Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
FLUVOXAMINE MALEATE (UNII: 5LGN83G74V) (FLUVOXAMINE - UNII:O4L1XPO44W)
NCS HealthCare of KY, Inc dba Vangard Labs
FLUVOXAMINE MALEATE
FLUVOXAMINE MALEATE 100 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 three trials in outpatients with OCD: two 10 week trials in adults, and one 10 week trial in pediatric patients (ages 8 to 17) (see CLINICAL STUDIES [14]). Coadministration of tizanidine, thioridazine, alosetron, or pimozide with fluvoxamine maleate tablets is contraindicated (see WARNINGS AND PRECAUTIONS [5.4 to 5.7]). The use of MAOIs concomitantly with
Fluvoxamine maleate tablets USP, 100 mg are available as pink to light-brick, film-coated capsule-shaped tablets debossed “93” on one side and scored between the two numbers, and are debossed “57” on the other side. They are available in blisterpacks of 30 tablets. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from high humidity. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Keep this and all medications out of the reach of children.
Abbreviated New Drug Application
FLUVOXAMINE MALEATE- FLUVOXAMINE MALEATE TABLET, FILM COATED NCS HealthCare of KY, Inc dba Vangard Labs ---------- Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions Rx only Read the Medication Guide that comes with your or your family member’s antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. Talk to your, or your family member’s, healthcare provider about: • all risks and benefits of treatment with antidepressant medicines • all treatment choices for depression or other serious mental illness What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? 1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. 2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions. 3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms. Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, Izlasiet visu dokumentu
FLUVOXAMINE MALEATE- FLUVOXAMINE MALEATE TABLET, FILM COATED NCS HEALTHCARE OF KY, INC DBA VANGARD LABS ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE FLUVOXAMINE MALEATE TABLETS USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FLUVOXAMINE MALEATE TABLETS USP. FLUVOXAMINE MALEATE TABLETS USP, 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 Indications and Usage, Long-Term Use (1.1) 4/2008 Warnings and Precautions, Abnormal Bleeding (5.8, 5.10) 4/2008 Warnings and Precautions, Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-Like Reactions (5.3) 2/2009 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 to 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 to 11 years) or 300 mg/day (12 to 17 years). Daily doses over 50 mg should be divided (2.2). Hepatically impaired: Decreased clearance may require modified dose and titration (2.3). Discontinuation: Gradual dose reduction is recommended (2.7, see WARNINGS AND PRECAUTIONS [5.9]). DOSAGE FORMS AND STRENGTHS 25 mg Tablets, 50 mg Tablets, and 100 mg Tablets (3) CONTRAINDICATIONS C Izlasiet visu dokumentu