FLUVOXAMINE MALEATE- fluvoxamine maleate capsule, extended release

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Torrent Pharmaceuticals Limited

INN (International ime):

FLUVOXAMINE MALEATE

Sastav:

FLUVOXAMINE MALEATE 100 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Fluvoxamine maleate extended-release capsules are indicated for the treatment of obsessive compulsive disorder (OCD), as defined in the DSM-IV. Obsessive compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. The obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning.  The efficacy of fluvoxamine maleate extended-release capsules was demonstrated in one 12-week trial in adults with fluvoxamine maleate extended-release capsules as well as in two 10-week trials in adults and in one 10-week trial in children and adolescents (ages 8 to 17 years) with immediate-release fluvoxamine tablets in outpatients with the diagnosis of OCD as defined in DSM-IV or DSM-III-R (see CLINICAL STUDIES  [14.1, 14.3] ). The efficacy of fluv

Proizvod sažetak:

Fluvoxamine maleate extended-release capsules are available in the following strengths, colors, imprints, and presentations: 100 mg Extended-Release Capsules: Available in size "2", hard gelatin capsule with dark blue opaque cap and white opaque body imprinted with "100" on the body and "1290" on the cap with grey ink containing yellowish - white to yellow pellets.                Bottles of 30                        NDC 13668-290-30                Bottles of 90                        NDC 13668-290-90 150 mg Extended-Release Capsules: Available in size "1", hard gelatin capsule with dark blue opaque cap and powder blue opaque body imprinted with "150" on the body and "1291" on the cap with grey ink containing yellowish - white to yellow pellets.                Bottles of 30                        NDC 13668-291-30                Bottles of 90                        NDC 13668-291-90 Keep out of reach of children. Fluvoxamine maleate extended-release capsules should be protected from high humidity and stored at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Avoid exposure to temperatures above 30°C (86°F). Dispense in tight containers.

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

FLUVOXAMINE MALEATE- FLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE
TORRENT PHARMACEUTICALS LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUVOXAMINE MALEATE EXTENDED-RELEASE
CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
FLUVOXAMINE MALEATE EXTENDED-RELEASE
C APSULE S.
FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES FOR ORAL ADMINISTRATION
INITIAL U.S. APPROVAL: 2008
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 (5.1).
RECENT MAJOR CHANGES
Warnings and Precautions (_5.3_) 07/2014
INDICATIONS AND USAGE
Fluvoxamine maleate extended-release capsules are a selective
serotonin reuptake inhibitor (SSRI) indicated for the
treatment of obsessive compulsive disorder (OCD) (_1_). (1)
Efficacy was demonstrated in: (1)
One 12-week study with fluvoxamine maleate extended-release capsules
in adults _(14.1)_ .
Two 10-week studies with immediate-release (IR) fluvoxamine tablets in
adults and one 10-week study with IR
fluvoxamine tablets in children and adolescents _(14.1, 14.3)_ .
One maintenance study with IR fluvoxamine tablets _(14.2)_ .
DOSAGE AND ADMINISTRATION
Adults: Recommended starting dose is 100 mg at bedtime, with weekly
increases of 50 mg as tolerated to maximum
effect, not to exceed 300 mg/day _(2.1)_ .
Pediatric patients na ve to fluvoxamine maleate: The lowest available
dose of fluvoxamine maleate extended-release
capsules may not be appropriate _(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 _(2.4)_ .
Discontinuation: Gradual dose reduction is recommended (_2.7, _see
Warnings and Precautions _[5.10]_ ).
DOSAGE FORMS AND STRENGTHS
100 mg