Orazid (Gliclazide) is a second generation oral hypoglycemic sulfonylurea which stimulates the release of insulin from pancreatic ß-cells by facilitating Ca2+ transport across the ß-cell membranes.
Orazid Tablet: Each tablet contains Gliclazide BP 80 mg.
Orazid is indicated for the treatment of non-insulin dependent diabetes mellitus (NIDDM) in patients who require oral antidiabetic treatment.
DOSAGE AND ADMINISTRATION:
The usual initial dose is 40-80 mg daily, gradually increased, if necessary up to 320 mg daily until adequate control is achieved. A single dose should not exceed 160 mg. When higher doses are required it should be taken twice daily, according to the main meals of the day.
Care should be exercised with patients having hepatic and/or renal impairment and a small starting dose should be used with careful patient monitoring. In long term clinical trials patients with renal insufficiency have been treated satisfactorily using gliclazide at reduced doses.
Hypoglycemia may occur in concurrent conditions such as hepatic & renal diseases, alcohol intoxication and adrenal & pituitary insufficiency. Mild gastro-intestinal disturbances including nausea, dyspepsia, diarrhoea, and constipation have been reported but these types of adverse reactions can be avoided if gliclazide is taken during a meal. Allergic dermatological reactions including rash, pruritus, erythema, bullous eruption have been reported during treatment with the drug but are not known to be directly attributable to it.
gliclazide should not be used in juvenile onset diabetes, diabetes complicated by ketosis and acidosis, diabetes undergoing surgery after severe trauma or during infections, patients known to have hypersensitivity to other sulfonylurea and related drugs, diabetic pre-coma & coma, severe renal or hepatic insufficiency, combination with miconazole etc.
The hypoglycemic effect of gliclazide may be potentiated by NSAIDs (in Particular aspirin), phenylbutazone, sulfonamides, coumarin derivatives, MAOIs, ß-adrenergic blockers, tetracyclines, chloramphenicol, clofibrate, cimetidine and miconazole tablets and ingestion of alcohol may also increase the hypoglycemic effect of gliclazide. Some drugs may, on the coronary, reduce its activity e.g. barbiturates, corticosteroids, thiazide diuretics, thyroid hormones, laxatives and oral contraceptives.
USE IN PREGNANCY AND LACTATION:
Gliclazide should not be used in pregnancy. No study has reported its presence in human breast milk.
· Store in cool & dry place, protect from light.
· Keep out of reach of children.
Orazid Tablet: Each box contains 3 x10 tablets in blister pack.