How to Take Kombiglyze XR

Who should not take KOMBIGLYZE XR?

Do not take KOMBIGLYZE XR if you:

  • Have kidney problems.
  • Are allergic to metformin hydrochloride, saxagliptin, or any of the ingredients in KOMBIGLYZE XR (saxagliptin and metformin HCI extended-release). See the Medication Guide for a complete list of ingredients in KOMBIGLYZE XR.
  • Symptoms of a serious allergic reaction of KOMBIGLYZE XR may include:
    • Swelling of your face, lips, throat, and other areas on your skin
    • Difficulty with swallowing or breathing
    • Raised, red areas on your skin (hives)
    • Skin rash, itching, flaking, or peeling
  • If you have these symptoms, stop taking KOMBIGLYZE XR and contact your doctor right away.
  • Have a condition called metabolic acidosis or diabetic ketoacidosis (increased ketones in the blood or urine).
5 mg saxagliptin/
500 mg metformin XR
5 mg saxagliptin/
1000 mg metformin XR
2.5 mg saxagliptin/
1000 mg metformin XR
5 mg saxagliptin and
2000 mg metformin XR
Two 2.5/1000 mg tablets taken as 1 dose for a total of 5 mg saxagliptin and
2000 mg metformin (Maximum dose)

    All tablets shown not actual size

Kombiglyze XR should generally be taken once a day with the evening meal to help lessen an upset stomach side effect.

Your doctor should do blood tests to check how well your kidneys are working before and during your treatment with Kombiglyze XR.

If you take Kombiglyze XR with another medicine that can cause low blood sugar, such as sulfonylureas or insulin, you have a higher risk of having low blood sugar. Symptoms of low blood sugar include shaking, sweating, rapid heartbeat, change in vision, hunger, headache, and change in mood. Follow your doctor's instructions for treating low blood sugar.

  • Kombiglyze XR tablets must be swallowed whole; do not crush, cut, or chew
  • You may sometimes pass the inactive ingredients of Kombiglyze XR as a soft mass in your bowel movements, which may look like the original tablet. This is not unusual
Stay on your prescribed diet and exercise program while taking Kombiglyze XR.

If you miss a dose of Kombiglyze XR

  • Take your next dose as prescribed, unless your doctor tells you differently
  • Do not take an extra dose the next day

If you take too much Kombiglyze XR

  • Call your doctor, local Poison Control Center, or go to the nearest hospital emergency room right away

Need help talking with your doctor about type 2 diabetes? The Doctor Discussion Guide can help.

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Kombiglyze XR FAQs
Find answers to your questions about helping adults with type 2 diabetes manage their blood sugar numbers.
IMPORTANT SAFETY INFORMATION for KOMBIGLYZE XR (saxagliptin and metformin HCI extended-release) tablets

Lactic Acidosis: Metformin hydrochloride, one of the medicines in KOMBIGLYZE XR, can cause a rare, but serious, side effect called lactic acidosis (a build-up of lactic acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital. Stop taking KOMBIGLYZE XR and call your doctor right away if you get any of the following symptoms of lactic acidosis: feel very weak and tired, unusual (not normal) muscle pain, trouble breathing, unusual sleepiness or sleep longer than usual, unexplained stomach or intestinal problems with nausea and vomiting or diarrhea, feel cold (especially in your arms and legs), dizzy or lightheaded, or have a slow or irregular heartbeat.

You have a higher chance of getting lactic acidosis if you have kidney or liver problems, have congestive heart failure that requires treatment with medicines, drink a lot of alcohol (very often or short-term “binge” drinking), get dehydrated (lose a large amount of body fluids), have certain x-ray tests with injectable dyes or contrast agents, have surgery, have a heart attack, severe infection, or stroke, or are 80 years of age or older and have not had your kidney function tested.

Do not take KOMBIGLYZE XR if you have kidney problems, have a condition called metabolic acidosis or diabetic ketoacidosis (increased ketones in the blood or urine), or are allergic to metformin hydrochloride, saxagliptin, or any of the ingredients in KOMBIGLYZE XR. Serious allergic reactions can occur with KOMBIGLYZE XR and may include swelling of the face, lips or throat, difficulty swallowing or breathing, swelling of the skin, hives, rash, itching, flaking, or peeling. If you have these symptoms, stop taking KOMBIGLYZE XR and contact your doctor right away.

Serious side effects can happen to people taking KOMBIGLYZE XR, including inflammation of the pancreas (pancreatitis) which may be severe and lead to death. Before taking KOMBIGLYZE XR, tell your doctor if you ever had pancreatitis, gallstones, history of alcoholism, or high triglyceride levels. Stop taking KOMBIGLYZE XR and contact your doctor 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.

Your doctor should do blood tests to check how well your kidneys are working before and during your treatment with KOMBIGLYZE XR.

If you take KOMBIGLYZE XR with another medicine that can cause low blood sugar (hypoglycemia), such as sulfonylureas or insulin, you have a higher risk of having low blood sugar. Symptoms of low blood sugar include, shaking, sweating, rapid heartbeat, change in vision, hunger, headache and change in mood. Follow your doctor's instructions for treating low blood sugar.

The most common side effects of KOMBIGLYZE XR include upper respiratory tract infection, stuffy or runny nose and sore throat, urinary tract infection, headache, diarrhea, and nausea and vomiting.

Tell your doctor if you will be starting or stopping certain other types of medicines, such as antibiotics, or medicines that treat fungus or HIV/AIDS, as your doctor may need to change your dose of KOMBIGLYZE XR.

Tell your doctor if you are pregnant, breast-feeding, or plan to become pregnant or breast-feed.

Swallow KOMBIGLYZE XR whole; do not crush, cut, or chew.

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 click here for Medication Guide, and click here for US Full Prescribing Information for KOMBIGLYZE XR, including Boxed WARNING about lactic acidosis.

WHAT IS KOMBIGLYZE XR?

KOMBIGLYZE XR is a prescription medicine that contains saxagliptin and metformin hydrochloride. KOMBIGLYZE XR is used with diet and exercise to help control high blood sugar (hyperglycemia) in adults with type 2 diabetes. Your doctor will decide if treatment with both saxagliptin and metformin is right for you.

KOMBIGLYZE XR should not be used to treat people with type 1 diabetes or diabetic ketoacidosis (increased ketones in the blood or urine).

If you have had inflammation of the pancreas (pancreatitis), it is not known if you have a higher chance of getting pancreatitis while taking KOMBIGLYZE XR.