Clopidogrel (generic PLAVIX) 75mg x30s Tablets

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Indications and Usage for Plavix

Plavix (clopidogrel bisulfate) is indicated for the reduction of atherothrombotic 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, Plavix 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.
• Acute Coronary Syndrome

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  For patients with non-ST-segment elevation acute coronary syndrome (unstable angina/non-Q-wave MI) including patients who are to be managed medically and those who are to be managed with percutaneous coronary intervention (with or without stent) or CABG, Plavix has been shown to decrease the rate of a combined endpoint of cardiovascular death, MI, or stroke as well as the rate of a combined endpoint of cardiovascular death, MI, stroke, or refractory ischemia.

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  For patients with ST-segment elevation acute myocardial infarction, Plavix has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction or stroke. This benefit is not known to pertain to patients who receive primary angioplasty.

Overdosage

Overdose following clopidogrel administration may lead to prolonged bleeding time and subsequent bleeding complications. A single oral dose of clopidogrel at 1500 or 2000 mg/kg was lethal to mice and to rats and at 3000 mg/kg to baboons. Symptoms of acute toxicity were vomiting (in baboons), prostration, difficult breathing, and gastrointestinal hemorrhage in all species.

Recommendations About Specific Treatment

Based on biological plausibility, platelet transfusion may be appropriate to reverse the pharmacological effects of Plavix if quick reversal is required.

Plavix Dosage and Administration

Recent MI, Recent Stroke, or Established Peripheral Arterial Disease

The recommended daily dose of Plavix is 75 mg once daily.

Contraindications

The use of Plavix 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.

Warnings

Reduced effectiveness due to impaired CYP2C19 function

The inhibition of platelet aggregation by clopidogrel is entirely due to an active metabolite. Clopidogrel is metabolized to this active metabolite in part by CYP2C19. This metabolism can be impaired by genetic variations in CYP2C19 and by concomitant medications that interfere with CYP2C19. Avoid use of Plavix in patients with impaired CYP2C19 function due to known genetic variation or due to drugs that inhibit CYP2C19 activity.

Genetic variations

Patients with genetically reduced CYP2C19 function have diminished antiplatelet responses and generally exhibit higher cardiovascular event rates following myocardial infarction than do patients with normal CYP2C19 function (see CLINICAL PHARMACOLOGY: Pharmacogenetics).

Drug interactions

Co-administration of Plavix with omeprazole, a proton pump inhibitor that is an inhibitor of CYP2C19, reduces the pharmacological activity of Plavix if given concomitantly or if given 12 hours apart. There is no evidence that other drugs that reduce stomach acid, such as most H2 blockers (except cimetidine, which is a CYP2C19 inhibitor) or antacids interfere with the antiplatelet activity of clopidogrel (see PRECAUTIONS: Drug Interactions).

Thrombotic thrombocytopenic purpura (TTP)

TTP has been reported rarely following use of Plavix, sometimes after a short exposure (<2 weeks). TTP is a serious condition that can be fatal and requires urgent treatment including plasmapheresis (plasma exchange). It is characterized by thrombocytopenia, microangiopathic hemolytic anemia (schistocytes [fragmented RBCs] seen on peripheral smear), neurological findings, renal dysfunction, and fever. (See ADVERSE REACTIONS.)

Precautions

General: Plavix prolongs the bleeding time and therefore should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery, or other pathological conditions (particularly gastrointestinal and intraocular). If a patient is to undergo elective surgery and an antiplatelet effect is not desired, Plavix should be discontinued 5 days prior to surgery.

Due to the risk of bleeding and undesirable hematological effects, blood cell count determination and/or other appropriate testing should be promptly considered, whenever such suspected clinical symptoms arise during the course of treatment (see ADVERSE REACTIONS).

In patients with recent TIA or stroke who are at high risk of recurrent ischemic events, the combination of aspirin and Plavix has not been shown to be more effective than Plavix alone, but the combination has been shown to increase major bleeding.

GI Bleeding: In CAPRIE, Plavix was associated with a rate of gastrointestinal bleeding of 2.0%, vs. 2.7% on aspirin. In CURE, the incidence of major gastrointestinal bleeding was 1.3% vs. 0.7% (Plavix + aspirin vs. placebo + aspirin, respectively). Plavix should be used with caution in patients who have lesions with a propensity to bleed (such as ulcers). Drugs that might induce such lesions should be used with caution in patients taking Plavix.

Use in Hepatically-Impaired Patients: Experience is limited in patients with severe hepatic disease, who may have bleeding diatheses. Plavix should be used with caution in this population.

Use in Renally-Impaired Patients: Experience is limited in patients with severe renal impairment. Plavix should be used with caution in this population.

Information for Patients

Patients should be told that while taking Plavix or Plavix combined with aspirin:

• it may take them longer than usual to stop bleeding;
• they may bruise and/or bleed more easily;
• they should report any unusual bleeding to their physician;
• they should tell their physician about any other medications they are taking, including prescription or over-the-counter omeprazole;
• they should inform physicians and dentists that they are taking Plavix and/or any other product known to affect bleeding before any surgery is scheduled and before any new drug is taken.

Drug Interactions

Clopidogrel is metabolized to its active metabolite in part by CYP2C19. Concomitant use of drugs that inhibit the activity of this enzyme results in reduced plasma concentrations of the active metabolite of clopidogrel and a reduction in platelet inhibition. Avoid concomitant use of drugs that inhibit CYP2C19, including omeprazole, esomeprazole, cimetidine, fluconazole, ketoconazole, voriconazole, etravirine, felbamate, fluoxetine, fluvoxamine, and ticlopidine.

Studies of specific drug interactions yielded the following results:

Omeprazole

In a crossover clinical study, 72 healthy subjects were administered Plavix (300-mg loading dose followed by 75 mg/day) alone and with omeprazole (80 mg at the same time as Plavix) for 5 days. The exposure to the active metabolite of clopidogrel was decreased by 46% (Day 1) and 42% (Day 5) when Plavix and omeprazole were administered together. Mean inhibition of platelet aggregation (IPA) was diminished by 47% (24 hours) and 30% (Day 5) when Plavix and omeprazole were administered together. In another study 72 healthy subjects were given the same doses of Plavix and omeprazole but the drugs were administered 12 hours apart; the results were similar indicating that administering Plavix and omeprazole at different times does not prevent their interaction.

Aspirin

Aspirin did not modify the clopidogrel-mediated inhibition of ADP-induced platelet aggregation. Concomitant administration of 500 mg of aspirin twice a day for 1 day did not significantly increase the prolongation of bleeding time induced by Plavix. Plavix potentiated the effect of aspirin on collagen-induced platelet aggregation. Plavix and aspirin have been administered together for up to one year.

Heparin

In a study in healthy volunteers, Plavix did not necessitate modification of the heparin dose or alter the effect of heparin on coagulation. Coadministration of heparin had no effect on inhibition of platelet aggregation induced by Plavix.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

In healthy volunteers receiving naproxen, concomitant administration of Plavix was associated with increased occult gastrointestinal blood loss. NSAIDs and Plavix should be coadministered with caution.

Warfarin

Because of the increased risk of bleeding, the concomitant administration of warfarin with Plavix should be undertaken with caution. 

Other Concomitant Therapy

No clinically significant pharmacodynamic interactions were observed when Plavix was coadministered with atenolol, nifedipine, or both atenolol and nifedipine. The pharmacodynamic activity of Plavix was also not significantly influenced by the coadministration of phenobarbital or estrogen.

The pharmacokinetics of digoxin or theophylline were not modified by the coadministration of Plavix (clopidogrel bisulfate).

At high concentrations in vitro, clopidogrel inhibits P450 (2C9). Accordingly, Plavix may interfere with the metabolism of phenytoin, tamoxifen, tolbutamide, warfarin, torsemide, fluvastatin, and many non-steroidal anti-inflammatory agents, but there are no data with which to predict the magnitude of these interactions. Caution should be used when any of these drugs is coadministered with Plavix.

In addition to the above specific interaction studies, patients entered into clinical trials with Plavix received a variety of concomitant medications including diuretics, beta-blocking agents, angiotensin converting enzyme inhibitors, calcium antagonists, cholesterol lowering agents, coronary vasodilators, antidiabetic agents (including insulin), thrombolytics, heparins (unfractionated and LMWH), GPIIb/IIIa antagonists, antiepileptic agents and hormone replacement therapy without evidence of clinically significant adverse interactions.

There are no data on the concomitant use of oral anticoagulants, non study oral anti-platelet drugs and chronic NSAIDs with clopidogrel.

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Below is the brand named package (Plavix)