Plavix

/ Sanofi

Adults and elderly: Plavix 75 should be given as a single daily dose of 75 mg.
Plavix 300 mg is intended for use as a loading dose.
As a maintenance dose clopidogrel should be given as a single daily dose of 75 mg.
In patients suffering from acute coronary syndrome:
− Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), clopidogrel treatment should be initiated with a single 300 mg loading dose and then continued at 75mg once a day [with acetylsalicylic acid (ASA) 75mg-325mg daily]. Since higher doses of ASA were associated with higher bleeding risk it is recommended that the dose of ASA should not be higher than 100 mg. The optimal duration of treatment has not been formally established. Clinical trial data support use up to 12 months, and the maximum benefit was seen at 3 months.
– ST segment elevation acute myocardial infarction: clopidogrel should be given as a single daily dose of 75 mg initiated with a 300 mg loading dose in combination with ASA and with or without thrombolytics. For patients greater than 75 years of age clopidogrel should be initiated without a loading dose. Combined therapy should be started as early as possible after symptoms start and continued for at least four weeks. The benefit of the combination of clopidogrel with ASA beyond mfour weeks has not been studied in this setting.
In patients with atrial fibrillation, clopidogrel should be given as a single daily dose of 75mg. ASA (75- 100mg daily) should be initiated and continued in combination with clopidogrel.
If a dose is missed:
– Within less than 12 hours after regular scheduled time: patients should take the dose immediately
and then take the next dose at the regular scheduled time.
– For more than 12 hours: patients should take the next dose at the regular scheduled time and
should not double the dose.
Pediatric population: Clopidogrel should not be used in children and adolescence because of efficacy concerns.
Renal impairment: Therapeutic experience is limited in patients with renal impairment.
Hepatic impairment: Therapeutic experience is limited in patients with moderate hepatic disease who may have bleeding
diatheses.
For full details see prescribing information.

For the prevention of atherothrombotic events: Adult patients suffering from MI (from a few days until less than 35 days), ischemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. Adult patients suffering from Acute Coronary Syndrome – Non-ST segment elevation acute coronary syndrome (unstable angina/non-Q-wave MI), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with ASA. – ST segment elevation acute MI, in combination with ASA in medicdbally treated patients eligible for thrombolytic therapy.
Prevention of atherothrombotic andthromboembolic events in atrial fibrillation: In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for the treatment with Vitamin K antagonists (VKA) Anti-Thrombin or Anti Factor Xa, and who have a low bleeding risk, in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.

Hypersensitivity to the active substance or to any of the excipients of the medicdbinal product. Severe liver impairment. Active pathological bleeding such as peptic ulcer or intracranial hemorrhage. Lactation.

Safety and efficacy in subjects below the age of 18 have not been established. There is no experience in children. Renal impairment: Therapeutic experience is limited in patients with renal impairment. Hepatic impairment: Therapeutic experience is limited in patients with moderate hepatic disease who may have bleeding diatheses. Contains lactose and hydrogenated castor oil. Patients should be evaluated for history of hypersensitivity to another thienopyridine (such as ticlopidine, prasugrel).

Eye bleeding (conjunctival, ocular, retinal), epistaxis. Gastrointestinal hemorrhage, diarrhea, abdominal pain, dyspepsia. Bruising, bleeding at puncture site. Acute generalised exanthematous pustulosis (AGEP), Gynaecomastia.
For full details please see prescribing information.

Oral anticoagulants: the concomitant administration of clopidogrel with Oral anticoagulants is not recommended since it may increase the intensity of bleedings. Although the administration of clopidogrel 75mg/day did not modify the pharmacokinetics of S-warfarin or INR in patients receiving long-term warfarin therapy, co administration of clopidogrel with warfarin increases the risk of bleeding because of independent effects on hemostasis.
Glycoprotein IIb/IIIa inhibitors: clopidogrel should be used with caution in patients who receive concomitant glycoprotein IIb/IIIa inhibitors. Warfarin, acetylsalicylic acid (ASA), heparin, thrombolytics, NSAIDs.
For full details see prescribing information.

Pregnancy: As no clinical data on exposure to clopidogrel during pregnancy are available, it is preferable not to use clopidogrel during pregnancy as a precautionary measure. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development
Lactation: It is not known whether clopidogrel is excreted in human breast milk. Animal studies have shown excretion of clopidogrel in breast milk. As a precautionary measure, breast-feeding should not be continued during treatment with Plavix .
Fertility: Clopidogrel was not shown to alter fertility in animal studies.

Overdose following clopidogrel administration may lead to prolonged bleeding time and subsequent bleeding complications. Appropriate therapy should be considered if bleedings are observed. No antidote to the pharmacological activity of clopidogrel has been found. If prompt correction of prolonged bleeding time is required, platelet transfusion may reverse the effects of clopidogre.