LUVOX CR fluvoxamine maleate capsule extended release

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Jazz Pharmaceuticals, Inc.

INN (Alþjóðlegt nafn):

FLUVOXAMINE MALEATE

Samsetning:

FLUVOXAMINE MALEATE 100 mg

Gerð lyfseðils:

PRESCRIPTION DRUG

Leyfisstaða:

New Drug Application

Vara einkenni

LUVOX CR- FLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE
JAZZ PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LUVOX CR (FLUVOXAMINE MALEATE)
EXTENDED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR LUVOX CR CAPSULES.
LUVOX CR (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 _(5.2)_ 01/2017
INDICATIONS AND USAGE
LUVOX CR Capsules is a selective serotonin reuptake inhibitor (SSRI)
indicated for the treatment of obsessive
compulsive disorder (OCD) _(1)_.
Efficacy was demonstrated in:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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One 12-week study with LUVOX CR 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)_.
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 naïve to fluvoxamine maleate: The lowest available
dose of LUVOX CR 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]_).
100 mg and 150 mg Exten