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:

Golden State Medical Supply, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Prasugrel tablets are 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 tablets have 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 (ICH) [see Warnings and Precautions (5.1) and

Product summary:

Prasugrel Tablets, USP are available containing prasugrel hydrochloride, USP equivalent to 5 mg or 10 mg prasugrel, respectively. The 5 mg tablets are yellow, film-coated, capsule shaped, unscored tablets debossed with M on one side of the tablet and PH1 on the other side. They are available as follows: NDC 51407-444-30 bottles of 30 tablets The 10 mg tablets are brown, film-coated, capsule shaped, unscored tablets debossed with M on one side of the tablet and PH2 on the other side. They are available as follows: NDC 51407-445-30 bottles of 30 tablets Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Protect from moisture. Keep and dispense only in original container. Keep container closed and do not remove desiccant from bottle. Do not break the tablet. PHARMACIST: Dispense a Medication Guide with each prescription.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Golden State Medical Supply, Inc.
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MEDICATION GUIDE
Prasugrel Tablets, USP
(pra′ soo grel)
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 are prasugrel tablets?
Prasugrel tablets are 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 tablets are 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 help prevent
platelets from sticking together and forming a
clot that can block an artery or a stent.
It is not known if prasugrel tablets are safe and work 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:
•
sudden slurring of speech,
•
sudden weakn

Summary of Product characteristics

PRASUGREL- PRASUGREL TABLET, FILM COATED
GOLDEN STATE MEDICAL SUPPLY, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
PRASUGREL TABLETS. 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
THEIR 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 are 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 treatm