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metformin and saxagliptin

Pronunciation: met FOR min and SAX a GLIP tin

Brand: Kombiglyze XR

Kombiglyze 2.5 mg-1000 mg

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Kombiglyze 5 mg-1000 mg

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oval, pink, imprinted with 5/1000, 4223

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Kombiglyze 5 mg-500 mg

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What is the most important information I should know about metformin and saxagliptin?

You should not use this medicine if you have severe kidney disease or diabetic ketoacidosis (call your doctor for treatment).

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. Call your doctor or get emergency medical help if you have unusual muscle pain, trouble breathing, stomach pain, dizziness, feeling cold, or feeling very weak or tired.

What is 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.

Metformin and saxagliptin is a combination medicine that is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. This medicine is not for treating type 1 diabetes.

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

What should I discuss with my healthcare provider before taking metformin and saxagliptin?

You should not use this medicine if you are allergic to metformin or saxagliptin (Onglyza), or if you have severe kidney disease or diabetic ketoacidosis (call your doctor for treatment with insulin).

Tell your doctor if you have ever had:

  • kidney disease (your kidney function may need to be checked before you take this medicine);
  • liver disease;
  • heart disease;
  • pancreatitis;
  • high triglycerides (a type of fat in the blood);
  • gallstones; or
  • alcoholism.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, a severe infection, chronic alcoholism, or if you are 65 or older. Ask your doctor about your risk.

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

Follow your doctor's instructions about using this medicine if you are pregnant or breast-feeding a baby. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester of pregnancy. Your dose needs may also be different while you are breast-feeding.

Metformin may stimulate ovulation in a premenopausal woman and may increase the risk of unintended pregnancy. Talk to your doctor about your risk.

This medicine is not approved for use by anyone younger than 18 years old.

How should I take metformin and saxagliptin?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take metformin and saxagliptin with food.

Swallow the tablet whole and do not crush, chew, or break it.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, irritability, dizziness, nausea, and feeling shaky. To quickly treat low blood sugar, always keep a fast-acting source of sugar with you such as fruit juice, hard candy, crackers, raisins, or non-diet soda.

Your doctor can prescribe a glucagon emergency injection kit to use in case you have severe hypoglycemia and cannot eat or drink. Be sure your family and close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination, blurred vision, headache, and tiredness.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

This medicine is only part of a complete treatment program that may also include diet, exercise, weight control, regular blood sugar testing, and special medical care. Follow your doctor's instructions very closely.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the medicine (with food) as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. You may have severely low blood sugar (extreme weakness, nausea, tremors, sweating, confusion, trouble speaking, fast heartbeats, or seizure).

What should I avoid while taking metformin and saxagliptin?

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

What are the possible side effects of metformin and saxagliptin?

Get emergency medical help if you have signs of an allergic reaction: hives, itching, peeling skin; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop taking this medicine 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 using metformin develop lactic acidosis, which can be fatal. Get emergency medical help if you have even mild symptoms such as:

  • unusual muscle pain;
  • feeling cold;
  • trouble breathing;
  • feeling dizzy, light-headed, tired, or very weak;
  • stomach pain, vomiting; or
  • irregular heart rate.

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

  • severe autoimmune reaction --itching, blisters, breakdown of the outer layer of skin;
  • severe or ongoing pain in your joints;
  • pain or burning when you urinate; or
  • symptoms of heart failure --shortness of breath (even while lying down), swelling in your legs or feet, rapid weight gain.

Common side effects may include:

  • diarrhea, 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.

What other drugs will affect metformin and saxagliptin?

Many drugs can affect metformin and saxagliptin, making this medicine less effective or increasing your risk of lactic acidosis.

Tell your doctor about all your other medicines, 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 affect metformin and saxagliptin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your pharmacist can provide more information about metformin and saxagliptin.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. 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. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. 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.

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