GLUCONOR

Glimepiride

Composition:

Gluconor-1: Each tablet contains Glimepiride INN 1 mg.

Gluconor-2: Each tablet contains Glimepiride INN 2 mg.

Description:     

The primary mechanism of action of Glimepiride is lowering of blood glucose by stimulating the release of insulin from functioning beta cells. In addition, extrapancreatic effects may also play vital role in the activity of Glimepiride. Administration of Glimepiride can lead to increase sensitivity of peripheral tissues to insulin. After oral administration, Glimepiride is completely (100%) absorbed from GIT. Glimepiride is completely metabolized by oxidative biotransformation after oral dose.

Indications:

Gluconor is indicated as an adjunct to diet and exercise to lower the blood glucose in patients with non-insulin dependent diabetes mellitus whose hyperglycaemia can not be controlled by diet and exercise alone. Gluconor is also indicated for use in combination with insulin to lower blood glucose in-patients whose hyperglycaemia cannot be controlled by diet and exercise or in conjunction with an oral hyperglycemic agent.

Dosage and administration:

Initial dose: 1-2 mg once daily, given with breakfast or the first main meal. Patients sensitive to hypoglycemic drugs should begin at 1 mg once daily. Maximum starting dose is 2 mg

Maintenance dose: 1-4 mg once daily. The maximum recommended dose is 8 mg once daily. After a dose of 2 mg is reached, increase dose at increments of 2 mg at 1-2 week intervals based on the patients' blood glucose response. Monitor long-term efficacy by measurements of HbA1c levels, for example, every 3-6 months.

Combination insulin therapy: The recommended dose is 8 mg once daily with the first main meal with low dose insulin

Patients on other oral antidiabetic agents: When transferring patients to Glimepiride, no transition period is necessary. No exact dosage relationship exists between Glimepiride and the other oral hypoglycaemic agents. Observe patients carefully when being transferred from longer half-life sulfonylureas to Glimepiride due to potential overlapping of drug effect.

Contraindications:

Glimepiride is not suitable for the treatment of Type-2 diabetes ( e.g. for the treatment of diabetes with a history of ketoacidosis), or of diabetic precoma or coma. Glimepiride must not be used in-patients hypersensitivity to Glimepiride, other sulfonylureas, other sulfonamides.

Precautions:

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. in the form of sugar lumps, sugar-sweetened fruit juice or sugar sweetened tea).

Side-effects:

Hypoglycemia, temporary visual impairment, nausea, vomiting, diarrhoea, abdominal pain, urticaria, fall in blood pressure.

Drug Interactions:

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, chloramphenical, coumarin derivatives, fluxetine, MAOIs, miconazole, para-aminosalicylic acid, pentoxifylline (high dose parenteral), phenylbutazone, oxyphenbutazone, quinolones, salicylates, sulfonamides, tetracyclines & beta blockers.

Weakening of the blood sugar lowering effect may occur with acetazolamide, barbiturates, corticosteroids, diazoxide, diuretics, epinephrine and other sympathomimetic agents, laxatives, oestrogens and progesterons, phenothiazines, phenytoin, rifampicin, thyroid hormones. H2 –receptors antagonists, clonidine and reserpine may lead to either potentiation or weakeing of the blood sugar lowering effect.

Both acute and chronic alcohol intakes may potentiate or weaken the blood sugar lowering action of Glimepiride unpredictably.

Use in pregnancy and lactation:

Pregnancy: Glimepiride must not be taken during pregnancy; a changeover to insulin is necessary. Patients planning a pregnancy must inform their physician, and should changeover to insulin.

Nursing mothers: Ingestion of Glimepiride with breast milk may harm the child. Therefore, breast-feeding women must not take Glimepiride. Either a changeover or a complete discontinuation of breast-feeding is necessary.

Packaging:

Gluconor-1: Each box contains 5×10's tablets in blister pack.

Gluconor-2: Each box contains 5×10's tablets in blister pack.