FLUOXETINE HCL- fluoxetine capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

DirectRX

INN (International Name):

FLUOXETINE HYDROCHLORIDE

Composition:

FLUOXETINE 40 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

- 1.1 Major Depressive Disorder Fluoxetine capsules, USP are 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)]. 1.2 Obsessive Compulsive Disorder Fluoxetine capsules, USP are 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 capsules, USP 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 capsules, USP for extended periods, should periodically re-evaluate the long-term usefulness of the drug for the i

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DirectRX
----------
Revised: 1/2020
Document Id: 9c9402dc-ee8d-6c1f-e053-2995a90adabd
34391-3
Set id: 62e08a06-2f62-42aa-828f-5c2d1415657e
Version: 4
Effective Time: 20200120
DirectRX

Summary of Product characteristics

FLUOXETINE HCL- FLUOXETINE CAPSULE
DIRECTRX
----------
FLUOXETINE
BOXED WARNING SECTION
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
Antidepressants increased the risk of suicidal thoughts and behavior
in children, adolescents,
and young adults in short-term studies. These studies did not show an
increase in the risk of
suicidal thoughts and behavior with antidepressant use in patients
over age 24; there was a
reduction in risk with antidepressant use in patients aged 65 and
older [see Warnings and
Precautions (5.1)].
In patients of all ages who are started on antidepressant therapy,
monitor closely for
worsening and for emergence of suicidal thoughts and behaviors. Advise
families and
caregivers of the need for close observation and communication with
the prescriber [see
Warnings and Precautions (5.1)].
Fluoxetine is not approved for use in children less than 7 years of
age [see Warnings and
Precautions (5.1) and Use in Specific Populations (8.4)].
When using fluoxetine and olanzapine in combination, also refer to
Boxed Warning section of
the package insert for olanzapine and fluoxetine hydrochloride
capsules.
INDICATIONS & USAGE SECTION
1.1 Major Depressive Disorder
Fluoxetine capsules, USP are 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)].
1.2 Obsessive Compulsive Disorder
Fluoxetine capsules, USP are 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 capsules, USP 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 flu