Plavix


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Related to Plavix: Clopidogrel, aspirin

clopidogrel bisulfate

Plavix

Pharmacologic class: Platelet aggregation inhibitor

Therapeutic class: Antiplatelet drug

Pregnancy risk category B

FDA Box Warning

• Effectiveness of clopidogrel depends on activation to an active metabolite by the cytochrome P(CYP) 450 system, principally CYP2C19.

• Patients identified as CYP2C19 poor metabolizers treated with clopidogrel at recommended dosages exhibit higher cardiovascular event rates following acute coronary syndrome or percutaneous coronary intervention than patients with normal CYP2C19 function.

• Tests are available to identify a patient's CYP2C19 genotype and can be used as an aid in determining therapeutic strategy.

• Consider alternative treatment or treatment strategies in patients identified as CYP2C19 poor metabolizers.

Action

Inhibits platelet aggregation by blocking binding of adenosine diphosphate to platelets, thereby preventing thrombus formation

Availability

Tablets: 75 mg, 300 mg

Indications and dosages

Recent myocardial infarction (MI) or stroke or established peripheral arterial disease

Adults: 75 mg/day P.O.

Acute coronary syndrome (ACS)

Adults: 300 mg P.O. as a loading dose, then 75 mg/day P.O. in combination with aspirin (75 to 325 mg once daily) for patients with non-ST-segment elevation ACS (unstable angina, non-ST-elevation MI)

Adults: 75 mg P.O. once daily in combination with aspirin (75 to 325 mg once daily), with or without a loading dose and with or without thrombolytics for patients with ST-elevation MI

Contraindications

• Hypersensitivity to drug

• Active pathologic bleeding

Precautions

Use cautiously in:

• thrombotic thrombocytopenic purpura

• increased risk of bleeding

• concomitant use of drugs that inhibit CYP2C19 (such as esomeprazole, omeprazole)

• concomitant use of aspirin in patients with recent transient ischemic attack or cerebrovascular accident

• premature discontinuation of drug

• pregnant or breastfeeding patients

• children (safety and efficacy not established).

Administration

• Give with or without food.

• Know that drug may need to be discontinued 5 days before surgery.

Adverse reactions

CNS: depression, dizziness, fatigue, headache

CV: chest pain, hypertension

EENT: epistaxis, rhinitis

GI: diarrhea, abdominal pain, dyspepsia, gastritis, GI bleeding

Hematologic: bleeding, neutropenia, thrombotic thrombocytopenic purpura

Metabolic: hypercholesterolemia, gout

Musculoskeletal: joint pain, back pain

Respiratory: cough, dyspnea, bronchitis, upper respiratory tract infection, bronchospasm

Skin: pruritus, rash, angioedema

Other: hypersensitivity reactions, anaphylactic reactions

Interactions

Drug-drug. Abciximab, aspirin, eptifibatide, heparin, heparinoids, nonsteroidal anti-inflammatory drugs (NSAIDs), thrombolytics, ticlopidine, tirofiban, warfarin: increased risk of bleeding

CYP2C19 inhibitors (such as esomeprazole, omeprazole): significantly reduced clopidogrel antiplatelet activity

Fluvastatin, many NSAIDs, phenytoin, tamoxifen, tolbutamide, torsemide: interference with metabolism of these drugs

Drug-diagnostic tests. Bilirubin, hepatic enzymes, nonprotein nitrogen, total cholesterol, uric acid: increased levels

Platelets: decreased count

Drug-herbs. Anise, arnica, chamomile, clove, fenugreek, feverfew, garlic, ginger, ginkgo, ginseng: increased risk of bleeding

Patient monitoring

• Monitor hemoglobin and hematocrit periodically.

• Monitor patient for unusual bleeding or bruising; drug significantly increases risk of bleeding.

• Assess for occult GI blood loss if patient is receiving naproxen concurrently with clopidogrel.

Patient teaching

• Tell patient to take tablets with or without food.

Advise patient to immediately report unusual or acute chest pain, respiratory difficulty, rash, purplish bruises on skin or in mouth, purple skin patches, unusual fatigue, fast heart rate, confusion, signs and symptoms of stroke (including weakness on one side, speech changes), low urine output, unresolved bleeding, diarrhea, GI distress, nosebleed, or acute headache.

Instruct patient not to discontinue drug without consulting prescriber.

• Instruct patient to tell all health care providers that he's taking clopidogrel, especially if surgery is scheduled or new drugs are prescribed.

• Advise patient to contact prescriber before taking over-the-counter products, particularly nonsteroidal anti-inflammatory drugs.

• Tell patient drug may cause headache and dizziness. Caution him to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.

• Advise patient to minimize adverse GI effects by eating small, frequent meals or chewing gum.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and herbs mentioned above.

Plavix

(plăv′ĭks)
A trademark for the drug clopidogrel bisulfate.

Plavix ®

Clopidogrel bisulfate Cardiology An antiplatelet agent used to ↓ risk of stroke, acute MI, or vascular death in Pts with known ASHD. See CAPRIE.

Plavix

A brand name for the antiplatelet drug CLOPIDOGREL.
References in periodicals archive ?
The researchers found that the primary outcome was experienced by 17.6 percent of patients prescribed Plavix and 17.9 percent prescribed clopidogrel at one year (hazard ratio, 1.02; 95 percent confidence interval, 0.96 to 1.08; P = 0.005 for noninferiority).
Meanwhile, Sanofi is appealing against the charge, claiming that it has never undermined the "bioequivalence" of Plavix substitutes but that it has merely "informed health professionals of the existence of different indications among copies of Plavix in general".
Plavix's rights in the US and Puerto Rico will continue unchanged under the terms of the existing agreement through December 2019.
Plavix [R], made by Bristol-Myers Squib, is one of the most profitable drugs of all time and has been used for secondary prevention of heart attacks and stroke in patients who have suffered these events.
One in three patients may not be responding adequately to their medications--to anti-plateict medications such as Plavix and aspirin.
Several days before the procedure, the neurosurgeon wrote a prescription for Plavix 150 mg daily with acetylsalicylic acid (ASA) 325 mg daily.
A: Taking Plavix with certain acid reflux drugs and a class of heartburn drugs called proton-pump inhibitors (for example, Aciphex, Nexium, Prevacid, and Protonix) can cut the effectiveness of Plavix by 50 percent, thereby increasing risk for heart attack or stroke.
Kemp said Astra's trial had proven the drug could stand up to rival Plavix, produced by French firm Sanofi-Aventis.
Casodex costs pounds 128 a pack, while Plavix costs pounds 35 a pack, the court heard.
All five also face charges of selling or supplying Casodex and Plavix without a marketing authorisation and of selling or distributing counterfeit Casodex and Plavix.
In the article, Agarwal, partner, and Pan, senior associate, describe the situation that led the US Food and Drug Administration (FDA) to require warning labels and recommend diagnostic testing for the blockbuster drug Plavix more than 10 years after the anti-thrombotic hit the market.
In that groups are the cholesterol drug Lipitor (atorvastatin), the blood clot preventer Plavix (clopidogrel), and the asthma medication Singulair (montelukast).