HIGHLIGHTS OF PRESCRIBING INFORMATION

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

FLUOXETINE HYDROCHLORIDE (UNII: I9W7N6B1KJ) (FLUOXETINE - UNII:01K63SUP8D)

Доступна с:

REMEDYREPACK INC.

ИНН (Международная Имя):

FLUOXETINE HYDROCHLORIDE

состав:

FLUOXETINE 40 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Fluoxetine is indicated for the treatment of: - Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)] . - Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)] . - Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)] . - Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)] . Fluoxetine and Olanzapine in Combination is indicated for the treatment of: - Acute treatment of depressive episodes associated with Bipolar I Disorder. Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder.

Обзор продуктов:

Fluoxetine Capsules USP, 40 mg** are white to off white powder filled in size “0” hard gelatin capsules with opaque light blue colored cap and opaque white colored body imprinted “SG” on cap and “115” on body with black ink. NDC: 70518-0997-00 30 in 1 BLISTER PACK Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762 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]. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Статус Авторизация:

Abbreviated New Drug Application

тонкая брошюра

FLUOXETINE- FLUOXETINE HYDROCHLORIDE CAPSULE
REMEDYREPACK INC.
----------
MEDICATION GUIDE
Fluoxetine Capsules, USP
(floo-ox-e-teen)
Read the Medication Guide that comes with fluoxetine capsules 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 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:
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:
Call your healthcare provider right away if you have any of the
following symptoms, or call 911 if an
emergency. Fluoxetine capsules may be associated with these serious
side effects:
2. Serotonin Syndrome. This condition can be life-threatening and may
include:
3.Severe allergic reactions:
4. Abnormal bleeding: Fluoxetine capsules and other antidepressant
medicines may increase your risk
of bleeding or bruising, especially if you take the blood thinner
warfarin (Coumadin ®, Jantoven ®),
a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen or
naproxen), or aspirin.
5. Visual problems:
Only some people are

Характеристики продукта

FLUOXETINE- FLUOXETINE HYDROCHLORIDE CAPSULE
REMEDYREPACK INC.
----------
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_
_SYMBYAX._
RECENT MAJOR CHANGES
Warnings and Precautions: Serotonin Syndrome (5.2) 01/2017
INDICATIONS AND USAGE
Fluoxetine capsules are a selective serotonin reuptake inhibitor
indicated for:
Acute and maintenance treatment of Major Depressive Disorder (MDD) (
1)
Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD)
( 1)
Acute and maintenance treatment of Bulimia Nervosa ( 1)
Acute treatment of Panic Disorder, with or without agoraphobia ( 1)
_Fluoxetine capsules and olanzapine in combination for treatment of:_
Acute Depressive Episodes Associated with Bipolar I Disorder ( 1)
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)
Oral in combination with
olanzapine: 2.5 mg of oral
olanzapine and 20 mg of
fluoxetine once daily (initial
dose )
A lower or less frequent dosage should be used in patients with
hepatic impairment, the elderly, and f