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Overdosage & Contraindications
CONTRAINDICATIONS
The use of PLAVIX is contraindicated in the following conditions: Hypersensitivity to the drug substance or any component of the product. Text Continues Below
Active pathological bleeding such as peptic ulcer or intracranial hemorrhage. OVERDOSAGE One case of deliberate overdosage with PLAVIX was reported in the large, CAPRIE controlled clinical study. A 34-year-old woman took a single 1,050-mg dose of PLAVIX (equivalent to 14 standard 75-mg tablets). There were no associated adverse events. No special therapy was instituted, and she recovered without sequelae. No adverse events were reported after single oral administration of 600 mg (equivalent to 8 standard 75-mg tablets) of PLAVIX in healthy volunteers. The bleeding time was prolonged by a factor of 1.7, which is similar to that typically observed with the therapeutic dose of 75 mg of PLAVIX per day. A single oral dose of clopidogrel at 1500 or 2000 mg/kg was lethal to mice and to rats and at 3000 mg/kg to baboons. Symptoms of acute toxicity were vomiting (in baboons), prostration, difficult breathing, and gastrointestinal hemorrhage in all species. Recommendations About Specific Treatment Based on biological plausibility, platelet transfusion may be appropriate to reverse the pharmacological effects of PLAVIX if quick reversal is required.
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