RILUZOLE tablet, film coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

RILUZOLE (UNII: 7LJ087RS6F) (RILUZOLE - UNII:7LJ087RS6F)

Commercializzato da:

American Health Packaging

INN (Nome Internazionale):

RILUZOLE

Composizione:

RILUZOLE 50 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Riluzole tablets are indicated for the treatment of amyotrophic lateral sclerosis (ALS). Riluzole tablets are 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)]. Risk Summary There are no studies of riluzole tablets 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 to 4% and 15 to 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 pos

Dettagli prodotto:

Riluzole tablets, USP are white to off-white coloured, film-coated, capsule shaped, biconvex and debossed with "APO" on one side and "RI-50" on the other side. Riluzole tablets, USP are supplied in unit dose packages of 30 (5 x 6) NDC 68084-908-25. STORE AT 20° TO 25°C (68° TO 77°F); EXCURSIONS PERMITTED FROM 15° TO 30°C (59° TO 86°F) [See USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. KEEP OUT OF THE REACH OF CHILDREN.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

RILUZOLE- RILUZOLE TABLET, FILM COATED
AMERICAN HEALTH PACKAGING
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RILUZOLE TABLETS SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR RILUZOLE TABLETS.
RILUZOLE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
INDICATIONS AND USAGE
Riluzole tablets are indicated for the treatment of amyotrophic
lateral sclerosis (ALS) ( 1)
DOSAGE AND ADMINISTRATION
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)
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
Hepatic injury: Use of riluzole tablets are not recommended in
patients with baseline elevations of serum
aminotransferases greater than 5 times upper limit of normal;
discontinue riluzole tablets if there is evidence of liver
dysfunction ( 5.1)
Neutropenia: Advise patients to report any febrile illness ( 5.2)
Interstitial lung disease: Discontinue riluzole tablets if
interstitial lung disease develops ( 5.3)
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 APOTEX CORP. AT
1-800-706-5575 OR FDA AT 1-800-FDA-
1088 OR _WWW.FDA.GOV/MEDWATCH_.
DRUG INTERACTIONS
Strong to moderate CYP1A2 inhibitors: Coadministration may increase
riluzole tablets-associated adverse reactions (
7.1)
Strong to moderate CYP1A2 inducers: Coadministration may result in
decreased efficacy ( 7.2)
Hepatotoxic drugs: Riluzole tablets-treated patients that take other
hepatotoxic drugs may be at increased risk for
hepatotoxicity ( 7.3)
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, may cause fetal harm ( 8.1)
SEE 17 F