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Red blood cell disorders Anemia aplastic, anemia hypochromic. Reproductive disorders, female Text Continues Below
Menorrhagia. Respiratory system disorders Hemothorax. Skin and appendage disorders Bullous eruption, rash erythematous, rash maculopapular, urticaria. Urinary system disorders Abnormal renal function, acute renal failure. White cell and reticuloendothelial system disorders Agranulocytosis, granulocytopenia, leukemia, leukopenia, neutrophils decreased. Postmarketing Experience
The following events have been reported spontaneously from worldwide postmarketing experience: Body as a whole: hypersensitivity reactions, anaphylactoid reactions Central and Peripheral Nervous System disorders: confusion, hallucinations, taste disorders Liver and Biliary system disorders: abnormal liver function test, hepatitis (non-infectious) Platelet, Bleeding and Clotting disorders: cases of bleeding with fatal outcome (especially intracranial, gastrointestinal and retroperitoneal hemorrhage) agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura (TTP) - see WARNINGS. conjunctival, ocular and retinal bleeding Respiratory system disorders: bronchospasm Skin and Appendage disorders: angioedema, erythema multiforme Urinary system disorders:
glomerulopathy, abnormal creatinine levels Drug Interactions Study of specific drug interactions yielded the following results: Aspirin Aspirin did not modify the clopidogrel-mediated inhibition of ADP-induced platelet aggregation. Concomitant administration of 500 mg of aspirin twice a day for 1 day did not significantly increase the prolongation of bleeding time induced by PLAVIX. PLAVIX potentiated the effect of aspirin on collagen-induced platelet aggregation. PLAVIX and aspirin have been administered together for up to one year. Heparin In a study in healthy volunteers, PLAVIX did not necessitate modification of the heparin dose or alter the effect of heparin on coagulation. Coadministration of heparin had no effect on inhibition of platelet aggregation induced by PLAVIX. Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) In healthy volunteers receiving naproxen, concomitant administration of PLAVIX was associated with increased occult gastrointestinal blood loss. NSAIDs and PLAVIX should be coadministered with caution. Warfarin Because of the increased risk of bleeding, the concomitant administration of warfarin with PLAVIX should be undertaken with caution. (See Precautions-General). Other Concomitant Therapy No clinically significant pharmacodynamic interactions were observed when PLAVIX was coadministered with atenolol, nifedipine, or both atenolol and nifedipine. The pharmacodynamic activity of PLAVIX was also not significantly influenced by the coadministration of phenobarbital, cimetidine or estrogen. The pharmacokinetics of digoxin or theophylline were not modified by the coadministration of PLAVIX (clopidogrel bisulfate). At high concentrations in vitro, clopidogrel inhibits P450 (2C9). Accordingly, PLAVIX may interfere with the metabolism of phenytoin, tamoxifen, tolbutamide, warfarin, torsemide, fluvastatin, and many non-steroidal anti-inflammatory agents, but there are no data with which to predict the magnitude of these interactions. Caution should be used when any of these drugs is coadministered with PLAVIX. In addition to the above specific interaction studies, patients entered into clinical trials with PLAVIX received a variety of concomitant medications including diuretics, beta-blocking agents, angiotensin converting enzyme inhibitors, calcium antagonists, cholesterol lowering agents, coronary vasodilators, antidiabetic agents (including insulin), antiepileptic agents, hormone replacement therapy, heparins (unfractionated and LMWH) and GPIIb/IIIa antagonists without evidence of clinically significant adverse interactions. The use of oral anticoagulants, non-study anti-platelet drug and chronic NSAIDs was not allowed in CURE and there are no data on their concomitant use with clopidogrel. Page: << Prev | 1 | 2 | 3 | 4 | 5
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