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:

Rebel Distributors Corp

INN (International Name):

FLUOXETINE HYDROCHLORIDE

Composition:

FLUOXETINE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fluoxetine capsules 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)] . Fluoxetine capsules 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 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 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 capsules are indic

Product summary:

Fluoxetine Capsules USP, 10 mg* are opaque green cap/opaque green body, size ‘3’ hard gelatin capsule filled with white to off-white granular powder and imprinted with ‘E’ on opaque green cap and ‘88’ on opaque green body with black ink.             Bottles of 20                           NDC 21695-052-20 Bottles of 30                           NDC 21695-052-30 Bottles of 60                           NDC 21695-052-60 Bottles of 90                           NDC 21695-052-90 Fluoxetine Capsules USP, 20 mg* are opaque green cap/opaque off white body, size ‘3’ hard gelatin capsule filled with white to off-white granular powder and imprinted with ‘E’ on opaque green cap and ‘91’ on opaque off white body with black ink.            Bottles of 30                           NDC 21695-053-30 Bottles of 60                           NDC 21695-053-60 Bottles of 90                           NDC 21695-053-90 *Fluoxetine base equivalent. 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]. Preserve in tight, light-resistant containers.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

FLUOXETINE- FLUOXETINE HYDROCHLORIDE CAPSULE
Rebel Distributors Corp
----------
MEDICATION GUIDE
Fluoxetine Capsules, USP
Read the Medication Guide that comes with fluoxetine capsules 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.
What is the most important information I should know about fluoxetine
capsules?
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
1.
Antidepressant medicines may increase suicidal thoughts or actions in
some children, teenagers,
and young adults within the first few months of treatment.
2.
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.
3.
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 about
symptoms.
Call a healthcare pro

Summary of Product characteristics

FLUOXETINE- FLUOXETINE HYDROCHLORIDE CAPSULE
REBEL DISTRIBUTORS CORP
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUOXETINE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR FLUOXETINE CAPSULES.
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_
_SYMBYAX._
RECENT MAJOR CHANGES
Indications and Usage, Fluoxetine Capsules and Olanzapine in
Combination:
Depressive Episodes Associated with Bipolar I Disorder
(1.5)
03/2009
Dosage and Administration, Fluoxetine Capsules 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 capsules are 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 capsules 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 (initial dose)
10 mg/day (initial dos