Philippines

Formulation

FDA Registration No.

One modified release tablet contains gliclazide 60 mg.
Excipient with known effect: lactose monohydrate.

For non-insulin-dependent diabetes (type 2) in adults, in association with dietary measures and with exercise, when these measures alone are not sufficient.
Dosage/Direction for Use
The daily dose of GLICLAZIDE (DIAMICRON 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 hypoglycemic 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 [half a tablet of GLICLAZIDE (DIAMICRON MR) 60 mg. 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 (DIAMICRON MR) 60 mg modified-release tablet is equivalent to two Gliclazide (Diamicron MR) 30 mg modified-release tablets. The breakability of the GLICLAZIDE (DIAMICRON MR) 60 mg modified-release tablet enables flexibility of dosing to be achieved.
Switching from Gliclazide (Diamicron) 80 mg tablets to GLICLAZIDE (DIAMICRON MR) 60 mg modified-release tablets: One tablet of Gliclazide (Diamicron) 80 mg tablet is comparable to 30 mg of the modified release formulation (i.e. half a tablet of DIAMICRON 60 mg.) Consequently the switch can be performed with careful blood monitoring.
Switching from another oral antidiabetic agent to GLICLAZIDE (DIAMICRON MR) 60 mg: GLICLAZIDE (DIAMICRON 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 GLICLAZIDE (DIAMICRON MR) 60 mg.