PRASUGREL 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:

Panacea Biotec Limited

INN (International Name):

Prasugrel Hydrochloride

Composition:

Prasugrel 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Prasugrel tablet 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 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 tablet is 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 tablet is contraindicated in patients wit

Product summary:

Prasugrel tablet is available as round, biconvex, film- coated, non-scored tablets in the following strengths, colors, imprints, 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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

PRASUGREL- PRASUGREL TABLET, FILM COATED
Panacea Biotec Limited
----------
MEDICATION GUIDE
Prasugrel tablets
(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 tablet 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

Summary of Product characteristics

PRASUGREL- PRASUGREL TABLET, FILM COATED
PANACEA BIOTEC LIMITED
----------
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 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 without food. Conside