PRASUGREL tablet, film coated

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Mylan Pharmaceuticals Inc.

SNN (starptautisko nepatentēto nosaukumu):

PRASUGREL HYDROCHLORIDE

Kompozīcija:

PRASUGREL 5 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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: 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 Adverse Reactions (6.1)] . Prasugrel tablets are contraindicated in patients with a history of prior transient ischemic attack (TIA) or stroke. In TRITON-TIMI 38 (TR ial to Assess I mprovement in T herapeutic Outcomes by O ptimizing Platelet InhibitioN with Prasugrel), patients with a history of TIA or ischemic stroke (> 3 months prior to enrollment) had a higher rate of stroke on prasugrel tablets (6.5%; of which 4.2% were thrombotic stroke and 2.3% were intracranial hemorrhage [ICH]) than on clopidogrel (1.2%; all thrombotic). In patients without such a history, the incidence of stroke was 0.9% (0.2% ICH) and 1.0% (0.3% ICH) with prasugrel tablets and clopidogrel, respectively. Patients with a history of ischemic stroke within 3 months of screening and patients with a history of hemorrhagic stroke at any time were excluded from TRITON-TIMI 38. Patients who experience a stroke or TIA while on prasugrel tablets generally should have therapy discontinued [see Adverse Reactions (6.1) and Clinical Studies (14)] . Prasugrel tablets are contraindicated in patients with hypersensitivity (e.g., anaphylaxis) to prasugrel or any component of the product [see Adverse Reactions (6.2)] . There are no data with prasugrel tablets use in pregnant women to inform a drug-associated risk. No structural malformations were observed in animal reproductive and developmental toxicology studies when rats and rabbits were administered prasugrel during organogenesis at doses of up to 30 times the recommended therapeutic exposures in humans [see Data] . Due to the mechanism of action of prasugrel tablets, and the associated identified risk of bleeding, consider the benefits and risks of prasugrel tablets and possible risks to the fetus when prescribing prasugrel tablets to a pregnant woman [see Boxed Warning and Warnings and Precautions (5.1, 5.3)] . The background risk of major birth defects and miscarriage for the indicated population is unknown. The background risk in the U.S. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies. In embryo-fetal developmental toxicology studies, pregnant rats and rabbits received prasugrel at maternally toxic oral doses equivalent to more than 40 times the human exposure. A slight decrease in fetal body weight was observed, but there were no structural malformations in either species. In prenatal and postnatal rat studies, maternal treatment with prasugrel had no effect on the behavioral or reproductive development of the offspring at doses greater than 150 times the human exposure. There is no information regarding the presence of prasugrel in human milk, the effects on the breastfed infant, or the effects on milk production. Metabolites of prasugrel were found in rat milk [see Data] . The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for prasugrel tablets and any potential adverse effects on the breastfed child from prasugrel tablets or from the underlying maternal condition. Following a 5 mg/kg oral dose of [14 C]-prasugrel to lactating rats, metabolites of prasugrel were detected in the maternal milk and blood. Safety and effectiveness in pediatric patients have not been established. In a randomized, placebo-controlled trial, the primary objective of reducing the rate of vaso-occlusive crisis (painful crisis or acute chest syndrome) in pediatric patients, aged 2 to less than 18 years, with sickle cell anemia was not met. In TRITON-TIMI 38, 38.5% of patients were ≥ 65 years of age and 13.2% were ≥ 75 years of age. The risk of bleeding increased with advancing age in both treatment groups, although the relative risk of bleeding (prasugrel tablets compared with clopidogrel) was similar across age groups. Patients ≥ 75 years of age who received prasugrel tablets 10 mg had an increased risk of fatal bleeding events (1.0%) compared to patients who received clopidogrel (0.1%). In patients ≥ 75 years of age, symptomatic intracranial hemorrhage occurred in 7 patients (0.8%) who received prasugrel tablets and in 3 patients (0.3%) who received clopidogrel. Because of the risk of bleeding, and because effectiveness is uncertain in patients ≥ 75 years of age [see Clinical Studies (14)] , use of prasugrel tablets is generally not recommended in these patients, except in high-risk situations (diabetes and past history of myocardial infarction) where their effect appears to be greater and their use may be considered [see Warnings and Precautions (5.1), Clinical Pharmacology (12.3), and Clinical Studies (14)] . In TRITON-TIMI 38, 4.6% of patients treated with prasugrel tablets had body weight < 60 kg. Individuals with body weight < 60 kg had an increased risk of bleeding and an increased exposure to the active metabolite of prasugrel [see Dosage and Administration (2), Warnings and Precautions (5.1), and Clinical Pharmacology (12.3)] . Consider lowering the maintenance dose to 5 mg in patients < 60 kg. The effectiveness and safety of the 5 mg dose have not been prospectively studied [see Dosage and Administration (2) and Clinical Pharmacology (12.3)] . No dosage adjustment is necessary for patients with renal impairment. There is limited experience in patients with end-stage renal disease, but such patients are generally at higher risk of bleeding [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3)] . No dosage adjustment is necessary in patients with mild to moderate hepatic impairment (Child-Pugh Class A and B). The pharmacokinetics and pharmacodynamics of prasugrel in patients with severe hepatic disease have not been studied, but such patients are generally at higher risk of bleeding [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3)] . In healthy subjects, patients with stable atherosclerosis, and patients with ACS receiving prasugrel, there was no relevant effect of genetic variation in CYP2B6, CYP2C9, CYP2C19, or CYP3A5 on the pharmacokinetics of prasugrel’s active metabolite or its inhibition of platelet aggregation.

Produktu pārskats:

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 0378-5185-93 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 0378-5186-93 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.

Autorizācija statuss:

Abbreviated New Drug Application

Lietošanas instrukcija

Mylan Pharmaceuticals 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:
o
currently have abnormal bleeding, such as stomach or intestinal
bleeding, or bleeding in your
head
o
have had a stroke or “mini-stroke” (also known as transient
ischemic attack or TIA)
o
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:
o
sudden slurring of speech,
o
sudden weakness or numbness i

Produkta apraksts

PRASUGREL- PRASUGREL TABLET, FILM COATED
MYLAN 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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•
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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:
•
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DOSAGE AND ADMINISTRATION
•
•
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DOSAGE FORMS AND STRENGTHS
5 mg and 10 mg tablets (3).
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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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).
12
Patients with unstable angina or non-ST-elevation myocardial
infarction (NSTE