Country: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
FLUVOXAMINE MALEATE (UNII: 5LGN83G74V) (FLUVOXAMINE - UNII:O4L1XPO44W)
Caraco Pharmaceutical Laboratories, Ltd.
FLUVOXAMINE MALEATE
FLUVOXAMINE MALEATE 25 mg
ORAL
PRESCRIPTION DRUG
Fluvoxamine Maleate Tablets, USP 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, USP was established in three trials in outpatients with OCD: two 10-week trials in adults, one 10-week trial in pediatric patients (ages 8-17). (See CLINICAL STUDIES [14].) Coadministration of tizanidine, thioridazine, alosetron, or pimozide with Fluvoxamine Maleate Tablets is contraindicated. (See WARNINGS AND PRECAUTIONS [5.4-5.7].) The use of MAOIs concomitantly wit
Fluvoxamine maleate tablets, USP, 25 mg are oval, beige, biconvex film-coated tablets with “357” debossed on one side and plain on the other side are available as follows: Fluvoxamine maleate tablets, USP, 50 mg are oval, yellow, biconvex film-coated tablets with “361” debossed on one side and scored on the other side are available as follows: Fluvoxamine maleate tablets, USP, 100 mg are oval, red, biconvex film-coated tablets with “362” debossed on one side and scored on the other side are available as follows: Keep out of reach of children. Fluvoxamine Maleate Tablets, USP should be protected from high humidity and stored at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. KEEP TIGHTLY CLOSED .
Abbreviated New Drug Application
FLUVOXAMINE MALEATE - FLUVOXAMINE MALEATE TABLET FLUVOXAMINE MALEATE - FLUVOXAMINE MALEATE TABLET CARACO PHARMACEUTICAL LABORATORIES, LTD. ---------- 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, USP FOR ORAL ADMINISTRATION 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 100mg 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 50mg 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 সম্পূর্ণ নথি পড়ুন