Clopidogrel Bisulfate
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]
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Black Box Warning
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WARNING: DIMINISHED EFFECTIVENESS IN POOR METABOLIZERS
See full prescribing information for complete Boxed Warning.
* Effectiveness of clopidogrel depends on activation to an active metabolite by the cytochrome P450 (CYP) system, principally CYP2C19. (5.1)
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Overview
Clopidogrel Bisulfate is a P2Y12 platelet inhibitor, Platelet aggregation inhibitor that is FDA approved for the {{{indicationType}}} of acute coronary syndrome (ACS), recent MI, recent stroke, or established peripheral arterial disease. There is a Black Box Warning for this drug as shown here. Common adverse reactions include non-major bleeding.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Condition 1
- Dosing Information
- (Dosage)
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Condition 1
- Developed by: (Organization)
- Class of Recommendation: (Class) (Link)
- Strength of Evidence: (Category A/B/C) (Link)
- Dosing Information/Recommendation
- (Dosage)
Non–Guideline-Supported Use
Condition 1
- Dosing Information
- There is limited information about Off-Label Non–Guideline-Supported Use of Clopidogrel Bisulfate in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Condition 1
- Dosing Information
- (Dosage)
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition 1
- Developed by: (Organization)
- Class of Recommendation: (Class) (Link)
- Strength of Evidence: (Category A/B/C) (Link)
- Dosing Information/Recommendation
- (Dosage)
Non–Guideline-Supported Use
Condition 1
- Dosing Information
- There is limited information about Off-Label Non–Guideline-Supported Use of Clopidogrel Bisulfate in pediatric patients.
Contraindications
- Condition 1
- Condition 2
- Condition 3
- Condition 4
- Condition 5
Warnings
|
WARNING: DIMINISHED EFFECTIVENESS IN POOR METABOLIZERS
See full prescribing information for complete Boxed Warning.
* Effectiveness of clopidogrel depends on activation to an active metabolite by the cytochrome P450 (CYP) system, principally CYP2C19. (5.1)
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Conidition 1
(Description)
Adverse Reactions
Clinical Trials Experience
Central Nervous System
- (list/description of adverse reactions)
Cardiovascular
- (list/description of adverse reactions)
Respiratory
- (list/description of adverse reactions)
Gastrointestinal
- (list/description of adverse reactions)
Hypersensitive Reactions
- (list/description of adverse reactions)
Miscellaneous
- (list/description of adverse reactions)
Postmarketing Experience
Central Nervous System
- (list/description of adverse reactions)
Cardiovascular
- (list/description of adverse reactions)
Respiratory
- (list/description of adverse reactions)
Gastrointestinal
- (list/description of adverse reactions)
Hypersensitive Reactions
- (list/description of adverse reactions)
Miscellaneous
- (list/description of adverse reactions)
Drug Interactions
- (Drug 1)
- (Description)
- (Drug 2)
- (Description)
- (Drug 3)
- (Description)
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Clopidogrel Bisulfate in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Clopidogrel Bisulfate in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Clopidogrel Bisulfate during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Clopidogrel Bisulfate in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Clopidogrel Bisulfate in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Clopidogrel Bisulfate in geriatric settings.
Gender
There is no FDA guidance on the use of Clopidogrel Bisulfate with respect to specific gender populations.
Race
There is no FDA guidance on the use of Clopidogrel Bisulfate with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Clopidogrel Bisulfate in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Clopidogrel Bisulfate in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Clopidogrel Bisulfate in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Clopidogrel Bisulfate in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Clopidogrel Bisulfate Administration in the drug label.
Monitoring
There is limited information regarding Clopidogrel Bisulfate Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Clopidogrel Bisulfate and IV administrations.
Overdosage
There is limited information regarding Clopidogrel Bisulfate overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Clopidogrel Bisulfate Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Clopidogrel Bisulfate Mechanism of Action in the drug label.
Structure
There is limited information regarding Clopidogrel Bisulfate Structure in the drug label.
Pharmacodynamics
There is limited information regarding Clopidogrel Bisulfate Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Clopidogrel Bisulfate Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Clopidogrel Bisulfate Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Clopidogrel Bisulfate Clinical Studies in the drug label.
How Supplied
There is limited information regarding Clopidogrel Bisulfate How Supplied in the drug label.
Storage
There is limited information regarding Clopidogrel Bisulfate Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Clopidogrel Bisulfate Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Clopidogrel Bisulfate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Clopidogrel Bisulfate Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Clopidogrel Bisulfate Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.