Amaryl

Amaryl

glimepiride

Manufacturer:

Kalventis Sinergi Farma
Concise Prescribing Info
Contents
Glimepiride
Indications/Uses
Adjunct to diet & exercise to lower the blood glucose in patients w/ type 2 DM (NIDDM). May be used in combination w/ metformin or insulin.
Dosage/Direction for Use
Initial dose & dose titration: 1 mg once daily. May be increased at intervals of 1-2 wk, & carried out stepwise as follows: 1 mg-2 mg-3 mg-4 mg, & in exceptional cases, 8 mg. Patients w/ well controlled diabetes 1-4 mg daily.
Administration
Should be taken with food: Take immediately before the 1st main meal of the day. Do not skip meals. Swallow whole, do not chew/crush.
Contraindications
Hypersensitivity to glimepiride & other sulfonylureas or sulfonamides. Not suitable for the treatment of IDDM (type 1), diabetic ketoacidosis, diabetic precoma or coma. Severe renal & hepatic impairment; dialysis patients. Not to be taken during pregnancy & lactation.
Special Precautions
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; diet alterations; alcohol consumption, especially in combination w/ skipped meals; overdosage w/ Amaryl; certain uncompensated endocrine disorders affecting carbohydrate metabolism or counter-regulation of hypoglycaemia (eg, in certain disorders of thyroid function & anterior pituitary or adrenocortical insufficiency); concurrent administration of certain other medicines. Regularly check fasting glucose levels in blood & urine; proportion of glycosylated Hb. Milder or absent symptoms of hypoglycaemia eg, in patients w/ autonomic neuropathy or taking β-blockers, clonidine, reserpine, guanethidine or other sympatholytics. Temporary changeover to insulin in exceptional stress situations (eg, trauma, surgery, febrile infections). Patients w/ G6PD deficiency. May impair alertness & reactions due to hypo-or-hyperglycaemia. Impaired renal function & severe liver impairment. Ped patients. Elderly.
Adverse Reactions
Hypoglycaemia; adrenergic counterregulation; temporary visual impairment; nausea, vomiting, feeling of fullness in the epigastrium, abdominal pain, diarrhea; allergic or pseudoallergic reactions eg, itching, urticaria or rashes. Severe thrombocytopenia & thrombocytopenic purpura. Severe hypoglycaemia, certain changes in blood picture, severe allergic or pseudoallergic reactions, or liver failure.
Drug Interactions
Co-administration w/ inducers (eg, rifampicin) or inhibitors (eg, fluconazole) of CYP 2C9. Potentiated blood sugar-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, pentoxifylline (high dose parenteral), phenylbutazone, azapropazone, oxyphenbutazone, probenecid, quinolones, salicylates, sulfinpyrazone, clarithromycin, sulfonamides, tetracyclines, tritoqualine, trofosfamide. Weakened blood sugar-lowering effect w/ acetazolamide, barbiturates, corticosteroids, diazoxide, diuretics, epinephrine (adrenaline) & other sympathomimetics, glucagon, laxatives (after protracted use), nicotinic acid (high dose), oestrogens & progestogens, phenothiazines, phenytoin, rifampicin, thyroid hormones. Either potentiated or weakened blood sugar-lowering effect w/ H2 receptor antagonist, clonidine & reserpine, acute & chronic alcohol intake. Decreased glucose tolerance & increased hypoglycemia tendency w/ β-blockers. Reduced or absence of adrenergic counter-regulation signs w/ β-blockers, clonidine, guanethidine & reserpine. Potentiated or weakened effect of coumarin derivatives. Reduced absorption from GI tract w/ colesevelam.
MIMS Class
Antidiabetic Agents
ATC Classification
A10BB12 - glimepiride ; Belongs to the class of sulfonylureas. Used in the treatment of diabetes.
Presentation/Packing
Form
Amaryl tab 1 mg
Packing/Price
5 × 10's (Rp274,180/boks)
Form
Amaryl tab 2 mg
Packing/Price
5 × 10's (Rp485,860/boks)
Form
Amaryl tab 3 mg
Packing/Price
5 × 10's (Rp767,284/boks)
Form
Amaryl tab 4 mg
Packing/Price
3 × 10's (Rp525,004/boks)
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