FLUVOXAMINE MALEATE tablet, film coated

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (International ime):

FLUVOXAMINE MALEATE

Sastav:

FLUVOXAMINE MALEATE 100 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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 three trials in outpatients with OCD: two 10 week trials in adults, and one 10 week trial in pediatric patients (ages 8 to 17) (see CLINICAL STUDIES [14]). Coadministration of tizanidine, thioridazine, alosetron, or pimozide with fluvoxamine maleate tablets is contraindicated (see WARNINGS AND PRECAUTIONS [5.4 to 5.7]). The use of MAOIs concomitantly with

Proizvod sažetak:

Fluvoxamine maleate tablets USP, 100 mg are available as pink to light-brick, film-coated capsule-shaped tablets debossed “93” on one side and scored between the two numbers, and are debossed “57” on the other side. They are available in blisterpacks of 30 tablets. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from high humidity. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Keep this and all medications out of the reach of children.

Status autorizacije:

Abbreviated New Drug Application

Uputa o lijeku

FLUVOXAMINE MALEATE- FLUVOXAMINE MALEATE TABLET, FILM COATED
NCS HealthCare of KY, Inc dba Vangard Labs
----------
Antidepressant Medicines, Depression and other Serious Mental
Illnesses, and Suicidal Thoughts or
Actions
Rx only
Read the Medication Guide that comes with your or your family
member’s antidepressant medicine. This
Medication Guide is only about the risk of suicidal thoughts and
actions with antidepressant medicines.
Talk to your, or your family member’s, healthcare provider about:
•
all risks and benefits of treatment with antidepressant medicines
•
all treatment choices for depression or other serious mental illness
What is the most important information I should know about
antidepressant medicines, depression and
other serious mental illnesses, and suicidal thoughts or actions?
1. Antidepressant medicines may increase suicidal thoughts or actions
in some children, teenagers, and
young adults within the first few months of treatment.
2. Depression and other serious mental illnesses are the most
important causes of suicidal thoughts and
actions. Some people may have a particularly high risk of having
suicidal thoughts or actions. These
include people who have (or have a family history of) bipolar illness
(also called manic-depressive
illness) or suicidal thoughts or actions.
3. How can I watch for and try to prevent suicidal thoughts and
actions in myself or a family member?
•
Pay close attention to any changes, especially sudden changes, in
mood, behaviors, thoughts, or
feelings. This is very important when an antidepressant medicine is
started or when the dose is
changed.
•
Call the healthcare provider right away to report new or sudden
changes in mood, behavior,
thoughts, or feelings.
•
Keep all follow-up visits with the healthcare provider as scheduled.
Call the healthcare provider
between visits as needed, especially if you have concerns about
symptoms.
Call a healthcare provider right away if you or your family member has
any of the following symptoms,
especially if they are new,

Svojstava lijeka

FLUVOXAMINE MALEATE- FLUVOXAMINE MALEATE TABLET, FILM COATED
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
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 USP, 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
Indications and Usage, Long-Term Use (1.1) 4/2008
Warnings and Precautions, Abnormal Bleeding (5.8, 5.10) 4/2008
Warnings and Precautions, Serotonin Syndrome or Neuroleptic Malignant
Syndrome (NMS)-Like Reactions (5.3) 2/2009
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).
Discontinuation: Gradual dose reduction is recommended (2.7, see
WARNINGS AND PRECAUTIONS [5.9]).
DOSAGE FORMS AND STRENGTHS
25 mg Tablets, 50 mg Tablets, and 100 mg Tablets (3)
CONTRAINDICATIONS
C