Clovixa

Light blue rectangular film coated tablet engraved 'ACME' on one face and a break line on the other face.
Each film-coated tablet contains: Clopidogrel (as bisulphate) 75 mg.

Pharmacology: Pharmacokinetics: Absorption: Clopidogrel is rapidly but incompletely absorbed following oral administration; absorption appears to be about 50%.
Distribution: Clopidogrel and the main circulating (inactive) metabolite bind reversibly in vitro to human plasma proteins (98% and 94% respectively). The binding is non-saturable in vitro over a wide concentration range.
Metabolism: Clopidogrel is extensively metabolized in the liver according to two pathways. The esterase mediated pathway leads to hydrolysis and subsequent formation of the inactive metabolite, carboxylic acid, which is 85% of the circulating metabolites. The cytochrome P450 enzyme mediate pathway leads to formation of an intermediate metabolite, 2-oxoclopidogrel, that is metabolized further to form the thiol derivative of clopidogrel which is the active metabolite responsible for rapid and irreversible binding to platelet receptors leading to inhibition of platelet aggregation. The active metabolite is formed mostly by CYP2C19 with contributions from several CYP enzymes such as CYP1A2, CYP2B6 and CYP3A4.
The Cmax of the active metabolite is twice as high following a single 300-mg clopidogrel loading dose compared to after four days of 75-mg of maintenance dose. Cmax occurs approximately 30 to 60 minutes after dosing.
Elimination: Its metabolites are excreted about equally in the urine and faeces. After a single oral dose of 75 mg, clopidogrel has a half-life of approximately 6 hours. The elimination half-life of the main circulating (inactive) metabolite was 8 hours after single and repeated administration.

Clopidogrel is indicated for the prevention of atherosclerotic events in patients with history of symptomatic atherosclerotic disease (ischaemic stroke, myocardial infarction or established peripheral arterial disease).

The recommended dose is a single daily dose of film coated tablet of Clopidogrel with or without food.
Or as directed by the physician.

Hypersensitivity to the active substance or to any of the excipients of the medicinal product.
Severe renal impairment.
Active pathological bleeding such as peptic ulcer or intracranial hemorrhage.
Breastfeeding.

If a patient is to undergo elective surgery and anti-platelet effect is not desired, Clopidogrel should be discontinued 7 days prior to surgery. It prolongs the bleeding time. So it 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). Patients should be informed that it may take them longer time than usual to stop bleeding when they take this drug and they should report any unusual bleeding to the physicians. This drug should be used with caution in hepatically and renally impaired patients.

Pregnancy: As no clinical data on exposed pregnancies are available, it is preferable not to use Clopidogrel during pregnancy as a precautionary measure. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/fetal development, parturition or postnatal development.
Lactation: Studies in rats have shown that Clopidogrel and/or its metabolites are excreted in the milk. It is not known whether this medicinal product is excreted in human milk.

Clopidogrel is generally well tolerated. A few common side effects like: Hemorrhage, abdominal discomfort, nausea, vomiting, diarrhea, headache, dizziness, vertigo, paraesthesia, rash, pruritus, hepatic and biliary disorder, neutropenia.

Aspirin: It does not modify the Clopidogrel mediated inhibition of ADP-induced platelet aggregation.
Warfarin: Because of the increased risk of bleeding, the concomitant use of Warfarin with Clopidogrel should be undertaken with caution.
NSAIDs: NSAIDs and Clopidogrel should be administered with caution. Concomitant administration of Clopidogrel with Naproxen is associated with gastrointestinal blood loss.
Others: No clinically significant pharmacodynamics interactions are observed when Clopidogrel administered with atenolol, nifedipine, or both atenolol and nifedipine.

Store at temperatures not exceeding 30°C. Protect from light.

Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)

B01AC04 - clopidogrel ; Belongs to the class of platelet aggregation inhibitors excluding heparin. Used in the treatment of thrombosis.

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