RILUZOLE tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Quinn Pharmaceuticals, Llc

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Riluzole tablets, USP is indicated for the treatment of amyotrophic lateral sclerosis (ALS). Riluzole tablets 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 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 associ

Resumen del producto:

Riluzole tablets, USP 50 mg is pale yellow, capsule-shaped, film-coated, and engraved with “611” on one side. Riluzole tablets, USP 50 mg is supplied in bottles of 60 tablets, NDC 69076-611-60. Store at controlled room temperature, 20°C to 25°C (68°F to 77°F), and protect from bright light.

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

RILUZOLE- RILUZOLE TABLET
QUINN PHARMACEUTICALS, LLC
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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, USP 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 QUINN PHARMACEUTICALS,
LLC AT 1-844-477-8466 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: 10/2018
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 tablets is 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)
Strong to moderate CYP1A2 inhibitors: Coadministration may increase
riluzole-associated adverse reactions (7.1)
Strong to moderate CYP1A2 inducers: Coadministration may result in
decreased ef