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clopidogrel bisulfate

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clopidogrel bisulfate

Plavix

Pharmacologic class: Platelet aggregation inhibitor

Therapeutic class: Antiplatelet drug

Pregnancy risk category B

Action

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

Availability

Tablets: 75 mg

Indications and dosages

To reduce atherosclerotic events in patients with recent myocardial infarction (MI) or cerebrovascular accident and in those with established peripheral arterial disease or acute coronary syndrome

Adults: 75 mg/day P.O.

Acute coronary syndrome (unstable angina or non-Q-wave MI)

Adults: 300 mg P.O. as a loading dose, then 75 mg/day P.O.

Contraindications

• Hypersensitivity to drug
• Active pathologic bleeding

Precautions

Use cautiously in:
• severe hepatic impairment, GI bleeding, ulcer disease
• increased risk of bleeding
• pregnant or breastfeeding patients
• children.

Administration

• Give with or without food.
• Know that drug may need to be discontinued 5 days before surgery.

RouteOnsetPeakDuration
P.O.Variable60 min3-4 hr

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

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

Advise patient to immediately report unusual or acute chest pain, respiratory difficulty, rash, unresolved bleeding, diarrhea, GI distress, nosebleed, or acute headache.
• Instruct patient to tell all health care providers that he's taking clopidogrel, especially if surgery is scheduled or new drugs are prescribed.
• 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.



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His current medications included glipizide (Glucotrol XL *) for control of diabetes mellitus, clopidogrel bisulfate (Plavix ([dagger])) to reduce platelet-induced thrombosis, simvastatin (Zocor ([double dagger])) to improve his plasma lipid profile, and amlodipine besylate (Norvasc *) for treatment of hypertension.
The lawsuit relates to the validity of a patent for clopidogrel bisulfate (the '265 patent) sold in the United States as PLAVIX(R).
 
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