FLUOXETINE capsule

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Direct_Rx

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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. When using Fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®. When using fluoxetine capsules and olanzapine in combination, also re

제품 요약:

16.1 How Supplied Fluoxetine Capsules, USP 10 mg** are white to off white powder filled in size “4” hard gelatin capsules with opaque light blue colored cap and opaque light orange colored body imprinted “SG” on cap and “113” on body with black ink. NDC 42543-725-30: Bottles of 30 capsules NDC 42543-725-01: Bottles of 100 capsules NDC 42543-725-05: Bottles of 500 capsules NDC 42543-725-10: Bottles of 1000 capsules Fluoxetine Capsules USP, 20 mg** are white to off white powder filled in size “2” hard gelatin capsules with opaque light blue colored cap and opaque light green colored body imprinted “SG” on cap and “114” on body with black ink. : Bottles of 30 capsules Bottles of 100 capsules Bottles of 500 capsules Bottles of 1000 capsules 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. Bottles of 30 capsules Bottles of 100 capsules Bottles of 500 capsules **Fluoxetine base equivalent. 16.2 Storage and Handling 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].

승인 상태:

Abbreviated New Drug Application

환자 정보 전단

FLUOXETINE- FLUOXETINE CAPSULE
Direct_Rx
----------
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:
New or sudden changes in mood, behavior, actions, thoughts, or
feelings, especially if severe.
Pay particular attention to such changes when fluoxetine capsules 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 symptoms, or call 911 if an
emergency. Fluoxeti

제품 특성 요약

FLUOXETINE- FLUOXETINE CAPSULE
DIRECT_RX
----------
FLUOXETINE
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
Antidepressants increased the risk of suicidal thoughts and behavior
in children, adolescents, and
young adults in short-term studies. These studies did not show an
increase in the risk of suicidal
thoughts and behavior with antidepressant use in patients over age 24;
there was a reduction in
risk with antidepressant use in patients aged 65 and older [see
Warnings and Precautions (5.1)].
In patients of all ages who are started on antidepressant therapy,
monitor closely for worsening
and for emergence of suicidal thoughts and behaviors. Advise families
and caregivers of the need
for close observation and communication with the prescriber [see
Warnings and Precautions
(5.1)].
Fluoxetine is not approved for use in children less than 7 years of
age [see Warnings and
Precautions (5.1) and Use in Specific Populations (8.4)].
When using fluoxetine and olanzapine in combination, also refer to
Boxed Warning section of the
package insert for Symbyax.
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.
When using Fluoxetine and olanzapine in combination, also refer to the
Clinical Studies section of the
package insert for Symbyax®.
2.1 Major Depressive Disorder
Initial Treatment
Adult �