Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
FLUVOXAMINE MALEATE (UNII: 5LGN83G74V) (FLUVOXAMINE - UNII:O4L1XPO44W)
Mylan 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)]. [See Warnings and Precautions (5.4 to 5.7).] The use of MAOIs intended to treat psychiatric disorders with fluvoxamine maleate tablets or within 14 days of stopping treatment
Fluvoxamine Maleate Tablets, USP are available containing 25 mg, 50 mg or 100 mg of fluvoxamine maleate, USP. The 25 mg tablets are orange, film-coated, oval, unscored tablets debossed with M407 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0407-01 bottles of 100 tablets The 50 mg tablets are orange, film-coated, oval, scored tablets debossed with M412 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-0412-01 bottles of 100 tablets The 100 mg tablets are orange, film-coated, oval, scored tablets debossed with M414 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-0414-01 bottles of 100 tablets Keep this and all medication out of the reach of children. Protect from high humidity. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
Abbreviated New Drug Application
FLUVOXAMINE MALEATE- FLUVOXAMINE MALEATE TABLET, FILM COATED Mylan Pharmaceuticals Inc. ---------- MEDICATION GUIDE Fluvoxamine Maleate Tablets, USP (floo vox′ a meen mal′ ee ate) Read the Medication Guide that comes with fluvoxamine maleate tablets before you start taking them 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 are 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 talki Przeczytaj cały dokument
FLUVOXAMINE MALEATE- FLUVOXAMINE MALEATE TABLET, FILM COATED MYLAN 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, Serotonin Syndrome (5.2) 1/2017 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 (2.7). Discontinuation: Gradual dose reduction is recommended (2.8), _[see Warnings and Precautions (5.9)]_. 25 mg, 50 mg and 100 mg tablets (3) Coadministration of tizanidine, thior Przeczytaj cały dokument