Drug Catalog - Product Detail
CLOPIDOGREL BI SULFATE TB 75MG 90
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 55111-0196-90 | DR.REDDY'S LABORATORIES, INC. | 90 | 75MG | TABLET |
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Description
DESCRIPTION Clopidogrel bisulfate USP is a thienopyridine class inhibitor of P2Y 12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)acetate sulfate (1:1). The molecular formula of clopidogrel bisulfate USP is C 16 H 16 Cl NO 2 S•H 2 SO 4 and its molecular weight is 419.9. The structural formula is as follows: Clopidogrel bisulfate USP is a white to off-white powder. It is freely soluble in methanol and practically insoluble in ether. It has a specific optical rotation of between +53° and + 58°. Clopidogrel for oral administration is provided as white, film coated, round, biconvex tablets debossed with “R” on one side and “196” on other side. Each tablet contains 97.875 mg of clopidogrel bisulfate which is the molar equivalent to 75 mg of clopidogrel base. Each tablet contains microcrystalline cellulose, colloidal silicon dioxide and magnesium stearate as inactive ingredients. The film coating contains hypromellose 2910-5cP, polyethylene glycol 400 and titanium dioxide.
How Supplied
HOW SUPPLIED Clopidogrel tablets USP, 75 mg are white, film coated, round, biconvex tablets debossed with “R” on one side and “196” on other side and are supplied in bottles of 30, 90, 100 and 500. Bottles of 30 NDC 55111-196-30 Bottles of 90 NDC 55111-196-90 Bottles of 100 NDC 55111-196-01 Bottles of 500 NDC 55111-196-05 Preserve in well-closed containers. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]
Indications & Usage
INDICATIONS & USAGE 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, clopidogrel tablets have been shown to decrease the rate of a combined endpoint of cardiovascular death, myocardial infarction (MI), or stroke as well as the rate of a combined endpoint of cardiovascular death, MI, stroke, or refractory ischemia. For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets have been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction, or stroke. The benefit for patients who undergo primary percutaneous coronary intervention is unknown. The optimal duration of clopidogrel tablet therapy in ACS is unknown. For patients with a history of recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease, clopidogrel tablets has been shown to reduce the rate of a combined endpoint of new ischemic stroke (fatal or not), new MI (fatal or not), and other vascular death.
Dosage and Administration
DOSAGE & ADMINISTRATION Clopidogrel tablets can be administered with or without food [see Clinical Pharmacology (12.3) ] For patients with non-ST-elevation ACS (UA/NSTEMI), initiate clopidogrel tablets with a single 300 mg oral loading dose and then continue at 75 mg once daily. Initiate aspirin (75-325 mg once daily) and continue in combination with clopidogrel tablets [see Clinical Studies (14.1) ]. For patients with STEMI, the recommended dose of clopidogrel tablets is 75 mg once daily orally, administered in combination with aspirin (75-325 mg once daily), with or without thrombolytics. Clopidogrel tablets may be initiated with or without a loading dose [see Clinical Studies (14.1) ]. The recommended daily dose of clopidogrel tablets is 75 mg once daily orally, with or without food [see Clinical Pharmacology (12.3 ) ]. CYP2C19 poor metabolizer status is associated with diminished antiplatelet response to clopidogrel. Although a higher dose regimen in poor metabolizers increases antiplatelet response [see Clinical Pharmacology (12.5 ) ], an appropriate dose regimen for this patient population has not been established. Avoid using omeprazole or esomeprazole with clopidogrel tablets. Omeprazole and esomeprazole significantly reduce the antiplatelet activity of clopidogrel tablets. When concomitant administration of a PPI is required, consider using another acid-reducing agent with minimal or no CYP2C19 inhibitory effect on the formation of clopidogrel active metabolite [see Warnings and Precautions ( 5.1 ) , Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.3 ) ].