PRASUGREL tablet, film coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Liberty Pharmaceuticals, Inc.

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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

Dettagli prodotto:

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.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

PRASUGREL- PRASUGREL TABLET, FILM COATED
Liberty Pharmaceuticals, Inc.
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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

Scheda tecnica

PRASUGREL- PRASUGREL TABLET, FILM COATED
LIBERTY PHARMACEUTICALS, INC.
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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._
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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
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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