PRASUGREL hydrochloride tablet film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Prasugrel hydrochloride (UNII: G89JQ59I13) (Prasugrel - UNII:34K66TBT99)

Available from:

Prasco Laboratories

INN (International Name):

Prasugrel hydrochloride

Composition:

Prasugrel 5 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

PRASUGREL- PRASUGREL HYDROCHLORIDE TABLET, FILM COATED
PRASCO LABORATORIES
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PRASUGREL SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR PRASUGREL. PRASUGREL TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2009
WARNING: BLEEDING RISK
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
PRASUGREL CAN CAUSE SIGNIFICANT, SOMETIMES FATAL, BLEEDING (5.1, 5.2,
6.1).
DO NOT USE PRASUGREL 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 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 IN PATIENTS LIKELY TO UNDERGO URGENT CORONARY
ARTERY BYPASS GRAFT SURGERY
(CABG). WHEN POSSIBLE, DISCONTINUE PRASUGREL 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. STOPPING
PRASUGREL INCREASES THE RISK
OF SUBSEQUENT CARDIOVASCULAR EVENTS (5.3).
RECENT MAJOR CHANGES
None
INDICATIONS AND USAGE
Prasugrel 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 without food. Consider 5-mg once
daily for patients <60 kg (2).
P