FLUVOXAMINE MALEATE tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

ANI Pharmaceuticals, Inc.

INN (International Name):

FLUVOXAMINE MALEATE

Composition:

FLUVOXAMINE MALEATE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fluvoxamine Maleate Tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD), as defined in DSM-III-R or DSM-IV. The obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. 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 efficacy of Fluvoxamine Maleate Tablets was established in four trials in outpatients with OCD: two 10-week trials in adults, one 10-week trial in pediatric patients (ages 8-17), and one maintenance trial in adults [see Clinical Studies (14)] . Coadministration Coadministration of tizanidine, thioridazine, alosetron, or pimozide with Fluvoxamine Maleate Tablets is contraindicated [see Warnings and Precautions (5.4,

Product summary:

Fluvoxamine Maleate Tablets USP are available in the following strengths, colors, imprints, and presentations:    Tablets 25 mg: unscored, white, elliptical, film-coated (debossed “1222” on one side)    Bottles of 100 ……………………………………………………NDC 62559-158-01    Tablets 50 mg: scored, yellow, elliptical, film-coated (debossed “1225” on one side and scored on the other)    Bottles of 100 ……………………………………………………NDC 62559-159-01    Tablets 100 mg: scored, beige, elliptical, film-coated (debossed “1221” on one side and scored on the other)    Bottles of 100 ……………………………………………………NDC 62559-160-01 Keep out of reach of children. Fluvoxamine Maleate Tablets 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]. Dispense in tight containers.

Authorization status:

New Drug Application Authorized Generic

Patient Information leaflet

FLUVOXAMINE MALEATE- FLUVOXAMINE MALEATE TABLET, COATED
ANI Pharmaceuticals, Inc.
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MEDICATION GUIDE
Fluvoxamine (Flu VOX ah meen) Maleate Tablets
Read the Medication Guide that comes with Fluvoxamine Maleate Tablets
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 with 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 Tablets?
Fluvoxamine is the same kind of medicine as those used to treat
depression and may cause serious side
effects, including:
1. Suicidal thoughts or actions:
•
Fluvoxamine Maleate Tablets and 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
Tablets 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 if 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 or panic attacks
•
feeling agitated, restless, angry or irritable
•
trouble sleeping
•
an increase in activity or talking more than what is normal for

Summary of Product characteristics

FLUVOXAMINE MALEATE- FLUVOXAMINE MALEATE TABLET, COATED
ANI PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUVOXAMINE MALEATE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
FLUVOXAMINE MALEATE
TABLETS.
FLUVOXAMINE MALEATE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1994
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
Warnings and Precautions (5.2, 5.10) 8/2023
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
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
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 100 mg should be
divided. (2.1).
Children and adolescents (8 -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 -
11 years) or 300 mg/day (12 -17 years). Daily doses over 50 mg should
be divided (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
(2.6).
Discontinuation: Gradual dose reduction is recommended (2.7, 5.9).
25 mg Tablets, 50 mg Tablets, and 100 mg Tablets (3)
Coadministration of tizanidine, thioridazine, alosteron, pimozide (4)
SEROTONI