FLUOXETINE- fluoxetine hydrochloride capsule

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

NCS HealthCare of KY, Inc dba Vangard Labs

DCI (Dénomination commune internationale):

FLUOXETINE HYDROCHLORIDE

Composition:

FLUOXETINE HYDROCHLORIDE 20 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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 binge

Descriptif du produit:

Fluoxetine Capsules USP 20 mg are available as white to off-white, powder-filled aqua blue opaque hard gelatin capsules, radial spin printed and “4356” on the cap and “20 mg” on the body in black ink, containing fluoxetine hydrochloride equivalent to 20 mg fluoxetine packaged in blisterpacks of 30, and 31 Capsules. 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).

Statut de autorisation:

Abbreviated New Drug Application

Notice patient

FLUOXETINE- FLUOXETINE HYDROCHLORIDE CAPSULE
NCS HealthCare of KY, Inc dba Vangard Labs
----------
MEDICATION GUIDE
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
fluoxetinecapsules 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
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

Résumé des caractéristiques du produit

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:
(1)
• Acute and maintenance treatment of Major Depressive Disorder (MDD)
in adult and pediatric patients aged 8 to 18 years
(1.1) (1)
• Acute and maintenance treatment of Obsessive Compulsive Disorder
(OCD) in adult and pediatric patients aged 7 to 17
years (1.2) (1)
• Acute and maintenance treatment of Bulimia Nervosa in adult
patients (1.3) (1)
• Acute treatment of Panic Disorder, with or without agoraphobia, in
adult patients (1.4) (1)
_Fluoxetine and olanzapine in combination for:_ (1)
• Acute treatment of Depressive Episodes Associated with Bipolar I
Disorder in adults (1.5) (1)
DOSAGE AND ADMINISTRATION
INDICATION
ADULT
PEDIATRIC
MDD (2.1)
20 mg/day in am (initial dose)
10 to 20