FLUOXETINE- fluoxetine hydrochloride liquid

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Lannett Company, Inc.

INN (Tarptautinis Pavadinimas):

FLUOXETINE HYDROCHLORIDE

Sudėtis:

FLUOXETINE 20 mg in 5 mL

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Fluoxetine oral solution is indicated for the treatment of: - Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)] . 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 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 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)] . Acute treatment of Panic Disorder, with or without agoraphobia

Produkto santrauka:

Fluoxetine Oral Solution, USP (contains fluoxetine hydrochloride, equivalent to 20 mg/5mL of fluoxetine), is a clear, colorless liquid with mint flavor, is available in 120 mL bottles (NDC 54838-523-40). Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure.

Autorizacija statusas:

Abbreviated New Drug Application

Pakuotės lapelis

FLUOXETINE- FLUOXETINE HYDROCHLORIDE LIQUID
Lannett Company, Inc.
----------
MEDICATION GUIDE
Fluoxetine (floo ox' e teen) Oral Solution, USP
Read the Medication Guide that comes with fluoxetine oral solution
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
oral solution?
Fluoxetine oral solution and other antidepressant medicines may cause
serious side effects, including:
1. Suicidal thoughts or actions:
•
Fluoxetine oral solution 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 oral solution
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 behav

Prekės savybės

FLUOXETINE- FLUOXETINE HYDROCHLORIDE LIQUID
LANNETT COMPANY, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUOXETINE ORAL
SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
FLUOXETINE ORAL
SOLUTION.
FLUOXETINE ORAL SOLUTION, FOR ORAL USE
INITIAL U.S. APPROVAL: 1991 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).
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:
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)
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
Oral solution: 20 mg per 5 mL (3)
CONTRAINDICATIONS
Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat
psychiatric disorders with
fluoxetine or within 5 weeks of stopping treatment with fluoxetine. Do
not use fluoxetine within 14 days
of stopping an MAOI intended to treat psychiatric disorders. In
addition, do not start fluoxetine in a
patient who is being treated with linezolid or intravenous met