FLUOXETINE- fluoxetine hydrochloride capsule

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

State of Florida DOH Central Pharmacy

Designació comuna internacional (DCI):

FLUOXETINE HYDROCHLORIDE

Composición:

FLUOXETINE 10 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Fluoxetine capsules 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 reevaluated [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 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 reevaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2.2) ]. Fluoxetine capsules are indicated for the

Resumen del producto:

Fluoxetine Capsules, USP are available containing fluoxetine hydrochloride, USP equivalent to 10 mg, 20 mg or 40 mg of fluoxetine. The 10 mg capsule is a hard-shell gelatin capsule with a white opaque cap and a flesh opaque body axially printed with MYLAN over 4210 in black ink on both the cap and the body. The capsule is filled with white to off-white powder. The 20 mg capsule is a hard-shell gelatin capsule with a light turquoise blue opaque cap and a flesh opaque body axially printed with MYLAN over 4220 in black ink on both the cap and the body. The capsule is filled with white to off-white powder. The 40 mg capsule is a hard-shell gelatin capsule with a light blue opaque cap and a white opaque body axially printed with MYLAN over 4350 in black ink on both the cap and the body. The capsule is filled with white to off-white powder. They are supplied by State of Florida DOH Central Pharmacy as follows: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light.

Estat d'Autorització:

Abbreviated New Drug Application

Informació per a l'usuari

FLUOXETINE - 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.
What is the most important information I should know about fluoxetine?
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 provider right awa

Fitxa tècnica

FLUOXETINE - 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 CAPSULES.
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 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:
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 and olanzapine in combination _for:
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 Diso