Clopidogrel (Clovix 75)
What to know about Clopidogrel — also sold as Clovix 75, Plidogrel, CLOPIDOGREL-WGR, Iscover, Clopidogrel Winthrop and 8 more: uses, side effects, interactions, and safety considerations for people taking it or caring for someone who is.
Clopidogrel (brand names: Clovix 75, Plidogrel, CLOPIDOGREL-WGR, Iscover, Clopidogrel Winthrop and 8 more) is classified as Low risk (2 risk points) by AllMeds. It is a S4 medication under the TGA in Australia. FDA approved in the United States. Antiplatelet agent with bleeding risk and drug interactions affecting CYP2C19 metabolism.
Key Takeaways
- TGA Schedule: S4 in Australia
- Risk level: Low (2 points)
- PBS listed: Subsidised under the Australian Pharmaceutical Benefits Scheme
Scheduling and Classification
| Jurisdiction | Classification | Status |
|---|---|---|
| Australia (TGA) | S4 | PBS listed |
| United States (FDA) | Rx only | FDA approved |
Risk Profile
Antiplatelet agent with bleeding risk and drug interactions affecting CYP2C19 metabolism.
How Clopidogrel is regulated
Clopidogrel is overseen by medicines regulators in each country. The rules below explain how it's scheduled, what oversight applies, and what to discuss with your doctor or pharmacist before starting, changing, or stopping this medication.
Australia TGA / PBS / State Schemes
Classified as S4 under the Therapeutic Goods Administration (TGA).
Listed on the Pharmaceutical Benefits Scheme (PBS) for subsidised prescribing.
United States FDA / CDC / State WC
FDA approved for use in the United States.
FDA Boxed Warning: WARNING:DIMINISHED ANTIPLATELET EFFECT IN PATIENTS WITH TWO LOSS-OF-FUNCTION ALLELES OF THE CYP2C19 GENE The effectiveness of clopidogrel results from its antiplatelet activity, which is dependent on its conversion to an active metabolite by the cytochrome P450 (CYP) system, principally CYP2C19 [ see Warnings and Precautions ( 5.1 ), Clinical Pharmacology ( 12.3 ) ]. Clopidogrel at recommended doses forms less of the active metabolite and so has a reduced effect on platelet activity in patients who are homozygous for nonfunctional alleles of the CYP2C19 gene, (termed “CYP2C19 poor metabolizers”). Tests are available to identify patients who are CYP2C19 poor metabolizers [ see Clinical Pharmacology ( 12.5 ) ]. Consider use of another platelet P2Y 12 inhibitor in patients identified as CYP2C19 poor metabolizers. WARNING: DIMINISHED ANTIPLATELET EFFECT IN PATIENTS WITH TWO LOSS-OF-FUNCTION ALLELES OF THE CYP2C19 GENE See full prescribing information for complete boxed warning. • Effectiveness of clopidogrel depends on conversion to an active metabolite by the cytochrome P450 (CYP) system, principally CYP2C19. ( 5.1 , 12.3 ) • Tests are available to identify patients who are CYP2C19 poor metabolizers. ( 12.5 ) • Consider use of another platelet P2Y 12 inhibitor in patients identified as CYP2C19 poor metabolizers. ( 5.1 )
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Important: This page is general health information, not personal medical advice. If you have questions about your medication — including starting it, stopping it, changing the dose, or combining it with something else — speak with your doctor or pharmacist. For an emergency or suspected overdose, call your local emergency number or poison information service immediately. Information is drawn from regulator and clinical guideline sources (TGA, FDA, MHRA, NICE, PBS, CDC); see our methodology for details.