COMPOSITION: Each tablet contains Gliclazide 80 mg.
PHARMACOLOGICAL CLASSIFICATION: A 21.2 Oral Hypoglycaemics.
PHARMACOLOGICAL ACTION: Gliclazide is a second generation sulphonylurea. Gliclazide causes hypoglycaemia by stimulating insulin release from pancreatic beta cells. It further increases insulin levels by reducing hepatic clearance of the hormone.
The effect of Gliclazide is initiated by binding to and blocking an A TP -sensitive K+ channel. PHARMACOKINETICS: Gliclazide is absorbed from the gastro-intestinal tract, peak concentrations occur 2 - 8 hours after administration. In plasma it is approximately 85 -97% bound to plasma protein, especially
albumin. The volume of distribution is 0.2 L/kg. The half-life of the drug is 3 to 5 hours, but the hypoglycaemic effect is evident for 12 to 24 hours. Gliclazide is metabolised by the liver, and all the metabolites are excreted in the urine.
INDICATIONS: Treatment of maturity onset Diabetes Mellitus (non-insulin dependent or Type II), where dietary management alone has been insufficient.
CONTRA-INDICATIONS: Do not use in patients with sulphonylurea intolerance or hypersensitivity to any of the ingredients of this formulation. Should not be used in Type I Diabetes Mellitus.
Use in Type II Diabetes Mellitus is contraindicated in patients with ketoacidosis, hepatic, adrenal or thyroid dysfunction and in those with severe infection, trauma, or other severe conditions where sulphonylurea is unlikely to control the hyperglycaemia. In such situations insulin should be administered.
Safety in pregnant and breastfeeding mothers has not been established (see Pregnancy and Lactation).
WARNINGS: Should be avoided in patients with impairment of renal or hepatic function especially in the elderly, debilitated or malnourished patients, and those with adrenal or pituitary insufficiency.
The administration of Alembic Gliclazide 80 may be associated with increased cardiovascular mortality as compared to treatment with diet alone or diet with insulin. Reduction in dose may be necessary in patients with renal dysfunction.
INTERACTIONS: Potentiation of the hypoglycaemic action of this medicine may occur with the concomitant administration of sulphonamides, salicylates, phenylbutazone, beta- adrenoreceptor blocking agents, monoamine oxidase inhibitors, ketoconazole, miconazole, chloramphenicol, clofibrate, or halofenate, cyclophosphamide, dicoumarol, and cimetidine.
The hypoglycaemic action of Alembic Gliclazide 80 may be reduced with the concomitant administration of thiazide diuretics, corticosteroids, oestrogen, and adrenaline. Beta-blockers may mask symptoms of hypoglycaemia and may inhibit the normal physiological response to hypoglycaemia.
PREGNANCY AND LACTATION: Safety in pregnant and breastfeeding mothers has not been established.
DOSAGE AND DIRECTIONS FOR USE: The usual initial dose is 40 to 80 mg daily, gradually increased if necessary, up to 320 mg daily. Doses of more than 160 mg daily are given in 2 divided doses.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS: Gastrointestinal disturbances:
Less frequent: Nausea, vomiting, heartburn, anorexia, diarrhoea, and a metallic taste may occur. This is usually dose dependent. Hypersensitivity reactions:
Less frequent: Skin rashes and pruritis may occur and photosensitivity has been reported. Rashes may progress to more serious disorders.
Other severe effects may be manifestations of hypersensitivity reactions. They include altered liver enzyme values and cholestatic jaundice, leucopoenia, thrombocytopenia, aplastic anaemia, agranulocytosis, haemolytic anaemia, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis and erythema nodosum.
SPECIAL PRECAUTIONS Alembic Gliclazide 80 should be used with caution in patients with renal impairment, and careful monitoring of blood glucose concentrations is essential.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: Hypoglycaemia is treated by the administration of intravenous dextrose. Gastric lavage is used to remove tablets if swallowed shortly before admission. The patients blood sugar should be continuously monitored until the effect of the medicine has ceased.
IDENTIFICATION: Alembic Gliclazide 80 is a white to off white, round, flat faced beveled edge, uncoated tablet, embossed with Aon one side and 114 on one side of bisection, on the other side.
PRESENTATION: Blister (PVC/PVDC and Aluminium) packs of 10 tablets packed in unit cartons of 60 tablets.
STORAGE INSTRUCTIONS: Do not remove from blister until required for use. Store in a dry place below 25ºC and protect from light.
KEEP OUT OF THE REACH OF CHILDREN
REGISTRATION NUMBER (OR REFERENCE NUMBER): A38/21.2/0560
NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION: Gulf Drug Company (Pty) Ltd
22 Burnside Drive
Old Mill Industrial Park
Mount Edgecombe, 4300
DATE OF PUBLICATION OF THIS PACKAGE INSERT: 06 October 2006
New addition to this site: July 2010
Source: Pharmaceutical Industry