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HOME >> API >> API List1 >> Clopidogrel Bisulfate >> Precautions

PRECAUTIONS
Clopidogrel Bisulfate CAS number 135046-48-9

If you've ever had a stomach ulcer or bleeding in the digestive tract, make sure the doctor is aware of it; Plavix should be used with caution. The drug should also be used carefully if you suffer from problems inside the eyes, have bleeding problems due to severe liver disease, or expect to be at risk of bleeding from any other cause.

Plavix may cause serious skin reactions such as toxic epidermal necrolysis, which is characterized by a large portion of skin turning red and peeling off (like a burn); it may also cause blisters. Contact your doctor immediately if these symptoms develop.

In extremely rare cases (about 4 in a million), a dangerous bleeding problem called thrombotic thrombocytopenic purpura has been known to develop in patients taking Plavix. Signs include fever and bleeding under the skin.

Tumorigenicity

Studies in mice and rats for 78 and 104 weeks, respectively, at doses of up to 77 mg per kg of body weight (mg/kg) per day (producing plasma exposures more than 25 times those in humans at the recommended daily dose of 75 mg) found no evidence of tumorigenicityMutagenicity

Clopidogrel was not found to be genotoxic in four in vitro tests (Ames test, DNA-repair test in rat hepatocytes, gene mutation assay in Chinese hamster fibroblasts, and metaphase chromosome analysis of human lymphocytes) or in one in vivo test (micronucleus test by oral route in mice)Pregnancy/Reproduction
Fertility—
Studies in rats and rabbits at doses of up to 500 and 300 mg/kg per day (65 and 78 times the recommended daily human dose on a mg per square meter of body surface area [mg/m 2] basis), respectively, found no evidence of impaired fertility. Studies in male and female rats at oral doses of up to 400 mg/kg per day (52 times the recommended human dose on a mg/m 2 basis) also found no evidence of impaired fertility.Breast-feeding

It is not known whether clopidogrel is distributed into human breast milk. Clopidogrel and/or its metabolites are distributed into the milk of lactating rats. Consideration of risk-benefit is recommended in making decisions about using clopidogrel in breast-feeding women or continuing breast-feeding in women taking clopidogrelAppropriate studies on the relationship of age to the effects of clopidogrel have not been performed in the pediatric population. Safety and efficacy have not been establishedDental

Because of the risk of increased surgical blood loss, it is recommended that clopidogrel be discontinued 7 days prior to elective dental surgery if an antiplatelet effect is not desired Surgical

Because of the risk of increased surgical blood loss, it is recommended that clopidogrel be discontinued 7 days prior to elective surgery if an antiplatelet effect is not desired

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