Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
FLUVOXAMINE MALEATE (UNII: 5LGN83G74V) (FLUVOXAMINE - UNII:O4L1XPO44W)
Actavis Pharma, Inc.
FLUVOXAMINE MALEATE
FLUVOXAMINE MALEATE 100 mg
ORAL
PRESCRIPTION DRUG
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 fluvoxa
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). 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.
Abbreviated New Drug Application
FLUVOXAMINE MALEATE- FLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE Actavis Pharma, Inc. ---------- Dispense with Medication Guide available at: www.tevausa.com/medguides MEDICATION GUIDE Fluvoxamine Maleate (floo vox' a meen mal' ee ate) Extended-Release Capsules Read the Medication Guide that comes with fluvoxamine maleate extended-release capsules 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 to 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 extended-release capsules? Fluvoxamine maleate extended-release is the same kind of medicine as those used to treat depression. These medicines may cause serious side effects, including: 1. Suicidal thoughts or actions: • Fluvoxamine maleate extended-release capsules and other 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 extended-release 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 in 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 dy Lue koko asiakirja
FLUVOXAMINE MALEATE- FLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE ACTAVIS PHARMA, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES. FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES, FOR ORAL USE INITIAL U.S. APPROVAL: 2008 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 (5.1). RECENT MAJOR CHANGES Warnings and Precautions (5.2) 6/2023 Warnings and Precautions (5.11) 6/2023 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). DOSAGE AND ADMINISTRATION Adults: Recommended starting dose is 100 mg at bedtime, with weekly increases of 50 mg as tolerated to maximum effect, not to exceed 300 mg/day (2.1). Pediatric patients naïve to fluvoxamine maleate: The lowest available dose of fluvoxamine maleate extended-release capsules may not be appropriate (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 (2.4). Discontinuation: Gradual dose reduction is recommended (2.7, see _Warnings and Precautions [5.10]_). DOSAGE FORMS AND STRENGTHS Extended-Release Capsules: Lue koko asiakirja