FLUOXETINE capsule

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Medsource Pharmaceuticals

INN (International ime):

FLUOXETINE HYDROCHLORIDE

Sastav:

FLUOXETINE 20 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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 re-evaluated [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 capsules 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 re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2.2) ]. Fluoxetine capsules are i

Proizvod sažetak:

16.1 How Supplied Fluoxetine Capsules USP 10 mg* are white to off-white powder filled in size ‘2’ hard gelatin capsules with opaque light blue cap and opaque light blue body, imprinted “FLUOXETINE” on cap and “R147” on body, with white ink and are supplied in bottles of 30, 90 and 100.   10 mg                                                                                                                                                                                                                                                                                Bottles of 30                                                               NDC 55111-147-30    Bottles of 90                                                               NDC 55111-147-90                Bottles of 100                                                             NDC 55111-147-01      Fluoxetine Capsules USP 20 mg* are white to off-white powder filled in size ‘2’ hard gelatin capsules with opaque light blue cap and opaque light torquoise blue body, imprinted “FLUOXETINE” on cap and “R148” on body, with black ink and are supplied in bottles of 30, 90, 100 and 1000.  20 mg Bottles of 30                                                      NDC 55111-148-30    Bottles of 90                                                      NDC 55111-148-90                Bottles of 100                                                    NDC 55111-148-01                Bottles of 1000                                                           NDC 55111-148-10      Fluoxetine Capsules USP 40 mg* are white to off-white powder filled in size ‘0’ hard gelatin capsules with opaque light blue cap and opaque white body, imprinted “FLUOXETINE” on cap and “R149” on body, with black ink and are supplied in bottles of 30, 90, 100 and 500.        40 mg                                                                                                                                                                                                                                                                                        Bottles of 30                                                               NDC 55111-149-30    Bottles of 90                                                               NDC 55111-149-90                Bottles of 100                                                            NDC 55111-149-01                Bottles of 500                                                             NDC 55111-149-05     * fluoxetine base equivalent   Protect From Light  Dispense in a tight, light-resistant container.

Status autorizacije:

Abbreviated New Drug Application

Uputa o lijeku

FLUOXETINE- FLUOXETINE CAPSULE
Medsource Pharmaceuticals
----------
MEDICATION GUIDE
Fluoxetine Capsules, USP
Read the Medication Guide that comes with fluoxetine 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?
Fluoxetine and other antidepressant medicines may cause serious side
effects, including:
1. Suicidal thoughts or actions:
•
Fluoxetine 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 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 behavior or mood
Call your healthcare provider right away if you have any of the
following symptom

Svojstava lijeka

FLUOXETINE- FLUOXETINE CAPSULE
MEDSOURCE PHARMACEUTICALS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
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 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 FLUOXETINE HYDROCHLORIDE AND OLANZAPINE CAPSULES.
RECENT MAJOR CHANGES
Warnings and Precautions:
Use in Patients with Concomitant Illness, Acute Narrow-Angle Glaucoma
(5.10) dd/yyyy
INDICATIONS AND USAGE
Fluoxetine capsules are 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 and olanzapine in combination for: (1)
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 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 olanzapine and
20 mg of