Clopidogrel Tablets IP 300 mg

Clopidogrel Tablets IP 300 mg

Composition :

Each film coated tablet contains
Clopidogrel Bisulphate IP
equivalent to Clopidogrel 300 mg
Colous : Titanium Dioxide IP and
Red Oxide or Iron

Clinical Information :

Indications :

As loading dose in patients with non ST segment elevation acute coronary syndrome (Unstable Angina (UA)/Non ST segment elevation Myocardial infarction (NSTMEI)

Dosage and administration :

A loading dose of one tablet 0f 300 mg before PCI can be given with or without food.

Use In Children :

Safety and efficacy of clopidogrel is not established.

Contraindications :

• Hypersensitivity to Clopidogrel or any of its components.
• Active pathological bleeding such as peptic ulcer or intracranial hemorrhage.
• Pregnancy and lactation
• Severe liver impairment.

Warning and Precautions :

• In patients who may be at high risk of increased bleeding from trauma, surgery or other pathological conditions, clopidogrel should be used with caution. If a patient is to undergo elective surgery and an antiplatelet effect is not desired, clopidogrel should be discontinued 7 days prior to surgery.
• In patients who have lesions with a ropensity to bleed particularly gastrointestinal and intraocular, clopidogrel should be used with caution as it proolongs bleeding. Drugs that might induce such lesions ( such as aspirin and other NSAIDs) should be used with caution in patients taking clopidogrel.
• Patients should inform physicians and dentists that they are taking clopidogrel before surgery is scheduled and before any new drugs is taken.
• Pharmacogenetics : Based on literature data, patients with genetically reduced CYP2C19 function have lower systemic exposure to the active metabolite of clopidogrel and diminished antiplatelet responses, and generally exhibit higher cardiovascular event rates following myocardial infarction than do patients with normal CYP2C19 function.
• Since clopidogrel is metabolised to its active metabolite parlty by CYP2C19, use of drugs thant inhibit the activity of this enzyme would be expected to result in reduced drug levels of the active metabolite of clopidogrel and a reduction in clinical efficacy. Concomitant use of durgs that inhibit CYP2C19 should be discouraged.

Use in patients with impaired Liver Function

          As clopidogrel is metabolite by specific hepatic CYP isoenzymes, mild to moderate hepatic impairment appears to slow the metabolic  tranformation. Experience with the drug is limited in those with moderate hepatic impairment especially in those who may have bleeding diathesis. Clopidogrel must be used caution in this population.

Use in Patients with impaired Kidney Function

          Higher plasma levels of the main circulation metabolite have been observed in elderly compared to young healthy volunteers. But this is not associated with difference in platelet aggregation and bleeding item. So no dosage adjustment required in elderly patients.

Interactions :

• Invitro studies using higher concentrations of Clopidogrel showed inhibition of CYP2C9 isoenzyme. Interaction of clopidogrel with drugs such as amoxifen, phenytoin, tolbutamide, warfarin, torsemide, fluvastain and many nonsteroidal anti-inflammatory drugs may be possible. But there are no dat to predict the magnitude of these interactions.
• the anticoagulant properties of heparin were unaffected by concurrent administration of clinicaly relevant dosage of clopidogrel.
• Concomitant administration of aspirin >33-mg/ day plus clopidogrel 75 mg/day did not prolong bleeding time to a significantly greater extent that that attributable to clopidogrel alone. The safety of chronic concomitant administration of aspirin and clopidogrel is not established Clopidogrel potentiated the effect of aspirin on collagen induced platelet aggregation.
• Concomitant administration of clopidogrel and naproxen resulted in an increase of occult gastrointestinal blood loss in healthy volunteers.
• Coadministration with warfarin has not been studied. consequently, concomitant administration of these two agents should be undertaken with caution.
• The steady state pharmacokinetics profile of digoxin, and theophyline were unaffected by coadministration of clopidogrel for 10 days. Similarly the platelet antiaggregating properties of clopidogrel were unchanged by coadministration of theophyline in these studies.
• There is no evidence of pharmacodynamic interaction between

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