Држава: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
FLUOXETINE HYDROCHLORIDE (UNII: I9W7N6B1KJ) (Fluoxetine - UNII:01K63SUP8D)
Upsher-Smith Laboratories, LLC
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 monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. The use of MAOIs intended to treat psychiatric disorders with fluoxetine or within 5 weeks of stopping treatment with fluoxetine is contraindicated because of an increased risk of serotonin syndrome. The use of fluoxetine within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contrai
Fluoxetine oral solution, USP (20 mg per 5 mL), clear, colorless liquid with spearmint flavor, is available in the following oral dosage forms: Dispense in a tight, light-resistant container. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light.
Abbreviated New Drug Application
FLUOXETINE HYDROCHLORIDE- FLUOXETINE HYDROCHLORIDE FOR SOLUTION Upsher-Smith Laboratories, LLC ---------- MEDICATION GUIDE Fluoxetine Oral Solution, USP (floo ox' e teen) Read the Medication Guide that comes with fluoxetine 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? Fluoxetine and other antidepressant medicines may cause serious side effects, including: 1. Suicidal thoughts or actions: • Fluoxetine and other 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 fluoxetine is 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 healthcare provid Прочитајте комплетан документ
FLUOXETINE HYDROCHLORIDE- FLUOXETINE HYDROCHLORIDE FOR SOLUTION UPSHER-SMITH LABORATORIES, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE FLUOXETINE ORAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FLUOXETINE ORAL SOLUTION. FLUOXETINE ORAL SOLUTION INITIAL U.S. APPROVAL: 1991 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). RECENT MAJOR CHANGES Warnings and Precautions, Serotonin Syndrome (5.2) 07/2023 Warnings and Precautions (5.7) 07/2023 INDICATIONS AND USAGE Fluoxetine is 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) DOSAGE AND ADMINISTRATION INDICATION ADULT PEDIATRIC MDD (2.1) 20 mg/day in a.m. (initial dose) 10 to 20 mg/day (initial dose) OCD (2.2) 20 mg/day in a.m. (initial dose) 10 mg/day (initial dose) Bulimia Nervosa (2.3) 60 mg/day in a.m. ‒ Panic Disorder (2.4) 10 mg/day (initial dose) ‒ A lower or less frequent dosage should be used in patients with hepatic impairment, the elderly, and for patients with concurrent disease or on multiple concomitant medications (2.7) DOSAGE FORMS AND STRENGTHS Oral solution: 20 mg per 5 mL (3) CONTRAINDICATIONS _Serotonin Syndrome and MAOIs:_ Do not use MAOIs intended to treat psychiatric disorders with fluoxetine or within 5 weeks of stopping treatment with fluoxetine. Do not use fluoxetine within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start fluoxetine in a patient who is being treated with lin Прочитајте комплетан документ