24 HR Fluvoxamine Maleate 150 MG Extended Release Oral Capsule
1 INDICATIONS AND USAGE Fluvoxamine maleate extended-release capsules are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of obsessive compulsive disorder (OCD) ( 1 ). Efficacy was demonstrated in: One 12-week study with fluvoxamine maleate extended-release capsules in adults ( 14.1 ). Two 10-week studies with immediate-release (IR) fluvoxamine tablets in adults and one 10-week study with IR fluvoxamine tablets in children and adolescents ( 14.1 , 14.3 ). One maintenance study with IR fluvoxamine tablets ( 14.2 ). 1.1 Obsessive Compulsive Disorder Fluvoxamine maleate extended-release capsules are indicated for the treatment of obsessive compulsive disorder (OCD), as defined in the DSM-IV. 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 obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. The efficacy of fluvoxamine maleate extended-release capsules was demonstrated in one 12-week trial in adults with fluvoxamine maleate extended-release capsules as well as in two 10-week trials in adults and in one 10-week trial in children and adolescents (ages 8 to 17 years) with immediate-release fluvoxamine tablets in outpatients with the diagnosis of OCD as defined in DSM-IV or DSM-III-R (see Clinical Studies [14.1 , 14.3] ) . The efficacy of fluvoxamine for long-term use was established in one maintenance study in adults with immediate-release fluvoxamine tablets (see Clinical Studies [14. 2 ] ) . The health care provider who elects to prescribe fluvoxamine maleate extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see Dosage and Administration [2.4] ) .
actavis pharma, inc.
CAPSULE WHITE logo 2849
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actavis pharma, inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
FLUVOXAMINE MALEATE extended-release capsules are available as follows: 100 mg – Each #2 capsule with olive opaque cap and gray opaque body, imprinted with and 2848 on both cap and body in black ink contains 100 mg of
FLUVOXAMINE MALEATE, USP. capsules are supplied in bottles of 30 (NDC 0228-2848-03). 150 mg – Each #1 capsule with olive opaque cap and white opaque body, imprinted with and 2849 on both cap and body in black ink contains 150 mg of
FLUVOXAMINE MALEATE, USP. capsules are supplied in bottles of 30 (NDC 0228-2849-03). ebfb06fd-figure-04 ebfb06fd-figure-05 16.2 Storage Keep out of reach of children. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from high humidity and avoid exposure to temperatures above 30°C (86°F). Dispense in tight, light-resistant container as defined in the USP.
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