FLUVOXAMINE MALEATE- fluvoxamine maleate tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Eon Labs, Inc.

INN (International Name):

FLUVOXAMINE MALEATE

Composition:

FLUVOXAMINE MALEATE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fluvoxamine maleate tablets, USP 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, USP was established in four trials in outpatients with OCD: two 10-week trials in adults, one 10-week trial in pediatric patients (ages 8 to 17), and one maintenance trial in adults (see CLINICAL STUDIES [14] ). ( see WARNINGS AND PRECAUTIONS [5.4 to 5.7]). The use of MAOIs intended to treat psychiatric disorders with fluvoxamine maleate or within 14 days of stopping tr

Product summary:

Fluvoxamine Maleate Tablets, USP, for oral administration, are available as 25 mg Off-white, round, biconvex, film-coated, debossed “E ” over “17” on one side and plain on the other side and supplied as: NDC 0185-0017-01 bottles of 100 50 mg Yellow, round, biconvex, film-coated, debossed “E ” over “27” on one side and bisected on the other side and supplied as: NDC 0185-0027-01 bottles of 100 NDC 0185-0027-05 bottles of 500 100 mg Beige, round, biconvex, film-coated, debossed “E ” over “157” on one side and bisected on the other side and supplied as: NDC 0185-0157-01 bottles of 100 NDC 0185-0157-05 bottles of 500 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. PROTECT FROM LIGHT. PROTECT FROM HIGH HUMIDITY. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

FLUVOXAMINE MALEATE- FLUVOXAMINE MALEATE TABLET, FILM COATED
Eon Labs, Inc.
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MEDICATION GUIDE
Fluvoxamine Maleate Tablets, USP
(floo-VOX-ah-meen)
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:
o
New or sudden changes in mood, behavior, actions, thoughts, or
feelings, especially if severe.
o
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 you

Summary of Product characteristics

FLUVOXAMINE MALEATE- FLUVOXAMINE MALEATE TABLET, FILM COATED
EON LABS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUVOXAMINE MALEATE TABLETS, USP
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
FLUVOXAMINE MALEATE TABLETS, USP.
FLUVOXAMINE MALEATE TABLETS, FOR ORAL ADMINISTRATION
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 IS
NOT APPROVED FOR USE IN PEDIATRIC PATIENTS EXCEPT THOSE WITH OBSESSIVE
COMPULSIVE DISORDER [5.1].
RECENT MAJOR CHANGES
Warnings and Precautions [5.3] 7/2014
INDICATIONS AND USAGE
Fluvoxamine maleate tablets, USP are indicated for the treatment of
obsessions and compulsions in patients with obsessive
compulsive disorder (OCD) [1].
DOSAGE AND ADMINISTRATION
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
25 mg Tablets, 50 mg Tablets and 100 mg Tablets [3]
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 to 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 to 11 years) or 300 mg/day (12 to 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 [2.7].
Discontinuation: Gradual dose reduction is recommended (2.8, see
WARNINGS AND PRECAUTIONS [5.9]).
Co-administration of tizanidine, th