Saxagliptin/ metformin extended-release tablets

Generic Name: saxagliptin/metformin (SAX-a-GLIP-tin/met-FOR-min)
Brand Name: Kombiglyze XR

Saxagliptin/metformin extended-release tablets may rarely cause a serious and sometimes fatal condition called lactic acidosis. Most of these cases have occurred in diabetic patients who also have certain kidney problems. The risk of lactic acidosis may be greater if you have a severe bloodstream infection (sepsis), liver problems, kidney problems, or heart failure. The risk may also be greater in patients who are dehydrated, elderly, or drink alcohol. Lab tests, including kidney function, may be performed while you take saxagliptin/metformin extended-release tablets.

Do not begin to take saxagliptin/metformin extended-release tablets if you are over 80 years old unless lab tests show that you do not have decreased kidney function. Do not take it if you have a severe infection, have low blood oxygen levels, or are dehydrated. Tell your doctor that you take saxagliptin/metformin extended-release tablets before you have any surgery or lab procedures.

Contact your doctor right away if you notice symptoms such as fast or difficult breathing; muscle pain or tenderness; slow or irregular heartbeat; unusual drowsiness, dizziness, or lightheadedness; unusual stomach discomfort; or unusual weakness or tiredness. Contact your doctor right away if you start to feel unusually cold or if you have a general feeling of being unwell.


Saxagliptin/ metformin extended-release tablets is used for:

Treating type 2 diabetes. It is used along with diet and exercise.

Saxagliptin/metformin extended-release tablets is a dipeptidyl peptidase-4 (DPP-4) inhibitor and biguanide combination. It works by increasing the amount of insulin released by your body. It decreases the amount of sugar that the liver produces and the intestines absorb. It also helps to make your body more sensitive to the insulin that you naturally produce.

Do NOT use saxagliptin/ metformin extended-release tablets if:

  • you are allergic to any ingredient in saxagliptin/metformin extended-release tablets
  • you have type 1 diabetes
  • you have a severe infection, low blood oxygen levels, kidney or liver problems, high blood or urine ketone or acid levels (eg, diabetic ketoacidosis), or dehydration
  • you have had a stroke or a recent heart attack, or you are in shock
  • you are 80 years old or older, unless lab tests show that you do not have decreased kidney function
  • you will be having surgery or certain lab procedures

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Prediabetes - Am I at Risk?

Before using saxagliptin/ metformin extended-release tablets:

Some medical conditions may interact with saxagliptin/metformin extended-release tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of angioedema (swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or hoarseness) caused by another DPP-4 inhibitor (eg, sitagliptin)
  • if you have heart failure, especially heart failure that is treated by medicine
  • if you have a history of heart problems, lung or breathing problems, thyroid problems, stomach or bowel problems (eg, paralysis, blockage), diabetic ketoacidosis, adrenal or pituitary problems, or lactic acidosis
  • if you have a history of pancreatitis, gallstones, or high blood triglyceride levels
  • if you have vomiting, diarrhea, poor health or nutrition, low blood calcium or vitamin B12 levels, or anemia
  • if you have an infection, fever, recent injury, or moderate to severe burns
  • if you drink alcohol or have a history of alcohol abuse
  • if you will be having surgery or certain lab procedures
  • if you are taking a beta-blocker (eg, propranolol)

Some MEDICINES MAY INTERACT with saxagliptin/metformin extended-release tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Calcium channel blockers (eg, nifedipine), corticosteroids (eg, prednisone), diuretics (eg, furosemide, hydrochlorothiazide), estrogen, hormonal contraceptives (eg, birth control pills), isoniazid, nicotinic acid, phenothiazine (eg, chlorpromazine), phenytoin, sympathomimetics (eg, albuterol, pseudoephedrine), or thyroid hormones (eg, levothyroxine) because the risk of high blood sugar may be increased
  • Insulin, sulfonylureas (eg, glipizide), or other medicines for diabetes because the risk of low blood sugar may be increased
  • Amiloride, cimetidine, clarithromycin, digoxin, itraconazole, ketoconazole, morphine, nefazodone, procainamide, protease inhibitors (eg, atazanavir, boceprevir, ritonavir), quinidine, quinine, ranitidine, telithromycin, triamterene, trimethoprim, or vancomycin because they may increase the risk of saxagliptin/metformin extended-release tablets's side effects
  • Medicines that may harm the kidney (eg, aminoglycoside antibiotics [eg, gentamicin], amphotericin B, cyclosporine, nonsteroidal anti-inflammatory drugs [NSAIDs] [eg, ibuprofen], tacrolimus) because they may increase the risk of saxagliptin/metformin extended-release tablets's side effects. Ask your doctor if you are unsure if any of your medicines might harm the kidney

This may not be a complete list of all interactions that may occur. Ask your health care provider if saxagliptin/metformin extended-release tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use saxagliptin/ metformin extended-release tablets:

Use saxagliptin/metformin extended-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Saxagliptin/metformin extended-release tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get saxagliptin/metformin extended-release tablets refilled.
  • Take saxagliptin/metformin extended-release tablets by mouth with the evening meal unless your doctor tells you otherwise.
  • Swallow saxagliptin/metformin extended-release tablets whole. Do not break, crush, or chew before swallowing.
  • Take saxagliptin/metformin extended-release tablets on a regular schedule to get the most benefit from it. Taking saxagliptin/metformin extended-release tablets at the same time each day will help you remember to take it.
  • Continue to take saxagliptin/metformin extended-release tablets even if you feel well. Do not miss any doses.
  • If you miss a dose of saxagliptin/metformin extended-release tablets, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use saxagliptin/metformin extended-release tablets.

Important safety information:

  • Saxagliptin/metformin extended-release tablets may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use saxagliptin/metformin extended-release tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Follow the diet and exercise program given to you by your health care provider.
  • Do not drink large amounts of alcohol while you use saxagliptin/metformin extended-release tablets. Talk to your doctor or health care provider before you drink alcohol while you use saxagliptin/metformin extended-release tablets.
  • Do NOT take more than the recommended dose without checking with your doctor.
  • Tell your doctor or dentist that you take saxagliptin/metformin extended-release tablets before you receive any medical or dental care, emergency care, or surgery.
  • Be careful not to become dehydrated, especially during hot weather or while you are being active. Dehydration may increase the risk of saxagliptin/metformin extended-release tablets's side effects.
  • If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.
  • If you become ill while you are taking saxagliptin/metformin extended-release tablets, contact your doctor.
  • You may notice undissolved parts of saxagliptin/metformin extended-release tablets in your stool. This is normal and not a cause for concern.
  • Carry an ID card at all times that says you have diabetes.
  • Check your blood sugar levels as directed by your doctor. If they are often higher or lower than they should be and you take saxagliptin/metformin extended-release tablets exactly as prescribed, tell your doctor.
  • Saxagliptin/metformin extended-release tablets does not usually cause low blood sugar. Low blood sugar may be more likely to occur if you skip a meal, exercise heavily, or drink alcohol. It may also be more likely if you take saxagliptin/metformin extended-release tablets along with certain medicines for diabetes (eg, sulfonylureas, insulin). It is a good idea to carry a reliable source of glucose (eg, tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.
  • Fever, infection, injury, or surgery may increase your risk for high or low blood sugar levels. If any of these occur, check your blood sugar levels closely and tell your doctor right away.
  • Saxagliptin/metformin extended-release tablets may commonly cause stomach upset, indigestion, nausea, vomiting, or diarrhea at the beginning of treatment. If you develop unusual or unexpected stomach problems, or if you develop stomach problems later during treatment, contact your doctor at once. This may be a sign of lactic acidosis.
  • Severe and sometimes fatal inflammation of the pancreas (pancreatitis) has been reported in patients taking saxagliptin/metformin extended-release tablets. Discuss any questions or concerns with your doctor. Contact your doctor immediately if you develop severe or persistent stomach or back pain with or without nausea or vomiting.
  • Lab tests, including kidney function, fasting blood glucose, hemoglobin A1c, and complete blood cell counts, may be performed while you use saxagliptin/metformin extended-release tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use saxagliptin/metformin extended-release tablets with caution in the ELDERLY; they may be more sensitive to its effects. Low blood sugar levels may also be more difficult to recognize in the elderly.
  • Saxagliptin/metformin extended-release tablets should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using saxagliptin/metformin extended-release tablets while you are pregnant. It is not known if saxagliptin/metformin extended-release tablets is found in breast milk. If you are or will be breast-feeding while you use saxagliptin/metformin extended-release tablets, check with your doctor. Discuss any possible risks to your baby.

When used for long periods of time, saxagliptin/metformin extended-release tablets may not work as well. If your blood sugar has been under control and then becomes hard to manage, contact your doctor. Do not change the dose of your medicine without checking with your doctor.

Possible side effects of saxagliptin/ metformin extended-release tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; gas; headache; indigestion; mild stomach pain or upset; nausea; symptoms of respiratory tract infection (eg, cough, mild sore throat, runny or stuffy nose, sneezing); temporary metallic taste; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); chest pain or discomfort; dizziness or light-headedness; fainting; fast or difficult breathing; feeling of being unusually cold; fever, chills, or persistent sore throat; flaking, peeling, or swelling of the skin; frequent or painful urination; general feeling of being unwell; muscle pain or weakness; slow or irregular heartbeat; symptoms of low blood sugar (eg, increased hunger or sweating, fast heartbeat, anxiety, dizziness or headache, tremors, chills, vision changes); symptoms of pancreatitis (eg, severe stomach or back pain with or without nausea or vomiting); unusual drowsiness; unusual or persistent stomach pain or discomfort; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include dizziness or light-headedness; fast or difficult breathing; feeling of being unusually cold; general feeling of being unwell; muscle pain or tenderness; slow or irregular heartbeat; unusual drowsiness; unusual stomach discomfort; unusual weakness or tiredness.

Proper storage of saxagliptin/metformin extended-release tablets:

Store saxagliptin/metformin extended-release tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep saxagliptin/metformin extended-release tablets out of the reach of children and away from pets.

General information:

  • If you have any questions about saxagliptin/metformin extended-release tablets, please talk with your doctor, pharmacist, or other health care provider.
  • Saxagliptin/metformin extended-release tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take saxagliptin/metformin extended-release tablets or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about saxagliptin/metformin extended-release tablets. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to saxagliptin/metformin extended-release tablets. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using saxagliptin/metformin extended-release tablets.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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