Each film-coated tablet contains: Clopidogel (as Bisulfate) 75 mg.
Pharmacology: Clopidogrel is rapidly but incompletely absorbed after oral administration; absorption appears to be at least 50%. It is prodrug and is extensively metabolized in the liver, mainly to the inactive carboxylic acid derivative. The active metabolite appears to be a thiol derivative but has not been identified in plasma. Clopidogrel and the carboxylic acid derivative are highly protein bound. Clopidogrel and its metabolites are excreted in urine and in feces. After oral administration, about 50% of a dose is recovered from the urine and about 46% from the feces.
Indicated for the reduction of thrombotic events in Recent Myocardial Infarction, Recent Stroke or Established Peripheral Arterial Disease, Acute Coronary Syndromes.
Recent Myocardial Infarction, Recent Stroke or Established Peripheral Arterial Disease: Recommended daily dose is 75 mg once daily.
Acute Coronary Syndrome-including unstable angina/non-Q-wave Myocardial Infarction: Should be initiated with single 300 mg loading dose and then continued at 75 mg once daily.
Clopidogrel can be administered with or without food.
No dosage adjustment is necessary for elderly patients or patients with renal disease.
The use of clopidogrel is contraindicated in the following conditions: A. Hypersensitivity to the drug substance or any component of the drug.
B. Active pathological bleeding such as peptic ulcer or intracranial hemorrhage.
Thrombotic thrombocytopenic purpura (TTP) has been reported rarely following use of clopidogrel, sometimes after a short exposure (<2 weeks). TPP is a serious condition requiring prompt treatment. It is characterized by thrombocytopenia, microangiopathic hemolytic anemia (schistocytes [fragmented RBCs] seen on peripheral smear), neurological findings, renal dysfunction, and fever.
Clopidogrel prolongs the bleeding time and therefore should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions (particularly gastrointestinal and intraocular). If a patient is to undergo elective surgery and an antiplatelet effect is not desired, clopidogrel should be discontinued 5 days prior to surgery. Due the risk of bleeding and undesirable hematological effects, blood cell count determination and/or other appropriate testing should be promptly considered, whenever such suspected clinical symptoms arise during the course of treatment.
Information to Patients: Patients should be told that it may take them longer than usual to stop bleeding when they take clopidogrel, and they should report any unusual bleeding to their physician. Patients should inform physicians and dentists that they are taking clopidogrel before any surgery is scheduled and before any new drug is taken.
Gastrointestinal disturbances, skin rashes, and bleeding are the most commonly reported adverse effects associated with clopidogrel therapy. Blood dyscrasias, including neutropenia, thrombotic thrombocytopenic purpura, and aplastic anemia, have also occurred. There have been reports of hepatitis and cholestatic jaundice. Blood-lipid concentrations may increase during long-term therapy.
Clopidogrel should be used with caution in patients receiving other drugs that increase the risk of bleeding, including anticoagulants, other antiplatelets, and NSAIDS.
Store at temperatures not exceeding 30°C.
B01AC04 - clopidogrel ; Belongs to the class of platelet aggregation inhibitors excluding heparin. Used in the treatment of thrombosis.
Deplatt FC tab 75 mg
100's (P3,304/pack)
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