Trade Name: GL-80

Generic Name : (Gliclazide) Tablet

DESCRIPTION:

GL-80 (Gliclazide) is a second generation oral hypoglycemic sulfonylurea, which stimulates the release of insulin from functioning pancreatic β-cells. This is mediated by an increase in the intracellular ratio of ATP/ADP, which inhibits K⁺-ATPase channels. In addition, there is evidence that GL-80 has action on peripheral tissues. This has been shown to enhance glycogen synthesis and inhabit glycogenolysis and gluconeogenesis in the liver. This may also improve peripheral glucose uptake by muscles.

COMPOSITION:

Each tablet contains Gliclazide BP 80 mg.

INDICATIONS:

GL-80 (Gliclazide) is indicated in non-insulin dependent diabetes mellitus (type II diabetes) when dietary modification has failed.

DOSAGE & ADMINISTRATION:

Adult: The usual initial dose is 40-80 mg (½-1tablet) given orally which may if needed gradually increased up to 320 mg daily until adequate control is achieved. A single dose should not exceed 160 mg (2 tablets). When higher doses are required GL-80 (Gliclazide) should be taken twice daily and according to the main meals of the day. In obese patients or those not showing adequate response to GL-80 alone, additional therapy may be required.

Elderly: Plasma clearance of GL-80 (Gliclazide) is not altered in the elderly and steady state plasma levels are similar to those in adults under 65 years. Clinical experience in the elderly show that GL-80 is effective and well tolerated. Because its effects are less prolonged than those of chlorpropamide or glibenclamide it may be more suitable for elderly patients. Who are prone to hypoglycemia with longer acting sulfonylureas.

OR AS DIRECTED BY THE PHYSICIAN

SIDE EFFECTS:

As with other sulfonylureas, hypoglycemia will occur if the patient’s dietary intake is reduced or if they are receiving a larger dose of Gliclazide than required. Mild gastro-intestinal disturbances including nausea, dyspepsia, diarrhoea and constipation have been reported, but this type of adverse reaction can be avoided if Gliclazide is taken during a meal.

CONTRAINDICATIONS:

GL-80 (Gliclazide) is contraindicated in patients with known hypersensitivity to the drug. It is also contraindicated in patients with diabetes associated with ketosis and acidosis, diabetic patients undergoing surgery, after severe injury or during infection.

PRECAUTIONS:

Care should be exercised in patients with hepatic and for renal impairment and a small starting dose should be used with careful patient monitoring. It has

been suggested that Gliclazide may be suitable for use in patients with renal impairment, but careful monitoring of blood sugar concentration is essential.

USE IN PREGNANCY AND LACTATION:

Pregnancy: Gliclazide, as other sulfonylureas, is contraindicated for use in pregnant women.

Lactation: It has not yet been established whether Gliclazide is transferred to human milk. However, other sulfonylureas have been found in milk and there is no evidence to suggest that Gliclazide differs from the group in this respect. Therefore, if use is deemed essential, the patient should stop nursing.

SUPPLY:

Each box contains 5 x 10 tablets in blisters.

Store in a cool & dry place protected from light.

Keep all medicines out of reach of children.

Further information is available on request.