国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
FLUOXETINE HYDROCHLORIDE (UNII: I9W7N6B1KJ) (FLUOXETINE - UNII:01K63SUP8D)
ScieGen Pharmaceuticals, Inc.
FLUOXETINE HYDROCHLORIDE
FLUOXETINE 10 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. - Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine monotherapy is not indicated for th
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. 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. 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. **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
FLUOXETINE- FLUOXETINE HYDROCHLORIDE CAPSULE ScieGen Pharmaceuticals, Inc. ---------- Medication Guide Fluoxetine Capsules, USP (floo ox' e teen) Read the Medication Guide that comes with fluoxetine 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 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 fluoxetine capsules? Fluoxetine capsules and other antidepressant medicines may cause serious side effects, including: 1. Suicidal thoughts or actions: • Fluoxetine capsules and other antidepressant medicines may increase suicidal thoughts or actionsin 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 fluoxetine capsules 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 talking more than what is normal for you • other unusual changes in behavior or mood Call your 阅读完整的文件
FLUOXETINE- FLUOXETINE HYDROCHLORIDE CAPSULE SCIEGEN PHARMACEUTICALS, 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 ( 5.2, 5.7) 08/2023 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) Treatment Resistant Depression ( 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) Treatment Resistant Depression ( 2.6) Oral in combination with olanzapine: 5 mg of 阅读完整的文件