PLAVIX Film-coated tablet (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership

Λέξεις κλειδιά

63653-1171 63653-1332

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

1. Indications and Usage

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 ...

2. Dosage and Administration

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 ...

3. Dosage Forms and Strengths

75 mg tablets: Pink, round, biconvex, film-coated tablets debossed with 75 on one side and 1171 on the other. 300 mg tablets: Pink, oblong, film-coated tablets debossed with 300 on one side and 1332 on ...

4. Contraindications

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 ...

5. Warnings and Precautions

5.1 Diminished Antiplatelet Activity in Patients with Impaired CYP2C19 Function Clopidogrel is a prodrug. Inhibition of platelet aggregation by clopidogrel is achieved through an active metabolite. The ...

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 ...

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 ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during postapproval use of Plavix. Because these reactions are reported voluntarily from a population of an unknown size, it is not always possible ...

7. Drug Interactions

7.1 CYP2C19 Inhibitors Clopidogrel is metabolized to its active metabolite in part by CYP2C19. Concomitant use of drugs that inhibit the activity of this enzyme results in reduced plasma concentrations ...

8.1. Pregnancy

Risk Summary Available data from cases reported in published literature and postmarketing surveillance with clopidogrel use in pregnant women have not identified any drug-associated risks for major birth ...

8.2. Lactation

Risk Summary There are no data on the presence of clopidogrel in human milk or the effects on milk production. No adverse effects on breastfed infants have been observed with maternal clopidogrel use during ...

8.4. Pediatric Use

Safety and effectiveness in pediatric populations have not been established. A randomized, placebo-controlled trial (CLARINET) did not demonstrate a clinical benefit of clopidogrel in neonates and infants ...

8.5. Geriatric Use

Of the total number of subjects in the CAPRIE and CURE controlled clinical studies, approximately 50% of patients treated with Plavix were 65 years of age and older, and 15% were 75 years and older. In ...

8.6. Renal Impairment

Experience is limited in patients with severe and moderate renal impairment [see Clinical Pharmacology (12.2)].

8.7. Hepatic Impairment

No dosage adjustment is necessary in patients with hepatic impairment [see Clinical Pharmacology (12.2)].

10. Overdosage

Platelet inhibition by Plavix is irreversible and will last for the life of the platelet. Overdose following clopidogrel administration may result in bleeding complications. A single oral dose of clopidogrel ...

11. Description

Plavix (clopidogrel tablets) is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-α(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H ...

12.1. Mechanism of Action

Clopidogrel is an inhibitor of platelet activation and aggregation through the irreversible binding of its active metabolite to the P2Y12 class of ADP receptors on platelets.

12.2. Pharmacodynamics

Clopidogrel must be metabolized by CYP450 enzymes to produce the active metabolite that inhibits platelet aggregation. The active metabolite of clopidogrel selectively inhibits the binding of adenosine ...

12.3. Pharmacokinetics

Clopidogrel is a prodrug and is metabolized to a pharmacologically active metabolite and inactive metabolites. Absorption After single and repeated oral doses of 75 mg per day, clopidogrel is rapidly absorbed. ...

12.5. Pharmacogenomics

CYP2C19 is involved in the formation of both the active metabolite and the 2-oxo-clopidogrel intermediate metabolite. Clopidogrel active metabolite pharmacokinetics and antiplatelet effects, as measured ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

There was no evidence of tumorigenicity when clopidogrel was administered for 78 weeks to mice and 104 weeks to rats at dosages up to 77 mg/kg per day, which afforded plasma exposures >25 times that in ...

14. Clinical Studies

14.1 Acute Coronary Syndrome CURE The CURE study included 12,562 patients with ACS without ST-elevation (UA or NSTEMI) and presenting within 24 hours of onset of the most recent episode of chest pain or ...

16.1. How Supplied

Plavix (clopidogrel tablets) 75 mg are available as pink, round, biconvex, film-coated tablets debossed with 75 on one side and 1171 on the other. Tablets are provided as follows: NDC 63653-1171-6 Bottles ...

16.2. Storage and Handling

Store at 25°C (77°F); excursions permitted to 15°C–30°C (59°F–86°F) [see USP Controlled Room Temperature].

17. Patient Counseling Information

Advise patients to read FDA approved patient labeling (Medication Guide). Discontinuation Advise patients not to discontinue Plavix without first discussing it with the healthcare provider who prescribed ...

BOXED WARNING SECTION

WARNING: DIMINISHED ANTIPLATELET EFFECT IN PATIENTS WITH TWO LOSS-OF-FUNCTION ALLELES OF THE CYP2C19 GENE The effectiveness of Plavix results from its antiplatelet activity, which is dependent ...