FLUOXETINE tablet, film coated

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

Fluoxetine hydrochloride (UNII: I9W7N6B1KJ) (fluoxetine - UNII:01K63SUP8D)

Dostupné s:

Dr.Reddy's Laboratories Limited

INN (Mezinárodní Name):

Fluoxetine hydrochloride

Složení:

fluoxetine 10 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Fluoxetine tablets are indicated for the acute and maintenance treatment of Major Depressive Disorder in adult patients and in pediatric patients aged 8 to18 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 tablets are 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 tablets 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 tablets 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 tablets are indicate

Přehled produktů:

Fluoxetine Tablets USP, 10 mg* are blue, oval shaped biconvex beveled edged film coated tablets, debossed "R" on one side and 0150 other side with break line separating ‘01’ from ‘50’ and are supplied in bottles of 30, 100, 500, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-150-30 Bottles of 100 NDC 55111-150-01 Bottles of 500 NDC 55111-150-05 Bottles of 1000 NDC 55111-150-10 Unit dose packages of 100 (10 x 10) NDC 55111-150-78 Fluoxetine Tablets USP, 20 mg* are white to off white film coated oval shaped beveled edged biconvex tablets debossed with '566' on one side and '20' on other side with breakline separating '2' from '0' and are supplied in bottles of 30's, 100's and 1000's. Bottles of 30 NDC 43598-566-30 Bottles of 100 NDC 43598-566-01 Bottles of 1000's NDC 43598-566-10 * fluoxetine base equivalent Store fluoxetine tablets at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature]. Protect From Light. Dispense in a tight, light-resistant container.

Stav Autorizace:

Abbreviated New Drug Application

Informace pro uživatele

FLUOXETINE- FLUOXETINE TABLET, FILM COATED
Dr.Reddy's Laboratories Limited
----------
Medication Guide
Fluoxetine (floo ox' e teen) Tablets, USP
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 you 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:
•
New or sudden changes in mood, behavior, actions, thoughts, or
feelings, especially if
severe.
•
Pay particular attention to such changes when fluoxetine tablets and
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 yo

Charakteristika produktu

FLUOXETINE- FLUOXETINE TABLET, FILM COATED
DR.REDDY'S LABORATORIES LIMITED
----------
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 a selective serotonin reuptake inhibitor indicated
for:
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)
DOSAGE FORMS AND STRENGTHS
Tablets: 10 mg and 20 mg (3)
CONTRAINDICATIONS
Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat
psychiatric disorders with
fluoxetine o