FLUVOXAMINE MALEATE capsule, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Actavis Pharma, Inc.

INN (International Name):

FLUVOXAMINE MALEATE

Composition:

FLUVOXAMINE MALEATE 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 fluvoxa

Product summary:

Fluvoxamine maleate extended-release capsules are available as follows: 100 mg – Each #2 capsule with olive opaque cap and gray opaque body, imprinted with and 2848 on both cap and body in black ink contains 100 mg of fluvoxamine maleate, USP. Capsules are supplied in bottles of 30 (NDC 0228-2848-03). 150 mg – Each #1 capsule with olive opaque cap and white opaque body, imprinted with and 2849 on both cap and body in black ink contains 150 mg of fluvoxamine maleate, USP. Capsules are supplied in bottles of 30 (NDC 0228-2849-03). Keep out of reach of children. Store 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 and avoid exposure to temperatures above 30°C (86°F). Dispense in tight, light-resistant container as defined in the USP.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

FLUVOXAMINE MALEATE- FLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE
Actavis Pharma, Inc.
----------
Dispense with Medication Guide available at: www.tevausa.com/medguides
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 is 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 is 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 dy

Summary of Product characteristics

FLUVOXAMINE MALEATE- FLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE
ACTAVIS PHARMA, 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 (5.2) 6/2023
Warnings and Precautions (5.11) 6/2023
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). 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, see
_Warnings and Precautions [5.10]_).
DOSAGE FORMS AND STRENGTHS
Extended-Release Capsules: