Dianorm 80Mg

COMPOSITION

Each uncoated tablet contains Gliclazide BP 80 mg.

INDICATIONS

It is used for treatment of Type 2 diabetes mellitus. 

CONTRAINDICATIONS

Hypersensitivity to Gliclazide or to any of the excipients. Presence of ketoaciclosis. Avoid where possible in acute porphyria's. The acute porphyria's (acute intermittent porphyria, variegate porphyria, hereditary coproporphyrin, and 5- aminolaevulinic acid dehydratase deficiency porphyria) are hereditary disorders of haem biosynthesis; they have a prevalence of about I in 10 000 of the population. 

SIDE EFFECTS/ADVERSE REACTIONS

For all SULFONYLUREAS: Uncommon: Hypoglycemia. Rare: Agranulocytosis; aplastic anemia; blood disorders; cholestatic jaundice; hemolytic anemia; hepatic failure; hepatitis; leucopenia; pancytopenia; thrombocytopenia. Frequency not known: Allergic skin reactions (usually in the first 6-8 weeks of therapy); constipation; diarrhea; disturbance in liver function; erythema multiforme (usually in the first 6-8 weeks of therapy); exfoliative dermatitis (usually in the first 6-8 weeks of therapy); fever (usually in the first 6-8 weeks of therapy); gastrointestinal disturbances; hypersensitivity reactions (usually in the first 6-8 weeks of therapy); jaundice (usually in the first 6-8 weeks of therapy); nausea; vomiting. Side-effects, further information: Hypoglycemia: This is uncommon and usually indicates excessive dosage. Sulfonylurea-induced hypoglycemia may persist for many hours and must always be treated in hospital. 

PRECAUTIONS AND WARNINGS

For all SULFONYLUREAS: Can encourage weight gain (should be prescribed only if poor control and symptoms persist despite adequate attempts at dieting); elderly; G6PD deficiency. Hepatic impairment: For all SULFONYLUREAS: Sulfonylureas should be avoided, or a reduced dose should be used in severe hepatic impairment, because there is an increased risk of hypoglycemia. Jaundice may occur. Renal impairment: For all SULFONYLUREAS: Sulfonylureas should be used with care in those with mild to moderate renal impairment, because of the hazard of hypoglycemia. Care is required to use the lowest dose that adequately controls blood glucose. Avoid where possible in severe renal impairment. For GLICLAZIDE: If necessary, Gliclazide which is principally metabolized in the liver, can be used in renal impairment but careful monitoring of blood-glucose concentration is essential. Patient and career advice: For all SULFONYLUREAS: Driving and skilled tasks: Drivers need to be particularly careful to avoid hypoglycemia and should be warned of the problems. The risk of hypoglycemia associated with sulfonylureas should be discussed with the patient, especially when concomitant glucose-lowering drugs are prescribed. 

OVERDOSAGE AND ANTIDOTE

An overdose of sulfonylureas may cause hypoglycemia. Moderate symptoms of hypoglycemia, without any loss of consciousness or neurological signs, must be corrected by carbohydrate intake, dose adjustment and/or change of diet. Strict monitoring should be continued until the doctor is sure that the patient is out of danger. Severe hypoglycemic reactions, with coma, convulsions or other neurological disorders are possible and must be treated as a medical emergency, requiring immediate hospitalization. If hypoglycemic coma is diagnosed or suspected, the patient should be given a rapid I.V. injection of 50 mL of concentrated glucose solution (20 to 30 %). This should be followed by continuous infusion of a more dilute glucose solution (10 %) at a rate that will maintain blood glucose levels above I g/L. Patients should be monitored closely and depending on the patient's condition after this time, the doctor will decide if further monitoring is necessary. Dialysis is of no benefit to patients due to the strong binding of gliclazide to proteins. 

MICRO LABS LIMITED