SB-Glic XR 30
Brand Name: SB-Glic
Generic Name with Specification: Gliclazide BP
Strength: 80 mg, XR 30 mg & XR 60 mg
SB-Glic 80 : Each tablet contains Gliclazide BP 80 mg.
SB-Glic XR 30 : Each extended release tablet contains Gliclazide BP 30 mg.
SB-Glic XR 60 : Each extended release tablet contains Gliclazide BP 60 mg.
SB-Glic 80, SB-Glic XR 30 and SB-Glic XR 60 are indicated for the treatment of type 2 diabetes in association with dietary measures when dietary measures alone are inadequate to control blood glucose.
Dosage & Administration:
The usual initial dose of SB-Glic is 40 to 80 mg daily, gradually increased, if necessary up to 320 mg daily until adequate control is achieved. A single dose should not exceed 160 mg. When higher doses are required it should be taken twice daily, according to the main meals of the day. For extended release tablet the initial recommended dose is 30 mg daily, even in elderly patients
(>65 years); the daily dose may vary from 30 to 120 mg (1-4 tablets) taken orally, once daily. SB-Glic XR 30 should be taken with food because there is increased risk of hypoglycemia if a meal is taken late. It is recommended that the medication be taken at breakfast time. If a dose is forgotten, the dose taken on the next day should not be increased. Dose titration should be carried out in steps of 30 mg, according to the fasting blood glucose response. Each step should last for at least two weeks. SB-Glic XR 30 is an extended release tablet and therefore, should be neither broken nor chewed. SB-Glic XR 30, can replace SB-Glic 80 tablets, tablet for tablet, for doses of 1 to 4 tablets per day. SB-Glic XR 60 should be taken with food because there is increased risk of hypoglycemia if a meal is taken late. It is recommended that the medication be taken at breakfast time. If a dose is forgotten, the dose taken on the next day should not be increased. SB-Glic XR 60 is an extended release tablet and therefore, should be neither broken nor chewed. SB-Glic XR 60 can replace two SB-Glic 80 tablets, for doses of 1 to 2 tablets per day.
Elderly: Plasma clearance of Gliclazide is not altered in the elderly and steady state plasma levels are similar to those in adults under 65 years. Clinical experience in the elderly shows that it is effective and well tolerated.
Children: Gliclazide as with other sulfonylureas is not indicated for the treatment of juvenile onset diabetes mellitus.
Hypoglycemia may occur in concurrent conditions such as hepatic & renal diseases, alcohol intoxication and adrenal & pituitary insufficiency. Weight gain & mild gastro-intestinal disturbances including nausea, dyspepsia, diarrhea, and constipation have been reported but these types of adverse reactions can be avoided if Gliclazide is taken during a meal. Allergic dermatological reactions including rash, pruritus, erythema, bullous eruption have been reported during treatment with the drug but are not known to be directly attributable to it. More serious reactions like leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, hemolytic anemia, cholestatic jaundice, Gl hemorrhage have not been reported with Gliclazide.
Gliclazide should not be used in juvenile onset diabetes, diabetes complicated by ketosis and acidosis, diabetes undergoing surgery, after severe trauma or during infections, patients known to have hypersensitivity to other sulfonylureas and related drugs, diabetic pre-coma & coma, severe renal or hepatic insufficiency, combination with miconazole tablets
Use in Pregnancy & Lactation:
Pregnancy: Safety in pregnant woman has not been established. Gliclazide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mother: It is not known whether Gliclazide is secreted in human milk. Because many drugs are excreted in human milk, it should not be administered to a breast-feeding woman.
SB-Glic 80 : Each box contains 50 tablets in blister pack.
SB-Glic XR 30 : Each box contains 30 tablets in blister pack.
SB-Glic XR 60 : Each box contains 30 tablets in blister pack.