Comprid®
Gliclazide BP
COMPOSITION
Comprid® tablet : Each tablet contains Gliclazide BP 80 mg.
Comprid®
XR 30 tablet: Each extended release tablet contains
Gliclazide BP 30 mg.
Comprid®
XR 60 tablet: Each extended release tablet contains
Gliclazide BP 60 mg.
PHARMACOLOGY
Gliclazide (Comprid®
) stimulates the release of insulin from
pancreatic beta-cells by facilitating Ca+2 transport across the
beta-cell membranes. It lowers blood glucose by stimulating the
release of insulin from the pancreas, an effect dependent upon
functioning beta cells in the pancreatic islets. Extrapancreatic
effects also may play a part in the mechanism of action of oral
sulfonylurea hypoglycemic drugs. Two extrapancreatic effects
shown to be important in the action of Gliclazide are an increase in
insulin sensitivity and a decrease in hepatic glucose production.
The anti-oxidant, platelet inhibiting and fibrinolytic actions of
Gliclazide involve processes which have been implicated in the
pathogenesis of vascular complications of type 2 diabetes.
INDICATION
Comprid®
, Comprid®
XR 30 and Comprid®
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 Comprid®
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, following 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. Comprid®
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. Comprid®
XR 30 is an extended
release tablet and therefore, should be neither broken nor chewed.
Comprid®
XR 30, can replace Gliclazide 80 mg tablets, tablet for
tablet, for doses of 1 to 4 tablets per day. Comprid® 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. Comprid®
XR 60 is an extended
release tablet and therefore, should be neither broken nor chewed.
Comprid®
XR 60, can replace 02 Gliclazide 80 mg 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.
PRECAUTION
Care should be exercised with patients having hepatic and or renal
impairment and a small starting dose should be used with careful
patient monitoring. In long term clinical trials, patients with renal
insufficiency have been treated satisfactorily using Gliclazide at
reduced doses.
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.
CONTRAINDICATION
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.
DRUG INTERACTION
The hypoglycemic effect of Gliclazide may be potentiated by
NSAID (in particular aspirin), phenylbutazone, sulfonamides,
coumarin derivatives, MAOIs, beta-adrenergic blockers,
tetracyclines, chloramphenicol, clofibrate, cimetidine and
miconazole tablets. Ingestion of alcohol may also increase the
hypoglycemic effect of Gliclazide. Some drugs may on the
contrary, reduce its activity e.g. barbiturates, corticosteroides,
thiazide diuretics, thyroid hormones, laxatives and oral
contraceptives.
USE IN PREGNANCY & LACTATION
Pregnancy: Gliclazide should not be used in pregnancy. Nursing
mothers: No study has reported its presence in human breast milk.
However, other sulfonylureas have been found in milk and there is
no evidence to suggest that gliclazide differs from the group in
this respect.
STORAGE
Store below 30º C, protect from light and moisture. Keep out of
reach of children.
HOW SUPPLIED
Comprid®
tablet: Each box containing 60 tablets in blister pack.
Comprid®
XR 30 tablet: Each box containing 50 tablets in blister
pack.
Comprid®
XR 60 tablet: Each box containing 30 tablets in blister
pack.
Brand: Square Pharmaceuticals Ltd
