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Kombiglyze XR


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

What is Kombiglyze XR?

Kombiglyze XR contains a combination of metformin and saxagliptin. 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.

Kombiglyze XR is used to treat type 2 diabetes.

Kombiglyze XR is not for treating type 1 diabetes.

Important information

You should not use Kombiglyze XR if you have kidney disease, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

Slideshow: 10 Things to Know About Metformin

Some people develop lactic acidosis while taking metformin. Early symptoms may get worse over time and this condition can be fatal. Stop taking Kombiglyze XR and get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, trouble breathing, stomach pain, nausea, and feeling very weak or tired.

Before taking this medicine

You should not use Kombiglyze XR 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).

Some people taking Kombiglyze XR develop a serious condition called lactic acidosis. This may be more likely if you have liver or kidney disease, congestive heart failure, a severe infection, if you are dehydrated, or if you drink large amounts of alcohol. Talk with your doctor about your risk.

To make sure Kombiglyze XR is safe for you, tell your doctor if you have:

  • liver disease;

  • heart disease;

  • pancreatitis;

  • high triglycerides (a type of fat in the blood);

  • gallstones;

  • a history of alcoholism; or

  • if you are over 80 years old and have not recently had your kidney function checked.

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 Kombiglyze XR. Be sure your caregivers know ahead of time that you are using this medication.

Kombiglyze XR is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether this medicine passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Kombiglyze XR is not approved for use by anyone younger than 18 years old.

How should I take Kombiglyze XR?

Take Kombiglyze XR exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take Kombiglyze XR with a meal.

Do not crush, chew, or break a Kombiglyze XR extended-release tablet. Swallow it whole.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, pale skin, irritability, dizziness, feeling shaky, or trouble concentrating. Always keep a source of sugar with you in case you have low blood sugar. Sugar sources include fruit juice, hard candy, crackers, raisins, and non-diet soda. Be sure your family and close friends know how to help you in an emergency.

If you have severe hypoglycemia and cannot eat or drink, use a glucagon injection. Your doctor can prescribe a glucagon emergency injection kit and tell you how to use it.

Check your blood sugar carefully during times of stress, travel, illness, surgery or medical emergency, vigorous exercise, or if you drink alcohol or skip meals. These things can affect your glucose levels and your dose needs may also change. Do not change your medication dose or schedule without your doctor's advice.

Your doctor may want you to stop taking Kombiglyze XR for a short time if you become ill, have a fever or infection, or if you have surgery or a medical emergency.

Kombiglyze XR is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, and eye care. Follow your diet, medication, and exercise routines very closely.

Store Kombiglyze XR at room temperature away from moisture and heat.

Kombiglyze XR dosing information

Usual Adult Dose for Diabetes Type 2:

Individualize dose based patient's current regimen, effectiveness, and tolerability; gradual dose titration of metformin is advised to reduce gastrointestinal side effects.

Saxagliptin-Metformin XR:
Usual dose: 1 tablet orally once a day with the evening meal
Maximum dose: saxagliptin 5 mg-metformin 2000 mg orally once a day
Maximum dose with concomitant strong CYP450 3A4/5 inhibitors: saxagliptin 2.5-metformin 1000 mg orally once a day

-Patients not currently treated with metformin: Initial dose saxagliptin 5 mg-metformin 500 mg orally once daily
-Patients currently treated with metformin: Initial dose: saxagliptin 5 mg plus the dose of metformin that is already being taken, or the nearest therapeutically appropriate dose.

-Patients requiring saxagliptin 2.5 mg per day AND are either metformin-naive or require a dose of metformin greater than 1000 mg per day should use the individual components.
-Following a switch from metformin immediate-release to metformin extended release, glycemic control should be closely monitored and dosage adjustments made according.
-When used in combination with a sulfonylurea or insulin, a lower dose of the sulfonylurea or insulin may be considered to reduce the risk of hypoglycemia.
-Note: There are saxagliptin-metformin combination products available internationally that contain immediate-release metformin; saxagliptin-metformin products containing immediate-release metformin should be dosed twice a day.

Use: An adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes when treatment with both saxagliptin and metformin is appropriate.

What happens if I miss a dose?

Take the missed dose as soon as you remember (be sure to take the medicine with food). Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. You may have signs of low blood sugar, such as extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, and seizure (convulsions).

What should I avoid while taking Kombiglyze XR?

Avoid drinking alcohol. It lowers blood sugar and may increase your risk of lactic acidosis.

Kombiglyze XR side effects

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

Stop taking Kombiglyze XR and call your doctor right away if you have symptoms of pancreatitis: severe pain in your upper stomach spreading to your back, nausea and vomiting, loss of appetite, or fast heartbeats.

Some people develop lactic acidosis while taking metformin. Early symptoms may get worse over time and this condition can be fatal. Stop taking this medicine and get emergency medical help if you have even mild symptoms such as:

  • muscle pain or weakness;

  • numb or cold feeling in your arms and legs;

  • trouble breathing;

  • feeling dizzy, light-headed, tired, or very weak;

  • stomach pain, nausea with vomiting; or

  • slow or uneven heart rate.

Call your doctor at once if you have:

  • severe or ongoing pain in your joints; or

  • pain or burning when you urinate.

Common Kombiglyze XR 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.

See also: Side effects (in more detail)

What other drugs will affect Kombiglyze XR?

Other drugs may increase or decrease the effects of Kombiglyze XR on lowering your blood sugar. Tell your doctor about all your current medicines and any you start or stop using, especially:

  • an antibiotic or antifungal medicine;

  • insulin or oral diabetes medicine; or

  • medicine to treat HIV or AIDS.

This list is not complete. Other drugs may interact with metformin and saxagliptin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your pharmacist can provide more information about Kombiglyze XR.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Kombiglyze XR only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2015 Cerner Multum, Inc. Version: 4.02. Revision Date: 2015-09-09, 2:08:29 PM.