FLUOXETINE tablet, film coated

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Alembic Pharmaceuticals Inc.

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Fluoxetine is indicated for the acute and maintenance treatment of Major Depressive Disorder in adult patients and in pediatric patients aged 8 to 18 years [see Clinical Studies (14.1)] . The usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods should periodically be re-evaluated [see Dosage and Administration (2.1)] . Fluoxetine is indicated for the acute and maintenance treatment of obsessions and compulsions in adult patients and in pediatric patients aged 7 to 17 years with Obsessive Compulsive Disorder (OCD [see Clinical Studies (14.2)] . The effectiveness of fluoxetine in long‑term use, i.e., for more than 13 weeks, has not been systematically evaluated in placebo‑controlled trials. Therefore, the physician who elects to use fluoxetine for extended periods should periodically re-evaluate the long‑term usefulness of the drug for the individual patient [see Dosage and Administration (2.2)] . Fluoxetine is indicated for the acute and maintenance treatment of bing

製品概要:

Fluoxetine Tablets, USP are available containing fluoxetine hydrochloride, USP equivalent to 10 mg or 20 mg of fluoxetine with a functional score for oral administration. Fluoxetine Tablets USP, 10 mg are white film-coated, oval tablet with score on one side of the tablet and debossed with “L553” on the other side. NDC 62332-242-30                30 Tablets HDPE Bottle Pack  NDC 62332-242-31                100 Tablets HDPE Bottle Pack NDC 62332-242-91                1,000 Tablets HDPE Bottle Pack Fluoxetine Tablets USP, 20 mg are white film-coated, oval tablet with score on one side of the tablet and debossed with “L554” on the other side. NDC 62332-243-30                30 Tablets HDPE Bottle Pack  NDC 62332-243-31                100 Tablets HDPE Bottle Pack NDC 62332-243-91                1,000 Tablets HDPE Bottle Pack Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

認証ステータス:

Abbreviated New Drug Application

情報リーフレット

FLUOXETINE - FLUOXETINE TABLET, FILM COATED
Alembic Pharmaceuticals Inc.
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MEDICATION GUIDE
Fluoxetine Tablets, USP
(floo ox’ e teen)
Read the Medication Guide that comes with Fluoxetine Tablets 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
Tablets?
Fluoxetine Tablets and other antidepressant medicines may cause
serious side effects, including:
1. Suicidal thoughts or actions:
•Fluoxetine Tablets 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:
oNew or sudden changes in mood, behavior, actions, thoughts, or
feelings, especially if severe.
oPay particular attention to such changes when Fluoxetine Tablets are
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

製品の特徴

FLUOXETINE - FLUOXETINE TABLET, FILM COATED
ALEMBIC PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUOXETINE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
FLUOXETINE TABLETS.
FLUOXETINE TABLETS, 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) 06/2023
Warnings and Precautions (5.7) 06/2023
INDICATIONS AND USAGE
Fluoxetine is a selective serotonin reuptake inhibitor indicated for:
(1)
Acute and maintenance treatment of Major Depressive Disorder (MDD) in
adult and pediatric patients
aged 8 to 18 years (1.1)
Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD)
in adults and pediatric
patients aged 7 to 17 years (1.2)
Acute and maintenance treatment of Bulimia Nervosa in adult patients
(1.3)
Acute treatment of Panic Disorder, with or without agoraphobia, in
adult patients (1.4)
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)
· 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)
DOSAGE FORMS AND STRENGTHS
· Tablets: 10 mg, 20 mg with a functional score(3) (3)
CONTRAINDICATIONS
• Serotonin Syndrome and MAOIs: Do not use MAOIs intended to