Acute Coronary Syndrome (ACS): This combination is indicated to reduce the rate of Myocardial Infarction (MI) and Stroke in patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation Myocardial Infarction (NSTEMI)] and acute ST-segment elevation ACS [ST-elevation ... Read more

Acute Coronary Syndrome (ACS): This combination is indicated to reduce the rate of Myocardial Infarction (MI) and Stroke in patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation Myocardial Infarction (NSTEMI)] and acute ST-segment elevation ACS [ST-elevation Myocardial Infarction (STEMI)].

Recent MI, recent Stroke, or established Peripheral Arterial Disease: In patients with established peripheral arterial disease or with a history of recent Myocardial Infarction (MI) or recent Stroke it is indicated to reduce the rate of MI and Stroke.

Dosage & Administration

The recommended dose of Clopidogrel is 75 mg once daily with or without food. No dosage adjustment is necessary for elderly patients or patients with renal patients. For patients with acute coronary syndrome (unstable angina/non-Q-wave MI), Clopidogrel should be initiated with a single 300 mg loading dose and then continued at 75 mg once daily. Aspirin (75 mg-325 mg once daily) should be initiated and continued in combination with Clopidogrel. In studies it was found that most patients with acute coronary syndrome also received heparin acutely.

Interaction

Study of specific drug interactions yielded the following results:

Aspirin: Aspirin does not modify the Clopidogrel-mediated inhibition of ADP-induced platelet aggregation. Clopidogrel potentiates the effect of aspirin on collagen-induced platelet aggregation.

Heparin: Clopidogrel does not necessitate modification of the heparin dose or alter the effect of heparin on coagulation. Co-administration of heparin has no effect on inhibition of platelet aggregation induced by Clopidogrel.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): Concomitant administration of Clopidogrel is associated with increased occult gastrointestinal blood loss. NSAIDs and Clopidogrel should be co-administered with caution.

Warfarin: The safety of the co-administration of Clopidogrel with warfarin has not been established. Consequently, concomitant administration of these two agents should be undertaken with caution.

Contraindications

This combination is contraindicated in the following conditions: Hypersensitivity to the drug substance or any component of the product. Active pathological bleeding such as peptic ulcer or intracranial hemorrhage.

Side Effects

This combination is generally well tolerated.

Precautions & Warnings

• This combination may prolongs the bleeding time.
• Thrombotic thrombocytopenic purpura (TTP): TTP has been reported rarely following use of this combination.
• Reye's syndrome: Reye's syndrome may develop in individuals who have chicken pox, influenza or flu symptoms. Hypersensitivity including rash, angioedema or hematologic reaction has been reported in patients receiving this combination or history of hypersensitivity to other thienopyridines

Overdose Effects

Clopidogrel overdose may lead to bleeding complications. Based on biological plausibility, platelet transfusion may restore clotting ability. In moderate aspirin intoxication dizziness, headache, tinnitus, confusion, and gastrointestinal symptoms may occur which can be treated by inducing vomiting followed by gastric lavage if needed. In severe Aspirin intoxication respiratory alkalosis respiratory acidosis, metabolic acidosis, hyperthermia, perspiration, dehydration can occur. It can be treated with haemodialysis and other symptomatic treatment.

Therapeutic Class

Anti-platelet drugs

Storage Conditions

Keep in a cool & dry place (below 30ºC), protected from light & moisture. Keep out of the reach of children.