SARAFEM- fluoxetine hydrochloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Allergan, Inc.

INN (International Name):

FLUOXETINE HYDROCHLORIDE

Composition:

FLUOXETINE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

SARAFEM is indicated for the treatment of premenstrual dysphoric disorder (PMDD) [see   Clinical Studies (14.1) ].   The effectiveness of SARAFEM in long-term use (that is, for more than 6 months) has not been systematically evaluated in placebo-controlled trials. The use of SARAFEM for extended periods should be periodically re-evaluated for the individual patient [see   Dosage and Administration (2.1) ]. The use of MAOIs intended to treat psychiatric disorders with SARAFEM or within 5 weeks of stopping treatment with SARAFEM is contraindicated because of an increased risk of serotonin syndrome. The use of SARAFEM within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated [se e Dosage and Administration (2.4)  and Warnings and Precautions (5.2) ]. Starting SARAFEM in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see Dosage and Administration (2.5)

Authorization status:

New Drug Application

Patient Information leaflet

SARAFEM- FLUOXETINE HYDROCHLORIDE TABLET
Allergan, Inc.
----------
Medication Guide
SARAFEM® (SAIR-a-fem)
(fluoxetine hydrochloride)
Tablets
Read the Medication Guide that comes with SARAFEM 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 you want to learn more about.
SARAFEM is in a class of drugs called selective serotonin reuptake
inhibitors (SSRIs), which are often
used for the treatment of depression and anxiety disorders. Although
SARAFEM is not a treatment for
depression, it contains fluoxetine hydrochloride, the same active
ingredient in some antidepressants.
What is the most important information I should know about SARAFEM?
SARAFEM and other antidepressant medicines may cause serious side
effects including:
1. Suicidal thoughts or actions:
•
SARAFEM 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 SARAFEM 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 depressi

Summary of Product characteristics

SARAFEM- FLUOXETINE HYDROCHLORIDE TABLET
ALLERGAN, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SARAFEM SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
SARAFEM.
SARAFEM (FLUOXETINE HYDROCHLORIDE TABLETS) 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. SARAFEM IS NOT APPROVED FOR USE IN PEDIATRIC
PATIENTS (5.1).
RECENT MAJOR CHANGES
Warnings and Precautions (5.2) 01/2017
INDICATIONS AND USAGE
SARAFEM is a selective serotonin reuptake inhibitor (SSRI) indicated
for
the treatment of Premenstrual Dysphoric Disorder (PMDD) (1.1)
DOSAGE AND ADMINISTRATION
20 mg/day continuously or intermittently (2.1)
DOSAGE FORMS AND STRENGTHS
Tablets: 10 mg, 15 mg, 20 mg (3)
CONTRAINDICATIONS
Serotonin Syndrome and MAOIs: Do not use with MAOIs intended to treat
psychiatric disorders with
SARAFEM or within 5 weeks of stopping treatment with SARAFEM. Do not
use SARAFEM within 14 days
of stopping an MAIO intended to treat psychiatric disorders. In
addition, do not start SARAFEM in a
patient who is being treated with linezolid or intravenous methylene
blue (4.1)
Do not use with pimozide due to risk of drug interaction or QT
prolongation (4.2, 7.9)
Do not use with thioridazine due to QTc interval prolongation or
potential for elevated thioridazine
plasma levels. Do not use thioridazine within 5 weeks of discontinuing
SARAFEM (4.2, 7.9)
WARNINGS AND PRECAUTIONS
_Clinical Worsening and Suicide Risk:_ Monitor for clinical worsening
and suicidal thinking and behavior (5.1)
_Serotonin Syndrome:_ Serotonin syndrome has been reported with SSRIs
and SNRIs, including SARAFEM,
both when taken alone, but especially when co-administered with other
serotonergic agents (including
tript