Amaryl M

Per 1/250 mg FC tab Glimepiride 1 mg, metformin HCl 250 mg. Per 2/500 mg FC tab 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 administration.

May be taken with or without food: Take immediately before or during meals.

Hypersensitivity to Amaryl M, 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. Renal failure or dysfunction (eg, serum creatinine levels ≥1.5 mg/dL in males, ≥1.4 mg/dL in females, or abnormal CrCl), severe hepatic dysfunction or hemodialysis. 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 hypoglycaemia 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, especially in combination w/ skipped meals; overdosage w/ glimepiride; certain uncompensated endocrine disorders affecting carbohydrate metabolism or counter-regulation of hypoglycaemia; concurrent administration of certain other medicines. Regularly monitor glucose & glycosylated Hb. Milder or absent symptoms of hypoglycaemia eg, patients w/ autonomic neuropathy or taking β-blockers, clonidine, reserpine, guanethidine or other sympatholytics. Patients w/ G6PD deficiency. Regularly monitor TSH levels in patients w/ hypothyroidism. Concomitant medications that may affect renal function. Hypoxic states; surgical procedures; excessive alcohol intake. Decreased vit B₁₂ serum levels w/ long term treatment w/ metformin. Discontinue immediately if unexplained hyperventilation, myalgia, malaise, unusual somnolence or other nonspecific symptoms occur. Renal or severe hepatic impairment. Monitor renal function. May impair alertness & reactions due to hypo-or-hyperglycaemia. Not to be taken during pregnancy & lactation. Childn. Elderly.

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

Metabolism of glimepiride is influenced by CYP2C9 inducers (eg, rifampicin) or inhibitors (eg, fluconazole). Potentiated blood-glucose lowering effect w/ 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, p-aminosalicylic acid, pentoxyfylline (high dose parenteral), phenylbutazone, azapropazone, oxyphenbutazone, probenecid, quinolones, salicylates, sulfinpyrazone, clarithromycin, sulfonamide antibiotics, tetracyclines, tritoqualine, trofosfamide. Weakened blood-glucose lowering effect w/ acetazolamide, barbiturates, corticosteroids, diazoxide, diuretics, epinephrine & other sympathomimetics, glucagon, laxatives (long-term use), nicotinic acid (high dose), oestrogens & progestogens, phenothiazines, phenytoin, rifampicin, thyroid hormones. Either potentiated or weakened blood-glucose-lowering effect 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 absortion 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. Reduced efficacy w/ organic cation transporters (OCT) 1 inhibitors eg, verapamil. Increased GI absorption & efficacy w/ OCT 1 inhibitors eg, rifampicin. Increased plasma conc w/ OCT 2 inhibitors eg, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole. Altered efficacy & renal elimination w/ OCT 1 & 2 inhibitors eg, crizotinib, olaparib.

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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