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metformin fda approved listing drug therapies
(met FORE min)
Glucophage, Glucophage XR

What is the most important information I should know about metformin?
• A small number of people who have taken metformin have developed a seriouscondition called lactic acidosis that has been fatal in up to 50% of cases metformin fda approved listing drug therapies. Lactic acidosis has occurred most often in people whose kidneys were not workingproperly metformin fda approved listing drug therapies. Liver problems may also increase the risk of developing lactic acidosis metformin fda approved listing drug therapies. Stop taking metformin and call your doctor immediately if you experience a feelingof general discomfort or sickness; weakness; sore or aching muscles; troublebreathing, unusual drowsiness, dizziness or lightheadedness; unusual or unexplainedstomach upset (after the initial stomach upset that may occur at the start oftherapy with metformin); or the sudden development of a slow or irregular heartbeat metformin fda approved listing drug therapies. These may be signs of lactic acidosis metformin fda approved listing drug therapies.
• Avoid excessive alcohol intake while taking metformin metformin fda approved listing drug therapies. Together, alcoholand metformin may increase the risk of lactic acidosis and hypoglycemia metformin fda approved listing drug therapies.
• Metformin does not usually cause hypoglycemia (low blood sugar) metformin fda approved listing drug therapies. Nevertheless,hypoglycemia may occur, as a result of skipped meals, excessive exercise, oralcohol consumption metformin fda approved listing drug therapies. Know the signs and symptoms of low blood sugar, which includehunger, headache, drowsiness, weakness, dizziness, a fast heartbeat, sweating,tremor, and nausea metformin fda approved listing drug therapies. Carry candy or glucose tablets to treat episodes of lowblood sugar metformin fda approved listing drug therapies.


What is metformin?
• Metformin is used to regulate blood glucose (sugar) levels metformin fda approved listing drug therapies. Metforminworks in three ways: first, it reduces the amount of glucose produced by yourliver; second, it reduces the amount of glucose absorbed from food through yourstomach; and third, it makes the insulin that your body produces work betterto reduce the amount of glucose already in your blood metformin fda approved listing drug therapies.
• Metformin is used to treat non-insulin-dependent diabetes mellitus (NIDDMor Type II diabetes) metformin fda approved listing drug therapies.
• Metformin may also be used for purposes other than those listed in thismedication guide metformin fda approved listing drug therapies.


What should I discuss with my healthcare provider before taking metformin?
• Do not take metformin without first talking to your doctor if you
· have kidney disease;
· have liver disease;
· have congestive heart failure;
· have acute or chronic metabolic acidosis, including diabetic ketoacidosis;
· have had a heart attack or a stroke;
· have a serious infection, illness, or injury;
· need to have surgery;
· need to have x-rays or other procedures using injectable contrast agents;
· are dehydrated (have lost water from your body) due to diarrhea, vomiting,fever, heat stroke, decreased fluid intake, or any other cause;
· drink alcohol; or
· are 80 years of age or older and have not had your kidney functiontested metformin fda approved listing drug therapies.
• You may not be able to take metformin, or you may require a dosage adjustmentor special monitoring during treatment if you have any of the conditions listedabove metformin fda approved listing drug therapies.
• Metformin is in the FDA pregnancy category B metformin fda approved listing drug therapies. This means that it is unlikelyto harm an unborn baby metformin fda approved listing drug therapies. Usually, your doctor will want to prescribe insulinto control diabetes during pregnancy metformin fda approved listing drug therapies. Do not take metformin without first talkingto your doctor if you are pregnant metformin fda approved listing drug therapies.
• Metformin passes into breast milk and may affect a nursing baby metformin fda approved listing drug therapies. Do nottake metformin without first talking to your doctor if you are breast-feedinga baby metformin fda approved listing drug therapies.
• If you are over the age of 65 years, there may be an slight increasein the risk of developing lactic acidosis due to a natural decline in kidneyfunction with advancing age metformin fda approved listing drug therapies. A lower dose or special monitoring may be necessaryduring your treatment metformin fda approved listing drug therapies.


How should I take metformin?
• Take metformin exactly as directed by your doctor metformin fda approved listing drug therapies. If you do not understandthese directions, ask your pharmacist, nurse, or doctor to explain the instructionsto you metformin fda approved listing drug therapies.
• Take each dose with a full glass of water metformin fda approved listing drug therapies.
• Take metformin with a meal to reduce nausea, diarrhea, and upset stomachthat may occur with metformin therapy metformin fda approved listing drug therapies. These symptoms may be more likely tooccur during the first few weeks of therapy metformin fda approved listing drug therapies.
• A decrease in vitamin B12 may also occur during metformin therapy metformin fda approved listing drug therapies. Yourdoctor may want to monitor your blood levels of vitamin B12 and you may needto take B12 supplements metformin fda approved listing drug therapies. A vitamin B12 deficiency may rarely cause anemia metformin fda approved listing drug therapies.
• Your doctor may want to monitor your blood sugar control and other factorswith regularly scheduled blood tests metformin fda approved listing drug therapies.
• Occasionally, inactive ingredients in the metformin extended-release(Glucophage XR) tablets may pass through your body undissolved and appear inthe stool as a soft mass metformin fda approved listing drug therapies. This is not harmful, and the medication has been absorbedby your body metformin fda approved listing drug therapies.
• Store metformin at room temperature away from moisture and heat metformin fda approved listing drug therapies.


What happens if I miss a dose?
• Take the missed dose as soon as you remember metformin fda approved listing drug therapies. However, if it is almosttime for your next dose, skip the missed dose and only take your next regularlyscheduled dose metformin fda approved listing drug therapies. Do not take a double dose metformin fda approved listing drug therapies.


What happens if I overdose?
• Seek emergency medical attention metformin fda approved listing drug therapies.
• An overdose of metformin is likely to cause lactic acidosis metformin fda approved listing drug therapies. Symptomsof lactic acidosis include a feeling of general discomfort or sickness; weakness;sore or aching muscles; trouble breathing; unusual drowsiness, dizziness orlightheadedness; unusual or unexplained stomach upset (after the initial stomachupset that may occur at the start of therapy with metformin); and the suddendevelopment of a slow or irregular heartbeat metformin fda approved listing drug therapies.


What should I avoid while taking metformin?
• Avoid excessive alcohol intake while taking metformin metformin fda approved listing drug therapies. Together, alcoholand metformin may increase the risk of lactic acidosis and hypoglycemia metformin fda approved listing drug therapies.
• Follow your diet, medication, and exercise routines very closely metformin fda approved listing drug therapies. Changingany of these things can effect your blood sugar levels metformin fda approved listing drug therapies.
• Tell your doctor or other health care provider that you are taking thismedication if you need to have surgery or x-ray procedures that require injectionof contrast agents metformin fda approved listing drug therapies. Treatment with metformin may need to be stopped for a shortperiod of time metformin fda approved listing drug therapies.
• Tell your doctor that you are taking metformin if you become ill, ifyou have a heart attack; if you have a stroke; if you develop congestive heartfailure; if you experience diarrhea, vomiting, fever, or dehydration from anycause; or if you decrease the amount of food or liquid in your normal diet metformin fda approved listing drug therapies. You may need to stop your treatment with metformin for a short amount of timeuntil you are feeling better metformin fda approved listing drug therapies.


What are the possible side effects of metformin?
• Stop taking metformin and seek emergency medical attention if you experiencean allergic reaction (difficulty breathing; closing of your throat; swellingof your lips, tongue, or face; or hives) metformin fda approved listing drug therapies.
• A small number of people who have taken metformin have developed a seriouscondition called lactic acidosis that has been fatal in up to 50% of cases metformin fda approved listing drug therapies. Lactic acidosis has occurred most often in people whose kidneys were not workingproperly metformin fda approved listing drug therapies. Liver problems may also increase the risk of developing lactic acidosis metformin fda approved listing drug therapies. Stop taking metformin and call your doctor immediately if you experience a feelingof general discomfort or sickness; weakness; sore or aching muscles; troublebreathing, unusual drowsiness, dizziness or lightheadedness; unusual or unexplainedstomach upset (after the initial stomach upset that may occur at the start oftherapy with metformin); or the sudden development of a slow or irregular heartbeat metformin fda approved listing drug therapies. These may be signs of lactic acidosis metformin fda approved listing drug therapies.
• Other, less serious side effects may be more likely to occur metformin fda approved listing drug therapies. Continueto take metformin and talk to your doctor if you experience
· nausea, vomiting, abdominal pain, or diarrhea at the start of therapy;
· abdominal bloating or increased gas production; or
· decreased appetite or changes in taste (metallic taste in your mouth) metformin fda approved listing drug therapies.
• Side effects other than those listed here may also occur metformin fda approved listing drug therapies. Talk to yourdoctor about any side effect that seems unusual or that is especially bothersome metformin fda approved listing drug therapies.


What other drugs will affect metformin?
• Before taking this medication, tell your doctor if you are taking anyof the following medications:
· a diuretic (water pill) such as furosemide (Lasix), bumetanide (Bumex),ethacrynic acid (Edecrin), torsemide (Demadex), amiloride (Midamor), triamterene(Dyazide, Maxzide, Dyrenium), spironolactone (Aldactone), hydrochlorothiazide(HydroDiuril), chlorothiazide (Diuril), chlorthalidone (Hygroton), indapamide(Lozol), metolazone (Zaroxolyn, Mykrox), and others;
· a phenothiazine such as chlorpromazine (Thorazine), prochlorperazine(Compazine), promethazine (Phenergan), and others
· an estrogen (Premarin, Prempro, Ogen, and others) or birth controlpill (Ovral, Lo-Ovral, Ortho-Novum, Triphasil, Levlen, Tri-Levlen, Alesse, andothers)
· a calcium channel blocker such as nifedipine (Adalat, Procardia), verapamil(Calan, Verelan, Isoptin), diltiazem (Cardizem, Dilacor XR), felodipine (Plendil),bepridil (Vascor), amlodipine (Norvasc), and others;
· a steroid medication such as prednisone (Deltasone), methylprednisolone(Medrol), dexamethasone (Decadron), and others;
· a thyroid medication (Synthroid, Levoxyl, Levothroid, and others),
· digoxin (Lanoxin, Lanoxicaps);
· procainamide (Pronestyl);
· quinidine (Cardioquin, others);
· cimetidine (Tagamet, Tagamet HB) or ranitidine (Zantac, Zantac 75);
· morphine (Astramorph, MS Contin, Roxanol, and others);
· trimethoprim (Proloprim, Trimpex, Septra, Bactrim);
· phenytoin (Dilantin);
· isoniazid (Nydrazid); or
· nicotinic acid or niacin (Nicobid, Nicolar, others) metformin fda approved listing drug therapies.
• You may not be able to take metformin, or you may require a dosage adjustmentor special monitoring if you are taking any of the medicines listed above metformin fda approved listing drug therapies.
• Drugs other than those listed here may also interact with metformin oraffect your condition metformin fda approved listing drug therapies. Talk to your doctor and pharmacist before taking anyprescription or over-the-counter medicines metformin fda approved listing drug therapies.


Where can I get more information?
• Your pharmacist has more information about metformin written for healthprofessionals that you may read metformin fda approved listing drug therapies.


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