COMPOSITION
CompridTM tablet : Each tablet contains Gliclazide BP 80 mg.
CompridTM XR 30 tablet: Each extended release tablet contains Gliclazide BP 30 mg.
CompridTM XR 60 tablet: Each extended release tablet contains Gliclazide BP 60 mg
INDICATION
CompridTM and CompridTM XR 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 CompridTM 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
taken orally, once daily. CompridTM XR 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. CompridTM XR is an extended release tablet and therefore, should be neither
broken nor chewed. CompridTM XR 30, can replace Gliclazide 80 mg tablets, tablet for
tablet, for doses of 1 to 4 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.
SIDE EFFECT
Hypoglycemia may occur in concurrent conditions such as hepatic & renal diseases,
alcohol intoxication and adrenal and pituitary insufficiency. 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 leucopenia,
thrombocytopenia, agranulocytosis, pancytopenia, hemolytic anemia, cholestatic
jaundice, GI hemorrhage have not been reported with Gliclazide.
STORAGE
Keep away from light and store at cool and dry place.
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