FLUVOXAMINE MALEATE tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

FLUVOXAMINE MALEATE (UNII: 5LGN83G74V) (FLUVOXAMINE - UNII:O4L1XPO44W)

Dostupno od:

American Health Packaging

INN (International ime):

FLUVOXAMINE MALEATE

Sastav:

FLUVOXAMINE MALEATE 50 mg

Tip recepta:

PRESCRIPTION DRUG

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

FLUVOXAMINE MALEATE- FLUVOXAMINE MALEATE TABLET
AMERICAN HEALTH PACKAGING
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUVOXAMINE MALEATE TABLETS, USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FLUVOXAMINE MALEATE
TABLETS, USP.
FLUVOXAMINE MALEATE TABLETS, USP FOR ORAL ADMINISTRATION
INITIAL U.S. APPROVAL: 1994
WARNING: SUICIDALITY AND ANTIDEPRESSANTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
INCREASED RISK OF SUICIDAL THINKING AND BEHAVIOR IN CHILDREN,
ADOLESCENTS, AND YOUNG ADULTS TAKING
ANTIDEPRESSANTS FOR MAJOR DEPRESSIVE DISORDER AND OTHER PSYCHIATRIC
DISORDERS. FLUVOXAMINE MALEATE
TABLETS ARE NOT APPROVED FOR USE IN PEDIATRIC PATIENTS EXCEPT THOSE
WITH OBSESSIVE COMPULSIVE DISORDER (
5.1).
RECENT MAJOR CHANGES
1. Warnings and Precautions ( 5.3) 7/2014
INDICATIONS AND USAGE
Fluvoxamine maleate tablets, USP are indicated for the treatment of
obsessions and compulsions in patients with obsessive
compulsive disorder (OCD) ( 1).
DOSAGE AND ADMINISTRATION
Adults: Recommended starting dose is 50 mg at bedtime, with increases
of 50 mg every 4 to 7 days as tolerated to
maximum effect, not to exceed 300 mg/day. Daily doses over 100 mg
should be divided ( 2.1).
Children and adolescents (8 to 17 years): Recommended starting dose is
25 mg at bedtime, with increases of 25 mg
every 4 to 7 days as tolerated to maximum effect, not to exceed 200
mg/day (8 to 11 years) or 300 mg/day (12 to 17
years). Daily doses over 50 mg should be divided ( 2.2).
Hepatically impaired: Decreased clearance may require modified dose
and titration ( 2.3).
Extended treatment: Adjust dose to maintain lowest effective dose;
reassess patients periodically ( 2.7).
Discontinuation: Gradual dose reduction is recommended ( 2.8, see
WARNINGS AND PRECAUTIONS [5.9]).
DOSAGE FORMS AND STRENGTHS
25 mg, 50 mg, and 100 mg Tablets ( 3)
CONTRAINDICATIONS
Coadministration of tizanidine, thioridazine, alosetron, pimozide (
4.1)
SEROTONIN SYNDROME AND MAOI