SENTRAFLOX AM-10- fluoxetine hydrochloride, choline kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physician Therapeutics LLC

INN (International Name):

FLUOXETINE HYDROCHLORIDE

Composition:

FLUOXETINE HYDROCHLORIDE 10 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 bi

Product summary:

Fluoxetine Capsules USP 10 mg are available as white, opaque capsules in bottles of 100, 500 and 1000, printed PLIVA 647 in green band on cap and body. 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). How Supplied  Sentra AM is supplied in opaque orange and white, size 0 capsules in bottles of 60 capsules.  Physician Supervision Sentra AM is a Medical Food product available by prescription only and must be used while the patient is under ongoing physician supervision.  U.S. patent pending.  Manufactured by Arizona Nutritional Supplements, Inc. Chandler AZ 85225  Distributed by Physician Therapeutics LLC, Los Angeles, CA 90077. www.ptlcentral.com   Copyright 2003-2006, Physician Therapeutics LLC, all rights reserved  NDC # 68405-1002-02

Authorization status:

unapproved drug other

Patient Information leaflet

SENTRAFLOX AM-10 - FLUOXETINE HYDROCHLORIDE, CHOLINE
Physician Therapeutics LLC
Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been
approved by FDA. For further information about unapproved drugs, click
here.
----------
MEDICATION GUIDE
FLUOXETINE CAPSULES USP
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 fee

Summary of Product characteristics

SENTRAFLOX AM-10 - FLUOXETINE HYDROCHLORIDE, CHOLINE
PHYSICIAN THERAPEUTICS LLC
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
----------
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. 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 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 A