Taste disorders, headache, ageusia Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Concomitant use of drugs that inhibit the activity of this enzyme results in reduced plasma concentrations of the active metabolite of Clopidogrel and a reduction in platelet inhibition [see Warnings and Precautions 5.
Omeprazole or Esomeprazole Avoid concomitant use of Clopidogrel bisulfate with omeprazole or esomeprazole. In clinical studies, omeprazole was shown to reduce significantly the antiplatelet activity of Clopidogrel bisulfate when given concomitantly or 12 hours apart. A similar reduction in antiplatelet activity was observed with esomeprazole when given concomitantly with Clopidogrel bisulfate.
Dexlansoprazole, lansoprazole and pantoprazole had less effect on the antiplatelet activity of Clopidogrel bisulfate than did omeprazole or esomeprazole [see Warnings and Precautions 5. Warfarin CYP2C9 Substrates 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 Clopidogrel bisulfate with warfarin increases the risk of bleeding because of independent effects on hemostasis.
Clopidogrel bisulfate can increase the systemic exposure to drugs that are primarily cleared by CYP2C8, thereby needing dose adjustment and appropriate monitoring. Avoid concomitant use of repaglinide with Clopidogrel bisulfate. If concomitant use cannot be avoided, initiate repaglinide at 0. Increased frequency of glucose monitoring may be required during concomitant use. There are, however, no adequate and well-controlled studies in pregnant women.
Because animal reproduction studies are not always predictive of a human response, Clopidogrel bisulfate 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, 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. 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 with cyanotic congenital heart disease palliated with a systemic-to-pulmonary arterial shunt. Possible factors contributing to this outcome were the dose of Clopidogrel, the concomitant administration of aspirin and the late initiation of therapy following shunt palliation.
It 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. Renal Impairment Experience is limited in patients with severe and moderate renal impairment [see Clinical Pharmacology Hepatic Impairment No dosage adjustment is necessary in patients with hepatic impairment [see Clinical Pharmacology The following rates of major bleed were seen: In this trial the following rates of bleeding were observed.
In CURE, there was no difference in the rate of non-bleeding adverse events. Combination with other drugs that affect blood clotting, such as aspirin , heparins and thrombolytics , showed no relevant interactions.
Naproxen did increase the likelihood of occult gastrointestinal bleeding , as might be the case with other nonsteroidal anti-inflammatory drugs. As clopidogrel inhibits the liver enzyme CYP2C9 in cellular models, it has been theorized that it might increase blood plasma levels of drugs that are metabolized by this enzyme, such as phenytoin and tolbutamide.
Clinical studies showed that this mechanism is irrelevant for practical purposes. It works by blocking certain blood cells called platelets and prevents them from forming harmful blood clots. This "anti-platelet" effect helps keep blood flowing smoothly in your body. Read the Medication Guide provided by your pharmacist before you start taking clopidogrel and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth with or without food as directed by your doctor, usually once daily. Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day. Dosage and duration of treatment are based on your medical condition and response to treatment.
If you notice other effects not listed above, contact your doctor or pharmacist. In Marchthe Clopidogrel. Platelet aggregation induced by agonists other than ADP is also inhibited by blocking the amplification of platelet activation by released ADP, clopidogrel usp 75mg. Clopidogrel 75mg Film-Coated Tablets Usp Please be ready to give the following information: While you are taking Clopidogrel Tablets: If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel Tablets: Platelet aggregation and bleeding time gradually return to baseline values after treatment is discontinued, generally in about 5 days. Ask your pharmacist how to dispose of medicines no longer required, clopidogrel usp 75mg. You may need to read it again while you are receiving your treatment. Usp CYP2C19 is clopidogrel in the formation of both the active metabolite and the 2-oxo-Clopidogrel intermediate metabolite, clopidogrel usp 75mg. Decreased active metabolite exposure and diminished inhibition of platelet aggregation were observed in the poor metabolizers as compared to the other groups. Cmax occurs approximately 30 75mg 60 minutes 75mg dosing. Taking Clopidogrel Tablets with food and drink Clopidogrel Tablets may be taken with or without food. Omeprazole Or Esomeprazole Avoid concomitant use of Plavix with omeprazole or esomeprazole. Omeprazole or Esomeprazole Avoid concomitant use of Clopidogrel bisulfate with omeprazole or esomeprazole.
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