FLUOXETINE HCL tablet, film coated

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Almatica Pharma Inc.

INN (Rahvusvaheline Nimetus):

FLUOXETINE HYDROCHLORIDE

Koostis:

FLUOXETINE 60 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Fluoxetine tablets are indicated for the treatment of: 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 (2.6) and Warnings and Precautions (5.2)] . Starting fluoxetine in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see Dosage and Administration ( 2.7) and Warnings and Precautions (5.2)] . The use of fluoxetine is contraindicated with the following: Pimozide and thioridazine prolong the QT interval. Fluoxetine can increase the levels of pimozide and thioridazine through inhibition of CYP2D6. Fluoxetine can also prolong the QT interval. Pregnancy Exposure Registry There is a pregnancy exposure

Toote kokkuvõte:

Fluoxetine tablets, USP 60 mg, are available as 60-mg (fluoxetine base equivalent), film-coated, functional-scored, capsule-shaped, white tablets debossed with “FL 60” on one side (“FL” above the score and “60” below the score). Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from light.

Volitamisolek:

New Drug Application

Infovoldik

FLUOXETINE HCL- FLUOXETINE HCL TABLET, FILM COATED
Almatica Pharma Inc.
----------
MEDICATION GUIDE
FLUOXETINE TABLETS
Read the Medication Guide that comes with fluoxetine 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 of the
following symptoms,

Toote omadused

FLUOXETINE HCL- FLUOXETINE HCL TABLET, FILM COATED
ALMATICA PHARMA 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_.
•
•
RECENT MAJOR CHANGES
Warnings and Precautions (5.2, 5.7)
8/2023
INDICATIONS AND USAGE
Fluoxetine tablets are a selective serotonin reuptake inhibitor (SSRI)
indicated for the treatment of:
•
•
•
•
DOSAGE AND ADMINISTRATION
•
INDICATION
ADULT
PEDIATRIC
MDD (2.1)
20 mg/day in morning (initial dose)
20 mg/day (target dose)
80 mg/day (maximum dose
studied)
10 to 20 mg/day (initial dose)*
*This product has not been studied
in doses greater than 20 mg/day in
pediatric MDD.
OCD (2.2)
20 mg/day in morning (initial dose)
20 to 60 mg/day (target dose)
10 mg/day (initial dose)
10 to 60 mg/day (target dose)
Bulimia Nervosa (2.3)
60 mg/day in morning
-
Panic Disorder (2.4)
10 mg/day (initial dose)
20 mg/day (target dose)
60 mg/day (maximum dose
studied)
-
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
•
•
•
WARNINGS AND PRECAUTIONS
_Suicidal Thoughts and Behaviors in Children, Adolescents, and Young
Adults:_ Monitor for clinical
worsening and suicidal thinking and behavior (5.1)
_Serotonin Syndrome:_ Serotonin syndrome has been reported with SSRIs
and serotonin-norepinephrine
reuptake inhibitors (SNRIs), including fluoxetine, both when taken
alone, but especially when co-
administered with other serotonergic agents. If such symptoms occur,
discontinue fluoxetine and
serotonergic agents and initiate supportive treatment. If concomitant
use of fluoxetine with other
serotonergic drugs is clinically warranted, patients should be made
aware of a potential increased risk
for serotonin syndrome, particularly during treatment initiation and
dose increas