Drugplain

Plavix 75 mg/1

clopidogrel · TABLET, FILM COATED · Sanofi-Aventis U.S. LLC

1 Recall on Record
Plain English

Plavix is a tablet, film coated containing clopidogrel at 75 mg/1, taken oral. Manufactured by Sanofi-Aventis U.S. LLC.

Key Facts

Brand Name
Plavix
Generic Name
clopidogrel
NDC Code (Product)
0024-1171
Manufacturer
Sanofi-Aventis U.S. LLC
Strength
75 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
NDA020839
Marketing Start
11/17/1997

Recall History

1 Recall on Record
Class III02/08/2011

Physicians Total Care, Inc.

Chemical Contamination: Uncharacteristic moldy odor due to presence of 2,4,6-tribromoanisole (TBA).

TerminatedVoluntary: Firm initiated

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Plavix is a P2Y 12 platelet inhibitor indicated for: Acute coronary syndrome – For patients with non–ST-segment elevation ACS (unstable angina [UA]/non–ST-elevation myocardial infarction [NSTEMI]), Plavix has been shown to reduce the rate of myocardial infarction (MI) and stroke. ( 1.1 ) – For patients with ST-elevation myocardial infarction (STEMI), Plavix has been shown to reduce the rate of MI and stroke. ( 1.1 ) Recent MI, recent stroke, or established peripheral arterial disease. Plavix has been shown to reduce the rate of MI and stroke. ( 1.2 ) 1.1 Acute Coronary Syndrome (ACS) Plavix is indicated to reduce the rate of myocardial infarction (MI) and stroke in 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. Plavix should be administered in conjunction with aspirin. Plavix is indicated to reduce the rate of myocardial infarction and stroke in patients with acute ST-elevation myocardial infarction (STEMI) who are to be managed medically. Plavix should be administered in conju…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Acute coronary syndrome ( 2.1 ) – Initiate Plavix with a single 300 mg oral loading dose and then continue at 75 mg once daily. – Initiating Plavix without a loading dose will delay establishment of an antiplatelet effect by several days. Recent MI, recent stroke, or established peripheral arterial disease: 75 mg once daily orally without a loading dose. ( 2.2 ) 2.1 Acute Coronary Syndrome In patients who need an antiplatelet effect within hours, initiate Plavix with a single 300 mg oral loading dose and then continue at 75 mg once daily. Initiating Plavix without a loading dose will delay establishment of an antiplatelet effect by several days [see Clinical Pharmacology (12.3) and Clinical Studies (14.1) ] . 2.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease 75 mg once daily orally without a loading dose [see Clinical Pharmacology (12.3) and Clinical Studies (14.2) ] .

Contraindications

4 CONTRAINDICATIONS Active pathological bleeding, such as peptic ulcer or intracranial hemorrhage ( 4.1 ) Hypersensitivity to clopidogrel or any component of the product ( 4.2 ) 4.1 Active Bleeding Plavix is contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage. 4.2 Hypersensitivity Plavix is contraindicated in patients with hypersensitivity (e.g., anaphylaxis) to clopidogrel or any component of the product [see Adverse Reactions (6.2) ] .

Drug Interactions

7 DRUG INTERACTIONS CYP2C19 inducers: Increases levels of clopidogrel active metabolite and increases platelet inhibition. ( 7.1 ) Opioids: Decreased exposure to clopidogrel. Consider use of parenteral antiplatelet agent. ( 7.3 ) Nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin, selective serotonin and serotonin norepinephrine reuptake inhibitors (SSRIs, SNRIs): Increases risk of bleeding. ( 7.4 , 7.5 , 7.6 ) Other Antiplatelet Agents: Increases the risk of bleeding due to an additive effect. ( 7.7 ) Repaglinide (CYP2C8 substrates): Increases substrate plasma concentrations. ( 7.8 ) 7.1 CYP2C19 Inducers Since clopidogrel is metabolized to its active metabolite partly by CYP2C19, use of drugs that induce the activity of this enzyme would be expected to result in increased drug levels of the active metabolite of clopidogrel. Rifampin strongly induces CYP2C19 resulting to both an increase level of clopidogrel active metabolite and platelet inhibition, which in particular might potentiate the risk of bleeding. As a precaution, avoid concomitant use of strong CYP2C19 inducers [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ] . 7.2 CYP2C19 Inhibitors Clopidogr…

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions are discussed below and elsewhere in the labeling: Bleeding [see Warnings and Precautions (5.2) ] Thrombotic thrombocytopenic purpura [see Warnings and Precautions (5.4) ] Bleeding, including life-threatening and fatal bleeding, is the most commonly reported adverse reaction. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis U.S. LLC at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions and durations of follow-up, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Plavix has been evaluated for safety in more than 54,000 patients, including over 21,000 patients treated for one year or more. The clinically important adverse reactions observed in trials comparing Plavix plus aspirin to placebo plus aspirin and trials comparing Plavix alone to aspirin alone are discussed below. Bleeding CURE In CURE, Plavix use with aspirin was associated with an increase…

Frequently Asked Questions

What is Plavix used for?

Plavix contains clopidogrel. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is Plavix a controlled substance?

Plavix is not classified as a controlled substance by the DEA.

What is the generic name for Plavix?

The generic name for Plavix is clopidogrel. There are 11 other brand versions of clopidogrel.

What is the NDC code for Plavix 75 mg/1?

The NDC (National Drug Code) for Plavix 75 mg/1 is 0024-1171, listed by Sanofi-Aventis U.S. LLC.

Product NDC

0024-1171

Package NDC

0024-1171-90

Other Plavix Dosages

Other Clopidogrel Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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