FLUOXETINE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Nostrum Laboratories Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 binge-eatin

Product summary:

Fluoxetine Oral Solution, USP (20 mg/5 mL) is available as a clear, colorless solution with a distinctive spearmint-like aroma. Supplied in 120 mL bottles (NDC 29033-503-31). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

FLUOXETINE- FLUOXETINE SOLUTION
Nostrum Laboratories Inc.
----------
MEDICATION GUIDE
FLUOXETINE ORAL SOLUTION, USP
(FLOO OX’ E TEEN)
Read the Medication Guide that comes with fluoxetine oral soluion
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 behavior or

Summary of Product characteristics

FLUOXETINE- FLUOXETINE SOLUTION
NOSTRUM LABORATORIES 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: 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).
RECENT MAJOR CHANGES
Warning and Precautions, Serotonon Syndrome (5.2)
07/2023
Warning and Precautions, Abnormal Bleeding (5.7)
07/2023
INDICATIONS AND USAGE
Fluoxetine is 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 adult 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
Oral Solution: 20 mg/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