Country: Ամերիկայի Միացյալ Նահանգներ
language: անգլերեն
source: NLM (National Library of Medicine)
FLUOXETINE HYDROCHLORIDE (UNII: I9W7N6B1KJ) (FLUOXETINE - UNII:01K63SUP8D)
TYA Pharmaceuticals
FLUOXETINE HYDROCHLORIDE
FLUOXETINE 10 mg
ORAL
PRESCRIPTION DRUG
Fluoxetine capsules, USP are indicated for the acute and maintenance treatment of Major Depressive Disorder in adult patients and in pediatric patients aged 8 to 18 years The usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods should periodically be re-evaluated . [see ]. Clinical Studies (14.1) [see ] Dosage and Administration (2.1) Fluoxetine capsules, USP are 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) The effectiveness of fluoxetine capsules, USP 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 capsules, USP for extended periods should periodically re-evaluate the long-term usefulness
NDC:64725-0192-1 in a BOTTLE of 100 CAPSULES are opaque green cap/opaque green body, size ‘3’ hard gelatin capsule filled with white to off-white granular powder and imprinted with ‘E’ on opaque green cap and ‘88’ on opaque green body with black ink. Bottles of 100 NDC 65862-192-01 Bottles of 500 NDC 65862-192-05 Bottles of 1000 NDC 65862-192-99 are opaque green cap/opaque off white body, size ‘3’ hard gelatin capsule filled with white to off-white granular powder and imprinted with ‘E’ on opaque green cap and ‘91’ on opaque off white body with black ink. Bottles of 100 NDC 65862-193-01 Bottles of 500 NDC 65862-193-05 Bottles of 1000 NDC 65862-193-99 are opaque green cap/opaque orange body, size ‘2’ hard gelatin capsule filled with white to off-white granular powder and imprinted with ‘E’ on opaque green cap and ‘92’ on opaque orange body with black ink. Bottles of 30 NDC 65862-194-30 Bottles of 100 NDC 65862-194-01 Bottles of 500 NDC 65862-194-05 Bottles of 1000 NDC 65862-194-99 *Fluoxetine base equivalent. Fluoxetine Capsules USP, 10 mg* Fluoxetine Capsules USP, 20 mg* Fluoxetine Capsules USP, 40 mg* 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Preserve in tight, light-resistant containers. Store at
Abbreviated New Drug Application
FLUOXETINE - FLUOXETINE HYDROCHLORIDE CAPSULE TYA Pharmaceuticals ---------- MEDICATION GUIDE 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. Fluoxetine capsules and other antidepressant medicines may cause serious side effects, including: Fluoxetine Capsules, USP (floo ox' e teen) What is the most important information I should know about fluoxetine capsules? 1. Suicidal thoughts or actions: • in some children, teenagers, or young adults within the Fluoxetine capsulesand other antidepressant medicines may increase suicidal thoughts or actionsfirst 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 are 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 healthc read_full_document
FLUOXETINE - FLUOXETINE HYDROCHLORIDE CAPSULE TYA PHARMACEUTICALS ---------- 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 ( ). •MONITOR FOR WORSENING AND EMERGENCE OF SUICIDAL THOUGHTS AND BEHAVIORS ( ) 5.1 5.1 _When using fluoxetine and olanzapine in combination, also refer to Boxed Warning section of the package insert for_ _Symbyax._ RECENT MAJOR CHANGES Angle-Closure Glaucoma 07/2014 WARNINGS AND PRECAUTIONS: (5.8) INDICATIONS AND USAGE Fluoxetine capsules, USP 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, USP and olanzapine in combination for:_ Acute treatment of Depressive Episodes Associated with Bipolar I Disorder (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 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 i read_full_document