FLUOXETINE HYDROCHLORIDE- fluoxetine tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (International Name):

FLUOXETINE HYDROCHLORIDE

Composition:

FLUOXETINE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Major Depressive Disorder Fluoxetine is indicated for the treatment of major depressive disorder. Adult The efficacy of fluoxetine was established in 5- and 6-week trials with depressed adult and geriatric outpatients (≥18 years of age) whose diagnoses corresponded most closely to the DSM-III (currently DSM-IV) category of major depressive disorder (see CLINICAL TRIALS ). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The effects of fluoxetine in hospitalized depressed patients have not been adequately studi

Product summary:

Fluoxetine Tablets USP are available as follows: 10 mg†, oval, normal convex, film coated, scored white tablet, debossed “FL 10” on one side and “G” on the other Blistercards of 30 NDC 0615-5501-39 Blistercards of 31 NDC 0615-5501-31 20 mg†, oval, normal convex, film coated, scored white tablet, debossed “FL 20” on one side and “G” on the other Blistercards of 30 NDC 0615-5502-39 † Fluoxetine base equivalent. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as described in the USP. Protect from light. Sarafem® is a trademark of Eli Lilly.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

FLUOXETINE HYDROCHLORIDE- FLUOXETINE TABLET, FILM COATED
NCS HealthCare of KY, Inc dba Vangard Labs
----------
MEDICATION GUIDE
FLUOXETINE TABLETS USP
Rx only
Antidepressant Medicines, Depression and other Serious Mental
Illnesses, and Suicidal Thoughts or
Actions
Read the Medication Guide that comes with your or your family
member’s antidepressant medicine.
This Medication Guide is only about the risk of suicidal thoughts and
actions with antidepressant
medicines. 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
What is the most important information I should know about
antidepressant medicines, depression and
other serious mental illnesses, and suicidal thoughts or actions?
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 member has
any of the following s

Summary of Product characteristics

FLUOXETINE HYDROCHLORIDE- FLUOXETINE TABLET, FILM COATED
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
FLUOXETINE TABLETS USP
RX ONLY
BOXED WARNING
SUICIDALITY AND ANTIDEPRESSANT DRUGS
ANTIDEPRESSANTS INCREASED THE RISK COMPARED TO PLACEBO OF SUICIDAL
THINKING AND BEHAVIOR
(SUICIDALITY) IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS IN SHORT-TERM
STUDIES OF MAJOR
DEPRESSIVE DISORDER (MDD) AND OTHER PSYCHIATRIC DISORDERS. ANYONE
CONSIDERING THE USE OF
FLUOXETINE OR ANY OTHER ANTIDEPRESSANT IN A CHILD, ADOLESCENT, OR
YOUNG ADULT MUST BALANCE
THIS RISK WITH THE CLINICAL NEED. SHORT-TERM STUDIES DID NOT SHOW AN
INCREASE IN THE RISK OF
SUICIDALITY WITH ANTIDEPRESSANTS COMPARED TO PLACEBO IN ADULTS BEYOND
AGE 24; THERE WAS A
REDUCTION IN RISK WITH ANTIDEPRESSANTS COMPARED TO PLACEBO IN ADULTS
AGED 65 AND OLDER.
DEPRESSION AND CERTAIN OTHER PSYCHIATRIC DISORDERS ARE THEMSELVES
ASSOCIATED WITH
INCREASES IN THE RISK OF SUICIDE. PATIENTS OF ALL AGES WHO ARE STARTED
ON ANTIDEPRESSANT
THERAPY SHOULD BE MONITORED APPROPRIATELY AND OBSERVED CLOSELY FOR
CLINICAL WORSENING,
SUICIDALITY, OR UNUSUAL CHANGES IN BEHAVIOR. FAMILIES AND CAREGIVERS
SHOULD BE ADVISED OF
THE NEED FOR CLOSE OBSERVATION AND COMMUNICATION WITH THE PRESCRIBER.
FLUOXETINE IS
APPROVED FOR USE IN PEDIATRIC PATIENTS WITH MDD AND OBSESSIVE
COMPULSIVE DISORDER
(OCD). (SEE WARNINGS: CLINICAL WORSENING AND SUICIDE RISK,
PRECAUTIONS:
INFORMATION FOR PATIENTS, AND PRECAUTIONS: PEDIATRIC USE.)
DESCRIPTION
Fluoxetine hydrochloride is a psychotropic drug for oral
administration. It is also marketed for the
treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine
hydrochloride). It is designated
(±)-N-methyl-3-phenyl-3-[(α, α, α-trifluoro-_p-_tolyl)
oxy]propylamine hydrochloride and has the
molecular formula of C17H18F3NO•HCl. Its molecular weight is 345.79.
The structural formula is:
Fluoxetine hydrochloride is a white to off-white crystalline solid
with a solubility of 14 mg/mL in
water. Each tablet contains fluoxetine hydrochloride equivalent to 10