PRASUGREL tablet, film coated

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

PRASUGREL HYDROCHLORIDE (UNII: G89JQ59I13) (PRASUGREL - UNII:34K66TBT99)

Доступно од:

Ascend Laboratories, LLC

INN (Међународно име):

PRASUGREL HYDROCHLORIDE

Састав:

PRASUGREL 5 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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: - Patients with unstable angina (UA) or non-ST-elevation myocardial infarction (NSTEMI). - Patients with ST-elevation myocardial infarction (STEMI) when managed with primary or delayed PCI. 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 R

Резиме производа:

Prasugrel tablets is available as oval, biconvex, film coated tablets, in the following strengths, colors, deboss, and presentations: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep and Dispense only in original container. Keep container closed and do not remove desiccant from bottle. Do not break the tablet.

Статус ауторизације:

Abbreviated New Drug Application

Информативни летак

PRASUGREL- prasugrel tablet, film coated
Ascend Laboratories, LLC
----------
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. Seethe 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 week (7 da

Карактеристике производа

PRASUGREL- PRASUGREL TABLET, FILM COATED
ASCEND LABORATORIES, LLC
----------
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._
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 FACTORS FOR BLEEDING INCLUDE: BODY WEIGHT <60 KG;
PROPENSITY TO
BLEED; CONCOMITANT USE OF MEDICATIONS THAT INCREASE THE RISK OF
BLEEDING ( 5.1).
SUSPECT BLEEDING IN ANY PATIENT WHO IS HYPOTENSIVE AND HAS RECENTLY
UNDERGONE
INVASIVE OR SURGICAL PROCEDURES ( 5.1).
IF POSSIBLE, MANAGE BLEEDING WITHOUT DISCONTINUING PRASUGREL TABLETS.
STOPPING
PRASUGREL TABLETS INCREASES THE RISK OF SUBSEQUENT CARDIOVASCULAR
EVENTS ( 5.3).
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:
Patients with unstable angina or non-ST-elevation myocardial
infarction (NSTEMI) ( 1.1).
Patients with ST-elevation myocardial infarction (STEMI) when managed
with either primary or delayed
PCI ( 1.1).
DOSAGE AND ADMINISTRATION
• Initiate treatment with a single 60-mg oral loading dose ( 2).
• Continue at 10-mg once daily with or w