Country: United States
Language: English
Source: NLM (National Library of Medicine)
FLUVOXAMINE MALEATE (UNII: 5LGN83G74V) (FLUVOXAMINE - UNII:O4L1XPO44W)
NuCare Pharmaceuticals,Inc.
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 cont
Tablets 50 mg: scored, yellow, elliptical, film-coated (debossed “1225” on one side and scored on the other) NDC 68071-2337-1 BOTTLES OF 100 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 NuCare 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 norm Read the complete document
FLUVOXAMINE MALEATE- FLUVOXAMINE MALEATE TABLET, COATED NUCARE 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 Dosage and Administration Pregnant Women During the Third Trimester (2.4) Removed 12/2019 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 -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). DOSAGE FORMS AND STRENGTHS 25 mg Tablets, 50 mg Tablets, and 100 mg Tablets ( 3) CONTRAINDICATIONS Coadministration of tizanidine, thioridazine, alosteron, pimozide ( 4) SEROTONIN SYNDROME AN Read the complete document