البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
FLUOXETINE HYDROCHLORIDE (UNII: I9W7N6B1KJ) (FLUOXETINE - UNII:01K63SUP8D)
REMEDYREPACK INC.
FLUOXETINE HYDROCHLORIDE
FLUOXETINE 20 mg
ORAL
PRESCRIPTION DRUG
Fluoxetine is indicated for the treatment of: • Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies ( 14.1)]. • Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies ( 14.2)]. • Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies ( 14.3)]. • Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies ( 14.4)]. Fluoxetine and Olanzapine in Combination is indicated for the treatment of: • Acute treatment of depressive episodes associated with Bipolar I Disorder. Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder. When using fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax ® . When using fluoxetine capsules and olanzap
Fluoxetine capsules, USP 10 mg ** are white to off white powder filled in size "4" hard gelatin capsules with opaque light blue colored cap and opaque light orange colored body imprinted "SG" on cap and "113" on body with black ink. Bottles of 30 NDC 31722-903-30 Bottles of 100 NDC 31722-903-01 Bottles of 500 NDC 31722-903-05 Bottles of 1000 NDC 31722-903-10 Fluoxetine Capsules USP, 20 mg ** are white to off white powder filled in size "2"hard gelatin capsules with opaque light blue colored cap and opaque light green colored body imprinted "SG"on cap and "114" on body with black ink. Bottles of 30 NDC 31722-904-30 Bottles of 100 NDC 31722-904-01 Bottles of 500 NDC 31722-904-05 Bottles of 1000 NDC 31722-904-10 Fluoxetine Capsules USP, 40 mg ** are white to off white powder filled in size "0" hard gelatin capsules with opaque light blue colored cap and opaque white colored body imprinted "SG" on cap and "115" on body with black ink. Bottles of 30 NDC 31722-905-30 Bottles of 100 NDC 31722-905-01 Bottles of 500 NDC 31722-905-05 ** Fluoxetine base equivalent. Store 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].
Abbreviated New Drug Application
REMEDYREPACK INC. ---------- Revised: 3/2019 Document Id: 835cb606-a031-305b-e053-2a91aa0a8164 34391-3 Set id: 46b85b8f-c9cd-4599-a0ed-b7bff1e610fd Version: 4 Effective Time: 20190305 REMEDYREPACK INC. اقرأ الوثيقة كاملة
FLUOXETINE- FLUOXETINE CAPSULE REMEDYREPACK INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE FLUOXETINE CAPSULES, SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FLUOXETINE CAPSULES. FLUOXETINE CAPSULES, FOR ORAL USE INITIAL U.S. APPROVAL: 1987 WARNING: SUICIDAL THOUGHTS AND BEHAVIORS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ •INCREASED RISK OF SUICIDAL THINKING AND BEHAVIOR IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS TAKING ANTIDEPRESSANTS ( 5.1). •MONITOR FOR WORSENING AND EMERGENCE OF SUICIDAL THOUGHTS AND BEHAVIORS ( 5.1). _WHEN USING FLUOXETINE AND OLANZAPINE IN COMBINATION, ALSO REFER TO BOXED WARNING SECTION OF THE PACKAGE INSERT FOR_ _SYMBYAX_. RECENT MAJOR CHANGES Warnings and Precautions: Serotonin Syndrome (5.2) 01/2017 INDICATIONS AND USAGE Fluoxetine capsules are a selective serotonin reuptake inhibitor indicated for: • Acute and maintenance treatment of Major Depressive Disorder (MDD) ( 1) • Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) ( 1) • Acute and maintenance treatment of Bulimia Nervosa ( 1) • Acute treatment of Panic Disorder, with or without agoraphobia ( 1) _Fluoxetine capsules and olanzapine in combination for treatment of:_ • Acute Depressive Episodes Associated with Bipolar I Disorder ( 1) DOSAGE AND ADMINISTRATION INDICATION ADULT PEDIATRIC MDD ( 2.1) 20 mg/day in am (initial dose) 10 to 20 mg/day (initial dose) OCD ( 2.2) 20 mg/day in am (initial dose) 10 mg/day (initial dose) Bulimia Nervosa ( 2.3) 60 mg/day in am Panic Disorder ( 2.4) 10 mg/day (initial dose) Depressive Episodes Associated with Bipolar I Disorder ( 2.5) Oral in combination with olanzapine: 5 mg of oral olanzapine and 20 mg of fluoxetine once daily (initial dose) Oral in combination with olanzapine: 2.5 mg of oral olanzapine and 20 mg of fluoxetine once daily (initial dose) A lower or less frequent dosage should be used in patients with hepatic impairment, the elderly, and for اقرأ الوثيقة كاملة