Lapigim

Glimepiride 2 mg, metformin HCl 500 mg

Adjunct to diet & exercise in NIDDM when glimepiride or metformin monotherapy results in inadequate glycemic control. Replacement of combination therapy of glimepiride & metformin.

Individualized dosage. Once or twice daily.

Should be taken with food: Take before or w/ a meal.

Hypersensitivity to glimepiride, metformin, sulfonylureas, sulfonamides or biguanides. IDDM (type 1 DM), diabetic ketonemia & coma/precoma; acute or chronic metabolic acidosis. Patients susceptible to lactic acidosis. Discontinue if administered w/ iodinated contrast IV. Severe infections, pre- & post-op, serious trauma; malnourished, starving or debilitated patients, pituitary/adrenal insufficiency. Severe lung dysfunction, hypoxemia, excessive alcohol intake, dehydration, GI disturbances eg, diarrhea & vomiting. CHF. Severe hepatic dysfunction or hemodialysis; in case of severe hepatic or renal function disorders, a changeover to insulin is required to achieve adequate control of blood glucose. Women of child-bearing potential, pregnancy & lactation.

Lactic acidosis. Increased risk of CV mortality. Temporary changeover to insulin in exceptional stress situations (eg, trauma, surgery, febrile infections). Use of intravascular iodinated contrast materials. Temporarily suspend for any surgical procedure (except minor procedures not associated w/ restricted food & fluid intake). Increased risk of hypoglycemia in case of unwillingness or incapacity to cooperate; undernourishment, irregular meal times or skipped meals; imbalance between physical exertion & carbohydrate intake; alterations of diet; alcohol consumption; overdosage w/ glimepiride; certain uncompensated endocrine disorders affecting carbohydrate metabolism or counter-regulation of hypoglycemia; concurrent administration of certain other medicines. Regularly monitor glucose & glycosylated Hb. Milder or absent symptoms of hypoglycemia eg, in the elderly, patients w/ autonomic neuropathy or taking β-blockers, clonidine, reserpine, guanethidine or other sympatholytic drugs. Patients w/ G6PD deficiency. Regularly monitor TSH in patients w/ hypothyroidism. Concomitant medications that may affect renal function. Hypoxic states; surgical procedures; excessive alcohol intake. Decreased vit B₁₂ serum levels. Discontinue immediately if unexplained hyperventilation, myalgia, malaise, unusual somnolence or other nonspecific symptoms occur. Hepatic or renal impairment. Monitor renal function. May impair ability to drive or operate machinery. Childn. Elderly.

Hypoglycemia. Temporary visual impairment. GI disturbances, elevation of liver enzyme. Liver impairment. Allergic or pseudo-allergic reactions eg, itching, urticaria or rashes. Severe thrombocytopenia & thrombocytopenic purpura. Metformin: Lactic acidosis; metallic taste.

Glimepiride is metabolized by CYP2C9; its metabolism is influenced by CYP2C9 inducers (eg, rifampicin) or inhibitors (eg, fluconazole). Potentiation of the blood glucose-lowering effect by insulin & other oral antidiabetics, ACE inhibitors, allopurinol, anabolic steroids, male sex hormones, chloramphenicol, coumarin derivatives, cyclophosphamide, disopyramide, fenfluramine, fenyramidol, fibrates, fluoxetine, guanethidine, ifosfamide, MAOIs, miconazole, fluconazole, aminosalicylic acid, pentoxyfylline (high dose parenteral), phenylbutazone, azapropazone, oxyphenbutazone, probenecid, quinolones, salicylates, sulfinpyrazone, clarithromycin, sulfonamide antibiotics, tetracyclines, tritoqualine, trofosfamide. Weakening of the blood glucose-lowering effect by acetazolamide, barbiturates, corticosteroids, diazoxide, diuretics, epinephrine & other sympathomimetics, glucagon, laxatives (long-term use), nicotinic acid (high dose), oestrogens & progestogens, phenothiazines, phenytoin, rifampicin, thyroid hormones. May either potentiate or weaken effects w/ H₂ receptor antagonist, clonidine, guanethidine & reserpine, acute & chronic alcohol intake. Effect of coumarin derivatives may be potentiated or weakened. β-blockers decrease glucose tolerance. Reduced absorption w/ colesevelam. Metformin: Concomitant use w/ iodinated contrast materials, gentamicin. Weakened effect w/ epinephrine, pyrazinamide, INH. Increased plasma conc w/ furosemide, nifedipine & cationic drugs. May decrease anticoagulant effect of phenprocoumon. Reduced hypoglycemic effect w/ levothyroxine.

Antidiabetic Agents

A10BD02 - metformin and sulfonylureas ; Belongs to the class of combinations of oral blood glucose lowering drugs. Used in the treatment of diabetes.

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