Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
FLUOXETINE HYDROCHLORIDE (UNII: I9W7N6B1KJ) (FLUOXETINE - UNII:01K63SUP8D)
Rebel Distributors Corp
FLUOXETINE HYDROCHLORIDE
FLUOXETINE 10 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 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 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 indic
Fluoxetine Capsules USP, 10 mg* 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 20 NDC 21695-052-20 Bottles of 30 NDC 21695-052-30 Bottles of 60 NDC 21695-052-60 Bottles of 90 NDC 21695-052-90 Fluoxetine Capsules USP, 20 mg* 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 30 NDC 21695-053-30 Bottles of 60 NDC 21695-053-60 Bottles of 90 NDC 21695-053-90 *Fluoxetine base equivalent. Store at 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.
Abbreviated New Drug Application
FLUOXETINE- FLUOXETINE HYDROCHLORIDE CAPSULE Rebel Distributors Corp ---------- 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 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 symptoms. Call a healthcare pro Lees het volledige document
FLUOXETINE- FLUOXETINE HYDROCHLORIDE CAPSULE REBEL DISTRIBUTORS CORP ---------- 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 Indications and Usage, Fluoxetine Capsules and Olanzapine in Combination: Depressive Episodes Associated with Bipolar I Disorder (1.5) 03/2009 Dosage and Administration, Fluoxetine Capsules 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 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 dos Lees het volledige document