General: 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 to 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.
In patients with recent TIA or stroke who are at high risk of recurrent ischemic events, the combination of aspirin and clopidogrel has not been shown to be more effective than clopidogrel alone, but the combination has been shown to increase major bleeding.
GI Bleeding: Clopidogrel should be used with caution in patients who have lesions with a propensity to bleed (eg, ulcers). Drugs that might induce such lesions should be used with caution in patients taking clopidogrel.
Use in Hepatically-Impaired Patients: Experience is limited in patients with severe hepatic disease, who may have bleeding diatheses. Clopidogrel should be used with caution in this population.
Use in Renally-Impaired Patients: Experience is limited in patients with severe renal impairment. Clopidogrel should be used with caution in this population.
Information for Patients: Patients should be told that while taking Ridlor or Ridlor combined with aspirin that: It may take them longer than usual to stop bleeding; they may bruise and/or bleed more easily; they should report any unusual bleeding to their physician; they should tell their physician about any other medications they are taking, including prescription or over-the-counter omeprazole; they should inform physicians and dentists that they are taking Ridlor and/or any other product known to affect bleeding before any surgery is scheduled and before any new drug is taken.
Effects on the Ability to Drive or Operate Machinery: No impairment of driving or psychometric performance was observed following clopidogrel administration.
Carcinogenicity, Mutagenicity & Impairment of Fertility: There is no evidence of tumorigenicity. Clopidogrel is not genotoxic. Clopidogrel has found to have no effect on fertility of male and female rats at oral doses up to 400 mg/kg/day (52 times the recommended human dose on a mg/m2 basis).
Use in pregnancy: Pregnancy Category B.
There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of a human response, Ridlor should be used during pregnancy only if clearly needed.
Use in lactation: Studies in rats have shown that clopidogrel and/or its metabolites are excreted in the milk. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the nursing woman.
Use in children: Safety and effectiveness in the pediatric population have not been established.