RILUZOLE tablet, film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Sun Pharmaceutical Industries, Inc.

INN (mednarodno ime):

RILUZOLE

Sestava:

RILUZOLE 50 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Riluzole tablets, USP 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 th

Povzetek izdelek:

Riluzole tablets, USP 50 mg are white to off white colored, round-shaped, biconvex film-coated tablets and debossed with “538” on one side and plain on other side. They are supplied as follows: Bottles of 30's with child-resistant closure.......................NDC 62756-538-83 Bottles of 60's with child-resistant closure.......................NDC 62756-538-86 Bottles of 100's withchild-resistant closure.....................NDC 62756-538-88 Bottles of 1000's ..................................................................NDC 62756-538-18 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature] and protect from bright light.   Keep out of the reach of children.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

RILUZOLE - RILUZOLE TABLET, FILM COATED
SUN PHARMACEUTICAL INDUSTRIES, 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 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 or to any of its components (4)
WARNINGS AND PRECAUTIONS
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)
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 SUN PHARMACEUTICAL
INDUSTRIES, INC. AT 1-800-818-4555
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 PATIENT COUNSELING INFORMATI