FLUVOXAMINE MALEATE capsule, extended release

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Bionpharma Inc.

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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,

Product samenvatting:

Fluvoxamine maleate extended-release capsules are available in the following strengths, colors, imprints, and presentations: 100 mg Extended-Release Capsules: Available in a size “2” hard gelatin capsule with purple opaque cap imprinted with “FL” in black ink and white opaque body imprinted with “100” in black ink, filled with white to off-white spherical pellets. Bottles of 30 with child-resistant closure………NDC 69452-182-13 Bottles of 1000…………………………………NDC 69452-182-32 150 mg Extended-Release Capsules: Available in a size “1” hard gelatin capsule with purple opaque cap imprinted with “FL” in black ink and white opaque body imprinted with “150” in black ink, filled with white to off-white spherical pellets. Bottles of 30 with child-resistant closure ………NDC 69452-183-13 Bottles of 1000………………………………… NDC 69452-183-32 Keep out of reach of children. Fluvoxamine maleate extended-release capsules should be stored at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from high humidity. Avoid exposure to temperatures above 30°C (86°F). Dispense in tight containers.

Autorisatie-status:

Abbreviated New Drug Application

Bijsluiter

FLUVOXAMINE MALEATE- FLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE
Bionpharma Inc.
----------
MEDICATION GUIDE
Fluvoxamine Maleate (floo vox' a meen mal' ee ate)
Extended-Release Capsules
Read the Medication Guide that comes with fluvoxamine maleate
extended-release capsules before you
start taking it and each time you get a refill. There may be new
information. This Medication Guide does
not take the place of talking to your healthcare provider about your
medical condition or treatment. Talk
to your healthcare provider if there is something you do not
understand or want to learn more about.
What is the most important information I should know about fluvoxamine
maleate extended-release
capsules?
Fluvoxamine maleate extended-release capsules are the same kind of
medicine as those used to treat
depression. These medicines may cause serious side effects, including:
1. Suicidal thoughts or actions:
•
Fluvoxamine maleate extended-release capsules and other antidepressant
medicines may increase
suicidal thoughts or actions in some children, teenagers, or young
adults within the first few
months of treatment or when the dose is changed.
•
Depression or other serious mental illnesses are the most important
causes of suicidal thoughts or
actions.
•
Watch for these changes and call your healthcare provider right away
if you notice:
•
New or sudden changes in mood, behavior, actions, thoughts, or
feelings, especially if severe.
•
Pay particular attention to such changes when fluvoxamine maleate
extended-release capsules are
started or when the dose is changed.
Keep all follow-up visits with your healthcare provider and call
between visits if you are worried about
symptoms.
Call your healthcare provider right away if you have any of the
following symptoms, or call 911 in an
emergency, especially if they are new, worse, or worry you:
•
attempts to commit suicide
•
acting on dangerous impulses
•
acting aggressive or violent
•
thoughts about suicide or dying
•
new or worse depression
•
new or worse anxiety

Productkenmerken

FLUVOXAMINE MALEATE- FLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE
BIONPHARMA INC.
----------
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 CAPSULES.
FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES, FOR ORAL USE
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, Serotonin Syndrome ( _5.2_) 01/2017
INDICATIONS AND USAGE
Fluvoxamine maleate extended-release capsules are selective serotonin
reuptake inhibitor (SSRI) indicated for the
treatment of obsessive compulsive disorder (OCD) ( _1_). Efficacy was
demonstrated in:
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 naïve 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, 5.10)
_.
DOSAGE FORMS AND STRENGTHS
100 mg and 150 mg Extended-Release Capsul