FLUOXETINE- fluoxetine hydrochloride capsule

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Proficient Rx LP

INN (Tarptautinis Pavadinimas):

FLUOXETINE HYDROCHLORIDE

Sudėtis:

FLUOXETINE 40 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Fluoxetine is indicated for the treatment of: Fluoxetine and Olanzapine in Combination is indicated for the treatment of: 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 refer to the Contraindications section of the package insert for Symbyax. The use of MAOIs intended to treat psychiatric disorders with fluoxetine or within 5 weeks of stopping treatment with fluoxetine is contraindicated because of an increased risk of serotonin syndrome. The use of fluoxetine within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated [see Dosage and Administration (2.9) and Warnings and Precautions (5.2)]. Starting fluoxetine in a patient who is being treated with MAOIs such as linezolid or intravenous methy

Produkto santrauka:

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 63187-361-30: Bottles of 30 capsules NDC 63187-361-60: Bottles of 60 capsules NDC 63187-361-90: Bottles of 90 capsules **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].

Autorizacija statusas:

Abbreviated New Drug Application

Pakuotės lapelis

FLUOXETINE- FLUOXETINE HYDROCHLORIDE CAPSULE
Proficient Rx LP
----------
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:
•
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 pr

Prekės savybės

FLUOXETINE- FLUOXETINE HYDROCHLORIDE 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._
•
•
_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:
Angle-Closure Glaucoma (5.8) 07/2014
INDICATIONS AND USAGE
Fluoxetine capsules are a selective serotonin reuptake inhibitor
indicated for:
•
•
•
•
_Fluoxetine capsules and olanzapine in combination for treatment of:_
•
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)
•
_Fluoxetine capsules and olanzapine in combination:_
•
•
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).
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)
Acute Depressive Episodes Associated with Bipolar I Disorder (1)
A lower or less frequent dosage should be used in patients with
hepatic impairment, the elderly, and for patients with
concurrent di