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Staclazide 60 MR
Rx

Staclazide 60 MR contains gliclazide, a type 2 antidiabetic (non-insulin-dependent diabetes mellitus), sulfonylurea, taken orally. Gliclazide is effective only in patients whose pancreas still operate (capable of producing insulin). Staclazide 60 MR is usually indicated as an adjunct to diet, exercise; it is used single or in combination with other hypoglycemia drugs such as metformin, insulin.

Pack size Box of 30 tablets, 60 tablets. Bottle of 100 tablets
Shelf-life 36 months
Composition Gliclazide
Dosage forms and strengths Modified-release tablet: 60 mg
Product code :

PRESCRIBING INFORMATION

Indications

Diabetic non-insulin-dependent (type 2) in adults.

Dosage

  • 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, 90 mg, 120 mg 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.

Usage

  • Staclazide 60 MR taken orally in a single intake at breakfast time.
  • The tablet be swallowed whole; do not crush or chew or break tablet.
  • 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.

Common

  • Hypoglycaemia;
  • Headache;
  • Disturbances, nausea;
  • Rashes.
  • 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 60 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.