RILUZOLE tablet

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Ascend Laboratories, LLC

SNN (starptautisko nepatentēto nosaukumu):

RILUZOLE

Kompozīcija:

RILUZOLE 50 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Riluzole is indicated for the treatment of amyotrophic lateral sclerosis (ALS).  Riluzole 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 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 wi

Produktu pārskats:

Riluzole Tablets, USP are white to off-white coloured, capsule-shaped film coated tablets, debossed with “RIL” on one side and “50” on other side. Riluzole Tablets, USP are supplied in the following presentations: Bottles of 60 tablets                                       NDC 67877-286-60 Bottles of 90 tablets                                       NDC 67877-286-90 Bottles of 500 tablets                                     NDC 67877-286-05 Bottles of 1000 tablets                                   NDC 67877-286-10 Blister pack of 140 (10 x 14) Tablets      NDC 67877-286-14   Store at 20° to 25°C (68° to 77°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
ASCEND LABORATORIES, LLC
----------
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 ASCEND LABORATORIES,
LLC AT 1-877-
ASCRX01 (877-272-7901) 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