国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
FLUOXETINE HYDROCHLORIDE (UNII: I9W7N6B1KJ) (FLUOXETINE - UNII:01K63SUP8D)
Medsource Pharmaceuticals
FLUOXETINE HYDROCHLORIDE
FLUOXETINE 20 mg
ORAL
PRESCRIPTION DRUG
Fluoxetine capsules are 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 capsules 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) [see Clinical Studies (14.2) ]. The effectiveness of fluoxetine capsules 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 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 capsules are i
16.1 How Supplied Fluoxetine Capsules USP 10 mg* are white to off-white powder filled in size ‘2’ hard gelatin capsules with opaque light blue cap and opaque light blue body, imprinted “FLUOXETINE” on cap and “R147” on body, with white ink and are supplied in bottles of 30, 90 and 100. 10 mg Bottles of 30 NDC 55111-147-30 Bottles of 90 NDC 55111-147-90 Bottles of 100 NDC 55111-147-01 Fluoxetine Capsules USP 20 mg* are white to off-white powder filled in size ‘2’ hard gelatin capsules with opaque light blue cap and opaque light torquoise blue body, imprinted “FLUOXETINE” on cap and “R148” on body, with black ink and are supplied in bottles of 30, 90, 100 and 1000. 20 mg Bottles of 30 NDC 55111-148-30 Bottles of 90 NDC 55111-148-90 Bottles of 100 NDC 55111-148-01 Bottles of 1000 NDC 55111-148-10 Fluoxetine Capsules USP 40 mg* are white to off-white powder filled in size ‘0’ hard gelatin capsules with opaque light blue cap and opaque white body, imprinted “FLUOXETINE” on cap and “R149” on body, with black ink and are supplied in bottles of 30, 90, 100 and 500. 40 mg Bottles of 30 NDC 55111-149-30 Bottles of 90 NDC 55111-149-90 Bottles of 100 NDC 55111-149-01 Bottles of 500 NDC 55111-149-05 * fluoxetine base equivalent Protect From Light Dispense in a tight, light-resistant container.
Abbreviated New Drug Application
FLUOXETINE- FLUOXETINE CAPSULE Medsource Pharmaceuticals ---------- MEDICATION GUIDE Fluoxetine Capsules, USP Read the Medication Guide that comes with fluoxetine 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 and other antidepressant medicines may cause serious side effects, including: 1. Suicidal thoughts or actions: • Fluoxetine 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 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 symptom 完全なドキュメントを読む
FLUOXETINE- FLUOXETINE CAPSULE MEDSOURCE PHARMACEUTICALS ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE FLUOXETINE CAPSULES 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 FLUOXETINE HYDROCHLORIDE AND OLANZAPINE CAPSULES. RECENT MAJOR CHANGES Warnings and Precautions: Use in Patients with Concomitant Illness, Acute Narrow-Angle Glaucoma (5.10) dd/yyyy INDICATIONS AND USAGE Fluoxetine capsules are 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) 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: (1) 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 Disorder (2.5) Oral in combination with olanzapine: 5 mg of oral olanzapine and 20 mg of 完全なドキュメントを読む