COMPOSITION:

Each Film Coated tablet contains:

• Clopidogrel bisulfate 97.875 mg. (Equivalent to 75 mg of clopidogrel base).

PHARMACOLOGICAL ACTION:

Clopidogrel is an inhibitor of platelet activation and aggregation through the irreversible binding of its active metabolite to the P2Y12 class of ADP receptors on platelets.

INDICATIONS AND CLINICAL USE:

Borgavix is a P2Y12 platelet inhibitor indicated for:

• Acute coronary syndrome
– For patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)] including patients who are to be managed medically and those who are to be managed with coronary revascularization.
– For patients with ST-elevation myocardial infarction (STEMI).
• Recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease.

DOSAGE & ADMINISTRATION:

• Acute coronary syndrome
– Non-ST-segment elevation ACS (UA/NSTEMI): 300 mg loading dose followed by 75 mg once daily, in combination with aspirin (75-325 mg once daily)
-STEMI: 75 mg once daily, in combination with aspirin (75-325 mg once daily), with or without a loading dose and with or without thrombolytics.
• Recent MI, recent stroke, or established peripheral arterial disease: 75 mg once daily.

SIDE EFFECTS:

Bleeding is the most commonly reported adverse reaction.

CONTRA-INDICATIONS:

•Active pathological bleeding, such as peptic ulcer or intracranial hemorrhage.
•Hypersensitivity to clopidogrel or any component of the product.

PRECAUTION & WARNING:

• Reduced effectiveness in impaired CYP2C19 function: Avoid concomitant use with omeprazole or esomeprazole.

• Bleeding: Clopidogrel increases risk of bleeding. Discontinue 5 days prior to elective surgery.
• Discontinuation of Borgavix 75: Premature discontinuation increases risk of cardiovascular events.
• Recent transient ischemic attack or stroke: Combination use of Clopidogrel and aspirin in these patients was not shown to be more effective than Clopidogrel alone, but was shown to increase major bleeding.
• Thrombotic thrombocytopenic purpura (TTP): TTP has been reported with Clopidogrel.

PREGNANCY & LACTATION:

Pregnancy Category B and it is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from clopidogrel, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

PACKAGE & STORAGE:

Carton box containing one or three blisters (PVC/Alu) each of 10 film coated tablets.
– Store at a temperature not exceeding 30 °C, in a dry place.
– Do not use unless under physician’s supervision.

RELATED PRODUCTS: (Cardiovascular Products)
Betaxolol 10-20
Borgastatin 10-40
Rosuvastatin 10

inquiry