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:

State of Florida DOH Central Pharmacy

INN (International Name):

FLUOXETINE HYDROCHLORIDE

Composition:

FLUOXETINE HYDROCHLORIDE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fluoxetine hydrochloride 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 reevaluated [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 tr

Product summary:

Fluoxetine capsules USP, 10 mg, 20 mg, and 40 mg are available as: 10 mg: white capsules, imprinted GG 575 with single green ink bands, filled with white powder. 20 mg: white capsules, imprinted GG 550 with green and black ink bands, filled with white powder. 40 mg: white capsules, imprinted GG 540 with single orange ink bands, filled with white powder. They are supplied by State of Florida DOH Central Pharmacy as follows: Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Protect from light.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

FLUOXETINE HYDROCHLORIDE - FLUOXETINE HYDROCHLORIDE CAPSULE
State of Florida DOH Central Pharmacy
----------
MEDICATION GUIDE
Fluoxetine Capsules
Read the Medication Guide that comes with fluoxetine capsules 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 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

Summary of Product characteristics

FLUOXETINE HYDROCHLORIDE - FLUOXETINE HYDROCHLORIDE CAPSULE
STATE OF FLORIDA DOH CENTRAL PHARMACY
----------
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.
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).
RECENT MAJOR CHANGES
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)
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)
–
Consider tapering the dose of fluoxetine for pregnant women during the
third trimester (2.7)
A lower or less frequent dosage should be used in patients with
hepatic impairment, the elderly, and for patients with
concurrent disease or on multiple concomitant medications (2.7)
DOSAGE FORMS AND STRENGTHS
Capsules: 10 mg, 20 mg, 40 mg (3) (3)
CONTRAINDICATIONS
Do not use with an MAOI or within 14 days of discontinuing an MAOI due
to risk of drug interaction. At least 5 weeks
should be allowed af