PRASUGREL- prasugrel hydrochloride 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:

Lupin Pharmaceuticals, Inc.

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Prasugrel tablet  is indicated to reduce the rate of thrombotic 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 tablet 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 is contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage (ICH) [see WARNINGS AND PRECAUTIONS (5.1) and ADVERSE REACTIONS (6.1)] . Prasugrel is contraindicated in patients with a history of prior

Резиме производа:

Prasugrel tablets, USP are available as modified capsule shaped film-coated tablets in the following strengths, colors, debossing, 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 HYDROCHLORIDE TABLET, FILM COATED
Lupin Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
Prasugrel (PRA-soo-grel)
Tablets
Rx only
What is the most important information I should know about prasugrel
tablets?
•
Prasugrel tablets are 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.
What is prasugrel tablet?
Prasugrel tablet is a prescription medicine used to treat people who:
•
have had a heart attack or severe chest pain that happens when your
heart does not get enough
oxygen, and
•
have been treated with a procedure called "angioplasty" (also called
balloon angioplasty).
Prasugrel tablet is used to lower your chance of having another
serious problem with your heart or blood
vessels, such as another heart attack, a stroke, blood clots in your
stent, or death.
Platelets are blood cells that help with normal blood clotting.
prasugrel tablets helps prevent platelets
from sticking together and forming a clot that can block an artery or
a stent.
It is not known if prasugrel tablet is safe and works in children.
Who should not take prasugrel tablets?
•
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:
•
sud

Карактеристике производа

PRASUGREL - PRASUGREL HYDROCHLORIDE TABLET, FILM COATED
LUPIN 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._
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 ISCHEMIC ATTACK OR STROKE (4.1, 4.2).
IN PATIENTS ≥75 YEARS OF AGE, PRASUGREL TABLETS ARE GENERALLY NOT
RECOMMENDED,
EXCEPT IN HIGH-RISK PATIENTS (DIABETES OR PRIOR MYOCARDIAL INFARCTION
[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 INCREASE THE RISK OF SUBSEQUENT CARDIOVASCULAR
EVENTS (5.3).
INDICATIONS AND USAGE
Prasugrel tablet 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
percutaneous coronary intervention (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 ora