Indications
Diabetic non-insulin-dependent (type 2) in adults.
Contraindications
Known hypersensitivity to any of the active substance or excipients.
Patients with type 1 diabetes.
Diabetic pre-coma and coma, diabetic keto-acidosis.
Severe infections or trauma, or major surgery.
Severe renal or hepatic insufficiency.
Treatment with miconazole.
Lactation.
Compositon/Ingredients
Gliclazide 30mg
Dosage and administration
- The initial dose is 30 mg, once daily. If blood glucose is effectively controlled, this dose may be used for maintenance treatment. If blood glucose is not adequately controlled, the dose may be increased to 60 mg (2 tablets), 90 mg (3 tablets), 120 mg (4 tablets) daily, in successive steps, the interval between each dose increment should be at least 1 month (in patients whose blood glucose has not reduced after two weeks of treatment, the dose may be increased at the end of the second week of treatment. Gliclazide can be given in combination with metformin, α-glucosidase inhibitors (e.g. acarbose) or insulin (under close monitoring).
- When switching from a hypoglycaemic sulfonylurea with a prolonged half-life, a treatment free period of a few days may be necessary to avoid an additive effect of the two products, which might cause hypoglycaemia.
Precaution
Sulfonylureas should be used with caution in patients with G6PD deficiency.
In patients with mild to moderate renal insufficiency.
Gliclazide should not be used in pregnant women.
The safety and efficacy of Staclazide 30 MR in children and adolescents have not been established.
Patients should be aware of how they react to drug before driving or operating machinery. They should be counselled in appropriate management of the situation of hypoglycaemic attacks while driving (stopping driving as soon as it is safe to do so, taking carbohydrate immediately, and quitting the driving seat and removing the ignition key from the car). Patients who have lost hypoglycaemic awareness, or have frequent hypoglycaemic episodes, should not drive.
Storage
Store at temperature below 30°C, protect from light.
