DOSAGE AND ADMINISTRATION

Oral
Adult: The total daily dose may vary from 40 to 320 mg taken orally. The dose should be adjusted according to the individual patient's response, commencing with 40-80 mg daily with breakfast and is increased in increments of 40 or 80 mg (usually weekly) until adequate glycaemic control is achieved. A single dose should not exceed 160 mg (2 tablets). When higher doses are required, gliclazide should be taken twice daily and according to the main meals of the day. Maximum doses have usually been 320 mg daily.

In the elderly: No dose adjustment required.

In impaired renal function: No dose adjustment required

In impaired hepatic function: Since Gliclazide is extensively metabolized in the liver, the drug should be used with caution in patients with hepatic impairment.

2. THERAPEUTIC / DIAGNOSTIC CLAIMS

Health 2000 Gliclazide 80 mg tablets is indicated in the treatment of Non-Insulin Dependent (Type II) Diabetes Mellitus.

3. DESCRIPTION OF DOSAGE FORM

Gliclazide represents the first anti-diabetic agent with both metabolic and vascular properties. It belongs to second generation of sulphonylurea drugs. Gliclazide restores the early peak of insulin secretion and ensures glycaemic control throughout 24 hours in right amount, without reactional hypoglycemia. It combats microthrombosis by decreasing platelet adhesiveness and hyperagregation, increasing fibrinolytic activity, normalizing prostaglandin metabolism, preventing damage microcappillaries and scavenging free radicals. Gliclazide also reduces plasma concentration of cholesterol, triglycerides and fatty acids. It also improves diabetic retinopathy. Gliclazide has additional effects in modulating the prothrombotic tendency of diabetes mellitus as it has powerful free radical scavenging properties.

4. CONTRAINDICATIONS

Health 2000 Gliclazide 80 mg tablets tablets are contraindicated in the following conditions: hypersensitivity to sulphonylureas and other related drugs; children and neonates; diabetes complicated by ketosis and acidosis; severe burns, trauma or infection; diabetic precoma and coma; severe renal or hepatic failure; pregnancy.

WARNING AND PRECAUTIONS

Drug Interactions: Care should be taken when giving gliclazide with drugs which are known to alter the diabetic state or potentiate the drug’s action. The hypoglycemic effect of gliclazide may be potentiated by phenylbutazones, salicylates, sulphonamides, coumarin derivatives, MAOIs, beta blockers, tetracyclinecompounds, chloramphenicol, clofibrate, disopyramide, miconazole (oral forms) and cimetidine.
It may be diminished by corticosteroids, oral contraceptives, thiazide diuretics, phenothiazine derivatives, thyroid hormones and abuse of laxatives.

Pregnancy: See Contraindications.

Nursing Mothers: It has not yet been established whether gliclazide is transferred to human milk. However, other sulphonylureas have been found in milk and there is no evidence to suggest that gliclazide differs from the group in this respect.

Chidren: See Contraindications.

Elderly: Care should be exercised, however when prescribing sulphonylureas in the elderly due to a possible age-related increased risk of hypoglycaemia.

Others: Like other Sulphonylureas, alcohol flush has been reported with Gliclazide.

5. SIDE EFFECTS

Common side effect observed is hypoglycemia. Mild gastrointestinal disturbances including nausea, dyspepsia, diarrhoea, stomach cramps and constipation have been reported, but this type of adverse reactions can be avoided if gliclazide is taken during a meal.
Skin reactions include rash, pruritis, erythema and bullous eruption. Headache, dizziness, appetite and weight changes have also been observed.

6. TOXIC EFFECTS

Mutagenicity, Carcinogenicity and Teratogenicity

Animal studies of gliclazide have not shown any teratogenic effect
No data is available regarding the mutagenicity and carcinogenicity of Gliclazide.