PLECAZ MR 60 mg is not able to deliver all approved dose regimens of gliclazide; other approved dosage forms and strengths of gliclazide should be used in such cases.
The daily dose of PLECAZ MR 60 mg 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.
It is recommended to swallow the dose without crushing or chewing.
If a dose is forgotten, there must be no increase in the dose taken the next day.
As with any hypoglycaemic agent, the dose should be adjusted according to the individual patient's metabolic response (blood glucose, HbA1c).
Initial dose: The recommended starting dose is 30 mg 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, 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.
Switching from gliclazide 80 mg tablets to PLECAZ MR 60 mg modified release tablets: One tablet of gliclazide 80 mg is comparable to 30 mg of the modified release formulation. Consequently, the switch can be performed with careful blood monitoring.
Switching from another oral antidiabetic agent to PLECAZ MR 60 mg: PLECAZ MR 60 mg can be used to replace other oral antidiabetic agents.
The dosage and the half-life of the previous antidiabetic agent should be taken into account when switching to PLECAZ MR 60 mg.
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 hypoglycaemic sulfonylureas 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. The procedure described for initiating treatment should also be used when switching to treatment with PLECAZ MR 60 mg, i.e. a starting dose of 30 mg/day, followed by a stepwise increase in dose, depending on the metabolic response.
Combination treatment with other antidiabetic agents: PLECAZ MR 60 mg can be given in combination with biguanides, alpha glucosidase inhibitors or insulin.
In patients not adequately controlled with PLECAZ MR 60 mg, concomitant insulin therapy can be initiated under close medical supervision.
Special Populations: Elderly: PLECAZ MR 60 mg 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 insufficiency, 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 hypoglycaemia: Undernourished or malnourished, Severe or poorly compensated endocrine disorders (hypopituitarism, hypothyroidism, adrenocorticotrophic insufficiency), Withdrawal of prolonged and/or high dose corticosteroid therapy, Severe vascular disease (severe coronary heart disease, severe carotid impairment, diffuse vascular disease); It is recommended that the minimum daily starting dose of 30 mg is used.
Paediatric population: The safety and efficacy of PLECAZ MR 60 mg in children and adolescents have not been established. No data are available.
Route of Administration: Oral.