Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
FLUOXETINE HYDROCHLORIDE (UNII: I9W7N6B1KJ) (FLUOXETINE - UNII:01K63SUP8D)
STAT RX USA LLC
FLUOXETINE HYDROCHLORIDE
FLUOXETINE HYDROCHLORIDE 20 mg
ORAL
PRESCRIPTION DRUG
Fluoxetine is indicated for the acute and maintenance treatment of Major Depressive Disorder in adult patients and in pediatric patients aged 8 to18 years [see Clinical Studies (14.1)]. The usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods, should periodically be re-evaluated [see Dosage and Administration (2.1)]. Fluoxetine is indicated for the acute and maintenance treatment of obsessions and compulsions in adult patients and in pediatric patients aged 7 to 17 years with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)]. The effectiveness of fluoxetine in long-term use, i.e., for more than 13 weeks, has not been systematically evaluated in placebo-controlled trials. Therefore, the physician who elects to use fluoxetine for extended periods, should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2.2)]. Fluoxetine is indicated for the acute and maintenance treatment of binge
Fluoxetine Capsules USP 20 mg are available as white to off-white, powder-filled aqua blue opaque hard gelatin capsules, radial spin printed and “4356” on the cap and “20 mg” on the body in black ink, containing fluoxetine hydrochloride equivalent to 20 mg fluoxetine packaged in bottles of 100, 500, and 1000 capsules and unit-dose boxes of 100 capsules. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Abbreviated New Drug Application
FLUOXETINE - FLUOXETINE HYDROCHLORIDE CAPSULE STAT RX USA LLC ---------- MEDICATION GUIDE Read the Medication Guide that comes with fluoxetine capsules USP before you start taking them 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 doctor or pharmacist if there is something you do not understand or you want to learn more about fluoxetine capsules USP. What is the most important information I should know about fluoxetinecapsules USP? Antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions: Talk to your, or your family member’s, healthcare provider about: • all risks and benefits of treatment with antidepressant medicines • all treatment choices for depression or other serious mental illness 1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. 2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions. 3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms Call a healthcare provider right away if yo Olvassa el a teljes dokumentumot
FLUOXETINE - FLUOXETINE HYDROCHLORIDE CAPSULE STAT RX USA LLC ---------- 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: SUICIDALITY AND ANTIDEPRESSANT DRUGS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ INCREASED RISK OF SUICIDAL THINKING AND BEHAVIOR IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS TAKING ANTIDEPRESSANTS FOR MAJOR DEPRESSIVE DISORDER (MDD) AND OTHER PSYCHIATRIC DISORDERS (5.1). _When using fluoxetine and olanzapine in combination, also refer to Boxed Warning section of the package insert for_ _olanzapine and fluoxetine hydrochloride capsules._ RECENT MAJOR CHANGES INDICATIONS AND USAGE, fluoxetine and olanzapine in combination: Depressive Episodes Associated with Bipolar I Disorder (1.5) 03/2009 DOSAGE AND ADMINISTRATION, fluoxetine and olanzapine in combination: Depressive Episodes Associated with Bipolar I Disorder (2.5) 03/2009 WARNINGS AND PRECAUTIONS: Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-Like Reactions (5.2) 01/2009 INDICATIONS AND USAGE Fluoxetine is a selective serotonin reuptake inhibitor indicated for: (1) • Acute and maintenance treatment of Major Depressive Disorder (MDD) in adult and pediatric patients aged 8 to 18 years (1.1) (1) • Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) in adult and pediatric patients aged 7 to 17 years (1.2) (1) • Acute and maintenance treatment of Bulimia Nervosa in adult patients (1.3) (1) • Acute treatment of Panic Disorder, with or without agoraphobia, in adult patients (1.4) (1) _Fluoxetine and olanzapine in combination for:_ (1) • Acute treatment of Depressive Episodes Associated with Bipolar I Disorder in adults (1.5) (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) Olvassa el a teljes dokumentumot