RILUTEK- riluzole tablet

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

riluzole (UNII: 7LJ087RS6F) (riluzole - UNII:7LJ087RS6F)

Доступна з:

Covis Pharma US, Inc

ІПН (Міжнародна Ім'я):

riluzole

Склад:

riluzole 50 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

RILUTEK is indicated for the treatment of amyotrophic lateral sclerosis (ALS). RILUTEK is contraindicated in patients with a history of severe hypersensitivity reactions to riluzole or to any of its components (anaphylaxis has occurred) [see Adverse Reactions (6.1)] . There are no studies of RILUTEK in pregnant women, and case reports have been inadequate to inform the drug-associated risk. The background risk for major birth defects and miscarriage in patients with amyotrophic lateral sclerosis is unknown. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. In studies in which riluzole was administered orally to pregnant animals, developmental toxicity (decreased embryofetal/offspring viability, growth, and functional development) was observed at clinically relevant doses [see Data] . Based on these results, women should be advised of a possible risk to the fetus associated with use of RILUTEK durin

Огляд продуктів:

RILUTEK 50 mg tablets are white, capsule-shaped, film-coated, and engraved with “RPR 202” on one side. RILUTEK is supplied in bottles of 60 tablets, NDC 70515-700-60. Store at controlled room temperature, 20°C to 25°C (68°F to 77°F), and protect from bright light.

Статус Авторизація:

New Drug Application

Характеристики продукта

RILUTEK- RILUZOLE TABLET
COVIS PHARMA US, INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RILUTEK SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RILUTEK
RILUTEK (RILUZOLE) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
INDICATIONS AND USAGE
RILUTEK is indicated for the treatment of amyotrophic lateral
sclerosis (ALS) (1)
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 50 mg (3)
CONTRAINDICATIONS
Patients with a history of severe hypersensitivity reactions to
riluzole or to any of its components (4)
WARNINGS AND PRECAUTIONS
•
•
•
ADVERSE REACTIONS
Most common adverse reactions (incidence greater than or equal to 5%
and greater than placebo) were
asthenia, nausea, dizziness, decreased lung function, and abdominal
pain (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Covis Pharma at
1-866-488-4423 or FDA at 1-800-
FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
•
•
•
USE IN SPECIFIC POPULATIONS
•
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 3/2020
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
®
Recommended dosage: 50 mg twice daily, taken at least 1 hour before or
2 hours after a meal (2)
Measure serum aminotransferases before and during treatment (2, 5.1)
Hepatic injury: Use of RILUTEK is not recommended in patients with
baseline elevations of serum
aminotransferases greater than 5 times upper limit of normal;
discontinue RILUTEK if there is
evidence of liver dysfunction (5.1)
Neutropenia: Advise patients to report any febrile illness (5.2)
Interstitial lung disease: Discontinue RILUTEK if interstitial lung
disease develops (5.3)
Strong to moderate CYP1A2 inhibitors: Coadministration may increase
RILUTEK-associated adverse
reactions (7.1)
Strong to moderate CYP1A2 inducers: Coadministration may result in
decreased efficacy (7.2)
Hepatotoxic drugs: RILUTEK-treated patients that take other
hepatotoxic drug