FLUOXETINE capsule

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Sun Pharmaceutical Industries, Inc.

INN (Medzinárodný Name):

FLUOXETINE HYDROCHLORIDE

Zloženie:

FLUOXETINE 40 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Fluoxetine capsules, USP are indicated for the treatment of: Fluoxetine capsules, USP monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder. When using fluoxetine capsules, USP and olanzapine in combination, also refer to the Clinical Studies section of the package insert for olanzapine and fluoxetine hydrochloride capsules. When using fluoxetine and olanzapine in combination, also refer to the Contraindications section of the package insert for olanzapine and fluoxetine hydrochloride capsules. 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 line

Prehľad produktov:

Fluoxetine capsules, USP 40 mg* are green opaque cap with orange opaque body, hard gelatin #2 capsules filled with white to off-white powder, imprinted with “RX632 ” on the cap and body in black ink. They are available as follows: NDC 63304-632-30 Bottles of 30 NDC 63304-632-90 Bottles of 90 NDC 63304-632-01 Bottles of 100 NDC 63304-632-05 Bottles of 500 NDC 63304-632-10 Bottles of 1000 NDC 63304-632-80 Strip unit-dose pack of 100 * Fluoxetine base equivalent – present as the hydrochloride. Protect from light. Dispense in a tight, light-resistant container. Store at 20° - 25° C (68° - 77° F) [See USP Controlled Room Temperature].

Stav Autorizácia:

Abbreviated New Drug Application

Príbalový leták

FLUOXETINE- FLUOXETINE CAPSULE
Sun Pharmaceutical Industries, Inc.
----------
MEDICATION GUIDE
FLUOXETINE (floo-OX-e-teen) CAPSULES, USP
Rx only
Read the Medication Guide that comes with fluoxetine capsules, USP
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, USP?
Fluoxetine capsules, USP and other antidepressant medicines may cause
serious side effects, including:
1. Suicidal thoughts or actions:
•
Fluoxetine capsules, USP 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, USP
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 be

Súhrn charakteristických

FLUOXETINE- FLUOXETINE CAPSULE
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
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._
•
•
_WHEN USING FLUOXETINE AND OLANZAPINE IN COMBINATION, ALSO REFER TO
BOXED WARNING SECTION OF THE PACKAGE INSERT FOR_
_OLANZAPINE AND FLUOXETINE HYDROCHLORIDE CAPSULES_.
RECENT MAJOR CHANGES
Warnings and Precautions:
Serotonin Syndrome (5.2) 01/2017
INDICATIONS AND USAGE
Fluoxetine capsules, USP is a selective serotonin reuptake inhibitor
indicated for: (1)
•
•
•
•
•
DOSAGE AND ADMINISTRATION
INDICATION (2)
ADULT (2)
PEDIATRIC (2)
MDD (2.1) (2)
20 mg/day in am (initial dose) (2)
10 to 20 mg/day
(initial dose) (2)
OCD (2.2) (2)
20 mg/day in am (initial dose) (2)
10 mg/day (initial
dose) (2)
Bulimia Nervosa (2.3) (2)
60 mg/day in am (2)
- (2)
Panic Disorder (2.4) (2)
10 mg/day (initial dose) (2)
- (2)
Depressive Episodes
Associated with Bipolar I
Disorder (2.5) (2)
Oral in combination with olanzapine: 5 mg of
oral olanzapine and 20 mg of fluoxetine once
daily (initial dose) (2)
- (2)
•
•
•
•
DOSAGE FORMS AND STRENGTHS
•
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)
_Fluoxetine capsules, USP and olanzapine in combination for treatment
of:_
Acute Depressive Episodes Associated with Bipolar I Disorder (1)
A lower or less frequent dosage