Gluclazide SR Dosage/Direction for Use

The daily dose of gliclazide may vary from one half to 2 tablets per day i.e. from 30 to 120 mg taken orally in a single intake at breakfast time.
If a dose is forgotten, there must be no increase in the dose taken next day. As with any hypoglycemic agent, the dose should be adjusted according to the individual patient's metabolic response (blood glucose, HbA_1C).
The recommended initial dose is 30 mg daily (half a tablet of Gliclazide 60 mg prolonged-release tablet). 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, 90 or 120 mg daily, in successive steps. The interval between each dose increment should be at least 1 month except in patients whose blood glucose has not reduced after two weeks of treatment. In such cases, the dose may be increased at the end of the second week of treatment.
The maximum recommended daily dose is 120 mg.
One gliclazide 60 mg prolonged-release tablet corresponds to two gliclazide 30 mg prolonged-release tablets. The breakability of the Gliclazide 60 mg prolonged-release tablets enables flexibility of dosing to be achieved.
Switching from gliclazide (80 mg) tablets (immediate-release formulation) to gliclazide 60 mg tablets with modified release: One tablet of gliclazide (80 mg) is comparable to one prolonged-release tablet 30 mg i.e. half a Gliclazide 60 mg prolonged-release tablet. Consequently, the switch can be performed with careful blood monitoring.
Switchover from another oral antidiabetic medicinal product to Gliclazide 60mg: Gliclazide prolonged-release tablets can be used to replace another oral antidiabetic medicinal product.
The dosage and the half-life of the previous antidiabetic agent should be taken into account when switching to gliclazide 60 mg prolonged-release tablet.
A transitional period is not generally necessary. A starting dose of 30 mg should be used and this should be adjusted to suit the patient's blood glucose response, as described previously.
When switching from a hypoglycemic 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 hypoglycemia. The procedure described for initiating treatment should also be used when switching to treatment with gliclazide prolonged-release tablets, i.e., a starting dose of 30 mg/day, followed by a stepwise increase in dose, depending on the metabolic response. Or as prescribed by the physician.
Combination with other antidiabetic medicines: Gliclazide prolonged-release tablets can be given in combination with biguanides, alpha-glucosidase inhibitors or insulin. In patients not adequately controlled with gliclazide 60 mg prolonged-release tablets, concomitant insulin therapy can be initiated under dose medical supervision.
Special populations: Elderly: Gliclazide prolonged-release tablets should be prescribed using the same dosing regimen recommended for patients under 65 years of age.
Renal impairment: In patients with mild to moderate renal impairment the same dosing regimen can be used as in patients with normal renal function with careful patient monitoring. These data have been confirmed in clinical trials.
Patients at risk of hypoglycemia: undernourishment or malnourishment; severe or poorly compensated endocrine disorders (hypopituitarism, hypothyroidism, adrenocorticotrophic insufficiency); withdrawal of a prolonged and/or high-dose corticoid therapy; severe vascular disease (serious coronary heart disease, severe carotid impairment, diffuse vascular disease).
It is recommended that the minimum daily dose of 30mg is used.
Pediatric population: The safety and efficacy of gliclazide in children and adolescents have not been established.
No data are available in children.
Method of administration: Gliclazide is to be taken as a single intake at breakfast time.
It is recommended to swallow the half tablet or tablet(s) without crushing or chewing.