Generic Plavix

CLOPIDOGREL
Tablets: 75 mg (Rx) Plavix (Sanofi)

Indications
Atherosclerotic events: Reduction of atherosclerotic events (MI, stroke, and vascular death) in patients with atherosclerosis documented by recent stroke, recent MI, or established peripheral arterial disease.

Administration and Dosage
The recommended dose of clopidogrel is 75 mg once daily with or without food.
No dosage adjustment is necessary for elderly patients or patients with renal disease.

Actions
Pharmacology: Clopidogrel is a thienopyridine derivative, chemically related to ticlopidine that inhibits platelet aggregation. It acts by irreversibly modifying the platelet ADP receptor. Consequently, platelets exposed to clopidogrel are affected for the remainder of their lifespan.
Dose-dependent inhibition of platelet aggregation can be seen 2 hours after single oral doses of clopidogrel. Platelet aggregation and bleeding time gradually return to baseline values after treatment is discontinued, generally in about 5 days.
Pharmacokinetics:
Absorption/Distribution - Clopidogrel absorption is > 50% and is rapid after oral administration. Bioavailability is unaffected by food. Both the parent compound and the main metabolite bind reversibly in vitro to plasma protein (98% and 94%, respectively).
Metabolism/Excretion - Clopidogrel is extensively metabolized by the liver. It undergoes rapid hydrolysis into its carboxylic acid derivative; glucuronidation also occurs. The elimination half-life of the main circulating metabolite was 8 hours with about 50% excreted in the urine and about 46% in the feces 5 days after dosing.

Contraindications
Hypersensitivity to the drug or any component of the product; active pathological bleeding such as peptic ulcer or intracranial hemorrhage.

Warnings
Neutropenia/agranulocytosis: Ticlopidine, a drug chemically similar to clopidogrel, is associated with a 0.8% rate of neutropenia ( Based on clinical trials, the risk of myelotoxicity with clopidogrel appears to be quite low. Consider this possibility when a patient receiving clopidogrel demonstrates fever or other signs of infection.
Hepatic function impairment: Experience is limited in patients with severe hepatic disease, who may have bleeding diatheses. Use with caution in this population.
Pregnanecy: Category B.
Lactation: Studies in rats have shown that clopidogrel and its metabolites are excreted in milk. It is not known whether this drag is excreted in human breast milk. Children: Safety and efficacy have not been established.

Precautions
Bleeding risk: As with other antiplatelet agents, use with caution in patients who may be at risk of increased bleeding from trauma, surgery, or other pathological conditions. If a patient is to undergo elective surgery and an antiplatelet effect is not desired, discontinue clopidogrel 7 days prior to surgery.
GI bleeding - Clopidogrel prolongs the bleeding time. Use with caution in patients who have lesions with a propensity to bleed (e.g., ulcers). Cautiously use drugs that might increase such lesions (e.g., aspirin, other NSAIDs) in patients taking clopidogrel.

Drug Interactions
At high concentrations in vitro, clopidogrel inhibits P450 2C9. Accordingly, clopidogrel 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. Use caution when any of these drugs is co-administered with clopidogrel.

Adverse Reactions
Adverse reactions occurring in > 3% of patients include flu-like symptoms, chest pain, edema, headache, dizziness, dyspepsia, abdominal pain, diarrhea, nausea, arthralgia, purpura, dyspnea, cough, rhinitis, rash, pruritus, depression, hypercholesteremia.
CARDIO & BLOOD/CHOLESTEROL

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