FLUOXETINE- fluoxetine capsules capsule

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

McKesson Packaging Services Business Unit of McKesson Corporation

INN (Nome Internazionale):

FLUOXETINE HYDROCHLORIDE

Composizione:

FLUOXETINE HYDROCHLORIDE 20 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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 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 treatment of bing

Dettagli prodotto:

The following products are manufactured by Alembic Limited, India. Fluoxetine Capsules USP, are available in: The 20-mg1 Capsule is a Dark blue opaque cap and Light blue opaque body, imprinted with “20” on the cap and “A106” on the body: NDC 63739-493-40 - Bottles of 1002 The 40-mg1 Capsule is a Light blue opaque cap and Light blue opaque body, imprinted with “40” on the cap and “A107” on the body: NDC 63739-494-40 - Bottles of 1002 _____________________ 1 Fluoxetine base equivalent 2 Protect from light.  Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59 to 86ºF), (See USP Controlled Room Temperature).

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

FLUOXETINE- FLUOXETINE CAPSULES CAPSULE
McKesson Packaging Services Business Unit of McKesson Corporation
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MEDICATION GUIDE
FLUOXETINE CAPSULES USP
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

Scheda tecnica

FLUOXETINE- FLUOXETINE CAPSULES CAPSULE
MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUOXETINE CAPSULES SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR FLUOXETINE CAPSULES.
FLUOXETINE CAPSULES 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 :
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 7-17
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 olazazpine 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