FLUVOXAMINE MALEATE - fluvoxamine maleate tablet FLUVOXAMINE MALEATE - fluvoxamine maleate tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Caraco Pharmaceutical Laboratories, Ltd.

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 three trials in outpatients with OCD: two 10-week trials in adults, one 10-week trial in pediatric patients (ages 8-17). (See CLINICAL STUDIES [14].) Coadministration of tizanidine, thioridazine, alosetron, or pimozide with Fluvoxamine Maleate Tablets is contraindicated. (See WARNINGS AND PRECAUTIONS [5.4-5.7].) The use of MAOIs concomitantly wit

Product summary:

Fluvoxamine maleate tablets, USP, 25 mg are oval, beige, biconvex film-coated tablets with “357” debossed on one side and plain on the other side are available as follows: Fluvoxamine maleate tablets, USP, 50 mg are oval, yellow, biconvex film-coated tablets with “361” debossed on one side and scored on the other side are available as follows: Fluvoxamine maleate tablets, USP, 100 mg are oval, red, biconvex film-coated tablets with “362” debossed on one side and scored on the other side are available as follows: Keep out of reach of children. Fluvoxamine Maleate Tablets, USP should be protected from high humidity and stored at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. KEEP TIGHTLY CLOSED .

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUVOXAMINE MALEATE - FLUVOXAMINE MALEATE TABLET
FLUVOXAMINE MALEATE - FLUVOXAMINE MALEATE TABLET
CARACO PHARMACEUTICAL LABORATORIES, LTD.
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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, USP 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
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 100mg
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 50mg 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