FLUOXETINE- fluoxetine capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

FLUOXETINE HYDROCHLORIDE

Composition:

FLUOXETINE 40 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fluoxetine capsules, USP are 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 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 individual patient [see Dosage and Administration (2.2) ] . Fluoxetin

Product summary:

Fluoxetine Capsules, USP 40mg * are green opaque cap with orange opaque body, hard gelatin #2 capsules filled with white to off-white powder, imprinted with "RX632" on the cap and body in black ink.  They are available as follows: Bottle of 30  NDC: 35356-729-30 Store at 20 - 25° C (68 - 77° F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

FLUOXETINE- FLUOXETINE CAPSULE
Lake Erie Medical DBA Quality Care Products LLC
----------
FLUOXETINE (floo-OX-e-teen) CAPSULES, USP
Rx only
Read the Medication Guide that comes with fluoxetine capsules, USP
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
capsules, USP?
Fluoxetine capsules, USP and other antidepressant medicines may cause
serious side effects, including:
1. Suicidal thoughts or actions:
• Fluoxetine capsules, USP 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 capsules, USP 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 behavio

Summary of Product characteristics

FLUOXETINE- FLUOXETINE CAPSULE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUOXETINE TABLETS, USP SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR FLUOXETINE TABLETS, 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
Warnings and Precautions:
Use in Patients with Concomitant Illness, Acute Narrow-Angle Glaucoma
(5.10) 06/2011
INDICATIONS AND USAGE
Fluoxetine capsules, USP is a selective serotonin reuptake inhibitor
indicated for: (1)
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, USP and olanzapine in combination_ for: (1)
Acute treatment of Depressive Episodes Associated with Bipolar I
Disorder in adults (1.5)
DOSAGE AND ADMINISTRATION
INDIC ATIO N
ADULT
PE DIATRIC
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 ola