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Luai Al Bakour
El Temamy Pharmacy
Akoni Hijyen Teknolojileri Sanayi ve Dış Ticaret LTD. ŞTİ
Britton Chance Center for Biomedical Photonics
Arabian Trade Center - ATC
Medical Facility (32206):
Legality International. (Pvt.) Ltd.
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Acute Coronary Syndrome (ACS) * For patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)], including patients who are to be managed medically and those who are to be managed with coronary revascularization,this medicine has been shown to decrease the rate of a combined endpoint of cardiovascular death, myocardial infarction (MI), or stroke as well as the rate of a combined endpoint of cardiovascular death, MI, stroke, or refractory ischemia. * For patients with ST-elevation myocardial infarction (STEMI), this medicine has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction, or stroke. The benefit for patients who undergo primary percutaneous coronary intervention is unknown. The optimal duration of this medicine therapy in ACS is unknown. Recent MI, Recent Stroke, or Established Peripheral Arterial Disease For patients with a history of recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease, this medicine has been shown to reduce the rate of a combined endpoint of new ischemic stroke (fatal or not), new MI (fatal or not), and other vascular death.
Active Bleeding it is contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage. Hypersensitivity it is contraindicated in patients with hypersensitivity (e.g., anaphylaxis) to clopidogrel or any component of the product
Easy bruising; minor bleeding. Seek medical attention right away if any of these SEVERE side effects occur when using Clopidogrel: Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; bleeding in the eye; change in vision; change in the amount of urine produced; chest pain; dark or bloody urine; fever or sore throat; loss of appetite; pale skin; seizures; severe, persistent headache; speech problems; unexplained weight loss; unusual bruising or bleeding; unusual or severe bleeding (eg, excessive bleeding from cuts, increased menstrual bleeding, unexplained vaginal bleeding, unusual bleeding from the gums when brushing); unusual tiredness or weakness; yellowing of the skin or eyes.
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 of the active metabolite of clopidogrel and a reduction in platelet inhibition. Avoid concomitant use of drugs that inhibit CYP2C19, e.g., omeprazole [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY]. Omeprazole In a crossover clinical study, 72 healthy subjects were administered this medicine (300 mg loading dose followed by 75 mg per day) alone and with omeprazole (80 mg at the same time as this medicine) for 5 days. The exposure to the active metabolite of clopidogrel was decreased by 46% (Day 1) and 42% (Day 5) when this medicine and omeprazole were administered together. Mean inhibition of platelet aggregation was diminished by 47% (24 hours) and 30% (Day 5) when this medicine and omeprazole were administered together. In another study, 72 healthy subjects were given the same doses of this medicine and omeprazole but the drugs were administered 12 hours apart; the results were similar, indicating that administering this medicine and omeprazole at different times does not prevent their interaction [see WARNINGS AND PRECAUTIONS]. Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Coadministration of this medicine and NSAIDs increases the risk of gastrointestinal bleeding. 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 this medicine with warfarin increases the risk of bleeding because of independent effects on hemostasis. However, at high concentrations in vitro, clopidogrel inhibits CYP2C9.
Diminished Antiplatelet Activity Due to Impaired CYP2C19 Function Clopidogrel is a prodrug. Inhibition of platelet aggregation by clopidogrel is entirely due to an active metabolite. The metabolism of clopidogrel to its active metabolite can be impaired by genetic variations in CYP2C19 [see Boxed Warning] and by concomitant medications that interfere with CYP2C19. Avoid concomitant use of this medicine and drugs that inhibit CYP2C19 activity. Co-administration of this medicine with omeprazole, a proton pump inhibitor that is an inhibitor of CYP2C19, reduces the pharmacological activity of this medicine if given concomitantly or if given 12 hours apart [see DRUG INTERACTIONS]. General Risk of Bleeding Thienopyridines, including this medicine, increase the risk of bleeding. If a patient is to undergo surgery and an antiplatelet effect is not desired, discontinue this medicine 5 days prior to surgery. In patients who stopped therapy more than five days prior to CABG the rates of major bleeding were similar (event rate 4.4% this medicine + aspirin; 5.3% placebo + aspirin). In patients who remained on therapy within five days of CABG, the major bleeding rate was 9.6% for this medicine + aspirin, and 6.3% for placebo + aspirin. Thienopyridines inhibit platelet aggregation for the lifetime of the platelet (7-10 days), so withholding a dose will not be useful in managing a bleeding event or the risk of bleeding associated with an invasive procedure. Because the half-life of clopidogrel’s active metabolite is short, it may be possible to restore hemostasis by administering exogenous platelets; however, platelet transfusions within 4 hours of the loading dose or 2 hours of the maintenance dose may be less effective. Discontinuation of this medicine Avoid lapses in therapy, and if this medicine must be temporarily discontinued, restart as soon as possible. Premature discontinuation of this medicine may increase the risk of cardiovascular events. Patients with Recent Transient Ischemic Attack (TIA) or Stroke In patients with recent TIA or stroke who are at high risk for recurrent ischemic events, the combination of aspirin and this medicine has not been shown to be more effective than this medicine alone, but the combination has been shown to increase major bleeding. Thrombotic Thrombocytopenic Purpura (TTP) TTP, sometimes fatal, has been reported following use of this medicine, sometimes after a short exposure ( < 2 weeks). TTP is a serious condition that requires urgent treatment including plasmapheresis (plasma exchange). It is characterized by thrombocytopenia, microangiopathic hemolytic anemia (schistocytes [fragmented RBCs] seen on peripheral smear), neurological findings, renal dysfunction, and fever [see ADVERSE REACTIONS]. Nonclinical Toxicology 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 humans at the recommended daily dose of 75 mg. Clopidogrel was not genotoxic in four in vitro tests (Ames test, DNA-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). Clopidogrel was found to have no effect on fertility of male and female rats at oral doses up to 400 mg/kg per day (52 times the recommended human dose on a mg/m2 basis). Use In Specific Populations Pregnancy Pregnancy Category B Reproduction studies performed in rats and rabbits at doses up to 500 and 300 mg/kg/day, respectively (65 and 78 times the recommended daily human dose, respectively, on a mg/m2 basis), revealed no evidence of impaired fertility or fetotoxicity due to clopidogrel. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of a human response, this medicine should be used during pregnancy only if clearly needed. Nursing Mothers Studies in rats have shown that clopidogrel and/or its metabolites are excreted in the milk. 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 the pediatric population have not been established. Geriatric Use Of the total number of subjects in the CAPRIE and CURE controlled clinical studies, approximately 50% of patients treated with this medicine were 65 years of age and older, and 15% were 75 years and older. In COMMIT, approximately 58% of the patients treated with this medicine were 60 years and older, 26% of whom were 70 years and older. The observed risk of thrombotic events with clopidogrel plus aspirin versus placebo plus aspirin by age category is provided in Figures 2 and 5 for the CURE and COMMIT trials, respectively [see Clinical Studies]. The observed risk of bleeding events with clopidogrel plus aspirin versus placebo plus aspirin by age category is provided in Tables 1 and 2 for the CURE and COMMIT trials, respectively . No dosage adjustment is necessary in elderly patients. Renal Impairment Experience is limited in patients with severe and moderate renal impairment. Hepatic Impairment No dosage adjustment is necessary in patients with hepatic impairment
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Samir Moussa M.D.
Yaser Habrawi , F.R.C.S.Ed
Dr. Tahsin Martini
Dr . Dirar Abboud
Dr. Hani Najjar
Dr. Faisal Dibsi
Dr. Samer Al-Jneidy
Dr. Talal Sabouni