Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
clopidogrel bisulfate (UNII: 08I79HTP27) (clopidogrel - UNII:A74586SNO7)
Physicians Total Care, Inc.
clopidogrel bisulfate
clopidogrel 75 mg
ORAL
PRESCRIPTION DRUG
- 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, Plavix 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), Plavix 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 Plavix therapy in ACS is unknown. For patients with a history of recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease, Plavix has been shown to reduce the rate of a combined endpoint of new ischemi
Plavix (clopidogrel bisulfate) 75 mg tablets 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: Store at 25° C (77° F); excursions permitted to 15°–30° C (59°–86° F) [see USP Controlled Room Temperature].
New Drug Application
Physicians Total Care, Inc. ---------- Medication Guide Plavix® (PLAV-iks) (clopidogrel bisulfate) tablets Read this Medication Guide before you start taking Plavix and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment. What is the most important information I should know about Plavix? 1. Plavix may not work as well in people who: • have certain genetic factors that affect how the body breaks down Plavix. Your doctor may do genetic tests to make sure Plavix is right for you. • take certain medicines, especially omeprazole (Prilosec®) or esomeprazole (Nexium®). Your doctor may change the medicine you take for stomach acid problems while you take Plavix. 2. Plavix can cause bleeding which can be serious and can sometimes lead to death. Plavix is a blood thinner medicine that lowers the chance of blood clots forming in your body. While you take Plavix: • you may bruise and bleed more easily • you are more likely to have nose bleeds • it will take longer for any bleeding to stop Call your doctor right away if you have any of these signs or symptoms of bleeding: • unexpected bleeding or bleeding that lasts a long time • blood in your urine (pink, red or brown urine) • red or black stools (looks like tar) • bruises that happen without a known cause or get larger • cough up blood or blood clots • vomit blood or your vomit looks like coffee grounds Do not stop taking Plavix without talking to the doctor who prescribes it for you. People who are treated with a stent, and stop taking Plavix too soon, have a higher risk of getting a blood clot on the stent, having a heart attack, or dying. If you must stop Plavix because of bleeding, your risk of a heart attack may be higher. What is Plavix? Plavix is a prescription medicine used to treat people who have any of the following: • chest pain due to heart problems • poor circulation in their legs (peripheral arterial disea Прочитайте повний документ
PLAVIX - CLOPIDOGREL BISULFATE TABLET, FILM COATED PHYSICIANS TOTAL CARE, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE PLAVIX SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PLAVIX. PLAVIX (CLOPIDOGREL BISULFATE) TABLETS INITIAL U.S. APPROVAL: 1997 WARNING: DIMINISHED EFFECTIVENESS IN POOR METABOLIZERS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ EFFECTIVENESS OF PLAVIX DEPENDS ON ACTIVATION TO AN ACTIVE METABOLITE BY THE CYTOCHROME P450 (CYP) SYSTEM, PRINCIPALLY CYP2C19. (5.1) POOR METABOLIZERS TREATED WITH PLAVIX AT RECOMMENDED DOSES EXHIBIT HIGHER CARDIOVASCULAR EVENT RATES FOLLOWING ACUTE CORONARY SYNDROME (ACS) OR PERCUTANEOUS CORONARY INTERVENTION (PCI) THAN PATIENTS WITH NORMAL CYP2C19 FUNCTION. (12.5) TESTS ARE AVAILABLE TO IDENTIFY A PATIENT'S CYP2C19 GENOTYPE AND CAN BE USED AS AN AID IN DETERMINING THERAPEUTIC STRATEGY. (12.5) CONSIDER ALTERNATIVE TREATMENT OR TREATMENT STRATEGIES IN PATIENTS IDENTIFIED AS CYP2C19 POOR METABOLIZERS. (2.3, 5.1) RECENT MAJOR CHANGES Dosage and Administration (2.4) 12/2011 Warnings and Precautions (5.1) 12/2011 INDICATIONS AND USAGE Plavix is a P2Y platelet inhibitor indicated for: Acute coronary syndrome - - Recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease. Plavix has been shown to reduce the combined endpoint of new ischemic stroke (fatal or not), new MI (fatal or not), and other vascular death. (1.2) DOSAGE AND ADMINISTRATION Acute coronary syndrome (2.1) - - Recent MI, recent stroke, or established peripheral arterial disease: 75 mg once daily (2.2) DOSAGE FORMS AND STRENGTHS Tablets: 75 mg, 300 mg (3) CONTRAINDICATIONS 12 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, Plavix has been shown to decrease the rate of a combined endpoint of Прочитайте повний документ