Kombiglyze XR

Pronunciation

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. This medication is not for treating type 1 diabetes.

Kombiglyze XR may also be used for purposes not listed in this medication guide.

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).

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 this medicine.

Slideshow: Flashback: FDA Drug Approvals 2013

Kombiglyze XR may cause a serious condition called lactic acidosis. 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, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or 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).

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.

Some people taking this medicine 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.

Certain oral diabetes medications may increase your risk of serious heart problems. However, not treating your diabetes can damage your heart and other organs. Talk to your doctor about the risks and benefits of taking Kombiglyze XR.

FDA pregnancy category B. Kombiglyze XR is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

See also: Pregnancy and breastfeeding warnings (in more detail)

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.

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 an 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.

This medicine 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.

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?

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

Kombiglyze XR side effects

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

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

Stop using this medicine and call your doctor at once if you have:

  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;

  • pain or burning when you urinate; or

  • swelling or rapid weight gain.

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 medications you use. This includes 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. Drug information contained herein may be time sensitive. 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 absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.

Copyright 1996-2014 Cerner Multum, Inc. Version: 4.01. Revision Date: 2013-07-02, 2:50:34 PM.

Hide
(web2)