Dclot 75 mg Tablet

Dclot 75 mg Tablet

DESCRIPTION

Dclot (Clopidogrel) is an inhibitor of platelet aggregation. It is a thienopyridine derivative that selectively inhibits the binding of adenosine diphosphate (ADP) to its platelet receptor and the subsequent ADP-mediated activation of the GP IIb/IIla complex, thereby inhibiting platelet aggregation.

COMPOSITION

Each film coated tablet contains Clopidogrel Bisulphate INN equivalent to Clopidogrel 75 mg.

INDICATIONS

Dclot 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).

DOSAGE AND ADMINISTRATION

The recommended dose is one tablet of Dclot daily with or without food.

OR AS DIRECTED BY THE PHYSICIAN.

CONTRAINDICATIONS

The use of Clopidogrel is contraindicated in the following conditions : Hypersensitivity to the drug substance or any component of the product. Active pathological bleeding such as peptic ulcer and intracranial haemorrhage.

PRECAUTIONS

If a patient is to undergo elective surgery and an antiplatelet 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.

SIDE EFFECTS

Clopidogrel is generally well tolerated. A few common side effects like haemorrhage (including gastrointestinal and intracranial), abdominal discomfort, nausea, vomiting, diarrhoea, headache, dizziness, vertigo, paraesthesia, rash, pruritus, hepatic and biliary disorder, neutropenia etc. may occur.

USE IN PREGNANCY & LACTATION

Pregnancy: There are no adequate and well-controlled studies of Clopidogrel in pregnant women. Clopidogrel should be used during pregnancy only if clearly needed.

Lactation : It is not known whether this drug is excreted in human milk. For this reason, Clopidogrel should not be prescribed to nursing mother unless absolutely necessary.

Drug Interactions

Aspirin : Aspirin does not modify the Clopidogrel mediated inhibition of ADPinduced platelet aggregation.

Warfarin : Because of the increased risk of bleeding, the concomitant administration of warfarin with Clopidogrel should be undertaken with caution.

NSAIDs: NSAIDs and Clopidogrel should be co-administered with caution. Concomitant administration of Clopidogrel with naproxen is associated with gastrointestinal blood loss.

Others : No clinically significant pharmacodynamic interactions are observed when Clopidogrel is co-administered with atenolol, nifedipine or both atenolol and nifedipine.

SUPPLY

Each box contains 3 X 10 tablets in blister.