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)
Proficient Rx LP
FLUOXETINE HYDROCHLORIDE
FLUOXETINE 40 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 [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, 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) [see Clinical Studies (14.2)]. 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 of the drug for the individual patient [see Dosage and Administration (2.2)] . Fluoxetine c
Fluoxetine capsules, USP 40 mg * are green opaque cap with orange opaque body, hard gelatin #2 capsules filled with white to off-white powder, imprinted with “RX632 ” on the cap and body in black ink. They are available as follows: NDC 63187-089-30 Bottles of 30 NDC 63187-089-90 Bottles of 90 * Fluoxetine base equivalent – present as the hydrochloride. Protect from light. Dispense in a tight, light-resistant container. Store at 20° - 25° C (68° - 77° F) [See USP Controlled Room Temperature].
Abbreviated New Drug Application
FLUOXETINE- FLUOXETINE CAPSULE Proficient Rx LP ---------- MEDICATION GUIDE FLUOXETINE CAPSULES, USP Rx only Read the Medication Guide that comes with fluoxetine capsules, USP 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, USP? Fluoxetine capsules, USP and other antidepressant medicines may cause serious side effects, including: 1. Suicidal thoughts or actions: • Fluoxetine capsules, USP 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, USP 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 完全なドキュメントを読む
FLUOXETINE- FLUOXETINE CAPSULE PROFICIENT RX LP ---------- 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 (5.1). MONITOR FOR WORSENING AND EMERGENCE OF SUICIDAL THOUGHTS AND BEHAVIORS (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 BOXED WARNING: Warnings: Suicidal Thoughts and Behaviors 07/2013 INDICATIONS AND USAGE: Fluoxetine Capsules, USP and Olanzapine in Combination: Depressive Episodes Associated with Bipolar I Disorder (1.5) 07/2013 DOSAGE AND ADMINISTRATION: Fluoxetine Capsules and Olanzapine in Combination: Depressive Episodes Associated with Bipolar I Disorder (2.5) 07/2013 Dosing in Specific Populations (2.7) 07/2013 Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders (2.9) 01/2013 Use of Fluoxetine Capsules with Other MAOIs such as Linezolid or Methylene Blue (2.10) 01/2013 CO NTRAINDIC ATIO NS: Monoamine Oxidase Inhibitors (MAOIs) (4.1) 01/2013 Other Contraindications (4.2) 07/2013 WARNINGS AND PRECAUTIONS: Clinical Worsening and Suicide Risk (5.1) 07/2013 Serotonin Syndrome (5.2) 01/2013 QT Prolongation (5.10) 07/2013 INDICATIONS AND USAGE Fluoxetine capsules, USP is a selective serotonin reuptake inhibitor indicated for: (1) • • • • _Fluoxetine capsules, USP and olanzapine in combination for:_ (1) • DOSAGE AND ADMINISTRATION INDIC ATIO N ADULT PE DIATRIC MDD (2.1) (2) 20 mg/day in am (initial dose) (2) 10 to 20 mg/day (initial dose) (2) OCD 完全なドキュメントを読む