THERAPEUTIC INDICATIONS

Type 2 DM inadequately controlled by diet, & exercise alone. Amaryl may be used in combination with metformin or insulin.

POSOLOGY AND METHOD OF ADMINISTRATION

Treatment with Amaryl must be initiated and monitored by a doctor. The initial and the maintenance doses are set based the result of regular checks of glucose in blood and urine. The usual initial dose is 1 mg Amaryl once daily. If necessary, the daily dose can be increased, based on regular blood sugar monitoring, and should be gradual. The usual dose range in patients with well controlled diabetes is 1 to 4 mg Amaryl daily. Only some benefit from daily doses of more than 6 mg. This dose should be taken immediately before a substantial breakfast of if none is taken immediately before the first main meal. It very important not to skip meal after taking Amaryl. Mistakes, e.g. forgetting to take a dose, must never be corrected by subsequently taking a large dose. Amaryl tablets must be swallowed without chewing and with sufficient amounts of liquid.

CONTRA-INDICATIONS

Insulin-dependent (type 1) diabetes mellitus (e.g. for the treatment of diabetics with a history of ketoacidosis), diabetic ketoacidosis, or of diabetic precoma or coma. Hypersensitivity to glimepiride, other sulfonylureas, other sulfonamides, or any of the excipients. Severe renal and hepatic impairment, and in dialysis patients. Pregnancy and lactation.

SPECIAL WARNINGS AND PRECAUTIONS FOR USE

During treatment with Amaryl, fasting glucose levels in blood and urine must be checked regularly, as should, additionally, the proportion of glycosylated haemoglobin. In exceptional stress situation (e.g. trauma, surgery, infections with fever) blood sugar control may deteriorate, and temporary change to insulin may be necessary. In the initial weeks of treatment, the risk of hypoglicaemia may be increased and necessitates especially careful monitoring. Those symptoms of hypoglycaemia which reflect the body’s adrenergic may be milder or absent in those situation where hypoglicaemia develops gradually, in the elderly, and in patients with a certain type of nervous disease (autonomic neuropathy) or those receiving concurrent treatment with beta-blockers, clonidine, reserpine, guanethidine, or other sympatholytic drugs. Safety and effectiveness in pediatric patients have not been established. Risk of haemolytic anaemia in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency.

INTERACTIONS

Potentiation of the blood-sugar-lowering effect and, thus, in some instances hypoglycaemia may occur when one of the following medicines is taken: Insulin and other oral anti-diabetics, ACE inhibitors, allopurinol, anabolic steroids and male sex hormones, chloramphenicol, coumarin derivatives, cyclophosphamide, disopyramide, fenfluramine, fenyramidol, fibrates, fluoexetin, guenethidine, ifosfamide, MAO inhibitors, miconazole, fluconazole, para-aminosalicylic acid, pentoxyfylline (high dose parenteral), phenylbutazone, azapropazone, oxyphenbutazone, probenicid, quinolones, salycilates, sulfinpyrazone, clarithromycin, sulfonamides, tetracyclines, tritoqualine, trofosfamide. Weakening of the blood-sugar-lowering effect and, thus, raised blood sugar level may occur when one of the following medicines is taken, for example: acetazolamide, barbiturates, corticosteroids, diazoxide, diuretics, epinephrine (adrenaline), and other sympathomimetic agents, glucagons, laxatives (after protacted use), nicotinic acid (in high doses), oestrogens and progesterons, phenothiazines, phenytoin, rifampicin, thyroid hormones. H2 receptor antagonist, clonidine and reserpine, acute and chronic alcohol intake, may lead to either potentiation or weakening of the blood-sugar-lowering effect. Beta-blockers decrease glucose tolerance. The effect of coumarin derivatives may be potentiated or weakened. Colesevelam reduces glimepiride.

PREGNANCY AND LACTATION

To avoid risk of harm to the child, Amaryl must not be taken during pregnancy and breast-feeding; a changeover to insulin or discontinuation of breast-feeding is necessary.

UNDESIRABLE EFFECTS

1. Metabolism and nutrition disorders: hypoglycaemia.
2. Eyes: temporary visual impairment.
3. GI disorder: nausea, vomiting, sensations of pressure of fullness in the epigastrum, abdominal pain, and diarrhea, rarely: increase liver enzyme levels, impairment of liver function (e.g. with cholestasis and jaundice) and hepatitis may develop, leading to liver failure.
4. Blood and lymphatic system disorders: thrombocytopenia (rare) and, in isolated cases, leucopenia, haemolytic anaemia or, e.g. erythrocytopenia, granulocytopenia, agranulocytosis, and pancytopenia. General disorder: Allergic and pseudoallergic, e.g.: itching, urticarial, or rashes (e.g. erythema, morbiliform or marculopapular eruptions), dyspnoea, a fall in blood pressure, shock, a decrease in serum, allergic vasculitis, and hypersensitivity of the skin to light.

OVERDOSE

Accidental or intentional overdose may cause severe and prolonged hypoglycemia which may be life- threatening. At the first signs of hypoglycemia, the patient must immediately take sugar, preferably glucose, unless a doctor has already started care. The patient’s blood glucose level should be carefully monitored for at least 24 hours. In severe cases with a protracted course, hypoglycemia, or the danger of slipping back into hypoglycemia, may persist for several days.

PHARMACODYNAMIC PROPERTIES

Presentation : Box, 3 blister (10 film coated tablet); AMARYL® M 1/250 tablet (DKI1422700117A1); AMARYL® M 2/500 tablet (DKI1422700117B1) Manufactured by : Handok Inc, Chungcheongbuk-do, Korea Imported and packaged by : PT Aventis Pharma.

Date of revision : 16-May-19

This information is intended for Health Care Professional only. See local product information for full details information