COMPOSITION
Clogrel Tablet: Each tablet contains Clopidogrel USP 75 mg (as Clopidogrel Bisulphate).
PHARMACOLOGY
Clopidogrel is a prodrug. It inhibits platelet activation and aggregation through the irreversible binding of its active metabolite to the P2Y12 class of ADP receptors on platelets. Dose-dependent inhibition of platelet aggregation can be seen 2 hours after single oral doses. Repeated doses of 75 mg per day inhibit ADP-induced platelet aggregation on the first day, and inhibition reaches steady state between Day 3 and Day 7.
INDICATION
Clogrel (Clopidogrel) is indicated for the prevention of atherosclerotic events in patients with history of symptomatic atherosclerotic disease (ischemic stroke, myocardial infarction or established peripheral arterial disease). It is given prophylactically as an alternative to aspirin in patients at risk of thrombo-embolic disorders such as myocardial infarction and stroke.
DOSAGE & ADMINISTRATION
The recommended dose of Clogrel (Clopidogrel) is 75 mg once daily, with or without food. No dosage adjustment is necessary for elderly patients or patients with renal disease.
CONTRAINDICATION
Hypersensitivity to the drug substance or any component of this product. Active pathological bleeding such as peptic ulcer or intracranial hemorrhage.
SIDE EFFECTS
Clogrel (Clopidogrel) is generally well tolerated drug. A few common side-effects like hemorrhage (including gastro-intestinal and intracranial), abdominal discomfort, nausea, vomiting, diarrhoea, headache, dizziness, vertigo, paraesthesia, rash, pruritus, hepatic and biliary disorder, neutropenia, etc. may occur.
USE IN PREGNANCY & LACTATION
There are no adequate & well-controlled studies of Clogrel (Clopidogrel) in pregnant women. So Clopidogrel should be used in pregnancy only if clearly needed. Clogrel (Clopidogrel) should not be prescribed to nursing mother unless absolutely necessary.
DRUG INTERACTION
Drugs that might induce lesions with a propensity to bleed (e.g. ulcer) like aspirin, NSAIDs, should be used with cautions to patients taking Clogrel (Clopidogrel). Cautions should be used in co-administration of Phenytoin, Tamoxifen, Tolbutamide, Warfarin, Fluvastatin with Clogrel (Clopidogrel) for possible impaired metabolism.
OVERDOSE
Overdose following clopidogrel administration may lead to bleeding complications. Based on biological plausibility, platelet transfusion may restore clotting ability.
STORAGE
Store in a cool and dry place, protect from light and moisture. Keep out of the reach of children.
PACKING
Clogrel Tablet: Each box contains 15 x 3 tablets in blister pack.
