FLUOXETINE- fluoxetine hydrochloride capsule

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

Fluoxetine hydrochloride (UNII: I9W7N6B1KJ) (Fluoxetine - UNII:01K63SUP8D)

Pieejams no:

Prodigy Health Supplier

SNN (starptautisko nepatentēto nosaukumu):

Fluoxetine hydrochloride

Kompozīcija:

Fluoxetine 10 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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 b

Produktu pārskats:

The following products are manufactured: Capsules are available in 10 mg and 20 mg capsule strengths and packages as follows: Store at Controlled Room Temperature, 15° to 30°C (59° to 86°F).

Autorizācija statuss:

Abbreviated New Drug Application

Lietošanas instrukcija

FLUOXETINE - FLUOXETINE HYDROCHLORIDE CAPSULE
Prodigy Health Supplier
----------
MEDICATION GUIDE
FLUOXETINE
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
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 away if you or your family mem

Produkta apraksts

FLUOXETINE - FLUOXETINE HYDROCHLORIDE CAPSULE
PRODIGY HEALTH SUPPLIER
----------
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.
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).
RECENT MAJOR CHANGES
Warnings and Precautions:
Use in Patients with Concomitant Illness, Acute Narrow-Angle Glaucoma
(5.10) 06/2011
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)
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 (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 after stopping Fl