FLUOXETINE capsule

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Alembic Pharmaceuticals Limited

INN (Διεθνής Όνομα):

FLUOXETINE HYDROCHLORIDE

Σύνθεση:

FLUOXETINE 10 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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 in adult. Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using Fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package

Περίληψη προϊόντος:

The following products are manufactured by Alembic Pharmaceuticals Limited, India. Fluoxetine Capsules USP, are available in: The 10-mg1 , Capsule is Blue opaque cap and white opaque body, imprinted with “10” on the cap and “A105” on the body: NDC 46708-271-30- Bottles of 302 NDC 46708-271-31- Bottles of 1002 NDC 46708-271-71- Bottles of 5002  NDC 46708-271-91 - Bottles of 10002 The 20-mg1 , Capsule is a Dark blue opaque cap and Light blue opaque body, imprinted with “20” on the cap and “A106” on the body: NDC 46708-272-30- Bottles of 302 NDC 46708-272-31- Bottles of 1002 NDC 46708-272-71- Bottles of 5002 NDC 46708-272-91 - Bottles of 10002 The 40-mg1 , Capsule is a Light blue opaque cap and Light blue opaque body, imprinted with “40” on the cap and “A107” on the body: NDC 46708-273-30- Bottles of 302 NDC 46708-273-31 - Bottles of 1002 NDC 46708-273-71- Bottles of 5002 NDC 46708-273-91- Bottles of 10002 _____________________________  1 Fluoxetine base equivalent 2 Protect from light. Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59 to 86ºF), (See USP Controlled Room Temperature).

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Φύλλο οδηγιών χρήσης

FLUOXETINE - FLUOXETINE CAPSULE
Alembic Pharmaceuticals Limited
----------
MEDICATION GUIDE
Fluoxetine (floo ox' e teen)
Capsules USP
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?
Fluoxetine and other antidepressant medicines may cause serious side
effects, including:
1. Suicidal thoughts or actions:
• Fluoxetine 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 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

Αρχείο Π.Χ.Π.

FLUOXETINE - FLUOXETINE CAPSULE
ALEMBIC PHARMACEUTICALS LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUOXETINE CAPSULES
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
FLUOXETINE CAPSULES.
FLUOXETINE CAPSULES 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:
Angle-Closure Glaucome (5.8) 08/2014
INDICATIONS AND USAGE
Fluoxetine is 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 and olanzapine in combination for treatment of:
• Acute treatment of Depressive Episodes Associated with Bipolar I
Disorder in adults (1) (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)
-
A lower or less frequent dosage should be used in patients with
hepatic impairment, the elderly, and for
patients with concurrent disease or on multiple concomitant
medications (2.7) (2)
_Fluoxetineand