Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
FLUOXETINE HYDROCHLORIDE (UNII: I9W7N6B1KJ) (FLUOXETINE - UNII:01K63SUP8D)
A-S Medication Solutions
FLUOXETINE HYDROCHLORIDE
FLUOXETINE 40 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 and olanzapine in combination, also refer to the Contr
Product: 50090-0750 NDC: 50090-0750-0 30 CAPSULE in a BOTTLE NDC: 50090-0750-1 90 CAPSULE in a BOTTLE
Abbreviated New Drug Application
FLUOXETINE- FLUOXETINE HYDROCHLORIDE CAPSULE A-S Medication Solutions ---------- MEDICATION GUIDE Fluoxetine Capsules, 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 doctor about your medical condition or treatment. Talk with your healthcare provider if there is something you do not understand or you want to learn more about Fluoxetine. What is the most important information I should know about Fluoxetine Capsules, USP? 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 a 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: • •attempt 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 irittable • •trouble sleeping • •an increase in activity or talking more than what is normal for you • •other unusual changes in behavior or mood Wh Les hele dokumentet
FLUOXETINE- FLUOXETINE HYDROCHLORIDE CAPSULE A-S MEDICATION SOLUTIONS ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE FLUOXETINE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FLUOXETINE. FLUOXETINE CAPSULES, USP 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 OF THE INSERT FOR FLUOXETINE HYDROCHLORIDE AND OLANZAPINE CAPSULES. RECENT MAJOR CHANGES •Warnings and Precautions: Angle-Closure Glaucoma (5.8) 07/2014 INDICATIONS AND USAGE Fluoxetine is a selective serotonin reuptake inhibitor indicated for: (1) •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 in adult patients (1) •Acute treatment of Panic Disorder, with or without agoraphobia (1) _Fluoxetine and olanzapine in combination for_: (1) •Acute Depressive Episodes Associated with Bipolar I Disorder (1) DOSAGE AND ADMINISTRATION INDIC ATIO N ADULT PE DIATRIC 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) - De pre ssive Episode s Associate d 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) - •A lower or less frequent dosage should be used in patients with hepatic impairment, the elderly, and for patients with concurren Les hele dokumentet