Երկիր: Ամերիկայի Միացյալ Նահանգներ
Լեզու: անգլերեն
Աղբյուրը: NLM (National Library of Medicine)
CLOPIDOGREL BISULFATE (UNII: 08I79HTP27) (CLOPIDOGREL - UNII:A74586SNO7)
Blenheim Pharmacal, Inc.
CLOPIDOGREL BISULFATE
CLOPIDOGREL 75 mg
ORAL
PRESCRIPTION DRUG
The optimal duration of clopidogrel bisulfate therapy in ACS is unknown. For patients with a history of recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease, clopidogrel bisulfate 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. Clopidogrel bisulfate is contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage. Clopidogrel bisulfate is contraindicated in patients with hypersensitivity (e.g., anaphylaxis) to clopidogrel or any component of the product [see Adverse Reactions (6.2)] . 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. Beca
Clopidogrel Tablets, USP 75 mg tablets are available as pink, round, biconvex, film-coated tablets engraved "APO' on one side and "CL" over "75" on the other side. They are supplied as follows: Bottles of 30, NDC 62034-015-30 Bottles of 90, NDC 62034-015-90 Bottles of 100, NDC 62034-015-01 Carton of 100 (10 x 10 Blister Pack) NDC 62034-015-77 Store at 25° C (77° F); excursions permitted to 15°–30° C (59°–86° F) [see USP Controlled Room Temperature]. Protect from moisture.
Abbreviated New Drug Application
CLOPIDOGREL BISULFATE- CLOPIDOGREL BISULFATE TABLET, FILM COATED Blenheim Pharmacal, Inc. ---------- 17.6 MEDICATION GUIDE Clopidogrel Bisulfate Tablets, USP 75 mg (kloe pid’ oh grel bye sul’ fate) Read this Medication Guide before you start taking clopidogrel bisulfate tablets 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 Clopidogrel Bisulfate Tablets? 1. Clopidogrel bisulfate tablets may not work as well in people who: • have certain genetic factors that affect how the body breaks down clopidogrel. Your doctor may do genetic tests to make sure clopidogdrel 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 clopiodgrel. 2. Clopiodgrel bisulfate tablets can cause bleeding which can be serious and can sometimes lead to death. Clopidogrel is a blood thinner medicine that lowers the chance of blood clots forming in your body. While you take clopiodgrel: • 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 clopidogrel bisulfate tablets without talking to the doctor who prescribes it for you. People who are treated with a stent, and stop taking clopidogrel too soon, have a higher risk of getting a blood clot on the stent, having a heart attack, or dying. If you must stop clopidogrel bisulfate tablets b Կարդացեք ամբողջական փաստաթուղթը
CLOPIDOGREL BISULFATE- CLOPIDOGREL BISULFATE TABLET, FILM COATED BLENHEIM PHARMACAL, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CLOPIDOGREL TABLETS, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CLOPIDOGREL TABLETS, USP. CLOPIDOGREL TABLETS, USP INITIAL U.S. APPROVAL: 1997 WARNING: DIMINISHED EFFECTIVENESS IN POOR METABOLIZERS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • • • • RECENT MAJOR CHANGES Dosage and Administration (2.4) 12/2011 Warnings and Precautions (5.1) 12/2011 INDICATIONS AND USAGE Clopidogrel bisulfate is a P2Y platelet inhibitor indicated for: • • DOSAGE AND ADMINISTRATION • • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS EFFECTIVENESS OF CLOPIDOGREL BISULFATE DEPENDS ON ACTIVATION TO AN ACTIVE METABOLITE BY THE CYTOCHROME P450 (CYP) SYSTEM, PRINCIPALLY CYP2C19. (5.1) POOR METABOLIZERS TREATED WITH CLOPIDOGREL BISULFATE 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) 12 Acute coronary syndrome 1. 2. 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, clopidogrel 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. (1.1) For patients with ST-elevation myocardial infarction (STEMI), clopidogrel has been shown to reduce the ra Կարդացեք ամբողջական փաստաթուղթը