Country: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
PRASUGREL HYDROCHLORIDE (UNII: G89JQ59I13) (PRASUGREL - UNII:34K66TBT99)
Liberty Pharmaceuticals, Inc.
ORAL
PRESCRIPTION DRUG
Prasugrel tablets is indicated to reduce the rate of thrombotic cardiovascular (CV) events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI) as follows: Prasugrel tablets has been shown to reduce the rate of a combined endpoint of cardiovascular death, nonfatal myocardial infarction (MI), or nonfatal stroke compared to clopidogrel. The difference between treatments was driven predominantly by MI, with no difference on strokes and little difference on CV death [see Clinical Studies (14)]. Prasugrel tablets are contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)]. Prasugrel tablets is contraindicated in patients with a history of prior transient ischemic attack (TIA) or stroke. In TRITON-TIMI 38 (TRial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition with Prasugrel), p
Prasugrel tablets is available as oval, biconvex, film coated tablets, non-scored tablets in the following strengths, colors, deboss, and presentations: Feature Strengths 5 mg 10 mg Tablet color Yellow Yellow Tablet debossed P5 P1 Presentation and NDC Codes Bottles of 30 0440-0604-30 0440-0605-30 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense and keep product in original container. Keep container closed and do not remove desiccant from bottle. Do not break the tablet.
Abbreviated New Drug Application
PRASUGREL- PRASUGREL TABLET, FILM COATED Liberty Pharmaceuticals, Inc. ---------- MEDICATION GUIDE Prasugrel (PRA-soo-grel) tablets Read this Medication Guide before you start taking Prasugrel 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 Prasugrel tablets? • Prasugrel tablets is used to lower your chance of having a heart attack or other serious problems with your heart or blood vessels. But, Prasugrel tablets can cause bleeding, which can be serious, and sometimes lead to death. You should not start to take Prasugrel tablets if it is likely that you will have heart bypass surgery (coronary artery bypass graft surgery or CABG) right away. You have a higher risk of bleeding if you take Prasugrel tablets and then have heart bypass surgery. • Do not take Prasugrel tablets if you: • currently have abnormal bleeding, such as stomach or intestinal bleeding, or bleeding in your head • have had a stroke or “mini-stroke” (also known as transient ischemic attack or TIA) • are allergic to prasugrel or any of the ingredients in Prasugrel tablets. See the end of this Medication Guide for a list of ingredients in Prasugrel tablets. • Get medical help right away if you think you may be having a stroke or TIA. Symptoms that you may be having a stroke or TIA include: • sudden slurring of speech, • sudden weakness or numbness in one part of your body, • sudden blurry vision, or sudden severe headache. • If you have a stroke or TIA while taking Prasugrel tablets, your doctor will probably stop your Prasugrel tablets. Follow your doctor's instructions about stopping Prasugrel tablets. Do not stop taking Prasugrel tablets unless your doctor tells you to. • Before having any surgery you should talk to your doctor about stopping Prasugrel tablets. If possible, Prasugrel tablets should be stopped at least 1 w Прочитајте комплетан документ
PRASUGREL- PRASUGREL TABLET, FILM COATED LIBERTY PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE PRASUGREL TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PRASUGREL TABLETS. PRASUGREL TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2009 WARNING: BLEEDING RISK _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • • • • • • • RECENT MAJOR CHANGES Dosage and Administration (2) 07/2015 INDICATIONS AND USAGE Prasugrel tablets is a P2Y platelet inhibitor indicated for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome who are to be managed with PCI as follows: • • DOSAGE AND ADMINISTRATION • Initiate treatment with a single 60-mg oral loading dose (2). • Continue at 10-mg once daily with or without food. Consider 5-mg once daily for patients <60 kg (2). • Patients should also take aspirin (75-mg to 325-mg) daily. DOSAGE FORMS AND STRENGTHS 5-mg and 10-mg tablets (3) CONTRAINDICATIONS • Active pathological bleeding (4.1) • Prior transient ischemic attack or stroke (4.2) • Hypersensitivity to prasugrel or any component of the product (4.3) WARNINGS AND PRECAUTIONS • • • • ADVERSE REACTIONS Bleeding, including life-threatening and fatal bleeding, is the most commonly reported adverse reaction (6.1). PRASUGREL TABLETS CAN CAUSE SIGNIFICANT, SOMETIMES FATAL, BLEEDING (5.1,5.2, 6.1). DO NOT USE PRASUGREL TABLETS IN PATIENTS WITH ACTIVE PATHOLOGICAL BLEEDING OR A HISTORY OF TRANSIENT IS CHEMIC ATTACK OR STROKE (4.1, 4.2). IN PATIENTS ≥75 YEARS OF AGE, PRASUGREL TABLETS IS GENERALLY NOT RECOMMENDED, EXCEPT IN HIGH-RISK PATIENTS (DIABETES OR PRIOR MI), WHERE ITS USE MAY BE CONSIDERED (8.5). DO NOT START PRASUGREL TABLETS IN PATIENTS LIKELY TO UNDERGO URGENT CORONARY ARTERY BYPASS GRAFT SURGERY (CABG). WHEN POSSIBLE, DISCONTINUE PRASUGREL TABLETS AT LEAST 7 DAYS PRIOR TO ANY SURGERY (5.2). ADDITIONAL RISK Прочитајте комплетан документ