FLUVOXAMINE MALEATE tablet

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Golden State Medical Supply, Inc.

INN:

FLUVOXAMINE MALEATE

composition:

FLUVOXAMINE MALEATE 25 mg

prescription_type:

PRESCRIPTION DRUG

authorization_status:

Abbreviated New Drug Application

SPC

FLUVOXAMINE MALEATE- FLUVOXAMINE MALEATE TABLET
GOLDEN STATE MEDICAL SUPPLY, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NEVIRAPINE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR NEVIRAPINE.
FLUVOXAMINE MALEATE, USP TABLETS, 25MG, 50MG, 100MG
INITIAL U.S. APPROVAL: 2001
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
Indications and Usage, Long-Term Use (1.1) 4/2008
Warnings and Precautions, Abnormal Bleeding (5.7, 5.10) 4/2008
Warnings and Precautions, Serotonin Syndrome or
Neuroleptic Malignant Syndrome (NMS)-like Reactions (5.3) 2/2009
INDICATIONS AND USAGE
Fluvoxamine Maleate Tablets 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 100mg
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).
Discontinuation: Gradual dose reduction is recommended (2.7, see
WARNINGS AND PRECAUTIONS [5.8]).
DOSAGE FORMS AND STRENGTHS
25 mg Tablets, 50 mg Tablets, and 100 mg Tablets (3)
CONTRAINDICATIONS
Coadministration of ti