your family members should pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when you start taking CONTRAVE or when your dose changes.

Stop taking CONTRAVE and call a healthcare provider right away if you or your family members notice any of the following symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying; attempts to commit suicide; depression; anxiety; feeling agitated or restless; panic attacks; irritability; aggression, anger, or violence; acting on dangerous impulses; an extreme increase in activity and talking; other unusual changes in behavior or mood; trouble sleeping.

CONTRAVE is not approved for use in children under the age of 18.

Do not take CONTRAVE if you have uncontrolled high blood pressure; have or have had seizures; use other medicines that contain bupropion such as WELLBUTRIN, WELLBUTRIN SR, WELLBUTRIN XL, APLENZIN and ZYBAN; have or have had an eating disorder called anorexia or bulimia; are dependent on opioid pain medicines or use medicines to help stop taking opioids, or are in opiate withdrawal; drink a lot of alcohol and abruptly stop drinking, or use medicines called sedatives (these make you sleepy), benzodiazepines, or anti‐seizure medicines and stop using them all of a sudden; are taking or have taken medicines called monoamine oxidase inhibitors (MAOIs) in the past 14 days; or are allergic to any of the ingredients in CONTRAVE.

Tell your healthcare provider about all of your medical conditions including if you have: depression or other mental illnesses; attempted suicide; seizures; head injury; tumor or infection of brain or spine; low blood sugar or low sodium; liver or kidney problems; high blood pressure; heart attack, heart problems, or stroke; eating disorder; drinking a lot of alcohol; prescription medicine or street drug abuse; are 65 or older; diabetes; pregnant or planning to become pregnant; or breastfeeding. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

CONTRAVE may cause serious side effects, including:

• Seizures. There is a risk of having a seizure when you take CONTRAVE. The risk of seizure is higher in people who take higher doses of CONTRAVE, have certain medical conditions, or take CONTRAVE with certain other medicines. Do not take any other medicines while you are taking CONTRAVE unless your healthcare provider has said it is okay to take them. If you have a seizure while taking CONTRAVE, stop taking CONTRAVE and call your healthcare provider right away.

• Risk of opioid overdose. Do not take large amounts of opioids, including opioid-containing medicines, such as heroin or prescription pain pills, to try to overcome the opioid-blocking effects of naltrexone. This can lead to serious injury, coma, or death.
  Get emergency medical help right away if you take opioids and you:

• have trouble breathing

• become very drowsy with slowed breathing

• have slow, shallow breathing

• feel faint, very dizzy, confused, or have unusual symptoms

• Sudden opioid withdrawal. People who take CONTRAVE must not use any type of opioid including street drugs, prescription pain medicines, cough, cold, or diarrhea medicines that contain opioids, or opioid dependence treatments, for at least 7 to 10 days before starting CONTRAVE. Using opioids in the 7 to 10 days before you start taking CONTRAVE may cause you to suddenly have symptoms of opioid withdrawal when you take it. Sudden opioid withdrawal can be severe, and you may need to go to the hospital. Tell your healthcare provider you are taking CONTRAVE before a medical procedure or surgery.

• Severe allergic reactions. Stop taking CONTRAVE and call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the following signs and symptoms of an allergic reaction: rash, itching, hives, fever, swollen lymph glands, painful sores in your mouth or around your eyes, swelling of your lips or tongue, chest pain, or trouble breathing.

• Increases in blood pressure or heart rate. Some people may get high blood pressure or have a higher heart rate when taking CONTRAVE. Your healthcare provider should check your blood pressure and heart rate before you start taking, and while you take CONTRAVE.

• Liver damage or hepatitis. Stop taking CONTRAVE and tell your healthcare provider if you have any of the following symptoms of liver problems: stomach area pain lasting more than a few days, dark urine, yellowing of the whites of your eyes, or tiredness. Your healthcare provider may need to stop treating you with CONTRAVE if you get signs or symptoms of a serious liver problem.

• Manic episodes. Bupropion can cause some people who were manic or depressed in the past to become manic or depressed again.

• Visual problems (angle-closure glaucoma). Signs and symptoms may include: eye pain, changes in vision, swelling or redness in or around the eye. Talk with your healthcare provider to find out if you are at risk for angle-closure glaucoma and to get treatment to prevent it if you are at risk.

• Increased risk of low blood sugar in people with type 2 diabetes mellitus who also take medicines to treat their diabetes (such as insulin or sulfonylureas). You should check your blood sugar before you start taking CONTRAVE and while you take CONTRAVE.

The most common side effects of CONTRAVE include nausea, constipation, headache, vomiting, dizziness, trouble sleeping, dry mouth, and diarrhea. These are not all of the possible side effects of CONTRAVE.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

 

Metformin

Important Safety Information

Postmarketing cases of Metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of Metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms suchas malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (> 5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and Metformin plasma levels generally > 5 mcg/mL .

Risk factors for Metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g. carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment.

Steps to reduce the risk of and manage Metformin-associated lactic acidosis in these high risk groups are provided.

If Metformin-associated lactic acidosis is suspected, immediately discontinue Metformin hydrochloride tablets and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended .

Contraindications
Metformin hydrochloride tablets are contraindicated in patients with:

Severe renal impairment (eGFR below 30 mL/min/1.73 m 2)
Hypersensitivity to Metformin.
Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Table of Contents

1. Valacyclovir

 

Valacyclovir

What are valacyclovir tablets?

• Valacyclovir tablets are a prescription antiviral medicine. Valacyclovir tablets lower the ability of herpes viruses to multiply in your body.

Valacyclovir tablets are used in adults:

• to treat cold sores (also called fever blisters or herpes labialis)
• to treat shingles (also called herpes zoster)
• to treat or control genital herpes outbreaks in adults with normal immune systems
• to control genital herpes outbreaks in adults infected with the human immunodeficiency virus (HIV) with CD4 + cell count greater than 100 cells/mm3
• with safer sex practices to lower the chances of spreading genital herpes to uninfected partners. Even with safer sex practices, it is still possible to spread genital herpes. Valacyclovir tablets used daily with the following safer sex practices can lower the chances of passing genital herpes to your partner.
• Do not have sexual contact with your partner when you have any symptom or outbreak of genital herpes.
• Use a condom made of latex or polyurethane whenever you have sexual contact.

What are cold sores, chickenpox, shingles and genital herpes?

• Cold sores are caused by a herpes virus that may be spread by kissing or other physical contact with the infected area of the skin. They are small, painful ulcers that you get in or around your mouth. It is not known if valacyclovir tablets can stop the spread of cold sores to others.

Chickenpox is caused by a herpes virus called Varicella Zoster Virus (VZV). It causes an itchy rash of multiple small, red bumps that look like pimples or insect bites usually appearing first on the abdomen or back and face. It can spread to almost everywhere else on the body and may be accompanied by flu-like symptoms.

Shingles is caused by the same herpes virus that causes chickenpox. It causes small, painful blisters to appear on your skin. Shingles occurs in people who have already had chickenpox. Shingles can be spread to people who have not had chickenpox or the chickenpox vaccine by contact with the infected areas of the skin. It is not known if valacyclovir tablets can stop the spread of shingles to others.

Genital herpes is a sexually transmitted disease. It causes small, painful blisters on your genital area. You can spread genital herpes to others, even when you have no symptoms. If you are sexually active, you can still pass herpes to your partner, even if you are taking valacyclovir tablets. Valacyclovir tablets, taken every day as prescribed and used with the following safer sex practices, can lower the chances of passing genital herpes to your partner.

Do not have sexual contact with your partner when you have any symptom or outbreak of genital herpes.

Use a condom made of latex or polyurethane whenever you have sexual contact. Ask your healthcare provider for more information about safer sex practices.

Who should not take valacyclovir tablets?

• Do not take valacyclovir tablets if you are allergic to any of its ingredients or to acyclovir. The active ingredient is valacyclovir.

Before taking valacyclovir tablets, tell your healthcare provider about all your medical conditions, including:

• if you have had a bone marrow transplant or kidney transplant, or if you have advanced HIV disease or “AIDS”. Patients with these conditions may have a higher chance for getting a blood disorder called thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS). TTP/HUS can result in death.
• if you have kidney problems. Patients with kidney problems may have a higher chance of side effects or more kidney problems with valacyclovir tablets. Your healthcare provider may give you a lower dose of valacyclovir tablets.
• if you are 65 years of age or older. Elderly patients have a higher chance of certain side effects. Also, elderly patients are more likely to have kidney problems. Your healthcare provider may give you a lower dose of valacyclovir tablets.
• if you are pregnant or planning to become pregnant. Talk with your healthcare provider about the risks and benefits of taking prescription drugs (including valacyclovir tablets) during pregnancy.
• if you are breast-feeding. Valacyclovir tablets may pass into your milk and it may harm your baby. Talk with your healthcare provider about the best way to feed your baby if you are taking valacyclovir tablets.
• about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Valacyclovir tablets may affect other medicines, and other medicines may affect valacyclovir tablets. It is a good idea to keep a complete list of all the medicines you take. Show this list to your healthcare provider and pharmacist any time you get a new medicine.
• Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.

How should I take valacyclovir tablets?

• Take valacyclovir tablets exactly as prescribed by your healthcare provider. Your dose of valacyclovir tablets and length of treatment will depend on the type of herpes infection that you have and any other medical problems that you have.
• Do not stop valacyclovir tablets or change your treatment without talking to your healthcare provider.
• Valacyclovir tablets can be taken with or without food.If you are taking valacyclovir tablets to treat cold sores, chickenpox, shingles or genital herpes, you should start treatment as soon as possible after your symptoms start. Valacyclovir tablets may not help you if you start treatment too late.
• If you miss a dose of valacyclovir tablets, take it as soon as you remember and then take your next dose at its regular time. However, if it is almost time for your next dose, do not take the missed dose. Wait and take the next dose at the regular time.
• Do not take more than the prescribed number of valacyclovir tablets each day. Call your healthcare provider right away if you take too much valacyclovir tablets.
• What are the possible side effects of valacyclovir tablets?
• Kidney failure and nervous system problems are not common, but can be serious in some patients taking valacyclovir tablets. Nervous system problems include aggressive behavior, unsteady movement, shaky movements, confusion, speech problems, hallucinations (seeing or hearing things that are really not there), seizures and coma.

Kidney failure and nervous system problems have happened in patients who already have kidney disease and in elderly patients whose kidneys do not work well due to age. Always tell your healthcare provider if you have kidney problems before taking valacyclovir tablets.

Call your doctor right away if you get a nervous system problem while you are taking valacyclovir tablets.

Common side effects of valacyclovir tablets in adults include headache, nausea, stomach pain, vomiting and dizziness. Side effects in HIV-infected adults include headache, tiredness and rash. These side effects usually are mild and do not cause patients to stop taking valacyclovir tablets.

Other less common side effects in adults include painful periods in women, joint pain, depression, low blood cell counts and changes in tests that measure how well the liver and kidneys work. The most common side effect seen in children < 18 years of age was headache.

Talk to your healthcare provider if you develop any side effects that concern you. These are not all the side effects of valacyclovir tablets. For more information ask your healthcare provider or pharmacist.

Keep valacyclovir tablets and all medicines out of the reach of children. General information about valacyclovir tablets Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use valacyclovir tablets for a condition for which it was not prescribed. Do not give valacyclovir tablets to other people, even if they have the same symptoms you have. It may harm them.

If you are experiencing a medical emergency, call 911 or seek immediate medical attention.

You are encouraged to report negative side effects of prescription products to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see the full Prescribing Information for complete safety information.

https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020487s014lbl.pdf

Table of Contents

1. Sertraline

 

Sertraline

Disclaimer: Sertraline and other antidepressant medicines may cause serious side effects. Call your healthcare provider right away if you have any of the following symptoms, or call 911 if there is an emergency.

Suicidal thoughts or actions:

• Sertraline and other antidepressant medicines may increase suicidal thoughts or actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed.
• Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.
• Watch for these changes and call your healthcare provider right away if you notice new or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.
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• Pay particular attention to such changes when sertraline is started or when the dose is changed.
• Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.

Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you:

• attempts to commit suicide
• acting aggressive or violent
• new or worse depression
• feeling agitated, restless, angry or irritable
• an increase in activity or talking more than what is normal for you
• acting on dangerous impulses
• thoughts about suicide or dying
• new or worse anxiety or panic attacks
• trouble sleeping
• other unusual changes in behavior or mood

Serotonin Syndrome

This condition can be life-threatening and symptoms may include:

• agitation, hallucinations, coma, or other changes in mental status
• coordination problems or muscle twitching (overactive reflexes)
• racing heartbeat, high or low blood pressure
• nausea, vomiting, or diarrhea
• sweating or fever
• muscle rigidity

Increased chance of bleeding

Sertraline and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin®, Jantoven®), a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin.

Manic episodes

Symptoms may include:

• greatly increased energy
• racing thoughts
• unusually grand ideas
• severe trouble sleeping
• reckless behavior
• excessive happiness or irritability
• talking more or faster than usual

Seizures or Convulsions

Glaucoma (angle-closure glaucoma)

Many antidepressant medicines including sertraline may cause a certain type of eye problem called angle-closure glaucoma. Call your healthcare provider if you have eye pain, changes in your vision, or swelling or redness in or around the eye. Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.

Changes in appetite or weight

Children and adolescents should have height and weight monitored during treatment.

Low salt (sodium) levels in the blood

Elderly people may be at greater risk for this. Symptoms may include:

• Headache
• weakness or feeling unsteady
• confusion, problems concentrating or thinking, or memory problems

Do not stop sertraline without first talking to your healthcare provider. Stopping sertraline too quickly may cause serious symptoms including:

• anxiety, irritability, high or low mood, feeling restless or changes in sleep habits
• headache, sweating, nausea, dizziness
• electric shock-like sensations, shaking, confusion

What is sertraline (ZOLOFT)?

Sertraline is a prescription medicine used to treat:

• Major Depressive Disorder (MDD)
• Panic Disorder
• Social Anxiety Disorder
• Obsessive Compulsive Disorder (OCD)
• Posttraumatic Stress Disorder (PTSD)
• Premenstrual Dysphoric Disorder (PMDD)

It is important to talk with your healthcare provider about the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider.

Sertraline is safe and effective in treating children with OCD age 6 to 17 years.

It is not known if sertraline is safe and effective for use in children under 6 years of age with OCD or children with other behavior health conditions.

Talk to your healthcare provider if you do not think that your condition is getting better with sertraline treatment.

Who should not take sertraline (ZOLOFT)?

Do not take sertraline if you:

• take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
• have taken an MAOI within 2 weeks of stopping sertraline unless directed to do so by your healthcare provider.
• have stopped taking an MAOI in the last 2 weeks unless directed to do so by your healthcare provider.
• take any other medicines that contain sertraline (such as sertraline HCl or sertraline hydrochloride).
• take the antipsychotic medicine pimozide (Orap®) because this can cause serious heart problems.
• are allergic to sertraline or any of the ingredients in sertraline. See the end of this Medication Guide for a complete list of ingredients in sertraline.
• take Antabuse® (disulfiram) (if you are taking the liquid form of sertraline) due to the alcohol content.

People who take sertraline close in time to an MAOI may have serious or even life-threatening side effects. Get medical help right away if you have any of these symptoms:

• high fever
• rapid changes in heart rate or blood pressure
• uncontrolled muscle spasms
• confusion
• stiff muscles
• loss of consciousness (pass out)

What should I tell my healthcare provider before taking sertraline (ZOLOFT)?

Before starting sertraline, tell your healthcare provider if you have:

• liver problems
• heart problems
• bipolar disorder or mania
• kidney problems
• or have had seizures or convulsions
• a history of a stroke
• high blood pressure
• or have had bleeding problems

Are pregnant or plan to become pregnant. Your baby may have withdrawal symptoms after birth or may be at increased risk for a serious lung problem at birth. Talk to your healthcare provider about the benefits and risks of taking sertraline during pregnancy.

Are breastfeeding or plan to breastfeed. A small amount of sertraline may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking sertraline.

Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Sertraline and some medicines may interact with each other, may not work as well, or may cause serious side effects

Your healthcare provider or pharmacist can tell you if it is safe to take sertraline with your other medicines. Do not start or stop any medicine while taking sertraline without talking to your healthcare provider first.

Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.

How should I take sertraline (ZOLOFT)?

• Take sertraline exactly as prescribed. Your healthcare provider may need to change the dose of sertraline until it is the right dose for you.
• Sertraline Tablets may be taken with or without food.
• Sertraline Oral Solution may look cloudy or hazy after mixing, this is normal.
• Sertraline Oral Solution must be diluted before use
• Do not mix sertraline until you are ready to take it.
• When diluting sertraline Oral Solution, use only water, ginger ale, lemon/lime soda, lemonade, or orange juice.
• The oral dropper contains latex. If you are sensitive or allergic to latex, ask your healthcare provider or pharmacist about the best way to measure your medicine.
• If you miss a dose of sertraline, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of sertraline at the same time

If you take too much sertraline, call your healthcare provider or poison control center right away, or go to the nearest hospital emergency room right away.

What should I avoid while taking sertraline (ZOLOFT)?

Sertraline can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how sertraline affects you. Do not drink alcohol while you take sertraline.

What are the possible side effects of sertraline (ZOLOFT)?

The most common side effects in adults who take sertraline include:

• nausea, loss of appetite,
• diarrhea, or indigestion
• increased sweating
• tremor or shaking
• agitation
• change in sleep habits including increased sleepiness or insomnia
• sexual problems including decreased libido and ejaculation failure
• feeling tired or fatigued
• anxiety

The most common side effects in children and adolescents who take sertraline include abnormal increase in muscle movement or agitation, nose bleeds, urinary incontinence, aggressive reaction, possible slowed growth rate, and weight change. Your child’s height and weight should be monitored during treatment with sertraline.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of sertraline. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

How should I store sertraline?

• Store sertraline at room temperature, 68°F to 77°F (20°C to 25°C).
• Keep sertraline bottle closed tightly.

Keep sertraline and all medicines out of the reach of children.

General information about the safe and effective use of sertraline:

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use sertraline for a condition for which it was not prescribed. Do not give sertraline to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about sertraline. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about sertraline that is written for healthcare professionals.

For more information about sertraline call 1-800-438-1985 or go to www.pfizer.com

What are the ingredients in sertraline?

Active ingredient: sertraline hydrochloride

Inactive ingredients: Tablets: dibasic calcium phosphate dihydrate, D&C Yellow #10 aluminum lake (in 25 mg tablet), FD&C Blue #1 aluminum lake (in 25 mg tablet), FD&C Red #40 aluminum lake (in 25 mg tablet), FD&C Blue #2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, synthetic yellow iron oxide (in 100 mg tablet), and titanium dioxide.

Oral solution: glycerin, alcohol (12%), menthol, butylated hydroxytoluene (BHT)

Popular Questions

Can I use sertraline with alcohol?

• The PDR states that it is not recommended to drink alcohol while taking sertraline although there is no known interaction between sertraline and alcohol.
• There is no major drug interaction between sertraline and alcohol. However, the manufacturer of Zoloft (brand name for sertraline) recommends against using sertraline with alcohol.

How is sertraline used to treat PE?

• Sertraline can be used in two ways to treat P.E. It can be taken daily at a convenient time (e.g. after brushing your teeth in the morning) or it can be taken 4-8 hours before you plan to have sex. Daily use is generally more effective. However, some people may prefer to take a pill only when they plan to have sex instead of daily. For example: people who have sex once or twice a month may not want to take a pill daily. Some people also may just not like the idea of having to take medicine every day.

Is sertraline affected by food?

• Sertraline can be taken with or without food. Grapefruit juice may increase sertraline levels in the blood by inhibiting the breakdown of sertraline.

Can I get a sertraline prescription online?

• Yes, you can get a prescription through a quick and easy online visit, if determined appropriate by a network of U.S. licensed physicians.

Table of Contents

1. Testosterone Cypionate Injection
2. Testosterone Gel 1.62% CIII
3. CLOMID® (clomiphene citrate)
4. Sermorelin

 

Testosterone Cypionate Injection

INDICATIONS AND USAGE

Testosterone Cypionate Injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone.

1. Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy.

2. Hypogonadotropic hypogonadism (congenital or acquired) - gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.

Safety and efficacy of Testosterone Cypionate Injection in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established.

CONTRAINDICATIONS

1. Known hypersensitivity to the drug

2. Males with carcinoma of the breast

3. Males with known or suspected carcinoma of the prostate gland

4. Women who are pregnant.

5. Patients with serious cardiac, hepatic or renal disease.

WARNINGS

Hypercalcemia may occur in immobilized patients. If this occurs, the drug should be discontinued.

Prolonged use of high doses of androgens (principally the 17-α alkyl-androgens) has been associated with development of hepatic adenomas, hepatocellular carcinoma, and peliosis hepatis —all potentially life-threatening complications.

Geriatric patients treated with androgens may be at an increased risk of developing prostatic hypertrophy and prostatic carcinoma although conclusive evidence to support this concept is lacking.

There have been postmarketing reports of venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone products, such as testosterone cypionate. Evaluate patients who report symptoms of pain, edema, warmth and erythema in the lower extremity for DVT and those who present with acute shortness of breath for PE. If a venous thromboembolic event is suspected, discontinue treatment with testosterone cypionate and initiate appropriate workup and management.

Long term clinical safety trials have not been conducted to assess the cardiovascular outcomes of testosterone replacement therapy in men. To date, epidemiologic studies and randomized controlled trials have been inconclusive for determining the risk of major adverse cardiovascular events (MACE), such as non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death, with the use of testosterone compared to non-use. Some studies, but not all, have reported an increased risk of MACE in association with use of testosterone replacement therapy in men. Patients should be informed of this possible risk when deciding whether to use or to continue to use Testosterone Cypionate Injection.

Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions.

If testosterone abuse is suspected, check serum testosterone concentrations to ensure they are within therapeutic range. However, testosterone levels may be in the normal or subnormal range in men abusing synthetic testosterone derivatives. Counsel patients concerning the serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids. Conversely, consider the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events.

Edema, with or without congestive heart failure, may be a serious complication in patients with pre-existing cardiac, renal or hepatic disease.

Gynecomastia may develop and occasionally persists in patients being treated for hypogonadism.

The preservative benzyl alcohol has been associated with serious adverse events, including the "gasping syndrome", and death in pediatric patients. Although normal therapeutic doses of this product ordinarily deliver amounts of benzyl alcohol that are substantially lower than those reported in association with the "gasping syndrome", the minimum amount of benzyl alcohol at which toxicity may occur is not known. The risk of benzyl alcohol toxicity depends on the quantity administered and the liver and kidneys' capacity to detoxify the chemical. Premature and low-birth weight infants may be more likely to develop toxicity.

Androgen therapy should be used cautiously in healthy males with delayed puberty. The effect on bone maturation should be monitored by assessing bone age of the wrist and hand every 6 months. In children, androgen treatment may accelerate bone maturation without producing compensatory gain in linear growth. This adverse effect may result in compromised adult stature. The younger the child the greater the risk of compromising final mature height.

This drug has not been shown to be safe and effective for the enhancement of athletic performance. Because of the potential risk of serious adverse health effects, this drug should not be used for such purpose.

PRECAUTIONS

General

Patients with benign prostatic hypertrophy may develop acute urethral obstruction. Priapism or excessive sexual stimulation may develop. Oligospermia may occur after prolonged administration or excessive dosage. If any of these effects appear, the androgen should be stopped and if restarted, a lower dosage should be utilized.

Testosterone cypionate should not be used interchangeably with testosterone propionate because of differences in duration of action.

Testosterone cypionate is not for intravenous use.

Information for patients

Patients should be instructed to report any of the following: nausea, vomiting, changes in skin color, ankle swelling, too frequent or persistent erections of the penis.

Laboratory tests

Hemoglobin and hematocrit levels (to detect polycythemia) should be checked periodically in patients receiving long-term androgen administration.

Serum cholesterol may increase during androgen therapy.

Drug interactions

Androgens may increase sensitivity to oral anticoagulants. Dosage of the anticoagulant may require reduction in order to maintain satisfactory therapeutic hypoprothrombinemia.

Concurrent administration of oxyphenbutazone and androgens may result in elevated serum levels of oxyphenbutazone.

In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, insulin requirements.

Drug/Laboratory test Interferences

Androgens may decrease levels of thyroxine-binding globulin, resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.

Carcinogenesis

Animal data

Testosterone has been tested by subcutaneous injection and implantation in mice and rats. The implant induced cervical-uterine tumors in mice, which metastasized in some cases. There is suggestive evidence that injection of testosterone into some strains of female mice increases their susceptibility to hepatoma. Testosterone is also known to increase the number of tumors and decrease the degree of differentiation of chemically induced carcinomas of the liver in rats.

Human data

There are rare reports of hepatocellular carcinoma in patients receiving long-term therapy with androgens in high doses. Withdrawal of the drugs did not lead to regression of the tumors in all cases.

Geriatric patients treated with androgens may be at an increased risk of developing prostatic hypertrophy and prostatic carcinoma although conclusive evidence to support this concept is lacking.

ADVERSE REACTIONS

The following adverse reactions in the male have occurred with some androgens:

Endocrine and urogenital: Gynecomastia and excessive frequency and duration of penile erections. Oligospermia may occur at high dosages.

Skin and appendages: Hirsutism, male pattern of baldness, seborrhea, and acne.

Cardiovascular Disorders: myocardial infarction, stroke.

Fluid and electrolyte disturbances: Retention of sodium, chloride, water, potassium, calcium, and inorganic phosphates.

Gastrointestinal: Nausea, cholestatic jaundice, alterations in liver function tests, rarely hepatocellular neoplasms and peliosis hepatis.

Hematologic: Suppression of clotting factors II, V, VII, and X, bleeding in patients on concomitant anticoagulant therapy, and polycythemia.

Nervous system: Increased or decreased libido, headache, anxiety, depression, and generalized paresthesia.

Allergic: Hypersensitivity, including skin manifestations and anaphylactoid reactions.

Vascular disorders: Venous thromboembolism.

Special senses: Rare cases of central serous chorioretinopathy (CSCR).

Miscellaneous: Inflammation and pain at the site of intramuscular injection.

DRUG ABUSE AND DEPENDENCE

Controlled Substance

Testosterone Cypionate Injection contains testosterone, a Schedule III controlled substance in the Controlled Substances Act.

Abuse

Drug abuse is intentional non-therapeutic use of a drug, even once, for its rewarding psychological and physiological effects. Abuse and misuse of testosterone are seen in male and female adults and adolescents. Testosterone, often in combination with other anabolic androgenic steroids (AAS), and not obtained by prescription through a pharmacy, may be abused by athletes and bodybuilders. There have been reports of misuse by men taking higher doses of legally obtained testosterone than prescribed and continuing testosterone despite adverse events or against medical advice.

Abuse-Related Adverse Reactions

Serious adverse reactions have been reported in individuals who abuse anabolic androgenic steroids and include cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy, congestive heart failure, cerebrovascular accident, hepatotoxicity, and serious psychiatric manifestations, including major depression, mania, paranoia, psychosis, delusions, hallucinations, hostility and aggression.

The following adverse reactions have also been reported in men: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemias, testicular atrophy, subfertility, and infertility.

The following additional adverse reactions have been reported in women: hirsutism, virilization, deepening of voice, clitoral enlargement, breast atrophy, male-pattern baldness, and menstrual irregularities.

The following adverse reactions have been reported in male and female adolescents: premature closure of bony epiphyses with termination of growth, and precocious puberty.

Because these reactions are reported voluntarily from a population of uncertain size and may include abuse of other agents, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Dependence

Behaviors Associated with Addiction

Continued abuse of testosterone and other anabolic steroids, leading to addiction is characterized by the following behaviors:

Taking greater dosages than prescribed

Continued drug use despite medical and social problems due to drug use

• Spending significant time to obtain the drug when supplies of the drug are interrupted
• Giving a higher priority to drug use than other obligations
• Having difficulty in discontinuing the drug despite desires and attempts to do so
• Experiencing withdrawal symptoms upon abrupt discontinuation of use

Physical dependence is characterized by withdrawal symptoms after abrupt drug discontinuation or a significant dose reduction of a drug. Individuals taking supratherapeutic doses of testosterone may experience withdrawal symptoms lasting for weeks or months which include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido and hypogonadotropic hypogonadism.

Drug dependence in individuals using approved doses of testosterone for approved indications has not been documented.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088

 

Testosterone Gel 1.62% CIII

Testosterone Gel 1.62% is a controlled substance, available by prescription, used to treat adult males who have low or no testosterone due to certain medical conditions.

It is not known if Testosterone Gel 1.62% is safe or effective to treat men who have low testosterone due to aging.

It is not known if Testosterone Gel 1.62% is safe or effective in children younger than 18 years old.

Testosterone Gel 1.62% is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep it in a safe place to protect it and never give it to anyone else. Selling or giving away this medicine may harm others and is against the law.

Testosterone Gel 1.62% is not meant for use in women.

IMPORTANT SAFETY INFORMATION

• Testosterone Gel 1.62% can transfer from your body to others, including children and women. This can happen if other people come into contact with the area where the Testosterone Gel 1.62% was applied. Children and women should avoid contact with the unwashed or not covered (unclothed) areas where Testosterone Gel 1.62% has been applied to your skin.
• Early signs and symptoms of puberty have occurred in young children who have come in direct contact with testosterone by touching areas where men have used Testosterone Gel 1.62%.
• Signs and symptoms of early puberty in a child who has come in direct contact with Testosterone Gel 1.62% may include:
• Abnormal sexual changes:
• Enlarged penis or clitoris.
• Early growth of hair near the vagina or around the penis (pubic hair).
• Erections or acting out sexual urges (sex drive).
• Behavior problems, including acting aggressively or behaving in an angry or violent way.
• Signs and symptoms in a woman who has come in direct contact with Testosterone Gel 1.62% may include:
• Changes in body hair.
• An abnormal increase in pimples (acne).
• To lower the risk of transfer of Testosterone Gel 1.62% from your body to others, you should follow these important instructions:
• Apply Testosterone Gel 1.62% only to your shoulders and upper arms that will be covered by a short-sleeve t-shirt.
• Wash your hands right away with soap and water after applying Testosterone Gel 1.62%.
• After the gel has dried, cover the application area with clothing. Keep the area covered until you have washed the application area well or have showered.
• If you expect to have skin-to-skin contact with another person, first wash the application area well with soap and water.
• If a child or woman touches the area where you have applied Testosterone Gel 1.62%, that area on the child or woman should be washed well with soap and water right away.
• Stop using Testosterone Gel 1.62% and call your healthcare provider right away if you see any signs and symptoms of puberty in a child, or changes in body hair or increased acne in a woman, that may have happened through accidental touching of the area where you have applied Testosterone Gel 1.62%.
• Do not use Testosterone Gel 1.62% if you:
• Have breast cancer or have or might have prostate cancer.
• Are pregnant. Testosterone Gel 1.62% may harm your unborn baby. Women who are pregnant should avoid contact with the area of skin where Testosterone Gel 1.62% has been applied.
• Before using Testosterone Gel 1.62%, tell your healthcare provider about all of your medical conditions, including if you have breast cancer; prostate cancer; urinary problems due to enlarged prostate; heart, kidney, or liver problems; or problems breathing while you sleep (sleep apnea).
• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take insulin, medicines that decrease blood clotting (blood thinners), or corticosteroids.
• Testosterone Gel 1.62% can cause serious side effects, including:
• If you already have an enlargement of your prostate gland, your signs and symptoms can get worse while using Testosterone Gel 1.62% (including changes in urination).
• Possible increased risk of prostate cancer.
• Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include leg pain, swelling, or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.
• Possible increased risk of heart attack or stroke.
• In large doses, Testosterone Gel 1.62% may lower your sperm count.
• Swelling of your ankles, feet, or body, with or without heart failure. This may cause serious problems for people who have heart, kidney, or liver disease.
• Enlarged or painful breasts.
• Having problems breathing while you sleep (sleep apnea).
• The most common side effects of Testosterone Gel 1.62% include increased prostate specific antigen (a test used to screen for prostate cancer), mood swings, high blood pressure, increased red blood cell count, and skin irritation where the gel is applied.
• This is the most important information to know about Testosterone Gel 1.62%. For further information, talk with your healthcare provider.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088

For more information about Testosterone Gel 1.62% call 1-844-XIROMED (844-947-6633) or go to www.xiromed.com.

 

CLOMID® (clomiphene citrate)

Before starting CLOMID®, tell your doctor about all of your medical conditions, including if you:

- have a known hypersensitivity or allergy to clomiphene citrate or any of its ingredients

- have a history of liver problems

- have preexisting or family history of high cholesterol - have any organic intracranial lesion such as pituitary tumor.

Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Tell your doctor if you start a new medicine. CLOMID® may affect the way other medicines work, and other medicines may affect how CLOMID® works.

Common side effects of CLOMID® are abdominal or pelvic pain/distension, discomfort and bloating, headache, nausea, and vomiting. Blurred vision and other visual symptoms may also occur during or after taking CLOMID®, which may be prolonged or potentially irreversible. These are not all of the possible side effects of CLOMID®

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088

Please see Full Prescribing Information.

 

Sermorelin

Sermorelin is used as a growth hormone releasing hormone (GHRH). Sermorelin appears to be equivalent to endogenous GHRH in its ability to stimulate growth hormone secretion in humans.

Sermorelin is used to treat growth hormone deficiency.

What should I tell my healthcare provider before I take this medicine?

They need to know if you have any of the following conditions:

-Hypersensitivity to Sermorelin or any of the components of the injection

-Hypothyroidism

-Intracranial lesions

-Obesity

-Hyperglycemia

-Hyperlipidemia

How should I use this medicine?

This medicine may be given either orally or by subcutaneous (SC) injection, usually at bedtime.

Ask your doctor or health care professional which way is right for you. You will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

-Glucocorticoids

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What side effects may I notice from receiving this medicine?

The most common side effects with Sermorelin (SC) injection include local injection reactions (pain, swelling or redness), but discontinuation of therapy is rare. Other treatment-related adverse reactions include headache, flushing, dysphagia, dizziness, hyperactivity, somnolence and urticaria. Heart rate/blood pressure changes may occur with inadvertent overdosage.

Antibody formation to Sermorelin has been reported frequently after chronic Sermorelin (SC) administration of large doses. The clinical significance is unknown, but antibodies do not appear to affect growth or appear to be related to a specific ADR profile. No generalized allergic reactions have been reported. A temporary allergic reaction described as severe redness, swelling and urticaria at the injection sites has been reported in one patient who developed antibodies. Patients should seek medical attention for suspected allergic reactions.

This list may not describe all possible side effects.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep this medicine?

Store unopened lyophilized product in the refrigerator 36- 46°F (2 - 8°C). Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom.

Table of Contents

1. Ramelteon
2. Trazodone
3. Doxepin

 

Ramelteon

Call your doctor if your insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problem.

Be sure that you are able to devote 7 to 8 hours to sleep before being active again. Never take this medicine during your normal waking hours, unless you have at least 7 to 8 hours to dedicate to sleeping.

Ramelteon should be taken within 30 minutes of bedtime. Do not take with alcohol or with other medicines that can make you sleepy. You should not drive or operate machinery at night after taking Ramelteon. Until you know how you will react to Ramelteon, you should be careful in performing such activities during the day following taking Ramelteon. Before you take Ramelteon, tell your doctor if you have a history of depression, mental illness or suicidal thoughts. You should call your doctor right away if after taking Ramelteon you walk, drive, eat or engage in other activities while asleep. Drowsiness is the most common adverse event observed in clinical trials. For more information, please see the complete Prescribing Information, including the Medication Guide.

What should I tell my healthcare provider before taking Ramelteon?

Before you take Ramelteon, tell your healthcare provider if you:

• Have a history of depression, mental illness, or suicidal thoughts
• Have severe sleep apnea
• Have kidney or liver problems
• Have a history of drug or alcohol abuse or addiction
• Have a history of glaucoma or urinary retention
• Have any other medical conditions

Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements.

Ramelteon and other medicines may affect each other causing side effects. Ramelteon may affect the way other medicines work, and other medicines may affects how Ramelteon works. Especially tell your healthcare provider if you take: Luvox (fluvoxamine).

Who should not take Ramelteon?

You should not use Ramelteon if you are allergic to it, or if:

• You have severe liver disease; or
• You also take fluvoxamine.

Ask your doctor or pharmacist if you are not sure if your medicine is one that is listed above.

Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.

Do not use Ramelteon for a condition for which it was not prescribed. Do not share Ramelteon with other people, even if you think they have the same symptoms that you have. It may harm them.

INDICATIONS

Ramelteon is a sedative, also called a hypnotic. It works by affecting certain substances in your body that help regulate your "sleep-wake cycle."

Ramelteon is used to treat insomnia that is associated with having trouble falling asleep.

Dosing In Adults

The recommended dose of Ramelteon is 8 mg taken within 30 minutes of going to bed. It is recommended that Ramelteon not be taken with or immediately after a high-fat meal. The total Ramelteon dose should not exceed 8 mg per day.

Dosing In The Elderly

The recommended starting dose of Ramelteon in elderly patients (≥ 65 years old) is 8 mg once daily.

Administration

Ramelteon should be taken within 30 minutes of bedtime.

To minimize the potential for next day effects, Ramelteon should not be taken within 3 hours of a meal.

The total Ramelteon dose should not exceed 8 mg per day.

How should I take Ramelteon?

• Take Ramelteon exactly as your healthcare provider tells you to take it.
• Your healthcare provider will tell you how much Ramelteon to take and when to take them.
• Your healthcare provider may change your dose if needed.
• Take Ramelteon within 30 minutes of bedtime. After taking Ramelteon, you should confine your activities to those necessary to prepare for bed.
• Do not take Ramelteon within 3 hours of a meal. Ramelteon may not work as well, or may make you sleepy the next day if taken with or right after a meal.
• Do not take Ramelteon unless you are able to get a full night of sleep before you must be active again.

Call your healthcare provider if your sleep problems get worse or do not get better within 7 to 10 days. This may mean that there is another condition causing your sleep problem.

If you take too much Ramelteon, call your doctor or get medical help right away.

What should I avoid while taking Ramelteon?

You should not drink alcohol while taking Ramelteon. Alcohol can increase your chances of getting serious side effects with Ramelteon. You should not drive, operate heavy machinery, or do other dangerous activities after Ramelteon. You may still feel drowsy the next day after taking Ramelteon. Do not drive or do other dangerous activities after taking Ramelteon until you feel fully awake.

What is the most important information I should know about Ramelteon?

The most common side effect of Ramelteon is drowsiness or tiredness.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Ramelteon. For more information ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

How should I store Ramelteon?

Store Ramelteon between 68° and 77°F (20° to 25°C).

Keep Ramelteon in a tightly closed container, and away from light. Safely throw away medicine that is out of date or no longer needed.

Keep Ramelteon and all medicines out of the reach of children.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

 

Trazodone

Read the Medication Guide that comes with trazodone hydrochloride tablets before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk to your healthcare provider or pharmacist if there is something you do not understand or you want to learn about trazodone hydrochloride tablets.

What is the most important information I should know about trazodone hydrochloride tablets?

Antidepressant medicines, depression or other serious mental illnesses, and suicidal thoughts or actions: Talk to your healthcare provider about:

• All risks and benefits of treatment with antidepressant medicines
• All treatment choices for depression or other serious mental illnesses

1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.

2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a higher risk of having suicidal thoughts or actions. These include people who have or have a family history of bipolar illness (also called manic- depressive illness) or suicidal thoughts or actions.

3. How can I watch for and try to prevent suicidal thoughts and actions?

Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts or feelings. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Call a healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you:

• Thoughts about suicide or dying
• Attempts to commit suicide
• New or worse depression
• New or worse anxiety
• Feeling very agitated or restless
• Panic attacks
• Trouble sleeping (insomnia)
• New or worse irritability
• Acting aggressive, being angry or violent
• Acting on dangerous impulses
• An extreme increase in activity and talking (mania)
• Other unusual changes in behavior or mood

4. Visual problems: eye pain changes in vision swelling or redness in or around the eye

• eye pain
• changes in vision
• swelling or redness in or around the eye

Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.

5. What else do I need to know about antidepressant medicines?

Never stop an antidepressant medicine without first talking to a healthcare provider.

Stopping an antidepressant medicine suddenly can cause other symptoms.

Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider, not just the use of antidepressants.

Antidepressant medicines have other side effects. Talk to your healthcare provider about the side effects of your medicines.

Antidepressant medicines can interact with other medicines. Know all of the medicines that you take. Keep a list of all medicines to show your healthcare provider. Do not start new medicines without first checking with your healthcare provider.

Trazodone hydrochloride tablets are not approved for use in children. Talk to your healthcare provider for more information

What are trazodone hydrochloride tablets?

Trazodone hydrochloride tablets are a prescription medicine used to treat major depressive disorder in adults.

What should I tell my healthcare provider before taking trazodone hydrochloride tablets?

Before you take trazodone hydrochloride tablets tell your healthcare provider if you:

• have heart problems, including QT prolongation or a family history of it
• have ever had a heart attack
• have bipolar disorder
• have liver or kidney problems
• have other serious medical conditions
• are pregnant or plan to become pregnant. Trazodone hydrochloride tablets may harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed. It is not known if trazodone hydrochloride tablets into your breast milk. You and your healthcare provider should decide if you will take trazodone hydrochloride or breastfeed.
• have taken a Monoamine Oxidase Inhibitor (MAOI) or if you have stopped taking an MAOI in the last 2 weeks.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Using trazodone hydrochloride tablets with certain other medicines can affect each other causing serious side effects.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take trazodone hydrochloride tablets?

• Take trazodone hydrochloride tablets exactly as your healthcare provider tells you.
• If you feel drowsy after taking trazodone hydrochloride tablets, talk to your healthcare provider. Your healthcare provider may change your dose or the time of day you take your trazodone hydrochloride tablets.
• Do not stop taking trazodone hydrochloride tablets without talking to your healthcare provider.
• Trazodone hydrochloride tablets should be swallowed whole or broken in half along the score line. Do not chew or crush trazodone hydrochloride tablets. Tell your healthcare provider if you cannot swallow trazodone either whole or as a half tablet. If you take too much trazodone hydrochloride, call your doctor or go to the nearest emergency room right away.

What should I avoid while taking trazodone hydrochloride tablets?

• Do not drive, operate heavy machinery, or do other dangerous activities until you know how trazodone hydrochloride tablets affect you. Trazodone hydrochloride tablets can slow your thinking and motor skills.
• Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking trazodone hydrochloride tablets until you talk with your healthcare provider. Trazodone hydrochloride tablets may make your sleepiness or dizziness worse if you take it with alcohol or other medicines that cause sleepiness or dizziness.

What are the possible side effects of trazodone hydrochloride tablets?

Trazodone hydrochloride tablets can cause serious side effects or death. See “What is the most important information I should know about trazodone hydrochloride tablets?”

Serious side effects include:

• Serotonin syndrome. Symptoms of serotonin syndrome include: agitation, hallucinations, problems with coordination, fast heartbeat, tight muscles, trouble walking, nausea, vomiting, diarrhea.
• Feeling high or in a very good mood, then becoming irritable, or having too much energy, feeling like you have to keep talking or do not sleep (mania).
• Irregular or fast heartbeat or faint (QT prolongation).
• Low blood pressure. You feel dizzy or faint when you change positions (go from sitting to standing).
• Unusual bruising or bleeding.
• Erection lasting for more than 6 hours (priapism).
• Low sodium in your blood (hyponatremia). Symptoms of hyponatremia include: headache, feeling weak, feeling confused, trouble concentrating, memory problems and feeling unsteady when you walk.
• Withdrawal symptoms. Symptoms of withdrawal can include anxiety, agitation, and sleep problems. Do not stop taking trazodone hydrochloride tablets without talking to your healthcare provider.

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of trazodone hydrochloride tablets include:

• Sleepiness
• Dizziness
• Constipation
• Blurry vision

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of trazodone hydrochloride tablets. For more information, ask your healthcare provider or pharmacist .

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

 

Doxepin

Call your doctor if your insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problem.

Be sure that you are able to devote 7 to 8 hours to sleep before being active again. Doxepin should be taken within 30 minutes of bedtime. Do not take with alcohol or with other medicines that can make you sleepy. If you are on a monoamine oxidase inhibitor (MAOI) or have taken a MAOI within the past two weeks, you should not take Doxepin. You should not take Doxepin if you have an eye problem called narrow angle glaucoma that is not being treated, if you have severe urinary retention, or if you are allergic to any of the ingredients in Doxepin. You should not drive or operate machinery at night after taking Doxepin. Until you know how you will react to Doxepin, you should be careful in performing such activities during the day following taking Doxepin. Before you take Doxepin, tell your doctor if you have a history of depression, mental illness or suicidal thoughts. You should call your doctor right away if after taking Doxepin you walk, drive, eat or engage in other activities while asleep. Drowsiness is the most common adverse event observed in clinical trials. For more information, please see the complete Prescribing Information, including the Medication Guide.

It is not known if Doxepin is safe and effective in children.

What should I tell my healthcare provider before taking Doxepin?

Before you take Doxepin, tell your healthcare provider if you:

• See “Who should not take Doxepin?”
• Have a history of depression, mental illness, or suicidal thoughts
• Have severe sleep apnea
• Have kidney or liver problems
• Have a history of drug or alcohol abuse or addiction
• Have a history of glaucoma or urinary retention
• Have any other medical conditions
• Are pregnant or plan to become pregnant. It is not known if Doxepin will harm your unborn baby.
• Talk to your healthcare provider if you are pregnant or plan to become pregnant.
• Are breast-feeding or plan to breast-feed. Doxepin can pass into your milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take Doxepin.
• You should not breast-feed while taking Doxepin.
• Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements.

Doxepin and other medicines may affect each other causing side effects. Doxepin may affect the way other medicines work, and other medicines may affects how Doxepin works. Especially tell your healthcare provider if you take:

• A monoamine oxidase inhibitor (MAOI).

Who should not take Doxepin?

You should not take Doxepin if you take:

• Cimetidine (Tagamet) or other medicines that can affect certain liver enzymes.
• Certain allergy medicines (antihistamines) or other medicines that can make you sleepy or affect your breathing.
• The diabetes medicine tolazamide.
• Ask your doctor or pharmacist if you are not sure if your medicine is one that is listed above.

Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.

Do not use Doxepin for a condition for which it was not prescribed. Do not share Doxepin with other people, even if you think they have the same symptoms that you have. It may harm them.

INDICATIONS

SILENOR® is indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration.

DOSAGE AND ADMINISTRATION

The dose of SILENOR® should be individualized.

Dosing In Adults

The recommended dose of SILENOR® for adults is 6 mg once daily. A 3 mg once daily dose may be appropriate for some patients, if clinically indicated.

Dosing In The Elderly

The recommended starting dose of SILENOR® in elderly patients (≥ 65 years old) is 3 mg once daily. The daily dose can be increased to 6 mg, if clinically indicated.

Administration

SILENOR® should be taken within 30 minutes of bedtime.

To minimize the potential for next day effects, SILENOR® should not be taken within 3 hours of a meal.

The total SILENOR® dose should not exceed 6 mg per day.

How should I take Doxepin?

• Take Doxepin exactly as your healthcare provider tells you to take it.
• Your healthcare provider will tell you how many Doxepin to take and when to take them.
• Your healthcare provider may change your dose if needed.
• Take Doxepin within 30 minutes of bedtime. After taking Doxepin, you should confine your activities to those necessary to prepare for bed.
• Do not take Doxepin within 3 hours of a meal. Doxepin may not work as well, or may make you sleepy the next day if taken with or right after a meal.
• Do not take Doxepin unless you are able to get a full night of sleep before you must be active again.
• Call your healthcare provider if your sleep problems get worse or do not get better within 7 to 10 days. This may mean that there is another condition causing your sleep problem.
• If you take too much Doxepin, call your healthcare provider or get medical help right away.

What should I avoid while taking Doxepin?

• You should not drink alcohol while taking Doxepin. Alcohol can increase your chances of getting serious side effects with Doxepin.
• You should not drive, operate heavy machinery, or do other dangerous activities after Doxepin.
• You may still feel drowsy the next day after taking Doxepin. Do not drive or do other dangerous activities after taking Doxepin until you feel fully awake.

What is the most important information I should know about Doxepin?

• The most common side effect of Doxepin is drowsiness or tiredness.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Doxepin. For more information ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

How should I store Doxepin?

• Store Doxepin between 68° and 77°F (20° to 25°C).
• Keep Doxepin in a tightly closed container, and away from light. Safely throw away medicine that is out of date or no longer needed.
• Keep Doxepin and all medicines out of the reach of children.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Table of Contents

1. Finasteride

 

Finasteride

Finasteride is for use by MEN ONLY and should NOT be used by women or children.

Read this Important Safety Information before you start taking finasteride and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

What is finasteride? Finasteride is a prescription medicine used for the treatment of male pattern hair loss (androgenetic alopecia). It is not known if finasteride works for a receding hairline on either side of and above your forehead (temporal area). Finasteride is not for use by women and children.

Who should not take finasteride?

Do not take Propecia if you:

• are pregnant or may become pregnant. PROPECIA may harm your unborn baby. Females who are pregnant or who may become pregnant should not come in contact with broken or crushed finasteride tablets. If a pregnant woman comes in contact with crushed or broken finasteride tablets, wash the contact area right away with soap and water. If a woman who is pregnant comes into contact with the active ingredient in finasteride, a healthcare provider should be consulted. o If a woman who is pregnant with a male baby swallows or comes in contact with the medicine in finasteride, the male baby may be born with sex organs that are not normal.
• are allergic to any of the ingredients in finasteride.

What should I tell my healthcare provider before taking finasteride?

Before taking finasteride, tell your healthcare provider if you:

• Have any other medical conditions, including problems with your prostate or liver
• Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm.

How should I take finasteride?

• Take finasteride exactly as your healthcare provider tells you to take it.
• You may take finasteride with or without food.
• If you forget to take finasteride, do not take an extra tablet. Just take the next tablet as usual.
• Finasteride will not work faster or better if you take it more than once a day.

What are the possible side effects of finasteride

• decrease in your blood Prostate Specific Antigen (PSA) levels. Finasteride can affect a blood test called PSA (Prostate-Specific Antigen) for the screening of prostate cancer. If you have a PSA test done you should tell your healthcare provider that you are taking finasteride because finasteride decreases PSA levels. Changes in PSA levels will need to be evaluated by your healthcare provider. Any increase in follow-up PSA levels from their lowest point may signal the presence of prostate cancer and should be evaluated, even if the test results are still within the normal range for men not taking finasteride. You should also tell your healthcare provider if you have not been taking finasteride as prescribed because this may affect the PSA test results. For more information, talk to your healthcare provider.
• There may be an increased risk of a more serious form of prostate cancer in men taking finasteride at 5 times the dose of finasteride.

The most common side effects of Finasteride® and generic Finasteride® are:

• decrease in sex drive
• trouble getting or keeping an erection
• a decrease in the amount of semen

The following have been reported in general use with finasteride:

• breast tenderness and enlargement. Tell your healthcare provider about any changes in your breasts such as lumps, pain or nipple discharge.
• depression
• decrease in sex drive that continued after stopping the medication;
• allergic reactions including rash, itching, hives and swelling of the lips, tongue, throat, and face;
• problems with ejaculation that continued after stopping medication;
• testicular pain;
• difficulty in achieving an erection that continued after stopping the medication;
• male infertility and/or poor quality of semen.
• in rare cases, male breast cancer. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of finasteride. For more information, ask your healthcare provider or pharmacist.

Keep PROPECIA and all medicines out of the reach of children. General information about the safe and effective use of PROPECIA. 3 Medicines are sometimes prescribed for purposes other than those listed in this Patient Information leaflet. Do not use PROPECIA for a condition for which it was not prescribed. Do not give PROPECIA to other people, even if they have the same symptoms you have. It may harm them.

If you are experiencing a medical emergency, call 911 or seek immediate medical attention.

Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.

You are encouraged to report negative side effects of prescription products to the FDA at 1-800-FDA-1088.