Plavix Drug Imprint

Plavix class action

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The structural formula is as follows:. Clopidogrel bisulfate is a white to off-white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether.

Plavix for oral administration is provided as either pink, round, biconvex, debossed, film-coated tablets containing Each tablet plavix class action hydrogenated castor oilplavix class action cellulose, mannitolmicrocrystalline cellulose and polyethylene glycol as inactive ingredients.

The pink film coating contains ferric oxide, hypromelloselactose monohydrate, titanium dioxide and triacetin. The tablets are polished with Carnauba wax. In patients with established peripheral arterial disease or with a history of recent myocardial infarction MI or recent stroke Plavix is indicated to reduce the rate of MI and stroke. In patients who need an antiplatelet effect within hours, initiate Plavix with a single mg oral loading dose and then continue at 75 mg once daily.

Tablets are provided as follows:, plavix class action. 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, patients, plavix class action, including over 21, 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.

In CURE, Plavix use with aspirin was associated with an increase in major bleeding primarily gastrointestinal and at puncture sites compared to placebo with aspirin see Table 1. The incidence of intracranial hemorrhage 0. Other bleeding events that were reported more frequently in the clopidogrel group were epistaxishematuriaand bruise. The incidence of intracranial hemorrhage was 0. Other bleeding events that were reported more frequently in the Plavix group were epistaxis and hematoma.

No other difference in the rate of adverse events other than bleeding was reported. The following adverse reactions have been identified during postapproval aciphex stopped working of Plavix. Because these reactions are reported voluntarily from a population of an unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hemorrhages, including those with fatal outcome, have been reported in patients treated with Plavix, plavix class action. Clopidogrel is metabolized to its active metabolite in part by CYP2C Avoid concomitant use of Plavix with omeprazole or esomeprazole.

In clinical studies, omeprazole was shown to reduce significantly the antiplatelet activity of Plavix when given concomitantly or 12 hours apart. A similar reduction in antiplatelet activity was observed with esomeprazole when given concomitantly with Plavix.

Although the administration of clopidogrel 75 mg per day did not modify the pharmacokinetics of S-warfarin a CYP2C9 substrate or INR in patients receiving long-term warfarin therapy, coadministration of Plavix with warfarin increases the risk of bleeding because of independent effects on hemostasis. Plavix can increase the systemic exposure to drugs that are primarily plavix class action by CYP2C8, thereby needing dose adjustment and appropriate monitoring, plavix class action.

Plavix increased repaglinide exposures by 3. Avoid concomitant use of repaglinide plavix class action Plavix. If concomitant use cannot be avoided, initiate repaglinide at 0. Increased frequency of glucose monitoring may be required during concomitant use. Clopidogrel is a prodrug. Inhibition of platelet aggregation by clopidogrel is achieved through an active metabolite.

The metabolism of clopidogrel can also be impaired by drugs that inhibit CYP2C19, such as omeprazole or esomeprazole. Thienopyridines inhibit platelet aggregation for the lifetime of the platelet days. Discontinuation of Plavix increases the risk of cardiovascular events. If Plavix must be temporarily discontinued e, plavix class action. When possible, interrupt therapy with Plavix for five days prior to plavix class action surgery.

Resume Plavix as soon as hemostasis is achieved. TTP is a serious condition that requires urgent treatment including plasmapheresis plasma plavix class action. Advise patients not to take omeprazole or esomeprazole while taking Plavix.

Clopidogrel was not genotoxic in four in vitro tests Ames testDNA-repair test in rat hepatocytes, gene mutation assay in Chinese hamster fibroblasts, and metaphase chromosome analysis of human lymphocytes and in one in vivo test micronucleus test by oral route in mice.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of a human response, plavix class action, Plavix should be used during pregnancy only if clearly needed. It is not known whether this drug is excreted in human milk.

Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from clopidogrel, plavix class action, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

A randomized, placebo-controlled trial CLARINET did not demonstrate a clinical benefit of clopidogrel in neonates and infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary arterial shunt. Possible factors contributing to this outcome were the dose of clopidogrel, plavix class action concomitant administration of aspirin plavix class action the late initiation of therapy following shunt palliation.

Personal action plan template cannot be ruled out that a trial with a different design would demonstrate a clinical benefit in this patient population. No dosage adjustment is necessary in elderly patients. Platelet inhibition by Plavix is irreversible and will last for the life of the platelet.

Overdose following clopidogrel administration may result in bleeding complications. Symptoms of acute toxicity were vomiting, prostration, difficult breathing, and gastrointestinal hemorrhage in animals. Plavix is contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage.

Plavix is contraindicated in patients with hypersensitivity e. 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. Clopidogrel must be metabolized by CYP enzymes to produce the active metabolite that inhibits platelet aggregation.

Plavix class action action is irreversible. Platelet aggregation induced by agonists other than ADP is also inhibited by blocking the amplification of platelet activation by released ADP, plavix class action. Dose-dependent inhibition of platelet aggregation can be seen 2 hours after single plavix class action doses of Plavix. Repeated doses of 75 mg Plavix per day inhibit ADP-induced platelet aggregation on the first day, plavix class action, and inhibition reaches steady state between Day 3 and Day 7, plavix class action.

Platelet aggregation and bleeding time gradually return to baseline values after treatment is discontinued, generally in about 5 days, plavix class action. After repeated doses of 75 mg Plavix per day for 10 days in patients with severe hepatic impairment, inhibition of ADP-induced platelet aggregation was similar to that observed in healthy subjects.

In a small study comparing men and women, plavix class action, less inhibition of ADP-induced plavix class action aggregation was observed in women. Clopidogrel is a prodrug and is metabolized to a pharmacologically active metabolite and inactive metabolites.

After single and repeated oral doses of 75 mg per day, clopidogrel is rapidly absorbed. Plavix can be administered with or without food. Similar results were observed when a Plavix mg loading dose was administered with a high-fat breakfast.

Clopidogrel is extensively metabolized by two main metabolic pathways: Cytochromes first oxidize clopidogrel to a 2-oxo-clopidogrel intermediate metabolite. Subsequent metabolism of the 2-oxoclopidogrel intermediate metabolite results in formation of the active metabolite, a thiol derivative of clopidogrel. The active thiol metabolite binds rapidly and irreversibly to platelet receptors, thus inhibiting platelet aggregation for the lifespan of the platelet.

The Cmax of the active metabolite is twice as high following a single mg clopidogrel loading dose as it is after four days of 75 mg maintenance dose. Cmax occurs approximately 30 to 60 minutes after dosing. In the 75 to mg dose range, the pharmacokinetics of the active metabolite deviates from dose proportionality: After a single, oral dose of 75 mg, clopidogrel has a half-life of approximately 6 hours. The half-life of the active metabolite is about 30 minutes.

Concomitant use of certain inhibitors of this enzyme results in reduced plasma concentrations of the active metabolite of clopidogrel and a reduction in platelet inhibition. The effect of proton pump inhibitors PPI on the systemic exposure to the clopidogrel active metabolite following multiple doses of Plavix 75 mg evaluated in dedicated drug interaction studies is presented in Figure plavix class action. Pharmacodynamic and pharmacokinetic parameters measured in these studies showed that the interaction was highest with omeprazole and least with dexlansoprazole.

In vitro studies have shown that the glucuronide metabolite of clopidogrel is a strong inhibitor of CYP2C8. CYP2C19 is involved in the formation of both the active metabolite and the plavix class action intermediate metabolite.

Clopidogrel active metabolite pharmacokinetics and antiplatelet effects, plavix class action, as measured by ex vivo platelet aggregation assays, differ according to CYP2C19 genotype. Tests are available plavix class action identify patients who are CYP2C19 poor metabolizers. A crossover study in 40 healthy subjects, 10 each in the four CYP2C19 metabolizer groups, evaluated pharmacokinetic and antiplatelet responses using mg followed by 75 mg per day and mg followed by mg per day, each for a total of 5 days.

Decreased active metabolite exposure and diminished inhibition of platelet aggregation were observed in the poor metabolizers as compared to the other groups. Values are mean SD. Patients were required to have either ECG changes compatible with new ischemia without ST-elevation or elevated cardiac enzymes or troponin I or T to at least twice the upper limit of normal.

Patients were randomized to receive Plavix mg loading dose followed by 75 mg once daily or placebo, and were treated for up to one year. Patients also received aspirin mg once daily and other standard therapies such as heparin. The number of patients experiencing the primary outcome CV death, MI, or stroke was 9. Most of the benefit of Plavix occurred in the plavix class action two months, plavix class action, but the difference from placebo was maintained throughout the course of the trial up to 12 months see Figure 2.

The effect of Plavix did not differ significantly in various subgroups, as shown in Figure 3. The efficacy of Plavix was observed independently of the dose of aspirin mg once daily.

The use nuclear accident response plan Plavix in CURE was associated with a decrease in the use of thrombolytic therapy 71 patients [1. Patients were randomized to receive Plavix 75 mg once daily or placebo, in combination with aspirin mg per dayfor 28 days or until hospital dischargewhichever came first.

The primary endpoints were death from any cause and the first occurrence of re-infarction, stroke plavix class action death.

 

Plavix class action

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