Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
FLUOXETINE HYDROCHLORIDE (UNII: I9W7N6B1KJ) (FLUOXETINE - UNII:01K63SUP8D)
Aphena Pharma Solutions - Tennessee, Inc.
FLUOXETINE HYDROCHLORIDE
FLUOXETINE 10 mg
ORAL
PRESCRIPTION DRUG
Fluoxetine hydrochloride 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 reevaluated [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 tr
Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Fluoxetine capsules USP, 10 mg, 20 mg, and 40 mg are available as: 10 mg: white capsules, imprinted GG 575 with single green ink bands, filled with white powder and supplied as: NDC 0781-2823-31 bottles of 30 NDC 0781-2823-01 bottles of 100 NDC 0781-2823-10 bottles of 1000 NDC 0781-2823-13 unit dose packages of 100 20 mg: white capsules, imprinted GG 550 with green and black ink bands, filled with white powder and supplied as: NDC 0781-2822-31 bottles of 30 NDC 0781-2822-01 bottles of 100 NDC 0781-2822-10 bottles of 1000 NDC 0781-2822-13 unit dose packages of 100 40 mg: white capsules, imprinted GG 540 with single orange ink bands, filled with white powder and supplied as: NDC 0781-2824-31 bottles of 30 NDC 0781-2824-01 bottles of 100 NDC 0781-2824-10 bottles of 1000 Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Protect from light.
Abbreviated New Drug Application
FLUOXETINE HYDROCHLORIDE- FLUOXETINE HYDROCHLORIDE CAPSULE Aphena Pharma Solutions - Tennessee, Inc. ---------- MEDICATION GUIDE Fluoxetine Capsules 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 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. What is the most important information I should know about fluoxetine capsules? 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 sympt Lesen Sie das vollständige Dokument
FLUOXETINE HYDROCHLORIDE- FLUOXETINE HYDROCHLORIDE CAPSULE APHENA PHARMA SOLUTIONS - TENNESSEE, INC. ---------- 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. 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_ _SYMBYAX_. 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: Acute and maintenance treatment of Major Depressive Disorder (MDD) in adult and pediatric patients aged 8 to 18 years (1.1) Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) in adult and pediatric patients aged 7 to 17 years (1.2) Acute and maintenance treatment of Bulimia Nervosa in adult patients (1.3) Acute treatment of Panic Disorder, with or without agoraphobia, in adult patients (1.4) _Fluoxetine and olanzapine in combination_ for: Acute treatment of Depressive Episodes Associated with Bipolar I Disorder in adults (1.5) 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 – Pani Lesen Sie das vollständige Dokument