Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
FLUOXETINE HYDROCHLORIDE (UNII: I9W7N6B1KJ) (FLUOXETINE - UNII:01K63SUP8D)
Med-Health Pharma, LLC
FLUOXETINE HYDROCHLORIDE
FLUOXETINE 10 mg
ORAL
PRESCRIPTION DRUG
- Monoamine Oxidase Inhibitors [see Drug Interactions (7.1)] - Pimozide [see Drug Interactions (7.9)] - Thioridazine [see Drug Interactions (7.9)] When using fluoxetine and olanzapine in combination, also refer to the Use in Specific Populations section of the package insert for Symbyax.
Abbreviated New Drug Application
FLUOXETINE - FLUOXETINE HYDROCHLORIDE CAPSULE Med-Health Pharma, LLC ---------- MEDICATION GUIDE Fluoxetine Capsules, USP Read the Medication Guide that comes with fluoxetine capsules 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 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 r Přečtěte si celý dokument
FLUOXETINE - FLUOXETINE HYDROCHLORIDE CAPSULE MED-HEALTH PHARMA, LLC ---------- 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 CAPSULES. 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_ _SYMBYAX._ RECENT MAJOR CHANGES Warnings and Precautions: Use in Patients with Concomitant Illness, Acute Narrow-Angle Glaucoma (5.10) 06/2011 INDICATIONS AND USAGE Fluoxetine capsules are 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 capsules and olanzapine in combination _for: Acute treatment of Depressive Episodes Associated with Bipolar I Disorder in adults (1.5) DOSAGE AND ADMINISTRATION INDICATION ADULT PEDIATRIC 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) - Depressive Episodes Associated with Bipolar I Disorde r (2.5) Oral in combination with olanzapine: 5 mg of oral olanzapine and 20 mg of fluoxetine once daily (initial dose ) - Consider tapering the dose Přečtěte si celý dokument