Clopidogrel Bisulfate

Clopidogrel Bisulfate

Clopidogrel Bisulfate Recall

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Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

1.1 Acute Coronary Syndrome (ACS)
  • 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.

1.2 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 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.

History

There is currently no drug history available for this drug.

Other Information

Clopidogrel bisulfate USP is a thienopyridine class inhibitor of P2Y12 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 C16H16Cl NO2S•H2SO4 and its molecular weight is 419.9.

 The structural formula is as follows:

structure

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.

Clopidogrel Bisulfate Manufacturers


  • State Of Florida Doh Central Pharmacy
    Clopidogrel Bisulfate Tablet, Film Coated [State Of Florida Doh Central Pharmacy]
  • Sun Pharma Global Fze
    Clopidogrel Bisulfate Tablet, Film Coated [Sun Pharma Global Fze]
  • Physicians Total Care, Inc.
    Clopidogrel Bisulfate Tablet, Film Coated [Physicians Total Care, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Clopidogrel Bisulfate Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Remedyrepack Inc.
    Clopidogrel Bisulfate Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Clopidogrel Bisulfate Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Clopidogrel Bisulfate Tablet [Remedyrepack Inc. ]
  • Cardinal Health
    Clopidogrel Bisulfate (Clopidogrel) Tablet, Film Coated [Cardinal Health]
  • Remedyrepack Inc.
    Clopidogrel Bisulfate (Clopidogrel) Tablet, Film Coated [Remedyrepack Inc. ]
  • Cardinal Health
    Clopidogrel Bisulfate Tablet, Film Coated [Cardinal Health]
  • Dr.reddy’s Laboratories Limited
    Clopidogrel Bisulfate Tablet, Film Coated [Dr.reddy’s Laboratories Limited]
  • Dr.reddy’s Laboratories Limited
    Clopidogrel Bisulfate Tablet, Film Coated [Dr.reddy’s Laboratories Limited]
  • Major Pharmaceuticals
    Clopidogrel Bisulfate Tablet [Major Pharmaceuticals]
  • Mylan Pharmaceuticals Inc.
    Clopidogrel Bisulfate (Clopidogrel) Tablet, Film Coated [Mylan Pharmaceuticals Inc.]
  • Preferred Pharmaceuticals, Inc.
    Clopidogrel Bisulfate Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]
  • Torrent Pharmaceuticals Limited
    Clopidogrel Bisulfate Tablet [Torrent Pharmaceuticals Limited]
  • Remedyrepack Inc.
    Clopidogrel Bisulfate Tablet, Film Coated [Remedyrepack Inc. ]
  • State Of Florida Doh Central Pharmacy
    Clopidogrel Bisulfate Tablet, Film Coated [State Of Florida Doh Central Pharmacy]
  • Golden State Medical Supply, Inc.
    Clopidogrel Bisulfate Tablet, Film Coated [Golden State Medical Supply, Inc.]
  • Blenheim Pharmacal, Inc.
    Clopidogrel Bisulfate Tablet, Film Coated [Blenheim Pharmacal, Inc.]
  • Mylan Institutional Inc.
    Clopidogrel Bisulfate (Clopidogrel) Tablet, Film Coated [Mylan Institutional Inc.]
  • Cardinal Health
    Clopidogrel Bisulfate Tablet [Cardinal Health]
  • Remedyrepack Inc.
    Clopidogrel Bisulfate Tablet, Film Coated [Remedyrepack Inc. ]
  • Carilion Materials Management
    Clopidogrel Bisulfate Tablet, Film Coated [Carilion Materials Management]
  • Cardinal Health
    Clopidogrel Bisulfate (Clopidogrel) Tablet, Film Coated [Cardinal Health]
  • Sciegen Pharmaceuticals Inc
    Clopidogrel Bisulfate Tablet, Film Coated [Sciegen Pharmaceuticals Inc]

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