ATHOREL

Clopidogrel

Composition:

Athorel Tablet: Each film coated tablet contains Clopidogrel Bisulfate USP equivalent to Clopidogrel 75 mg. 

Pharmacology:

Athorel (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.

Indications: 

Athorel (Clopidogrel) is indicated for the reduction of thrombotic events as follows: Recent MI, recent stroke or established peripheral arterial disease: For patients with a history of recent myocardial infarction (MI), recent stroke or established peripheral arterial disease, Clopidogrel has been shown to reduce the rate of a combined endpoint of new ischemic stroke, new MI and other vascular death. Acute coronary syndrome: For patients with acute coronary syndrome including patients who are to be managed with medically and those who are to be managed with percutaneous coronary intervention, Clopidogrel has been shown to decrease the rate of a combined endpoint of cardiovascular death, MI, stroke or refractory ischemia. Dosage and administration: The recommended daily dose of Athorel (Clopidogrel) is 75 mg once daily, with or without food. No dosage adjustment is necessary for elderly patients or patients with renal disease.

Contraindications:

Hypersensitivity to the drug substance, active pathological bleeding such as peptic ulcer or intracranial ulcer. 

Side-effects:

Clopidogrel is generally well tolerated. Side effects are abdominal pain, dyspepsia, gastritis, diarrhoea, constipation, gastrointestinal haemorrhage, neutropenia, rash, palpitation, asthenia, neuralgia and vertigo. 

Precautions:

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

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. Clopidogrel 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 interactions:

Use caution with Phenytoin, Tamoxifen, Tolbutamide, Warfarin, Torsemide, Fluvastatin, and non-steroidal anti-inflammatory agents. No significant interactions were observed in the co-administration with Atenolol, Nifedipine or both the drugs.

Storage:

Store in a cool and dry place, protect from light. Keep out of the reach of children.

Packing:

Athorel Tablet: Each box contains 2x10's tablets in  blister pack.