FLUVOXAMINE MALEATE tablet, coated

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Aidarex Pharmaceuticals LLC

INN (Medzinárodný Name):

FLUVOXAMINE MALEATE

Zloženie:

FLUVOXAMINE MALEATE 50 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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)]. The use of MAOIs intended to treat psychiatric disorders with Fluvoxamine Maleate Tablets or within 14 days of stopping treatment with Fluvoxamine Maleate Tablets is contra

Prehľad produktov:

Fluvoxamine Maleate Tablets, USP are available in the following strengths, colors, imprints, and presentations: Tablets 50 mg: scored, yellow, elliptical, film-coated (debossed “1225” on one side and scored on the other) Bottles of 30 ……………………………………………………NDC 33261-0683-30 Keep out of reach of children. Fluvoxamine Maleate Tablets should be protected from high humidity and stored at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in tight containers.

Stav Autorizácia:

New Drug Application Authorized Generic

Príbalový leták

FLUVOXAMINE MALEATE- FLUVOXAMINE MALEATE TABLET, COATED
Aidarex Pharmaceuticals LLC
----------
MEDICATION GUIDE
Fluvoxamine (Flu VOX ah meen) 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 you
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Súhrn charakteristických

FLUVOXAMINE MALEATE- FLUVOXAMINE MALEATE TABLET, COATED
AIDAREX PHARMACEUTICALS LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
FLUVOXAMINE MALEATE TABLETS
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 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 Tablets are not approved for use in
pediatric patients except those with obsessive compulsive disorder
(5.1).
RECENT MAJOR CHANGES
Indications and Usage, Long-term Use (1.1) 4/2008
Dosage and Administration, Maintenance (2.7) 4/2008
Warnings and Precautions, Abnormal Bleeding (5.7, 5.9) 4/2008
Warnings and Precautions, Serotonin Syndrome (5.2) 2/2009
Dosage and Administration (2.5, 2.6), Contraindications (4.2),
Warnings and Precautions (5.2), Use in Specific Populations (8.1)
9/2012
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 -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 dos