FLUVOXAMINE MALEATE tablet, film coated

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

Fluvoxamine maleate (UNII: 5LGN83G74V) (Fluvoxamine - UNII:O4L1XPO44W)

Dostupné z:

Upsher-Smith Laboratories, LLC

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 to 17), and one maintenance trial in adults [see Clinical Studies (14)] . Coadministration Coadministration of tizanidine, thioridazine, alosetron, or pimozide with fluvoxamine maleate tablets are contraindicated [see Warnings and Precautions (5

Prehľad produktov:

Fluvoxamine maleate tablets, USP, for oral administration, are available as: 25 mg: Off-white, round, biconvex, film-coated, debossed "U" over "70" on one side and plain on the other side. They are supplied as: 50 mg: Yellow, round, biconvex, film-coated, debossed "U" over "71" on one side and bisected on the other side. They are supplied as: 100 mg: Beige, round, biconvex, film-coated, debossed "U" over "672" on one side and bisected on the other side. They are supplied as: Fluvoxamine maleate tablets, USP 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 contents in a tight, light-resistant container as defined in the USP with a child-resistant closure. Keep out of reach of children.

Stav Autorizácia:

Abbreviated New Drug Application

Príbalový leták

FLUVOXAMINE MALEATE- FLUVOXAMINE MALEATE TABLET, FILM COATED
Upsher-Smith Laboratories, LLC
----------
MEDICATION GUIDE
Fluvoxamine (Flu-VOX-ah-meen) Maleate Tablets, USP
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 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 talking more than wh

Súhrn charakteristických

FLUVOXAMINE MALEATE- FLUVOXAMINE MALEATE TABLET, FILM COATED
UPSHER-SMITH LABORATORIES, LLC
----------
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), Abnormal bleeding
(5.10)
7/2023
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
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 (2.6).
Discontinuation: Gradual dose reduction is recommended (2.7, _5.9)_.
DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg, 50 mg, 100 mg (3)
CONTRAINDICATIONS
Coadministration of tizanidine, thioridazine, alosetron, pimozide (4)
SEROTONIN SYNDROME AND MAOIS: Do not use