Concise Prescribing Info
Type 2 DM, as monotherapy or in combination w/ metformin or insulin.
Dosage/Direction for Use
Individualized dosage. Initially 1-2 mg once daily. Maintenance dose: 1-4 mg once daily. Max: 8 mg once daily. After reaching 2-mg dose, increments should not be >2 mg at 1-2 wk intervals based on the patient's glucose response. May also be combined w/ metformin. Glimepiride-insulin combination therapy: 8 mg once daily. Start w/ low dose insulin & adjust wkly.
Should be taken with food: Take immediately before the 1st main meal of the day. Do not skip meals.
Hypersensitivity to glimepiride or other sulfonylureas. Type 1 DM, diabetic ketoacidosis w/ or w/o coma, severe renal or hepatic insufficiency. Pregnancy & lactation.
Special Precautions
Patients allergic to other sulfonamide derivatives. High-risk patients w/ CV disease, hypoglycemia (particularly in debilitated or malnourished patients & those w/ renal or hepatic dysfunction; adrenal or pituitary insufficiency), loss of blood glucose control, hemolytic anemia (in patients w/ G6PD deficiency). Discontinue use if hypersensitivity reaction eg, anaphylaxis, angioedema & Stevens-Johnson syndrome occur. May affect ability to drive or operate machinery. Renal & hepatic insufficiency. Childn. Elderly.
Adverse Reactions
Hypoglycemia, hyperglycemia, syndrome of inappropriate antidiuretic hormone secretion, aggravation of DM, hyponatremia, increased appetite, anorexia, wt gain; diarrhea, nausea, vomiting, heartburn, abdominal discomfort, distention & pain, GI pain, dyspepsia, sensation of fullness, metallic taste; bradycardia, palpitations, vasodilation; anemia (aplastic & hemolytic), leukopenia, granulocytopenia, agranulocytosis, thrombocytopenia, thrombocytopenic purpura, erythrocytopenia, pancytopenia; leukocytoclastic vasculitis, worsening hypersensitivity reactions; cross-sensitivity reaction to other sulfonylureas; disulfiram-like reactions, headache, dizziness, insomnia, tremor, paresthesia, nervousness, dry mouth, hot flashes; cholestasis, jaundice, abnormal liver function, hepatitis, hepatic porphyria reactions, increased liver enzyme levels; allergic or pseudo-allergic reactions, Stevens-Johnson syndrome, exfoliative dermatitis, porphyria cutanea tarda, photosensitivity reactions; increased urinary frequency, nocturia; asthenia, pain in extremity, allergic vasculitis, sweating, visual disturbance/abnormal vision, flu syndrome, accidental injury, abnormal lab test, decrease in serum Na conc.
Drug Interactions
Increased mean AUC & decreased mean Cmax w/ aspirin. Potential significant increases in Cmax, AUC & t½ w/ propranolol. Severe hypoglycemia w/ oral miconazole. May potentiate or weaken pharmacodynamic response to warfarin. CYP2C9 inducers, inhibitors or substrates (eg, rifampicin, fluconazole, amiodarone, tolbutamide, diclofenac, ibuprofen, naproxen). Reduced or absent signs of adrenergic counter-regulation to hypoglycemia w/ sympatholytics (eg, β-blockers, clonidine, guanethidine & reserpine). Reduced absorption w/ colesevelam. May unpredictably potentiate or reduce activity w/ acute & chronic alcohol intake. May potentiate hypoglycemic action w/ NSAIDs eg, ibuprofen, phenylbutazone, oxyphenbutazone & azapropazone; clarithromycin, highly protein bound drugs, coumarins, probenecid, β-blockers, salicylates, aminosalicylic acid, anabolic steroids & male sex hormones, chloramphenicol, certain long-acting sulfonamides, tetracyclines, quinolones, fenfluramine, fibrates, ACE inhibitors, fluoxetine, MAOIs, disopyramide, allopurinol, sulfinpyrazone, cyclophosphamide, trosphosphamide, ifosfamide, miconazole, fluconazole, pentoxifylline (high-dose parenteral), tritoqualine, insulin, other oral antidiabetic drugs. Risk of hyperglycemia & loss of glycemic control w/ thiazides & other diuretics, corticosteroids, phenothiazines, chlorpromazine, thyroid products, estrogens, progestogens, nicotinic acid (high doses) & its derivatives, laxatives (long-term use), OCs, phenytoin, diazoxide, glucagons, barbiturates, rifampicin, acetazolamide, adrenaline, sympathomimetics & INH.
MIMS Class
ATC Classification
A10BB12 - glimepiride ; Belongs to the class of sulfonylureas. Used in the treatment of diabetes.
Norizec tab 2 mg
60's (P1,055/box)
Norizec tab 3 mg
60's (P1,453/box)
Norizec tab 1 mg
60's (P695/box)
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