RILUZOLE tablet, film coated

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Kupi sada

Preuzimanje Svojstava lijeka (SPC)
03-10-2023

Aktivni sastojci:

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

Dostupno od:

Quinn Pharmaceuticals

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Riluzole tablets 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)] . 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 2-4% 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, wome

Proizvod sažetak:

Riluzole Tablets, USP 50 mg are white to off-white, film-coated, capsule-shaped and engraved with “795” on one side, plain on the other. Riluzole is supplied in bottles of 60 tablets, NDC 69076-200-60. Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Protect from bright light.

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

                                RILUZOLE- RILUZOLE TABLET, FILM COATED
QUINN PHARMACEUTICALS
----------
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 is 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 tablets or to any of its components (
4)
WARNINGS AND PRECAUTIONS
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)
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
AT 844-477-
8466 OR FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH. _
DRUG INTERACTIONS
Strong to moderate CYP1A2 inhibitors: Coadministration may increase
riluzole -associated adverse
reactions ( 7.1)
Strong to moderate CYP1A2 inducers: Coadministration may result in
decreased efficacy ( 7.2)
Hepatotoxic drugs: Riluzole-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 FOR PAT
                                
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