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Saxagliptin and Metformin Hydrochloride Extended-Release Tablets
(sax″ a glip′ tin met for′ min hye″ droe klor′ ide)
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What is the most important information I should know about saxagliptin and metformin hydrochloride extended-release tablets?
Serious side effects can happen in people taking saxagliptin and metformin hydrochloride extended-release tablets, including:
1. Lactic acidosis. Metformin, one of the medicines in saxagliptin and metformin hydrochloride extended-release tablets, can cause a rare but serious condition called lactic acidosis (a build-up of an acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital.
Call your doctor right away if you have any of the following symptoms, which could be signs of lactic acidosis:
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- you feel cold in your hands or feet
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- you feel dizzy or lightheaded
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- you have a slow or irregular heartbeat
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- you feel very weak or tired
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- you have unusual (not normal) muscle pain
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- you have trouble breathing
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- you feel sleepy or drowsy
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- you have stomach pains, nausea or vomiting
Most people who have had lactic acidosis with metformin have other things that, combined with the metformin, led to the lactic acidosis. Tell your doctor if you have any of the following, because you have a higher chance for getting lactic acidosis with saxagliptin and metformin hydrochloride extended-release tablets if you:
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- have severe kidney problems or your kidneys are affected by certain x-ray tests that use injectable dye
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- have liver problems
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- drink alcohol very often, or drink a lot of alcohol in short-term "binge" drinking
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- get dehydrated (lose a large amount of body fluids). This can happen if you are sick with a fever, vomiting, or diarrhea. Dehydration can also happen when you sweat a lot with activity or exercise and do not drink enough fluids.
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- have surgery
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- have a heart attack, severe infection, or stroke
The best way to keep from having a problem with lactic acidosis from metformin is to tell your doctor if you have any of the problems in the list above. Your doctor may decide to stop your saxagliptin and metformin hydrochloride extended-release tablets for a while if you have any of these things.
Saxagliptin and metformin hydrochloride extended-release tablets can have other serious side effects. See “What are the possible side effects of saxagliptin and metformin hydrochloride extended-release tablets?”
2. Inflammation of the pancreas (pancreatitis) which may be severe and lead to death. Certain medical problems make you more likely to get pancreatitis.
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Before you start taking saxagliptin and metformin hydrochloride extended-release tablets:
Tell your healthcare provider if you have ever had:
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- inflammation of your pancreas (pancreatitis)
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- a history of alcoholism
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- stones in your gallbladder (gallstones)
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- high blood triglyceride levels
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- It is not known if having these medical problems will make you more likely to get pancreatitis with saxagliptin and metformin hydrochloride extended-release tablets.
Stop taking saxagliptin and metformin hydrochloride extended-release tablets and contact your healthcare provider right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.
3. Heart failure. Heart failure means your heart does not pump blood well enough.
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Before you start taking saxagliptin and metformin hydrochloride extended-release tablets:
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- Tell your healthcare provider if you:
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- have ever had heart failure or have problems with your kidneys.
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- Contact your healthcare provider right away if you have any of the following symptoms:
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- increasing shortness of breath or trouble breathing, especially when you lie down
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- swelling or fluid retention, especially in the feet, ankles or legs
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- an unusually fast increase in weight
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- unusual tiredness
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- These may be symptoms of heart failure.
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What are saxagliptin and metformin hydrochloride extended-release tablets?
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- Saxagliptin and metformin hydrochloride extended-release tablets are a prescription medicine that contains saxagliptin and metformin hydrochloride. Saxagliptin and metformin hydrochloride extended-release tablets are used with diet and exercise to help control high blood sugar (hyperglycemia) in adults with type 2 diabetes.
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- Saxagliptin and metformin hydrochloride extended-release tablets are not for people with type 1 diabetes.
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- Saxagliptin and metformin hydrochloride extended-release tablets are not for people with diabetic ketoacidosis (increased ketones in your blood or urine).
It is not known if saxagliptin and metformin hydrochloride extended-release tablets are safe and effective in children younger than 18 years old.
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Who should not take saxagliptin and metformin hydrochloride extended-release tablets?
Do not take saxagliptin and metformin hydrochloride extended-release tablets if you:
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- have kidney problems.
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- are allergic to metformin hydrochloride, saxagliptin, or any of the ingredients in saxagliptin and metformin hydrochloride extended-release tablets. See the end of this Medication Guide for a complete list of ingredients in saxagliptin and metformin hydrochloride extended-release tablets. Symptoms of a serious allergic reaction to saxagliptin and metformin hydrochloride extended-release tablets may include:
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- swelling of your face, lips, throat, and other areas on your skin
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- raised, red areas on your skin (hives)
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- difficulty with swallowing or breathing
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- skin rash, itching, flaking, or peeling
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- If you have these symptoms, stop taking saxagliptin and metformin hydrochloride extended-release tablets and contact your healthcare provider right away.
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- have a condition called metabolic acidosis or diabetic ketoacidosis (increased ketones in your blood or urine).
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Before taking saxagliptin and metformin hydrochloride extended-release tablets, tell your healthcare provider about all of your medical conditions, including if you:
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- have type 1 diabetes. Saxagliptin and metformin hydrochloride extended-release tablets should not be used to treat type 1 diabetes.
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- have a history or risk for diabetic ketoacidosis (high levels of certain acids, known as ketones, in the blood or urine). Saxagliptin and metformin hydrochloride extended-release tablets should not be used for the treatment of diabetic ketoacidosis.
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- have kidney problems.
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- have liver problems.
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- have heart problems, including congestive heart failure.
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- are older than 80 years. If you are over 80 years old you should not take saxagliptin and metformin hydrochloride extended-release tablets unless your kidneys have been checked and they are normal.
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- drink alcohol very often, or drink a lot of alcohol in short-term “binge” drinking.
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- are going to get an injection of dye or contrast agents for an x-ray procedure or if you are going to have surgery and will not be able to eat or drink much. In these situations, saxagliptin and metformin hydrochloride extended-release tablets may need to be stopped for a short time. Talk to your healthcare provider about when you should stop saxagliptin and metformin hydrochloride extended-release tablets and when you should start saxagliptin and metformin hydrochloride extended-release tablets again. See “What is the most important information I should know about saxagliptin and metformin hydrochloride extended-release tablets?”
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- have any other medical conditions.
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- are pregnant or plan to become pregnant. It is not known if saxagliptin and metformin hydrochloride extended-release tablets will harm your unborn baby. If you are pregnant, talk with your healthcare provider about the best way to control your blood sugar while you are pregnant.
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- are breast-feeding or plan to breast-feed. It is not known if saxagliptin and metformin pass into your breast milk. Talk with your healthcare provider about the best way to feed your baby while you take saxagliptin and metformin hydrochloride extended-release tablets.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter 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. Saxagliptin and metformin hydrochloride extended-release tablets may affect the way other medicines work, and other medicines may affect how saxagliptin and metformin hydrochloride extended-release tablets work.
Tell your healthcare provider if you will be starting or stopping certain other types of medicines, such as antibiotics, or medicines that treat fungus or HIV/AIDS, because your dose of saxagliptin and metformin hydrochloride extended-release tablets might need to be changed.
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How should I take saxagliptin and metformin hydrochloride extended-release tablets?
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- Take saxagliptin and metformin hydrochloride extended-release tablets exactly as your healthcare provider tells you.
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- Saxagliptin and metformin hydrochloride extended-release tablets should be taken with meals to help lessen an upset stomach side effect.
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- Swallow saxagliptin and metformin hydrochloride extended-release tablets whole. Do not crush, cut, or chew saxagliptin and metformin hydrochloride extended-release tablets.
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- You may sometimes pass a soft mass in your stools (bowel movement) that looks like saxagliptin and metformin hydrochloride extended-release tablets.
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- When your body is under some types of stress, such as fever, trauma (such as a car accident), infection, or surgery, the amount of diabetes medicine that you need may change. Tell your healthcare provider right away if you have any of these problems.
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- Your healthcare provider should do blood tests to check how well your kidneys are working before and during your treatment with saxagliptin and metformin hydrochloride extended-release tablets.
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- Your healthcare provider will check your diabetes with regular blood tests, including your blood sugar levels and your hemoglobin A1C.
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- Follow your healthcare provider’s instructions for treating blood sugar that is too low (hypoglycemia). Talk to your healthcare provider if low blood sugar is a problem for you. See “What are the possible side effects of saxagliptin and metformin hydrochloride extended-release tablets?”
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- Check your blood sugar as your healthcare provider tells you to.
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- Stay on your prescribed diet and exercise program while taking saxagliptin and metformin hydrochloride extended-release tablets.
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- If you miss a dose of saxagliptin and metformin hydrochloride extended-release tablets, take your next dose as prescribed unless your healthcare provider tells you differently. Do not take an extra dose the next day.
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- If you take too many saxagliptin and metformin hydrochloride extended-release tablets, call your healthcare provider or go to the nearest hospital emergency room right away.
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What are the possible side effects of saxagliptin and metformin hydrochloride extended-release tablets?
Saxagliptin and metformin hydrochloride extended-release tablets can cause serious side effects, including:
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- See “What is the most important information I should know about saxagliptin and metformin hydrochloride extended-release tablets?”
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Allergic (hypersensitivity) reactions, such as:
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- swelling of your face, lips, throat, and other areas on your skin
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- raised, red areas on your skin (hives)
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- difficulty with swallowing or breathing
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- skin rash, itching, flaking, or peeling
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- If you have these symptoms, stop taking saxagliptin and metformin hydrochloride extended-release tablets and contact your healthcare provider right away.
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Low blood sugar (hypoglycemia). May become worse in people who also take another medication to treat diabetes, such as sulfonylureas or insulin. Tell your healthcare provider if you take other diabetes medicines. If you have symptoms of low blood sugar, you should check your blood sugar and treat if low, then call your healthcare provider. Symptoms of low blood sugar include:
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- shaking
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- hunger
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- sweating
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- headache
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- rapid heartbeat
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- change in mood
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- change in vision
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Joint pain. Some people who take medicines called DPP4 inhibitors, one of the medicines in saxagliptin and metformin hydrochloride extended-release tablets, may develop joint pain that can be severe. Call your healthcare provider if you have severe joint pain.
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Skin reaction. Some people who take medicines called DPP4 inhibitors, one of the medicines in saxagliptin and metformin hydrochloride extended-release tablets, may develop a skin reaction called bullous pemphigoid that can require treatment in a hospital. Tell your healthcare provider right away if you develop blisters or the breakdown of the outer layer of your skin (erosion). Your healthcare provider may tell you to stop taking saxagliptin and metformin hydrochloride extended-release tablets.
Common side effects of saxagliptin and metformin hydrochloride extended-release tablets include:
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- upper respiratory tract infection
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- headache
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- stuffy or runny nose and sore throat
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- diarrhea
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- urinary tract infection
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- nausea and vomiting
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Taking saxagliptin and metformin hydrochloride extended-release tablets with meals can help lessen the common stomach side effects of metformin. If you have unexplained stomach problems, tell your healthcare provider. Stomach problems that start later during treatment may be a sign of something more serious.
These are not all of the possible side effects of saxagliptin and metformin hydrochloride extended-release tablets.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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How should I store saxagliptin and metformin hydrochloride extended-release tablets?
Store saxagliptin and metformin hydrochloride extended-release tablets between 20° to 25°C (68° to 77°F).
Keep saxagliptin and metformin hydrochloride extended-release tablets and all medicines out of the reach of children.
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General information about the use of saxagliptin and metformin hydrochloride extended-release tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use saxagliptin and metformin hydrochloride extended-release tablets for a condition for which they were not prescribed. Do not give saxagliptin and metformin hydrochloride extended-release tablets to other people, even if they have the same symptoms you have. They may harm them.
You can ask your pharmacist or healthcare provider for information about saxagliptin and metformin hydrochloride extended-release tablets that is written for health professionals.
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What are the ingredients of saxagliptin and metformin hydrochloride extended-release tablets?
Active ingredients: saxagliptin and metformin hydrochloride.
Inactive ingredients in each tablet: carbomer homopolymer type A, colloidal silicon dioxide, hypromellose, magnesium stearate, polyethylene glycol, polyvinyl alcohol, povidone, red iron oxide, stearic acid, talc and titanium dioxide. The 2.5 mg/1000 mg tablets also contain yellow iron oxide. In addition, the black imprinting ink contains ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze.
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What is type 2 diabetes?
Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should. Your body can also make too much sugar. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems. The main goal of treating diabetes is to lower your blood sugar so that it is as close to normal as possible. High blood sugar can be lowered by diet and exercise, and by certain medicines when necessary.
Talk to your healthcare provider about how to prevent, recognize, and take care of low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), and problems you have because of your diabetes.
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Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Manufactured by: Mylan Laboratories Limited, Hyderabad — 500 096, India
For more information, call Mylan at 1-877-446-3679 (1-877-4-INFO-RX).
The brands listed are trademarks of their respective owners.
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