metformin and rosiglitazone

Generic Name: metformin and rosiglitazone (met FOR min and ROE zi GLI ta zone)
Brand Name: Avandamet

What is metformin and rosiglitazone?

Metformin and rosiglitazone is a combination of two oral diabetes medicines that help control blood sugar levels. This medicine is for people with type 2 diabetes, and is not for treating type 1 diabetes.

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

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

You should not use this medicine if you have severe or uncontrolled heart failure, or severe kidney problems. Do not use this medicine if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin). Metformin and rosiglitazone is not recommended for use with insulin, and is not for treating type 1 diabetes.

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If you need to have 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 rosiglitazone.

Metformin and rosiglitazone can cause or worsen congestive heart failure. Call your doctor at once if you have shortness of breath (even with mild exertion), swelling, or rapid weight gain.

This medicine 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, fast or uneven heart rate, dizziness, or feeling very weak or tired.

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

You should not use metformin and rosiglitazone if you are allergic to it, or if you have:

  • severe or uncontrolled heart failure;

  • severe kidney problems;

  • metabolic acidosis; or

  • if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

If you need to have 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 rosiglitazone.

Some people develop a life-threatening condition called lactic acidosis while taking metformin. You may be more likely to develop lactic acidosis 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 individual risk.

To make sure this medication is safe for you, tell your doctor if you have:

  • heart disease, or a history of heart attack or stroke;

  • liver disease; or

  • eye problems caused by diabetes.

Taking this medicine may increase your risk of heart problems. However, not treating your diabetes can damage your heart and other organs. Talk to your doctor about the risks and benefits of treating your diabetes with metformin and rosiglitazone.

Women may be more likely than men to have bone fractures in the upper arm, hand, or foot while taking medicine that contains rosiglitazone. Talk with your doctor if you are concerned about this possibility.

FDA pregnancy category C. It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Some women using metformin and rosiglitazone have started having menstrual periods, even after not having a period for a long time due to a medical condition. You may be able to get pregnant if your periods restart. Talk with your doctor about the need for birth control.

It is not known whether metformin and rosiglitazone passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How should I take metformin and rosiglitazone?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take this medicine with food if it upsets your stomach.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office.

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.

If you take extra vitamin B12 while you are taking metformin and rosiglitazone, take only the amount of vitamin B12 that your doctor has prescribed.

Metformin and rosiglitazone is only part of a treatment program that may also include diet, exercise, weight control, 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 missed dose as soon as you remember. 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.

What should I avoid while taking metformin and rosiglitazone?

Avoid drinking alcohol while taking metformin and rosiglitazone.

Metformin and rosiglitazone side effects

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.

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, fast or uneven heart rate, dizziness, or feeling very weak or tired.

Call your doctor at once if you have:

  • chest pain or heavy feeling, pain spreading to the jaw or shoulder, nausea, sweating, general ill feeling;

  • sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

  • shortness of breath (even with mild exertion), swelling, rapid weight gain;

  • pale skin, easy bruising or bleeding, weakness;

  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

  • changes in your vision.

Common side effects may include:

  • cold symptoms such as stuffy nose, sneezing, sore throat;

  • headache; or

  • upset stomach, diarrhea.

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)

Metformin and rosiglitazone dosing information

Usual Adult Dose for Diabetes Type 2:

Individualize dose based on safety, efficacy, and prior therapy; asses the risk versus benefit of initiating with combination therapy versus monotherapy

-Initial dose: rosiglitazone 2 mg/metformin 500 mg orally once or twice a day
-If glycosylated hemoglobin (HbA1c) is greater than 11% or fasting plasma glucose (FPG) is greater than 270 mg/dL: consider a starting dose of rosiglitazone 2 mg/metformin 500 mg orally twice a day
Titration: Increase in increments of rosiglitazone 2 mg/metformin 500 mg per day in divided doses if not adequately controlled after 4 weeks

Patients Inadequately Controlled on Rosiglitazone Monotherapy:
-Initial dose: Current rosiglitazone dose plus metformin 1000 mg per day orally in 2 divided doses
Patients Inadequately Controlled on Metformin Monotherapy:
-Initial dose: Current metformin dose plus rosiglitazone 4 mg per day orally in 2 divided doses
Patients currently receiving rosiglitazone and metformin as individual components:
-Switch to combination product containing the same dose of each component

-Titration: Allow sufficient time to assess adequacy of response; increase in increments of rosiglitazone 4 mg/metformin 500 mg per day in divided doses; allow 1 to 2 weeks to assess metformin dose increase; allow 8 to 12 weeks to assess rosiglitazone dose increase
-Maximum dose: rosiglitazone 8 mg/metformin 2000 mg per day

Comments:
-This drug should be given in divided doses with meals.
-Gradual dose escalation is recommended in order to reduce the gastrointestinal side effects of metformin and allow for determination of the minimum effective dose.
-Coadministration with insulin is not recommended.

Use: To improve glycemic control in adult patients with type 2 diabetes mellitus as an adjunct to diet and exercise.

What other drugs will affect metformin and rosiglitazone?

Tell your doctor if you use insulin. Taking metformin and rosiglitazone while you are using insulin may increase your risk of serious heart problems.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with metformin and rosiglitazone, especially:

  • cimetidine;

  • gemfibrozil; or

  • an antibiotic--rifampin, trimethoprim, vancomycin.

You may be more likely to have hyperglycemia (high blood sugar) if you also take other drugs that can raise blood sugar, such as:

  • isoniazid;

  • steroids (prednisone and others);

  • niacin (Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others);

  • phenothiazines (Compazine and others);

  • thyroid medicine (Synthroid and others);

  • birth control pills and other hormones; and

  • diet pills or medicines to treat asthma, colds or allergies.

These lists are not complete and many other medicines can increase or decrease the effects of metformin and rosiglitazone on lowering your blood sugar. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

  • Your pharmacist can provide more information about metformin and rosiglitazone.
  • 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.
  • Disclaimer: 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.

Copyright 1996-2012 Cerner Multum, Inc. Version: 12.01. Revision Date: 2014-03-05, 9:17:01 PM.

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