Semaglutide
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
Tell your doctor if you are pregnant or planning to become pregnant. Do not use this medicine for at least 2 months before you plan to become pregnant.
It is very important to carefully follow any instructions from your health care team about:
- Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.
- Other medicines—Do not take other medicines during the time you are using semaglutide unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
- Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, diabetic patients may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur during pregnancy in patients with diabetes.
- Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.
In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.
This medicine may increase the risk of having thyroid tumors. Tell your doctor right away if you have a lump or swelling in your neck or throat, trouble swallowing or breathing, or if your voice gets hoarse.
Pancreatitis (swelling of the pancreas) may occur while you are using this medicine. Check with your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.
Check with your doctor right away if you have gaseous stomach pain, indigestion, recurrent fever, severe nausea or vomiting, stomach fullness, or yellow eyes or skin. These may be symptoms of gallbladder problems (eg, cholelithiasis, cholecystitis).
This medicine may cause diabetic retinopathy. Check with your doctor if you have blurred vision or any other changes in vision.
This medicine does not cause hypoglycemia (low blood sugar). However, low blood sugar can occur when you use semaglutide with other medicines, including insulin or sulfonylureas, that can lower blood sugar. Low blood sugar also can occur if you delay or miss a meal or snack, exercise more than usual, drink alcohol, or cannot eat because of nausea or vomiting.
- Symptoms of low blood sugar include anxiety, behavior change similar to being drunk, blurred vision, cold sweats, confusion, cool, pale skin, difficulty with thinking, drowsiness, excessive hunger, fast heartbeat, headache (continuing), nausea, nervousness, nightmares, restless sleep, shakiness, slurred speech, or unusual tiredness or weakness.
- If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes, or drink fruit juice, non-diet soft drink, or sugar dissolved in water to relieve the symptoms. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms including seizures or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your family should also know how to use it.
This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.
This medicine may cause acute kidney injury. Check with your doctor right away if you have bloody urine, decreased urine output, muscle twitching, nausea, rapid weight gain, seizures, stupor, swelling of the face, ankles, or hands, or unusual tiredness or weakness.
This medicine may increase your heart rate while you are at rest. Check with your doctor right away if you have a fast or pounding heart beat.
Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your antidiabetic medicine, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual.
- Symptoms of high blood sugar include blurred vision, drowsiness, dry mouth, flushed, dry skin, fruit-like breath odor, increased urination (frequency and amount), ketones in the urine, loss of appetite, stomachache, nausea or vomiting, tiredness, trouble breathing (rapid and deep), unconsciousness, or unusual thirst.
- If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions.
This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Also tell your doctor if you have sudden or strong feelings, including feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these side effects, tell your doctor right away.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Mounjaro
Mounjaro® is an injectable medicine for adults with type 2 diabetes used along with diet and exercise to improve blood sugar (glucose).
- It is not known if Mounjaro can be used in people who have had inflammation of the pancreas (pancreatitis). Mounjaro is not for use in people with type 1 diabetes. It is not known if Mounjaro is safe and effective for use in children under 18 years of age.
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 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 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.
Mounjaro is a prescription medicine. For more information, call 1-833-807-MJRO (833-807-6576) or go to www.mounjaro.com.
This summary provides basic information about Mounjaro 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 Mounjaro and how to take it. Your healthcare provider is the best person to help you decide if Mounjaro is right for you.
TR CON CBS 14SEP2022
Mounjaro® and its delivery device base are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.
Tirzepatide
Description
Tirzepatide injection is used to treat type 2 diabetes. It is used together with diet and exercise to help control your blood sugar. Tirzapatide is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist.
Tirzepatide injection is also used to help lose weight and keep the weight off in patients with obesity caused by certain conditions.
This medicine is available only with your doctor's prescription.
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of tirzepatide injection in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tirzepatide injection in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Desogestrel
- Dienogest
- Drospirenone
- Estetrol
- Estradiol
- Ethinyl Estradiol
- Ethynodiol
- Gestodene
- Levonorgestrel
- Mestranol
- Nomegestrol
- Norethindrone
- Norgestimate
- Norgestrel
- Warfarin
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acarbose
- Chlorpropamide
- Glimepiride
- Glipizide
- Glyburide
- Insulin
- Insulin Aspart, Recombinant
- Insulin Bovine
- Insulin Degludec
- Insulin Detemir
- Insulin Glulisine
- Insulin Lispro, Recombinant
- Liraglutide
- Metformin
- Nateglinide
- Repaglinide
- Semaglutide
- Tolazamide
- Tolbutamide
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Dehydration or
- Depression, history of or
- Pancreatitis (inflammation of the pancreas), history of—Use with caution. May make these conditions worse.
- Diabetic retinopathy, history of or
- Kidney disease—Use with caution. May make these conditions worse.
- Gastroparesis (stomach does not empty food normally), severe or
- Multiple endocrine neoplasia syndrome type 2 (MEN 2) or
- Thyroid cancer, history of—Should not be used in patients with these conditions.
- Type 1 diabetes—Should not be used in patients with these conditions.
Proper Use
When you start using this medicine, it is very important that you check your blood sugar often, especially before and after meals and at bedtime. This will help lower the chance of having very low blood sugar.
Carefully follow the special meal plan your doctor gave you. This is the most important part of controlling your diabetes, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.
This medicine comes with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.
If you will be using tirzepatide at home, your doctor will teach you how the injections will be given. Be sure you understand exactly how the medicine is to be injected.
This medicine is given as a shot under the skin of your stomach, thighs, or upper arm. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas.
Check the liquid in the pen. it should be clear and colorless to slightly yellow. Do not use it if it is cloudy, discolored, or has particles in it.
Use a new needle each time you inject your medicine.
Never share medicine pens with others under any circumstances. It is not safe for one pen to be used for more than one person. Sharing needles or pens can result in transmission of infection.
Use this medicine on the same day each week, at any time of the day, with or without meals.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For injection dosage form (solution):some text
- For type 2 diabetes, obesity, or excess weight caused by medical problems:some text
- Adults—At first, 2.5 milligrams (mg) injected under the skin once a week for 4 weeks. Your doctor may increase your dose as needed. However, the dose is usually not more than 15 mg once a week.
- Children—Use and dose must be determined by your doctor.
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If you miss a dose, use it as soon as possible within 4 days after your missed dose. If you miss a dose for more than 4 days, skip the missed dose and go back to your regular dosing schedule.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store in the refrigerator. Do not freeze.
Store your medicine pen in its original carton in the refrigerator. Do not freeze. Do not use this medicine if it is frozen. You may store the pen at room temperature for up to 21 days. Do not put this medicine back in the refrigerator if it has been stored at room temperature. Throw away an unused pen within 21 days after removing it from the refrigerator.
Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
Mounjaro®: Tell your doctor if you are pregnant or planning to become pregnant. Do not use this medicine for at least 2 months before you plan to become pregnant.
If you are using birth control pills, your doctor may recommend another type of birth control for 4 weeks after you start using this medicine and after each increase in your dose.
It is very important to carefully follow any instructions from your health care team about:
- Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.
- Other medicines—Do not take other medicines during the time you are using tirzepatide unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
- Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, diabetic patients may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur during pregnancy in patients with diabetes.
- Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.
In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.
This medicine may increase the risk of having thyroid tumors. Tell your doctor right away if you have a lump or swelling in your neck or throat, trouble swallowing or breathing, or if your voice gets hoarse.
Pancreatitis (swelling of the pancreas) may occur while you are using this medicine. Check with your doctor right away if you have sudden and sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.
Check with your doctor right away if you have gaseous stomach pain, indigestion, recurrent fever, severe nausea or vomiting, stomach fullness, or yellow eyes or skin. These may be symptoms of gallbladder problems (eg, cholelithiasis, cholecystitis).
This medicine may cause diabetic retinopathy. Check with your doctor if you have blurred vision or any other changes in vision.
This medicine does not cause hypoglycemia (low blood sugar). However, low blood sugar can occur when you use tirzepatide with other medicines, including insulin or sulfonylureas, that can lower blood sugar. Low blood sugar also can occur if you delay or miss a meal or snack, exercise more than usual, drink alcohol, or cannot eat because of nausea or vomiting.
- Symptoms of low blood sugar include anxiety, behavior change similar to being drunk, blurred vision, cold sweats, confusion, cool, pale skin, difficulty with thinking, drowsiness, excessive hunger, fast heartbeat, headache (continuing), nausea, nervousness, nightmares, restless sleep, shakiness, slurred speech, or unusual tiredness or weakness.
- If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes, or drink fruit juice, non-diet soft drink, or sugar dissolved in water to relieve the symptoms. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms including seizures or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your family should also know how to use it.
This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.
This medicine may cause acute kidney injury. Check with your doctor right away if you have a bloody urine, decreased urine output, muscle twitching, nausea, rapid weight gain, seizures, stupor, swelling of the face, ankles, or hands, or unusual tiredness or weakness.
This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Also tell your doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these side effects, tell your doctor right away.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
Less common
- Difficulty in breathing or swallowing
- fast heartbeat
- gaseous stomach pain
- heartburn
- recurrent fever
- skin itching, rash, or redness
- stomach fullness
- swelling of the face, throat, or tongue
- vomiting
- yellow eyes or skin
Incidence not known
- Anxiety
- bloating
- blurred vision
- change in vision
- changes in behavior
- chest tightness
- chills
- cold sweats
- coma
- confusion
- constipation
- cool, pale skin
- cough
- darkened urine
- depression
- dizziness
- fast heartbeat
- fever
- increased hunger
- indigestion
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of appetite
- nausea
- nervousness
- nightmares
- pains in the stomach, side, or abdomen, possibly radiating to the back
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- seizures
- shakiness
- slurred speech
- thoughts of harming oneself
- unusual tiredness or weakness
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Acid or sour stomach
- belching
- constipation
- diarrhea
- stomach discomfort or upset
Less common
- Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Ozempic
Do not share your Ozempic® 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.
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 healthcare 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.
Ozempic® Side Effects:
Ozempic® may cause serious side effects, including:
- inflammation of your pancreas (pancreatitis). Stop using Ozempic® 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 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 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 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.
- 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.
The most common side effects of Ozempic® may include nausea, vomiting, diarrhea, stomach (abdominal) pain, and constipation.
Metformin
Description
Metformin is used to treat high blood sugar levels that are caused by a type of diabetes mellitus or sugar diabetes called type 2 diabetes. With this type of diabetes, insulin produced by the pancreas is not able to get sugar into the cells of the body where it can work properly. Using metformin alone, with a type of oral antidiabetic medicine called a sulfonylurea, or with insulin, will help to lower blood sugar when it is too high and help restore the way you use food to make energy.
Many people can control type 2 diabetes with diet and exercise. Following a specially planned diet and exercise will always be important when you have diabetes, even when you are taking medicines. To work properly, the amount of metformin you take must be balanced against the amount and type of food you eat and the amount of exercise you do. If you change your diet or exercise, you will want to test your blood sugar to find out if it is too low. Your doctor will teach you what to do if this happens.
Metformin does not help patients who have insulin-dependent or type 1 diabetes because they cannot produce insulin from their pancreas gland. Their blood glucose is best controlled by insulin injections.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet, Extended Release
- Suspension, Extended Release
- Tablet
- Solution
- Tablet, Extended Release, 24 HR
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of metformin oral solution, extended-release oral suspension, and tablets in children 10 to 16 years of age. However, safety and efficacy of metformin extended-release tablets in the pediatric population have not been established.
Geriatric
Although appropriate studies on the relationship of age to the effects of metformin have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of metformin in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution in patients receiving metformin. This medicine is not recommended in patients 80 years of age and older who have kidney problems.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abiraterone Acetate
- Acetazolamide
- Alogliptin
- Aspirin
- Bexagliflozin
- Bictegravir
- Brinzolamide
- Bupropion
- Capmatinib
- Chloroquine
- Chlorpropamide
- Cimetidine
- Ciprofloxacin
- Dasabuvir
- Delafloxacin
- Diatrizoate
- Dichlorphenamide
- Dofetilide
- Dolutegravir
- Dorzolamide
- Enoxacin
- Ethiodized Oil
- Fedratinib
- Fexinidazole
- Gatifloxacin
- Gemifloxacin
- Glimepiride
- Glipizide
- Glyburide
- Grepafloxacin
- Hydroxychloroquine
- Insulin
- Insulin Aspart, Recombinant
- Insulin Bovine
- Insulin Degludec
- Insulin Detemir
- Insulin Glargine, Recombinant
- Insulin Glulisine
- Insulin Lispro, Recombinant
- Iodipamide
- Iodixanol
- Iohexol
- Iopamidol
- Iopanoic Acid
- Iopromide
- Iothalamate
- Iotrolan
- Ioversol
- Ioxaglate
- Ipodate
- Isavuconazole
- Lanreotide Acetate
- Levofloxacin
- Levoketoconazole
- Liraglutide
- Lomefloxacin
- Methazolamide
- Metrizamide
- Moxifloxacin
- Nateglinide
- Norfloxacin
- Octreotide Acetate
- Ofloxacin
- Ombitasvir
- Paritaprevir
- Pasireotide Diaspartate
- Pioglitazone
- Pramlintide
- Ranolazine
- Repaglinide
- Semaglutide
- Sitagliptin
- Somatrogon-ghla
- Sotagliflozin
- Sparfloxacin
- Tafenoquine
- Thioctic Acid
- Tolazamide
- Tolbutamide
- Topiramate
- Trovafloxacin
- Vandetanib
- Zonisamide
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acebutolol
- Atenolol
- Betaxolol
- Bisoprolol
- Bitter Melon
- Carteolol
- Carvedilol
- Celiprolol
- Colesevelam
- Esmolol
- Fenugreek
- Glecaprevir
- Glucomannan
- Goldenseal
- Guar Gum
- Hydrastis
- Isocarboxazid
- Labetalol
- Levobunolol
- Linezolid
- Methylene Blue
- Metipranolol
- Metoprolol
- Nadolol
- Nebivolol
- Oxprenolol
- Ozanimod
- Patiromer
- Penbutolol
- Phenelzine
- Pibrentasvir
- Pindolol
- Practolol
- Procarbazine
- Propranolol
- Psyllium
- Rasagiline
- Rifampin
- Safinamide
- Selegiline
- Sotalol
- Timolol
- Tirzepatide
- Tranylcypromine
- Verapamil
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Alcohol, excessive use or
- Underactive adrenal glands or
- Underactive pituitary gland or
- Undernourished condition or
- Weakened physical condition or
- Any other condition that causes low blood sugar—Patients with these conditions may be more likely to develop low blood sugar while taking metformin.
- Anemia (low levels of red blood cells) or
- Vitamin B12 deficiency—Use with caution. May make these conditions worse.
- Congestive heart failure, acute or unstable or
- Dehydration or
- Heart attack, acute or
- Hypoxemia (decreased oxygen in the blood) or
- Kidney disease or
- Liver disease or
- Sepsis (blood poisoning) or
- Shock (low blood pressure, blood circulation is poor)—A rare condition called lactic acidosis can occur. Talk with your doctor if you have concerns about this.
- Diabetic ketoacidosis (ketones in the blood) or
- Kidney disease, severe or
- Metabolic acidosis (extra acids in the blood) or
- Type 1 diabetes—Should not be used in patients with these conditions.
- Fever or
- Infection or
- Surgery or
- Trauma—These conditions may cause temporary problems with blood sugar control and your doctor may want to treat you with insulin.
Proper Use
This medicine usually comes with a patient information insert. Read the information carefully and make sure you understand it before taking this medicine. If you have any questions, ask your doctor.
Carefully follow the special meal plan your doctor gave you. This is a very important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.
Metformin should be taken with meals to help reduce stomach or bowel side effects that may occur during the first few weeks of treatment.
Swallow the tablet or extended-release tablet whole with a full glass of water. Do not crush, break, or chew it.
While taking the extended-release tablet, part of the tablet may pass into your stool after your body has absorbed the medicine. This is normal and nothing to worry about.
Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.
Use the supplied dosing cup to measure the mixed extended-release oral suspension. Ask your pharmacist for a dosing cup if you do not have one.
Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.
You may notice improvement in your blood glucose control in 1 to 2 weeks, but the full effect of blood glucose control may take up to 2 to 3 months. Ask your doctor if you have any questions about this.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For type 2 diabetes:some text
- For oral dosage form (extended-release tablets):some text
- Adults—some text
- Metformin alone (Fortamet®): At first, 1000 milligrams (mg) once a day taken with the evening meal. Your doctor may increase your dose if needed until your blood sugar is controlled. However, the dose is usually not more than 2500 mg per day.
- Metformin alone (Glucophage® XR): At first, 500 mg once daily with the evening meal. Your doctor may increase your dose if needed until your blood sugar is controlled. However, the dose is usually not more than 2000 mg per day.
- Metformin alone (Glumetza®): At first, 500 mg once a day taken with the evening meal. Then, your doctor may increase your dose if needed until your blood sugar is controlled. However, the dose is usually not more than 2000 mg per day.
- Metformin with a sulfonylurea: Your doctor will determine the dose of each medicine.
- Metformin with insulin: At first, 500 mg once a day. Then, your doctor may increase your dose by 500 mg every week if needed until your blood sugar is controlled. However, the dose is usually not more than 2500 mg per day.
- Children—Use and dose must be determined by your doctor.
- For oral dosage form (extended-release suspension):some text
- Adults—At first, 5 milliliters (mL) once a day taken with the evening meal. Your doctor may increase your dose by 5 mL weekly if needed until your blood sugar is controlled. However, the dose is usually not more than 20 mL per day.
- Children 10 to 16 years of age—At first, 5 mL once a day taken with the evening meal. Your doctor may increase your dose by 5 mL weekly if needed until your blood sugar is controlled. However, the dose is usually not more than 20 mL per day.
- Children younger than 10 years of age—Use and dose must be determined by your doctor.
- For oral dosage form (solution):some text
- Adults—some text
- Metformin alone: At first, 5 milliliters (mL) two times a day, or 8.5 mL once a day with meals. Your doctor may increase your dose if needed until your blood sugar is controlled. However, the dose is usually not more than 25.5 mL per day.
- Metformin with a sulfonylurea: Your doctor will determine the dose of each medicine.
- Metformin with insulin: At first, 5 mL once a day. Your doctor may increase your dose if needed until your blood sugar is controlled. However, the dose is usually not more than 25 mL per day.
- Children 10 to 16 years of age—At first, 5 mL two times a day with meals. Your doctor may increase your dose if needed until your blood sugar is controlled. However, the dose is usually not more than 20 mL per day.
- Children younger than 10 years of age—Use and dose must be determined by your doctor.
- For oral dosage form (tablets):some text
- Adults—some text
- Metformin alone: At first, 500 milligrams (mg) two times a day taken with the morning and evening meals, or 850 mg a day taken with the morning meal. Your doctor may increase your dose if needed until your blood sugar is controlled. Later, your doctor may want you to take 500 or 850 mg two to three times a day with meals. However, the dose is usually not more than 2550 mg per day.
- Metformin with a sulfonylurea: Your doctor will determine the dose of each medicine.
- Metformin with insulin: At first, 500 mg a day. Your doctor may increase your dose by 500 mg every week if needed until your blood sugar is controlled. However, the dose is usually not more than 2500 mg per day.
- Children 10 to 16 years of age—At first, 500 mg two times a day taken with the morning and evening meals. Your doctor may increase your dose if needed until your blood sugar is controlled. However, the dose is usually not more than 2000 mg per day.
- Children younger than 10 years of age—Use and dose must be determined by your doctor.
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your or your child's progress at regular visits, especially during the first few weeks that you take this medicine. Blood and urine tests may be needed to check for unwanted effects.
This medicine may interact with the dye used for an X-ray or CT scan. Your doctor should advise you to stop taking it before you have any medical exams or diagnostic tests that might cause less urine output than usual. You may be advised to start taking the medicine again 48 hours after the exams or tests if your kidney function is tested and found to be normal.
Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.
It is very important to carefully follow any instructions from your health care team about:
- Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.
- Other medicines—Do not take other medicines unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
- Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur with lifestyle changes, such as changes in exercise or diet. Counseling on birth control and pregnancy may be needed because of the problems that can occur in pregnancy for patients with diabetes.
- Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.
- In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.
Under certain conditions, too much metformin can cause lactic acidosis. The symptoms of lactic acidosis are severe and quick to appear, and usually occur when other health problems not related to the medicine are present and are very severe, such as a heart attack or kidney failure. Symptoms of lactic acidosis include abdominal or stomach discomfort, decreased appetite, diarrhea, fast or shallow breathing, a general feeling of discomfort, severe muscle pain or cramping, and unusual sleepiness, tiredness, or weakness.
If symptoms of lactic acidosis occur, you should get immediate emergency medical help.
This medicine may cause some premenopausal women who do not have regular monthly periods to ovulate. This can increase the chance of pregnancy. If you are a woman of childbearing potential, you should discuss birth control options with your doctor.
This medicine may cause hypoglycemia (low blood sugar). This is more common when this medicine is taken together with certain medicines. Low blood sugar must be treated before it causes you to pass out (unconsciousness). People feel different symptoms of low blood sugar. It is important that you learn which symptoms you usually have so you can treat it quickly. Talk to your doctor about the best way to treat low blood sugar.
Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your medicine, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual. High blood sugar can be very serious and must be treated right away. It is important that you learn which symptoms you have in order to treat it quickly. Talk to your doctor about the best way to treat high blood sugar.
High blood sugar may occur if you do not exercise as much as usual, have a fever or infection, do not take enough or skip a dose of your diabetes medicine, or overeat or do not follow your meal plan.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Abdominal or stomach discomfort
- cough or hoarseness
- decreased appetite
- diarrhea
- fast or shallow breathing
- fever or chills
- general feeling of discomfort
- lower back or side pain
- muscle pain or cramping
- painful or difficult urination
- sleepiness
Less common
- Anxiety
- blurred vision
- chest discomfort
- cold sweats
- coma
- confusion
- cool, pale skin
- depression
- difficult or labored breathing
- dizziness
- fast, irregular, pounding, or racing heartbeat or pulse
- feeling of warmth
- headache
- increased hunger
- increased sweating
- nausea
- nervousness
- nightmares
- redness of the face, neck, arms, and occasionally, upper chest
- seizures
- shakiness
- slurred speech
- tightness in the chest
- unusual tiredness or weakness
Rare
- Behavior change similar to being drunk
- difficulty with concentrating
- drowsiness
- lack or loss of strength
- restless sleep
- unusual sleepiness
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Acid or sour stomach
- belching
- bloated
- excess air or gas in the stomach or intestines
- full feeling
- heartburn
- indigestion
- loss of appetite
- metallic taste in the mouth
- passing of gas
- stomachache
- stomach upset or pain
- vomiting
- weight loss
Less common
- Abnormal stools
- bad, unusual, or unpleasant (after) taste
- change in taste
- difficulty with moving
- discoloration of the fingernails or toenails
- flu-like symptoms
- joint pain
- rash
- sneezing
- stuffy or runny nose
- swollen joints
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088