Brand Names: Kombiglyze XR

Generic Name: metformin and saxagliptin (Pronunciation: met FOR min and SAX a GLIP tin)

• What is metformin and saxagliptin (Kombiglyze XR)?
• What are the possible side effects of metformin and saxagliptin (Kombiglyze XR)?
• What is the most important information I should know about metformin and saxagliptin (Kombiglyze XR)?
• What should I discuss with my healthcare provider before taking metformin and saxagliptin (Kombiglyze XR)?
• How should I take metformin and saxagliptin (Kombiglyze XR)?
• What happens if I miss a dose (Kombiglyze XR)?
• What happens if I overdose (Kombiglyze XR)?
• What should I avoid while taking metformin and saxagliptin (Kombiglyze XR)?
• What other drugs will affect metformin and saxagliptin (Kombiglyze XR)?
• Where can I get more information?

What is metformin and saxagliptin (Kombiglyze XR)?

Metformin and saxagliptin are oral diabetes medicines that help control blood sugar levels. Metformin works by decreasing glucose (sugar) production in the liver and decreasing absorption of glucose by the intestines. Saxagliptin works by regulating the levels of insulin your body produces after eating.

The combination of metformin and saxagliptin is used to treat type 2 diabetes. This medication is not for treating type 1 diabetes.

Metformin and saxagliptin may also be used for purposes not listed in this medication guide.

What are the possible side effects of metformin and saxagliptin (Kombiglyze XR)?

This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or irregular heart rate, dizziness, or feeling very weak or tired.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• pain or burning when you urinate; or
• swelling or rapid weight gain.

Less serious side effects may include:

• diarrhea, mild nausea;
• headache; or
• cold symptoms such as runny or stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Kombiglyze XR (saxagliptin and metformin hcl extended-release) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about metformin and saxagliptin (Kombiglyze XR)?

You should not use this medication if you are allergic to metformin (Actoplus Met, Avandamet, Fortamet, Glucophage, Riomet) or saxagliptin (Onglyza), if you have kidney disease, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

If you need to have surgery or any type of x-ray or CT scan using a dye that is injected into your veins, you will need to temporarily stop taking metformin and saxagliptin.

Some people develop lactic acidosis while taking metformin. Early symptoms may get worse over time and this condition can be fatal. Get emergency medical help if you have: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or irregular heart rate, dizziness, or feeling very weak or tired.