RILUZOLE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

INN (International Name):

RILUZOLE

Composition:

RILUZOLE 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 their components (anaphylaxis has occurred) [see Adverse Reactions (6.1)]. 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 2-4% 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 associa

Product summary:

Riluzole Tablets, USP are available containing 50 mg of riluzole, USP. The 50 mg tablets are white, film-coated, capsule shaped, unscored tablets debossed with M on one side of the tablet and RE 50 on the other side. They are available as follows: NDC 0378-4145-91 bottles of 60 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from bright light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RILUZOLE- RILUZOLE 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
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 MYLAN AT 1-877-446-3679
(1-877-4-INFO-RX) 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: 8/2020
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 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 tablet-associated adverse reactions
(7.1)
Strong to moderate CYP1A2 inducers: Coadministration may result in