ASPIN-PLUS

Clopidogrel plus Aspirin

Description:

Aspin-Plus is a combination of Clopidogrel plus Aspirin. Clopidogrel and Aspirin are inhibitors of platelet aggregation.

Composition:

Each film coated tablet contains Clopidogrel (as bisulphate) USP 75 mg plus Aspirin BP 75 mg.

Pharmacology:

Clopidogrel selectively inhibits the binding of adenosine diphosphate (ADP) to its platelet receptor and the subsequent ADP-mediated activation of the glycoprotein. GPIIb/IIIa complex, thereby inhibiting platelet aggregation. Clopidogrel also inhibits platelet aggregation induced by agonists other than ADP.

Aspirin inhibits platelet aggregation by irreversible inhibition of platelet cyclooxygenase and thus inhibiting the generation of thromboxane A2 a powerful inducer of platelet aggregation and vasoconstriction.

Dosage and administration:

The recommended daily dose is one tablet.

Aspin-Plus can be administered with or without food.

Contraindications:

The use of Aspin-Plus is contraindicated in the following conditions

Hypersensitivity to the drug substance or any component of the product

Adverse effects:

This drug is generally well tolerated. Side effects that have been reported include chest pain, fatigue, edema, headache, dizziness, abdominal pain, dyspepsia, diarrhoea, nausea, and depression.

Precaution:

Use with caution in patients at increased risk of bleeding from trauma, surgery or other pathological conditions.

Severe hepatic impairment: Use with caution in patients with severe hepatic disease.

Special groups:

Pediatric use: Safety and efficacy have not been established in pediatric patients.

Renal impairment: Dosage adjustment does not appear to be necessary in-patients with renal impairment.

Special groups:

Geriatric use: Dosage adjustment based solely on age does not appear to be necessary in geriatric patients.

Use in pregnancy:There were no adequate and well controlled studies in pregnant women. Aspin-Plus should be used during pregnancy only if clearly needed.

Use in nursing mothers: It is not known whether this drug is excreted in human milk. 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.

Drug interaction:

Use caution with phenytoin, tamoxifen, tolbutamide, warfarin, torsemide, fluvastatin, and non-steroidal anti-inflammatory agents.

Storage:

Store in a cool and dry place. Keep out of the reach of children.

Packing:

Aspin-Plus: Each box contains 3x10's tablets in alu-alu blister pack.