PROZAC- fluoxetine hydrochloride capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Dista Products Company

INN (International Name):

Fluoxetine hydrochloride

Composition:

Fluoxetine 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

PROZAC® is indicated for the treatment of: - 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 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)]. PROZAC and Olanzapine in Combination is indicated for the treatment of: - Acute treatment of depressive episodes associated with Bipolar I Disorder. - Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). PROZAC monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatm

Product summary:

The following products are manufactured by Eli Lilly and Company for Dista Products Company: Pulvule are available in 10 mg, 20 mg and 40 mg capsule strengths and packages as follows: 1 Fluoxetine base equivalent. 2 Protect from light. Store at Controlled Room Temperature, 15° to 30°C (59° to 86°F).

Authorization status:

New Drug Application

Patient Information leaflet

PROZAC- FLUOXETINE HYDROCHLORIDE CAPSULE
Dista Products Company
----------
Medication Guide
PROZAC® (PRO-zac)
(fluoxetine capsules)
for oral use
Read the Medication Guide that comes with PROZAC 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 PROZAC?
PROZAC and other antidepressant medicines may cause serious side
effects, including:
1.
Suicidal thoughts or actions:
•
PROZAC 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 PROZAC 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

Summary of Product characteristics

PROZAC- FLUOXETINE HYDROCHLORIDE CAPSULE
DISTA PRODUCTS COMPANY
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PROZAC SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PROZAC.
PROZAC (FLUOXETINE CAPSULES) 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 PROZAC AND OLANZAPINE IN COMBINATION, ALSO REFER TO BOXED
WARNING_
_SECTION OF THE PACKAGE INSERT FOR SYMBYAX_.
RECENT MAJOR CHANGES
Warnings and Precautions (5.2, 5.7) 08/2023
INDICATIONS AND USAGE
PROZAC 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)
_PROZAC and olanzapine in combination for treatment of:_
Acute Depressive Episodes Associated with Bipolar I Disorder (1)
Treatment Resistant Depression (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)
Depressive Episodes
Associated with Bipolar I
Disorder (2.5)
Oral in combination with olanzapine: 5 mg
of oral olanzapine and 20 mg of fluoxetine
once daily (initial dose)
Oral in combination with
olanzapine: 2.5 mg of oral
olanzapine and 20 mg of
fluoxetine once daily (initial
dose)
Treatment Resistant
Depression (2.6)
Oral in combination with olanzapine: 5 mg
of oral olanzapine and 20 mg of fluoxetine
once daily (initial dose)
A lower o