Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Dr-reddy
MISTRO (tablet) SCHEDULING STATUS: S3 PROPRIETARY NAME (and dosage form): MISTRO (tablet) COMPOSITION MISTRO: Each film-coated tablet contains clopidogrel bisulfate 97,875 mg equivalent to 75 mg clopidogrel base. Sugar free. PHARMACOLOGICAL CLASSIFICATION A 8.2 Anticoagulants PHARMACOLOGICAL ACTION Pharmacodynamics Clopidogrel is a specific and potent inhibitor of platelet aggregation. It acts by irreversibly modifying the platelet ADP- receptors. It inhibits the binding of adenosine diphosphate (ADP) to its platelet receptor and subsequent ADP-mediated activation of the glycoprotein GPIIb/IIIa complex, thereby inhibiting platelet aggregation. Consequently platelets exposed to clopidogrel are affected for the remainder of their lifespan and recovery of normal platelet function occurs at a rate consistent with platelet turnover (of about 7 days). Clopidogrel also inhibits platelet aggregation induced by other agonists by blocking the amplification of platelet activation by released ADP. Biotransformation of clopidogrel is necessary to produce inhibition of platelet aggregation. Repeated doses of 75 mg per day may produce inhibition of ADP-induced platelet aggregation from the first day; this may increase progressively and reach steady state between day 3 and day 7. At steady state the average inhibition level observed with a dose of 75 mg per day may be between 40% and 60%. Platelet aggregation and bleeding time gradually returns to baseline values, generally within 7 days after treatment has been discontinued. Pharmacokinetics After oral doses clopidogrel is rapidly absorbed. Absorption is at least 50%. Clopidogrel is extensively metabolized by the liver and the main metabolite which is inactive, is the carboxylic acid derivative which represents about 85% of the circulating compound i Read the complete document