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:

Mylan Institutional Inc.

INN (International Name):

FLUVOXAMINE MALEATE

Composition:

FLUVOXAMINE MALEATE 50 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 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 tablets or w

Product summary:

Fluvoxamine Maleate Tablets, USP are available containing 50 mg or 100 mg of fluvoxamine maleate, USP. The 50 mg tablets are orange, film-coated, oval, scored tablets debossed with M412 on one side of the tablet and scored on the other side. They are available as follows: NDC 51079-992-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 100 mg tablets are orange, film-coated, oval, scored tablets debossed with M414 on one side of the tablet and scored on the other side. They are available as follows: NDC 51079-993-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Keep this and all medication out of the reach of children. Protect from high humidity. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] PHARMACIST: Dispense a Medication Guide with each prescription.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

FLUVOXAMINE MALEATE- FLUVOXAMINE MALEATE TABLET, FILM COATED
Mylan Institutional Inc.
----------
MEDICATION GUIDE
Fluvoxamine Maleate Tablets, USP
(floo vox′ a meen mal′ ee ate)
Read the Medication Guide that comes with fluvoxamine maleate tablets
before you start taking them 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 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 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

Summary of Product characteristics

FLUVOXAMINE MALEATE- FLUVOXAMINE MALEATE TABLET, FILM COATED
MYLAN INSTITUTIONAL 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, Serotonin Syndrome ( 5.2) 1/2017
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
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)] _.
DOSAGE FORMS AND STRENGTHS
25 mg, 50 mg and 100 mg tablets ( 3)
CONTRAINDICATIONS
Coadministration of tizanidine, thioridazine, alosetron, pimozide (
4.1).
Serotonin Syndrome and