RILUZOLE tablet, film coated

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Glenmark Pharmaceuticals Inc., USA

SNN (starptautisko nepatentēto nosaukumu):

RILUZOLE

Kompozīcija:

RILUZOLE 50 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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 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 possible risk to the fetus associated with use of riluzole during pregnancy. Data Risk Summary It is not known if riluzole is excreted in human milk. Riluzole or its metabolites have been detected in milk of lactating rats. Women should be advised that many drugs are excreted in human milk and that the potential for serious adverse reactions in nursing infants from riluzole is unknown. In rats, oral administration of riluzole resulted in decreased fertility indices and increases in embryolethality [see Nonclinical Toxicology (13.1)]. Safety and effectiveness of riluzole in pediatric patients have not been established. In clinical studies of riluzole, 30% of patients were 65 years and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Patients with mild [Child-Pugh’s (CP) score A] or moderate (CP score B) hepatic impairment had increases in AUC compared to patients with normal hepatic function. Thus, patients with mild or moderate hepatic impairment may be at increased risk of adverse reactions. The impact of severe hepatic impairment on riluzole exposure is unknown. Use of riluzole is not recommended in patients with baseline elevations of serum aminotransferases greater than 5 times upper limit of normal or evidence of liver dysfunction (e.g., elevated bilirubin) [Clinical Pharmacology (12.3)]. Japanese patients are more likely to have higher riluzole concentrations. Consequently, the risk of adverse reactions may be greater in Japanese patients [see Clinical Pharmacology (12.3)].

Produktu pārskats:

Riluzole tablets USP, 50 mg are white to off-white, capsule shaped, beveled edged, film-coated tablets, engraved with ‘381’ on one side and ‘G’ on the other side. Riluzole tablets USP, 50 mg are supplied in: Store at 20°C to 25°C (68°F to77°F) [see USP Controlled Room Temperature] and protect from bright light. Keep out of the reach of children.

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

RILUZOLE- RILUZOLE TABLET, FILM COATED
GLENMARK PHARMACEUTICALS INC., USA
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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
•
•
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 GLENMARK
PHARMACEUTICALS INC., USA AT
1 [phone] 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: 7/2020
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
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 riluzole is not recommended in patients with
baseline elevations of serum
aminotransferases greater than 5 times upper limit of normal;
discontinue riluzole if there is evidence
of liver dysfunction (5.1)
Neutropenia: Advise patients to report any febrile illness (5.2)
Interstitial lung disease: Discontinue riluzole if interstitial lung
disease develops (5.3)
Strong to moderate CYP1A2 inhibitors: Coadministration may increase
riluzole-associated adverse
reactions (7.1)
Strong to moderate CYP1A2 inducers: Coadministration may result in
decreased