• Metformin

    (met for' min)

    IMPORTANT WARNING:

    Metformin may rarely cause a serious, life-threatening condition called lactic acidosis. Tell your doctor if you are over 80 years old and if you have ever had a heart attack; stroke; diabetic ketoacidosis (blood sugar that is high enough to cause severe symptoms and requires emergency medical treatment) or coma; or heart, kidney, or liver disease.
    Tell your doctor if you have recently had any of the following conditions, or if you develop them during treatment: serious infection; severe diarrhea, vomiting, or fever; or if you drink much less fluid than usual for any reason. You may have to stop taking metformin until you recover.
    If you are having surgery, including dental surgery, any x-ray procedure in which dye is injected, or any major medical procedure, tell the doctor that you are taking metformin. You may need to stop taking metformin before the procedure and wait 48 hours to restart treatment. Your doctor will tell you exactly when you should stop taking metformin and when you should start taking it again.
    If you experience any of the following symptoms, stop taking metformin and call your doctor immediately: extreme tiredness, weakness, or discomfort; nausea; vomiting; stomach pain; decreased appetite; deep and rapid breathing or shortness of breath; dizziness; lightheadedness; fast or slow heartbeat; flushing of the skin; muscle pain; or feeling cold.
    Tell your doctor if you regularly drink alcohol or sometimes drink large amounts of alcohol in a short time (binge drinking). Drinking alcohol increases your risk of developing lactic acidosis or may cause a decrease in blood sugar. Ask your doctor how much alcohol is safe to drink while you are taking metformin.
    Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to metformin. Talk to your doctor about the risk(s) of taking metformin.

    WHY is this medicine prescribed?

    Metformin is used alone or with other medications, including insulin, to treat type 2 diabetes (condition in which the body does not use insulin normally and, therefore, cannot control the amount of sugar in the blood). Metformin is in a class of drugs called biguanides. Metformin helps to control the amount of glucose (sugar) in your blood. It decreases the amount of glucose you absorb from your food and the amount of glucose made by your liver. Metformin also increases your body's response to insulin, a natural substance that controls the amount of glucose in the blood. Metformin is not used to treat type 1 diabetes (condition in which the body does not produce insulin and therefore cannot control the amount of sugar in the blood).

    HOW should this medicine be used?

    Metformin comes as a liquid, a tablet, and an extended-release (long-acting) tablet to take by mouth. The liquid is usually taken with meals one or two times a day. The regular tablet is usually taken with meals two or three times a day. The extended-release tablet is usually taken once daily with the evening meal. To help you remember to take metformin, take it around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take metformin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
    Swallow metformin extended-release tablets whole; do not split, chew, or crush them.
    Your doctor may start you on a low dose of metformin and gradually increase your dose not more often than once every 1–2 weeks. You will need to monitor your blood sugar carefully so your doctor will be able to tell how well metformin is working.
    Metformin controls diabetes but does not cure it. Continue to take metformin even if you feel well. Do not stop taking metformin without talking to your doctor.
    Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

    Are there OTHER USES for this medicine?

    This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

    What SPECIAL PRECAUTIONS should I follow?

    Before taking metformin,
    • tell your doctor and pharmacist if you are allergic to metformin, any of the ingredients of metformin liquid or tablets, or any other medications. Ask your pharmacist or check the manufacturer's patient information for a list of the ingredients.
    • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: acetazolamide(Diamox); amiloride (Midamor, in Moduretic); angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), and trandolapril (Mavik); beta-blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal); calcium channel blockers such as amlodipine (Norvasc), diltiazem (Cardizem, Dilacor, Tiazac, others), felodipine (Plendil), isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat, Procardia), nimodipine (Nimotop), nisoldipine (Sular), and verapamil (Calan, Isoptin, Verelan); cimetidine (Tagamet); digoxin (Lanoxin); diuretics ('water pills'); furosemide (Lasix); hormone replacement therapy; insulin or other medications for diabetes; isoniazid; medications for asthma and colds; medications for mental illness and nausea; medications for thyroid disease; morphine (MS Contin, others); niacin; oral contraceptives ('birth control pills'); oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone); phenytoin (Dilantin, Phenytek); procainamide (Procanbid); quinidine; quinine; ranitidine (Zantac); topiramate (Topamax); triamterene (Dyazide, Maxzide, others); trimethoprim (Primsol); vancomycin (Vancocin); or zonisamide (Zonegran). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
    • tell your doctor if you have or have ever had any medical condition, especially those mentioned in the IMPORTANT WARNING section.
    • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking metformin, call your doctor.
    • tell your doctor if you eat less or exercise more than usual. This can affect your blood sugar. Your doctor will give you instructions if this happens.

    What SPECIAL DIETARY instructions should I follow?

    Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. It is important to eat a healthful diet.

    What should I do IF I FORGET to take a dose?

    Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

    What SIDE EFFECTS can this medicine cause?

    This medication may cause changes in your blood sugar. You should know the symptoms of low and high blood sugar and what to do if you have these symptoms.
    Metformin may cause side effects. Tell your doctor if any of these symptoms are severe, do not go away, go away and come back, or do not begin for some time after you begin taking metformin:
    • diarrhea
    • bloating
    • stomach pain
    • gas
    • indigestion
    • constipation
    • unpleasant metallic taste in mouth
    • heartburn
    • headache
    • flushing of the skin
    • nail changes
    • muscle pain
    Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency treatment:
    • chest pain
    • rash
    Some female laboratory animals given high doses of metformin developed non-cancerous polyps (abnormal growths of tissue) in the uterus (womb). It is not known if metformin increases the risk of polyps in humans. Talk to your doctor about the risks of taking this medication.
    Metformin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

    What should I know about STORAGE and DISPOSAL of this medication?

    Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat, and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

    What should I do in case of OVERDOSE?

    In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
    Symptoms of overdose may include hypoglycemia symptoms as well as the following:
    • extreme tiredness
    • weakness
    • discomfort
    • vomiting
    • nausea
    • stomach pain
    • decreased appetite
    • deep, rapid breathing
    • shortness of breath
    • dizziness
    • lightheadedness
    • abnormally fast or slow heartbeat
    • flushing of the skin
    • muscle pain
    • feeling cold

    What OTHER INFORMATION should I know?

    Your doctor will tell you how to check your response to this medication by measuring your blood sugar levels at home. Follow these instructions carefully.
    If you are taking the extended-release tablets, you may notice something that looks like a tablet in your stool. This is just the empty tablet shell, and this does not mean that you did not get your complete dose of medication.
    You should always wear a diabetic identification bracelet to be sure you get proper treatment in an emergency.
    Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
    It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

    Brand Names

    • Fortamet®
    • Glucophage®
    • Glumetza®
    • Riomet®
    • Actoplus Met® (as a combination product containing Metformin, Pioglitazone)
    • Avandamet® (as a combination product containing Metformin, Rosiglitazone)
    • Janumet® (as a combination product containing Metformin, Sitagliptin)
    • Jentadueto® (as a combination product containing Linagliptin, Metformin)
    • Kombiglyze® XR (as a combination product containing Metformin, Saxagliptin)
    • Metaglip® (as a combination product containing Glipizide, Metformin)[¶]
    • Prandimet® (as a combination product containing Metformin, Repaglinide)
    • Also available generically
    This branded product is no longer on the market. Generic alternatives may be available.

    Rosiglitazone

    (roe si gli' ta zone)

    IMPORTANT WARNING:

    Rosiglitazone may cause fluid retention (a condition where the body keeps excess fluid) that may lead to or worsen congestive heart failure (condition in which the heart is unable to pump enough blood to the other parts of the body). Before you start to take rosiglitazone, tell your doctor if you have or have ever had congestive heart failure, especially if your heart failure is so severe that you must limit your activity and are only comfortable when you are at rest or you must remain in a chair or bed. Also tell your doctor if you were born with a heart defect, and if you have or have ever had swelling of the arms, hands, feet, ankles, or lower legs; heart disease, high blood pressure; coronary artery disease (narrowing of the blood vessels that lead to the heart); a heart attack; an irregular heartbeat; or high cholesterol or fats in the blood. Your doctor may tell you not to take rosiglitazone or may monitor you carefully during your treatment.
    If you develop congestive heart failure or other heart problems, you may experience certain symptoms. Tell your doctor immediately if you have any of the following symptoms, especially when you first start taking rosiglitazone or after your dose is increased: large weight gain in a short period of time; shortness of breath; swelling of the arms, hands, feet, ankles, or lower legs; swelling or pain in the stomach; waking up short of breath during the night; the need to sleep with extra pillows in order to breathe while lying down; frequent dry cough; or increased tiredness.
    Taking rosiglitazone may increase the risk that you will experience a heart attack. This risk may be higher if you take insulin along with rosiglitazone. Your doctor may tell you not to take rosiglitazone if you are taking insulin. Tell your doctor or get emergency medical care immediately if you experience any of the following symptoms: shortness of breath; pain in the jaw, arm, back, neck, or stomach; pain in the center of the chest that lasts for a more than a few minutes or that goes away and comes back; uncomfortable pressure, fullness, or squeezing in the chest; breaking out in a cold sweat; nausea or vomiting; or lightheadedness.
    A program has been set up to limit the use of rosiglitazone and to inform people about the increased the risk of heart attack while taking this medication. Only people are already taking rosiglitazone and people whose blood sugar cannot be controlled by other medications should consider taking rosiglitazone. The program also makes sure that everyone who takes rosiglitazone understands the risks and benefits of taking the medication and has talked to his or her doctor about these risks.
    You will be able to take rosiglitazone only if you and the doctor who prescribes your medication have enrolled in the program. You will receive your medication by mail from a participating pharmacy; you will not be able to get your medication from a local retail pharmacy. Ask your doctor if you have any questions about participating in the program or receiving your medication.
    Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with rosiglitazone and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website ( http://www.fda.gov/Drugs) or the manufacturer's website to obtain the Medication Guide.
    Talk to your doctor about the risks of taking rosiglitazone.

    WHY is this medicine prescribed?

    Rosiglitazone is used along with a diet and exercise program and sometimes with one or more other medications to treat type 2 diabetes (condition in which the body does not use insulin normally and therefore cannot control the amount of sugar in the blood). Because of the risk of serious side effects, rosiglitazone should only be used to treat people who are already taking the medication, or people whose blood sugar cannot be controlled with other medications and who have decided not to take pioglitazone (Actos, a medication that is similar to rosiglitazone but that may not cause the same serious side effects) for medical reasons. Rosiglitazone is in a class of medications called thiazolidinediones. It works by increasing the body's sensitivity to insulin, a natural substance that helps control blood sugar levels. Rosiglitazone is not used to treat type 1 diabetes (condition in which the body does not produce insulin and therefore cannot control the amount of sugar in the blood) or diabetic ketoacidosis (a serious condition that may occur if high blood sugar is not treated).

    HOW should this medicine be used?

    Rosiglitazone comes as a tablet to take by mouth. It is usually taken once or twice daily with or without meals. Take rosiglitazone at about the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take rosiglitazone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
    Your doctor may increase your dose of rosiglitazone after 8-12 weeks, based on your body's response to the medication.
    Rosiglitazone helps control type 2 diabetes but does not cure it. It may take 2 weeks for your blood sugar to decrease, and 2-3 months or longer for you to feel the full benefit of rosiglitazone. Continue to take rosiglitazone even if you feel well. Do not stop taking rosiglitazone without talking to your doctor.

    Are there OTHER USES for this medicine?

    This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

    What SPECIAL PRECAUTIONS should I follow?

    Before taking rosiglitazone,
    • tell your doctor and pharmacist if you are allergic to rosiglitazone or any other medications.
    • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: gemfibrozil (Lopid); other medications for diabetes; medications for high blood pressure, high cholesterol, heart failure, or prevention of heart attack or stroke; and rifampin (Rifadin, Rimactane, in Rifamate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
    • tell your doctor if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section or diabetic eye disease such as macular edema (swelling of the back of the eye); or liver disease. Also tell your doctor if you have ever taken troglitazone (Rezulin, no longer available in the United States), especially if you stopped taking it because you experienced side effects.
    • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking rosiglitazone, call your doctor.
    • if you have not yet experienced menopause (change of life; end of monthly menstrual periods) you should know that rosiglitazone may increase the chance that you will become pregnant even if you do not have regular monthly periods or you have a condition that prevents you from ovulating (releasing an egg from the ovaries). Talk to your doctor about methods of birth control that will work for you.

    What SPECIAL DIETARY instructions should I follow?

    Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. It is important to eat a healthy diet, exercise regularly, and lose weight if necessary. This will help to control your diabetes and help rosiglitazone work more effectively

    What should I do IF I FORGET to take a dose?

    Take the missed dose as soon as you remember it. However, if it is time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

    What SIDE EFFECTS can this medicine cause?

    This medication may cause changes in your blood sugar. You should know the symptoms of low and high blood sugar and what to do if you have these symptoms.
    Rosiglitazone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
    • headache
    • runny nose and other cold symptoms
    • sore throat
    • back pain
    Some side effects can be serious. If you experience any of the following symptoms, or those listed in the IMPORTANT WARNING section, call your doctor immediately:
    • loss of appetite
    • nausea
    • vomiting
    • stomach pain
    • dark urine
    • yellowing of the skin or eyes
    • blurred vision
    • vision loss
    • difficulty seeing colors
    • difficulty seeing in the dark
    • pale skin
    • dizziness
    • swelling of the eyes, face, lips, tongue, or throat
    • hoarseness
    • difficulty swallowing or breathing
    • hives
    • itching
    • fever
    • blisters
    Rosiglitazone may cause other side effects. Call your doctor if you experience any unusual problems while you are taking this medication.
    Taking rosiglitazone may increase the risk that you will experience a fracture, usually in the upper arms, hands, or feet. Talk to your doctor about the risk of taking this medication and about ways to keep your bones healthy during your treatment.
    If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch ] or by phone [1-800-332-1088].

    What should I know about STORAGE and DISPOSAL of this medication?

    Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat, and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

    What should I do in case of OVERDOSE?

    In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

    What OTHER INFORMATION should I know?

    Keep all appointments with your doctor, your eye doctor, and the laboratory. Your doctor will probably order regular eye examinations and certain laboratory tests to check your body's response to rosiglitazone. Your blood sugar and glycosylated hemoglobin should be checked regularly to determine your response to rosiglitazone. Your doctor may also tell you how to check your response to rosiglitazone by measuring your blood sugar levels at home. Follow these directions carefully.
    You should always wear a diabetic identification bracelet to be sure you get proper treatment in an emergency.
    Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
    It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

    Brand Names

    • Avandia®
    • Avandamet® (as a combination product containing Metformin, Rosiglitazone)
    • Avandaryl® (as a combination product containing Glimepiride, Rosiglitazone)
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