Rosiglitazone/metformin (By mouth)
Metformin Hydrochloride (met-FOR-min hye-droe-KLOR-ide), Rosiglitazone Maleate (roe-zi-GLI-ta-zone MAL-ee-ate)
Treats type 2 diabetes. Used together with diet and exercise to help control your blood sugar.
There may be other brand names for this medicine.
When This Medicine Should Not Be Used
You should not use this medicine if you have had an allergic reaction to rosiglitazone or metformin, or if you have type 1 diabetes or diabetic ketoacidosis (ketones in the blood). You should not use this medicine if you have kidney disease, severe heart failure, or metabolic acidosis (extra acid in the blood).
How to Use This Medicine
- Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
- It is best to take this medicine with food or milk.
- It may take up to 2 weeks for this medicine to start lowering your blood sugar. It may be 2 to 3 months before you get the full effect from the medicine.
- Carefully follow your doctor's instructions about any special diet.
- This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one. Your doctor might ask you to sign some forms to show that you understand this information.
If a dose is missed:
- If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.
How to Store and Dispose of This Medicine
- Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
- Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine after you have finished your treatment. You will also need to throw away old medicine after the expiration date has passed.
- Keep all medicine away from children and never share your medicine with anyone.
Drugs and Foods to Avoid
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.
- Make sure your doctor knows if you are using other medicines to treat your diabetes (such as insulin) or nitrate medicines (such as isosorbide, nitroglycerin, Imdur®, Isordil®, Nitrostat®, or Tridil®).
- Make sure your doctor knows if you also use digoxin (Lanoxin®), gemfibrozil (Lopid®), isoniazid (Nydrazid®), morphine, nicotinic acid (Nicobid®, Nicolar®), phenytoin (Dilantin®), procainamide (Procanbid®, Pronestyl®), quinidine (Quinidex®), quinine, ranitidine (Zantac®), rifampin (Rifadin®), trimethoprim (Bactrim®, Primsol®, Proloprim®, Septra®), or vancomycin (Vancocin®, Vancoled®).
- Tell your doctor if you use asthma medicine, decongestants, diuretics or "water pills" (such as amiloride, furosemide, triamterene, Dyrenium®, or Lasix®), a steroid medicine (such as dexamethasone, prednisolone, prednisone, or Medrol®), a phenothiazine medicine (such as prochlorperazine, Compazine®, Mellaril®, Phenergan®, Thorazine®, or Trilafon®), thyroid replacement (such as levothyroxine, liothyronine, Cytomel®, or Synthroid®), estrogen hormones (Premarin®), or birth control pills. Make sure your doctor knows if you use heart or blood pressure medicine (such as amlodipine, nifedipine, verapamil, Adalat®, Cardizem®, Lotrel®, Norvasc®, Procardia®, or Tiazac®).
- Do not drink alcohol while you are using this medicine.
Warnings While Using This Medicine
- Make sure your doctor knows if you are pregnant or breastfeeding, or if you have any kind of heart disease, heart failure, high cholesterol, or a history of a heart attack. Also tell your doctor if you have liver disease, edema (problems with fluid retention or swelling), an eye disease such as macular edema (swelling of the back of the eye), or fragile bones (especially women).
- Check with your doctor right away if you start having chest pain; shortness of breath; excessive swelling of the hands, wrist, ankles, or feet; or if you are rapidly gaining weight. These may be symptoms of a serious heart problem.
- This medicine may cause a rare, but serious condition called lactic acidosis in some people. Call your doctor right away if you get sick, or if you have unusual tiredness, weakness, muscle pain, stomach pain, trouble breathing, fever, or nausea.
- Your doctor will need to check your blood or urine at regular visits while you are using this medicine. Be sure to keep all appointments.
- Tell your doctor right away if you have a loss of appetite, nausea, vomiting, stomach pain, unusual tiredness or weakness, dark urine, or yellow eyes or skin. These may be signs of liver problems.
- Women: If you have had problems ovulating before, this medicine may cause you to ovulate. This could increase your chance of becoming pregnant. Talk with your doctor if you have questions or concerns about this.
- This medicine may increase the risk of bone fractures in women. Ask your doctor about ways to keep your bones strong to help prevent fractures.
- Check with your doctor if blurred vision, decreased vision, or any other change in vision occurs during your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
- If your blood sugar gets too low, you may feel weak, drowsy, confused, anxious, or very hungry. You may also sweat, shake, or have blurred vision, a fast heartbeat, or a headache that will not go away. If you have symptoms of low blood sugar (hypoglycemia), check your blood sugar. If your blood sugar is 70 mg/dL (milligrams per deciliter) or below, do one of the following: Drink 4 ounces (one-half cup) of fruit juice, or eat 5 to 6 pieces of hard candy, or take 2 to 3 glucose tablets. Recheck your blood sugar 15 minutes later. If your blood sugar goes above 70 mg/dL, eat a snack or a meal. If your blood sugar is still below 70 mg/dL, drink one-half cup juice, or eat 5 to 6 pieces of candy, or take 2 to 3 glucose tablets. Carry candy or some type of sugar with you at all times, especially if you are away from home. You can take this if you feel that your blood sugar is too low, even if you do not have a blood glucose meter. Always carefully follow your doctor's instructions about how to treat your low blood sugar. Learn what to do if your blood sugar gets too low. Teach friends, coworkers, and family members what they can do to help if you have low blood sugar.
- Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.
- This medicine is only part of a complete program for controlling diabetes. You can also help yourself by eating a healthy diet, watching your weight, and getting regular exercise.
Possible Side Effects While Using This Medicine
Call your doctor right away if you notice any of these side effects:
- Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing.
- Blistering, peeling, or red skin rash.
- Blurred vision or other changes in vision.
- Chest pain, which may spread to your arm, jaw, or back.
- Dark-colored urine or pale stools.
- Extreme weakness, tiredness, or confusion.
- Fast, pounding, or uneven heartbeat.
- Lightheadedness, dizziness, shakiness, or hunger.
- Nausea, vomiting, loss of appetite, or pain in your upper stomach.
- Rapid breathing, trouble breathing, and muscle pain.
- Rapid weight gain.
- Shortness of breath, cold sweats, and bluish-colored skin.
- Swelling in your hands, ankles, or feet.
- Unusual bleeding or bruising.
- Yellowing of your skin or the whites of your eyes.
If you notice these less serious side effects, talk with your doctor:
- Back pain.
- Cough, runny nose, sneezing, or sore throat.
- Mild skin rash or itching.
If you notice other side effects that you think are caused by this medicine, tell your doctor
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088
Review Date: 2011-02-04
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