Bal Pharma


Endure Medical
Full Prescribing Info
Clopidogrel bisulfate.
Each film-coated tablet contains: Clopidogrel (as bisulfate) 75 mg.
Pharmacokinetics: Clopidogrel is rapidly but incompletely absorbed after oral doses; absorption appears to be at least 50%. It is a prodrug and is extensively metabolized in the liver, mainly to the inactive carboxylic acid derivative; metabolism is mediated by the cytochrome P450 isoenzymes CYP3A4 and CYP2B6, and to a lesser extent by CYP1A2, CYP1A1, and CYP2C19. The active metabolite appears to be a thiol derivative; it has been identified in vitro but appears to be too unstable to be isolated from plasma. Clopidogrel and the carboxylic acid derivative are highly protein bound. Clopidogrel and its metabolites are excreted in urine and in feces; about 50% of an oral dose is recovered from the urine and about 46% from the feces.
For prophylaxis of thromboembolytic events and treatment of acute coronary syndromes, including unstable angina and non-Q wave myocardial infarction.
Dosage/Direction for Use
For the prophylaxis of thromboembolic events, the usual dose of Clopidogrel is 75 mg once daily. In the management of acute coronary syndromes, including unstable angina and non-Q wave myocardial infarction, given as a single loading dose of 300 mg, followed by 75mgonce daily or as prescribed by the physician.
Contraindicated in patients with history of hypersensitivity to the drug or any of its components.
Special Precautions
Consideration should be given to stopping Clopidogrel 5 to 7 days before elective surgery. Clopidogrel should be used with caution in patients receiving other drugs that increase the risk of bleeding, including anticoagulants, other antiplatelets, and NSAIDs.
Adverse Reactions
The incidence of adverse effects, particularly blood dyscrasias, is lower with Clopidogrel, although fatalities have been reported rarely; include serum sickness, interstitial pneumonitis, erythema multiforme, Stevens-Johnson syndrome, lichen planus and myalgia.
Drug Interactions
Risk of bleeding is increased when the drug is used with anticoagulant, other antiplatelets, and NSAIDs. Clopidogrel may inhibit the Cytochrome P450 isoenzyme CYP2C9 and interactions with drugs metabolized by this isoenzyme are theoretically possible; it may also inhibit CYP2B6.
Antifungals: Ketoconazole decreased the plasma concentration of the active metabolite of clopidogrel; platelet inhibitory action was also reduced.
Bupropion: Clopidogrel reduced the conversion of bupropion to its active metabolite, suggesting that clopidogrel inhibits the cytochrome P450 isoenzyme CYP2B6.
HMG-COA Reductase Inhibitors: There have been reports of rhabdomyolysis developing in patients when given clopidogrel in addition to ciclosporin and a statin.
Store at temperatures not exceeding 30°C.
ATC Classification
B01AC04 - clopidogrel ; Belongs to the class of platelet aggregation inhibitors excluding heparin. Used in the treatment of thrombosis.
FC tab 75 mg x 10's, 30's, 100's.
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