Glix Mr 60Mg

DESCRIPTION

GLIX MR is a second-generation sulphonyl urea oral hypoglycemic agent used in the treatment of non-insulin dependent diabetes mellitus (NIDDM). It has been recommended for use on the basis of both its metabolic and non-metabolic effects. 

COMPOSITION

GLIX MR 30: Each uncoated modified release tablet contains: Gliclazide B.P 30 mg. GLIX MR 60: Each uncoated modified release tablet contains: Gliclazide B.P 60 mg. Colour: Tartrazine Lake. 

INDICATIONS

Type 2 diabetes (NIDDM) in adults when diet and exercise alone is insufficient to control blood glucose. Newly diagnosed diabetics should not be started with Glix MR 60, instead Glix MR 30 should be used. 

CONTRAINDICATIONS

Hypersensitivity to gliclazide or an excipient, Type 1 diabetes, severe renal or hepatic failure, pregnancy or lactation, severe infections. 

WARNINGS

Hypoglycemia may occur if the patient's dietary intake is reduced or after accidental or deliberate overdose or after severe exercise, alcohol intake, trauma and stress. Hypoglycemic symptoms can be reduced by prescribing a diabetic meal plan. Immediate intervention should be done if signs and symptoms of hypoglycemia occur. 

PRECAUTIONS

Adjust dose of gliclazide according to blood and urinary glucose levels during the first few months. Begin treatment with low doses in patients with renal and/or hepatic impairment. Usage in pregnancy: Contraindicated. 

DRUG INTERACTIONS

Diuretics, barbiturates, phenytoin, rifampicin, corticosteroids, estrogens, estroprogestins and pure progestogens may reduce the glycemic control. Its hypoglycemic action may be potentiated by salicylates, phenylbutazone, sulphonamides, beta-blockers, clofibric acid, vitamin K antagonist, allopurinol, theophylline, caffeine and monoamine oxidase inhibitors. Concomitant administration of miconazole, perhexiline or cimetidine with gliclazide may result in hypoglycemia. Concomitant administration of gliclazide with agents that increase blood glucose levels should not be considered without careful monitoring of blood glucose levels to avoid hyperglycemia. 

ADVERSE REACTIONS

Gastrointestinal disturbances - Nausea, diarrhea, gastric pain, constipation and vomiting. Dermatological effects - Rash, pruritus, urticaria, erythema and flushing. Miscellaneous Headache and dizziness. Hypoglycemia - Gliclazide appears to be associated with a low incidence of Hypoglycemia. 

OVERDOSAGE AND TREATMENT

Hypoglycemia may occur in case of an overdosage. In the event of an overdosage, gastric lavage should be performed, and correction of hypoglycemia attempted by intravenous administration of hypertonic glucose (10 or 30%) with continued monitoring of the patient's blood glucose levels. 

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