Lozide MR^®

Lozide MR is a preparation of Gliclazide which stimulates the release of insulin from pancreatic beta-cells by facilitating Ca 2+ transport across the beta-cell membranes. It lowers blood glucose by stimulating the release of insulin from the pancreas. Extrapancreatic effects also may play a part in the mechanism of action of oral sulfonylurea hypoglycemic drugs. Two extrapancreatic effects shown to be important in the action of Gliclazide are an increase in insulin sensitivity and a decrease in hepatic glucose production. The anti oxidant, platelet inhibiting and fibrinolytic actions of Gliclazide involve processes which have been implicated in the pathogenesis of vascular complications of type 2 diabetes

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Lozide MR is indicated for the treatment of type 2 diabetes in association with dietary measures and physical exercise when dietary measures alone are inadequate to control blood glucose.

Route of administration:

Lozide MR should be taken in oral route with food at breakfast time because there is risk of hypoglycaemia.

The daily dose may vary from 30 to 120 mg once daily according to patient's response. If a dose is forgotten, the dose taken on the next day should not be increased. The initial recommended dose is 30 mg daily.

Dose titration should be carried out in steps of 30 mg, according to the fasting blood glucose response. Each step should last for at least two weeks. The daily dose should not exceed 120 mg.
Lozide MR can replace Lozide ® 80 tablets, for doses of 1 to 4 tablets per day.

Lozide MR may be used to replace other antidiabetic treatments without any transitional period. Lozide ® MR may be given in combination with biguanides, alpha glucosidase inhibitors or insulin. The tablets should not be broken or chewed.

Pregnancy: There are no adequate and well-controlled studies in pregnant women with gliclazide. Gliclazide may enter the fetal circulation and cause neonatal hypoglycaemia. Gliclazide is contraindicated in pregnant women.

Lactation: There is no information regarding the presence of gliclazide in human milk, the effects on the breastfed infant or the effects on milk production. Gliclazide is contraindicated during lactation.

Use in children and adolescents
Safety and effectiveness in pediatric patients have not been established.

Gliclazide can provoke a moderate or severe hypoglycaemia particularly in cases of insufficient glucose or caloric intake, accidental overdose, prolonged physical activity and patients with uncompensated thyroid function disorders. Caution should be taken. Blood glucose control in treated patients may be jeopardised by fever, trauma, infection or surgical intervention. It may be necessary to discontinue treatment and to administer insulin in these cases. Treatment of patients with G6PD-deficiency with sulfonylurea agents can lead to hemolytic anemia. The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia or hyperglycaemia or, for example, as a result of visual impairment. Caution should be taken where these abilities are of a special importance e.g., driving a car or operating machinery

The most common side effects are hypoglycaemia, abdominal pain, diarrhea, nausea/vomiting, dyspepsia and constipation

It is contraindicated in patients with serious hypersensitivity reaction to gliclazide or any other component of this product. It is also contraindicated in patients with insulin-dependent (type 1) diabetes mellitus, diabetic ketoacidosis, diabetic pre-coma and coma, in patients with complete secondary failure to sulphonylurea-therapy, patients with severe renal and/or hepatic failure, in cases where insulin is required e.g., surgery and severe trauma or infection

Drug interaction with medication: Concomitant use with insulin, acarbose, other sulphonylureas, biguanides, sulphonamides, phenylbutazone, NSAIDs, aspirin and salicylates, coumarins, allopurinol, miconazole, ketoconazole, fibrates, theophylline, caffeine, monoamine oxidase inhibitors, beta-adrenoceptor antagonists, ACE inhibitor, chloramphenicol, cyclophosphamide and derivatives may cause hypoglycaemia. Dose adjustment may be required. Concomitant use with barbiturates, phenytoin, rifampicin, corticosteroids, corticotropin, estrogen, progestogen, oral contraceptive, diazoxide and sympathomimetic drugs, thyroid hormone, thiazide diuretics can cause hyperglycaemia. Dose adjustment may be required. Co- administration with danazol is contraindicated.

Drug interaction with food and others: Not applicable

In case of overdose, hypoglycaemia can occur. Moderate symptoms of hypoglycaemia should be corrected by carbohydrate intake, dose adjustment and/or modification of diet. Strict monitoring should be continued until the patient is out of danger. In case of severe hypoglycaemia, patient should be hospitalized immediately.

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Lozide MR 30 Tablet: Each modified release tablet contains Gliclazide BP 30 mg.

Lozide MR 60 Tablet: Each modified release tablet contains Gliclazide BP 60 mg.

Storage
Store below 30°C in a dry place, protected from light. Keep away from the reach of children.

Packing
Lozide MR 30 Tablet: Carton of 30 tablets in blister pack.
Lozide MR 60 Tablet: Carton of 30 tablets in blister pack.