Hexagon Pharma
Concise Prescribing Info
Metformin HCl
Type II DM. In adults, as monotherapy or in combinations w/ other oral antidiabetic agents or w/ insulin. In childn >10 yr & adolescents, as monotherapy or in combination w/ insulins.
Dosage/Direction for Use
Individualized dosage. Adult Initially 500 mg bid. May be increased in increments of 500 mg wkly, up to a total of 2,000 mg/day in divided doses. May also be titrated from 500-850 mg bid after 2 wk. Patient requiring additional glycemic control Max: 2,550 mg/day. Childn Initially 500 mg bid. May be increased in increments of 500 mg wkly. Max: 2,000 mg/day.
Should be taken with food.
Hypersensitivity. Renal disease or dysfunction (Cr levels ≥1.5 mg/dL for males, 1.4 mg/dL for females), CHF, acute or chronic metabolic acidosis including diabetic ketoacidosis w/ or w/o coma. Temporarily discontinue in patients undergoing radiologic studies. Renal impairment (estimated GFR <30 mL/min/1.73 m2).
Special Precautions
Lactic acidosis. Monitor renal function prior to treatment & at least annually thereafter. Concomitant use w/ medications that may affect renal function or metformin disposition or result in significant hemodynamic change eg, cationic drugs that are eliminated by renal tubular secretion. Intravascular contrast studies w/ iodinated materials may lead to acute alteration of renal function. CV collapse, acute CHF & MI & conditions characterized by hypoxemia; prerenal azotemia. Temporarily discontinue use for any surgical procedures (except minor procedures not associated w/ restricted intake of food & fluids). Acute or chronic excessive alcohol intake. Patients w/ clinical or laboratory evidence of hepatic disease. Measure hematologic parameters on annual basis. Perform routine serum vit B12 measurements at 2- or 3-yr intervals. Renal (not recommended w/ GFR 30-45 mL/min/1.73 m2) & hepatic impairment. Not recommended during pregnancy & in childn <10 yr. Elderly.
Adverse Reactions
GI disturbances, taste disturbance. Lactic acidosis.
Drug Interactions
Enhanced absorption w/ nifedipine. Compete for common renal tubular transport systems w/ cationic drugs eg, amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim or vancomycin. Hyperglycemia & loss of glycemic control w/ thiazides & other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, OCs, phenytoin, nicotinic acid, sympathomimetics, Ca channel blockers & INH.
MIMS Class
ATC Classification
A10BA02 - metformin ; Belongs to the class of biguanides. Used in the treatment of diabetes.
Metform FC tab 500 mg
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