Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
FLUOXETINE HYDROCHLORIDE (UNII: I9W7N6B1KJ) (FLUOXETINE - UNII:01K63SUP8D)
RedPharm Drug, 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 olanzapine in combination, also re
16.1 How Supplied 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. NDC 42543-725-30: Bottles of 30 capsules NDC 42543-725-01: Bottles of 100 capsules NDC 42543-725-05: Bottles of 500 capsules NDC 42543-725-10: Bottles of 1000 capsules 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. NDC 42543-726-30: Bottles of 30 capsules NDC 42543-726-01: Bottles of 100 capsules NDC 42543-726-05: Bottles of 500 capsules NDC 42543-726-10: Bottles of 1000 capsules 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. NDC 42543-727-30: Bottles of 30 capsules NDC 42543-727-01: Bottles of 100 capsules NDC 42543-727-05: Bottles of 500 capsules **Fluoxetine base equivalent. 16.2 Storage and Handling 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 RedPharm Drug, 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 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 capsules 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 provider right away if you have any of the following sympto Perskaitykite visą dokumentą
FLUOXETINE- FLUOXETINE HYDROCHLORIDE CAPSULE REDPHARM DRUG, INC. ---------- FLUOXETINE 20MG BOXED WARNING WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see WARNINGS AND PRECAUTIONS (5.1)]. In patients of all ages who are started on antidepressant therapy, monitor closely for worsening and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see WARNINGS AND PRECAUTIONS (5.1)]. Fluoxetine is not approved for use in children less than 7 years of age [see WARNINGS AND PRECAUTIONS (5.1) and USE IN SPECIFIC POPULATIONS (8.4)]. When using fluoxetine and olanzapine in combination, also refer to Boxed Warning section of the package insert for Symbyax. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use fluoxetine capsules, USP safely and effectively. See full prescribing information for fluoxetine capsules, USP. 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 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: Fluoxetine capsules are a selective serotonin reuptake i Perskaitykite visą dokumentą