Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
FLUVOXAMINE MALEATE (UNII: 5LGN83G74V) (FLUVOXAMINE - UNII:O4L1XPO44W)
ANI Pharmaceuticals, Inc.
FLUVOXAMINE MALEATE
FLUVOXAMINE MALEATE 25 mg
ORAL
PRESCRIPTION DRUG
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 8-17), and one maintenance trial in adults [see Clinical Studies (14)] . Coadministration Coadministration of tizanidine, thioridazine, alosetron, or pimozide with Fluvoxamine Maleate Tablets is contraindicated [see Warnings and Precautions (5.4,
Fluvoxamine Maleate Tablets USP are available in the following strengths, colors, imprints, and presentations: Tablets 25 mg: unscored, white, elliptical, film-coated (debossed “1222” on one side) Bottles of 100 ……………………………………………………NDC 62559-158-01 Tablets 50 mg: scored, yellow, elliptical, film-coated (debossed “1225” on one side and scored on the other) Bottles of 100 ……………………………………………………NDC 62559-159-01 Tablets 100 mg: scored, beige, elliptical, film-coated (debossed “1221” on one side and scored on the other) Bottles of 100 ……………………………………………………NDC 62559-160-01 Keep out of reach of children. Fluvoxamine Maleate Tablets 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 in tight containers.
New Drug Application Authorized Generic
FLUVOXAMINE MALEATE- FLUVOXAMINE MALEATE TABLET, COATED ANI Pharmaceuticals, Inc. ---------- MEDICATION GUIDE Fluvoxamine (Flu VOX ah meen) Maleate Tablets 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 is 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 what is normal for Lesen Sie das vollständige Dokument
FLUVOXAMINE MALEATE- FLUVOXAMINE MALEATE TABLET, COATED ANI PHARMACEUTICALS, INC. ---------- 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 (5.2, 5.10) 8/2023 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 • • • • • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • • WARNINGS AND PRECAUTIONS • • • 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 -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 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). 25 mg Tablets, 50 mg Tablets, and 100 mg Tablets (3) Coadministration of tizanidine, thioridazine, alosteron, pimozide (4) SEROTONI Lesen Sie das vollständige Dokument