BEXIMCO PHARMACEUTICALS LTD.
Glimepiride is indicated as an adjunct to diet to lower the blood glucose in patients with non-insulin-dependent diabetes mellitus (type 2 diabetes) whose hyperglycemia cannot be controlled by diet, physical exercise and weight reduction. Glimepiride is also indicated for use in combination with Insulin to lower blood glucose in patients whose hyperglycaemia can not be controlled by diet and exercise or in conjunction with an oral hypoglycaemic agent.
Glimepiride stimulates the insulin release from pancreatic 8-cells and reduces glucose output from the liver. It also increases insulin sensitivity at peripheral target sites.
In principle, the dosage of Glimepiride is governed by the desired blood sugar level. The dosage of Glimepiride must be the lowest which is sufficient to achieve the desired metabolic control. The initial and the maintenance doses are set based on the results of regular checking of glucose in blood and urine. Monitoring of glucose levels in blood and urine also serves to detect either primary or secondary failure of therapy. Initial dose and dose titration: Usual initial dose is 1 mg once daily. If necessary, the daily dose can be increased. Any increase can be based on regular blood sugar monitoring, and should be gradual, i.e., at intervals of one to two weeks and carried out step wise at follows: 1 mg-2 mg-3 mg-4 mg-6 mg. Dose range in patients with well controlled diabetes: Usual dose range in patients with well controlled diabetes is 1 to 4 mg daily. Distribution of doses: Timing and distribution of doses are decided by the physician, in consideration of the patient's current life style. Normally, a single daily dose is sufficient. This should be taken immediately before a substantial breakfast or - if none is taken - immediately before the first main meals. It is very important not to skip meals after taking the drug. Secondary dosage adjustment: As the control of diabetes improves, sensitivity to insulin increases; therefore, Glimepiride requirement may fall as treatment proceeds. To avoid hypoglycaemia, timely dose reduction or cessation of Glimepiride therapy must be considered. A dose adjustment must also be considered whenever the patient's weight or life style changes, or other factors arise which cause an increased susceptibility to hypo- or hyperglycaemia. Changeover from other oral antidiabetics to Glimepiride: There is no exact dosage relationship between Glimepiride and other oral blood sugar lowering agents. When substituting Glimepride for other such agents, the initial daily dose is 1 mg; this applies even in changeover from the maximum dose of other oral blood sugar lowering agents. Any dose increase should be in accordance with guideline given above in initial dose and dose titration. Consideration must be given to the potency and duration of action of the previous blood sugar lowering agent. It may be necessary to interrupt treatment to avoid additive effects which would increase the risk of hypoglycaemia.Diaryl tablet must be swallowed without chewing and with sufficient amount of liquid (approximately 8 glass).
Potentiation of the blood-sugar-lowering effect may occur with Insulin and other oral anti-diabetics, ACE inhibitors, Allopurinol, anabolic steroids and male sex hormones, Chloramphenicol, coumarin derivatives, Fluoxetine, MAO inhibitors, Miconazole, Para-aminosalicyclic acid, Pentoxifylline (high dose parenteral), Phenylbutazone, Oxyphenbutazone, quinolones, salicylates, sulphonamides, tetracyclines, 8 blockers. Weakening of the blood-sugar-lowering effect may occur with Acetazolamide, barbiturates, corticosteroids, Diazoxide, diuretics, Epinephrine and other sympathomimetic agents, laxative, oestrogens and progestogens, phenothiazines, Phenytoin, Rifampicin, and thyroid hormones. H2 -receptor antagonists, Clonidine and Reserpine may lead to either potentiation or weakening of the blood-sugar-lowering effect. Both acute and chronic alcohol intake may potentiate or weaken the blood-sugar-lowering action of Glimepiride unpredictably.
Glimepiride is not suitable for the treatment of insulin dependent (type-I) diabetes mellitus, or of diabetic pre-coma or coma. Glimepiride must not be used in patients hypersensitive to Glimepiride or other sulphonylureas.
Hypoglycaemia, temporary visual impairment, nausea, vomiting, diarrhoea, abdominal pain, urticaria & fall in blood pressure.
Pregnancy: Glimepiride must not be taken during pregnancy; a changeover to Insulin is necessary. Patients planning a pregnancy must inform their physician, and should be shifted to Insulin. Lactation: Ingestion of Glimepiride with breast milk may harm the child. Therefore, Glimepiride must not be taken by lactating women. Either a changeover or a complete discontinuation of breast-feeding is necessary.
Accidental or intentional overdose may cause severe and prolonged hypoglycemia which may be life-threatening. In case of overdosage with Glimepiride, a doctor must be notified immediately. At the first signs of hypoglycemia, the patient must immediately take sugar, preferably glucose, unless a doctor has already started care.
In the initial weeks of treatment, the risk of hypoglycaemia may be increased and necessitates careful monitoring. If such risk is present it may be necessary to adjust the dosage of Glimepiride. Hypoglycaemia can almost always be promptly controlled by immediate intake of carbohydrates (glucose or sugar, e.g., sugar sweetened fruit juice or sugar sweetened tea)
Store at 258 C.