Full Prescribing Info
Pharmacology: Gliclazide is a sulfonylurea antidiabetic.
Pharmacokinetics: Gliclazide is readily absorbed from the gastrointestinal tract. It is extensively bound to plasma proteins. The half-life (t½) is about 10-12 hrs. Gliclazide is extensively metabolized in the liver to metabolites that have no significant hypoglycemic activity. Metabolites and a small amount of unchanged drug are excreted in the urine.
Special Populations: Elderly: Because its effects are less prolonged than those of chlorpropamide or glibenclamide, gliclazide may be more suitable for elderly patients who are prone to hypoglycemia with longer-acting sulfonylureas.
Treatment of type 2 diabetes mellitus.
Dosage/Direction for Use
Usual Initial Dose: 30 mg once daily, increased if necessary up to maximum of 120 mg daily.
It has a duration of action of 12-24 hrs.
Administration: Gliclazide is given by mouth in the treatment of type 2 diabetes mellitus.
Severe hepatic and renal impairment. Porphyria, sulfonylureas may precipitate an acute post attack. Insulin therapy may be given instead. Sulfonylureas are contraindicated in the presence of ketoacidosis.
Use in pregnancy & lactation:
Pregnancy and breastfeeding is contraindicated.
Special Precautions
Gliclazide should not be used in type 1 diabetes mellitus. Use in type 2 diabetes mellitus is contraindicated in patients with ketoacidosis and in those with severe infections, trauma or other severe conditions where the drug is unlikely to control the hyperglycemia; insulin should be administered in such situations. Gliclazide may be suitable for use in patients with renal impairment, but that careful monitoring of blood-glucose concentration is essential. It should not be used in patients with severe renal impairment.
Use In Pregnancy & Lactation
Pregnancy and breastfeeding is contraindicated.
Adverse Reactions
Gastrointestinal disturbances eg, nausea, vomiting, heartburn, anorexia, diarrhea and a metallic taste may occur with gliclazide and are usually mild and dose-dependent; increased appetite and weight gain may occur. Skin rashes and pruritus may occur and photosensitivity has been reported.
Drug Interactions
Numerous interactions have been reported with the sulfonylureas, largely representing either pharmacokinetics interactions (due to the displacement of the antidiabetic plasma proteins or alteration in its metabolism or excretion) or pharmacological interactions with drugs having an independent effect on blood glucose. In the former class, most reports concern older sulfonylureas eg, chlorpropamide and tolbutamide, although the possibility of such reactions with newer drugs should be borne in mind.
Store at temperatures not exceeding 30°C.
MIMS Class
ATC Classification
A10BB09 - gliclazide ; Belongs to the class of sulfonylureas. Used in the treatment of diabetes.
MR tab 30 mg x 15's, 60's.
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