Fluvoxamine Maleate 50 MG Oral Tablet
1 INDICATIONS AND USAGE Fluvoxamine maleate tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD) ( 1 ). 1.1 Obsessive-Compulsive Disorder 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 )].
Apotex Corp
ROUND YELLOW APO F50
APO F50 ROUND YELLOW
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16 HOW SUPPLIED/STORAGE AND HANDLING
FLUVOXAMINE MALEATE tablets, USP are available in the following strengths, colors, imprints, and presentations: Tablets 25 mg: white to off-white, round, unscored, film coated tablets, engraved “APO” on one side and “F25” on the other side. Bottles of 100...........................................................................NDC 60505-0164-1 Tablets 50 mg: golden, round, scored, film coated tablets, engraved “APO” on one side and “F50” with a partial bisect on the other side. Bottles of 100...........................................................................NDC 60505-0165-1 Tablets 100 mg: Reddish-brown, pillow shaped, scored, film coated tablets, engraved “APO” on one side and “FLU” bisect “100” on the other side. Bottles of 100...........................................................................NDC 60505-0166-1 Keep out of reach of children.
FLUVOXAMINE MALEATE tablets, USP should be protected from high humidity and stored at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.
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