FLUOXETINE- 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:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (International Name):

FLUOXETINE HYDROCHLORIDE

Composition:

FLUOXETINE HYDROCHLORIDE 10 mg

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 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 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 bin

Product summary:

Fluoxetine capsules USP, 10 mg, contain fluoxetine hydrochloride, equivalent to 10 mg fluoxetine, and are available as hard gelatin capsules with a powder blue cap and body. Both the body and cap of the #3 capsule are imprinted “93” and “42.” They are available in blisterpacks of 30. Store at 20° to 25°C (68° to 77°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 (as required).

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

FLUOXETINE- FLUOXETINE HYDROCHLORIDE CAPSULE
NCS HealthCare of KY, Inc dba Vangard Labs
----------
MEDICATION GUIDE
FLUOXETINE CAPSULES USP
Read the Medication Guide that comes with fluoxetine capsules USP
before you start taking them and
each time you get a refill. There may be new information. This
Medication Guide does not take the place
of talking to your doctor about your medical condition or treatment.
Talk with your doctor or pharmacist
if there is something you do not understand or you want to learn more
about fluoxetine capsules USP.
What is the most important information I should know about fluoxetine
capsules USP?
Antidepressant medicines, depression and other serious mental
illnesses, and suicidal thoughts or actions:
Talk to your, or your family member’s, healthcare provider about:
•
all risks and benefits of treatment with antidepressant medicines
•
all treatment choices for depression or other serious mental illness
•
Antidepressant medicines may increase suicidal thoughts or actions in
some children, teenagers,
and young adults within the first few months of treatment.
•
Depression and other serious mental illnesses are the most important
causes of suicidal thoughts
and actions. Some people may have a particularly high risk of having
suicidal thoughts or actions.
These include people who have (or have a family history of) bipolar
illness (also called manic-
depressive illness) or suicidal thoughts or actions.
•
How can I watch for and try to prevent suicidal thoughts and actions
in myself or a family
member?
•
Pay close attention to any changes, especially sudden changes, in
mood, behaviors,
thoughts, or feelings. This is very important when an antidepressant
medicine is started or
when the dose is changed.
•
Call the healthcare provider right away to report new or sudden
changes in mood,
behavior, thoughts, or feelings.
•
Keep all follow-up visits with the healthcare provider as scheduled.
Call the healthcare
provider between visits as needed, especially if you have concerns
abo

Summary of Product characteristics

FLUOXETINE- FLUOXETINE HYDROCHLORIDE CAPSULE
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUOXETINE CAPSULES USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FLUOXETINE CAPSULES
USP.
FLUOXETINE CAPSULES USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1987
WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
INCREASED RISK OF SUICIDAL THINKING AND BEHAVIOR IN CHILDREN,
ADOLESCENTS, AND YOUNG ADULTS TAKING
ANTIDEPRESSANTS FOR MAJOR DEPRESSIVE DISORDER (MDD) AND OTHER
PSYCHIATRIC DISORDERS (5.1).
_WHEN USING FLUOXETINE AND OLANZAPINE IN COMBINATION, ALSO REFER TO
BOXED WARNING SECTION OF THE PACKAGE INSERT FOR_
_OLANZAPINE AND FLUOXETINE HYDROCHLORIDE CAPSULES._
RECENT MAJOR CHANGES
INDICATIONS AND USAGE, fluoxetine and olanzapine in combination:
Depressive Episodes Associated with Bipolar I Disorder (1.5) 03/2009
DOSAGE AND ADMINISTRATION, fluoxetine and olanzapine in combination:
Depressive Episodes Associated with Bipolar I Disorder (2.5) 03/2009
WARNINGS AND PRECAUTIONS:
Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-Like
Reactions (5.2) 01/2009
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)
_Fluoxetine and olanzapine in combination_ for:
Acute treatment of Depressive Episodes Associated with Bipolar I
Disorder in adults (1.5)
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