FLUOXETINE HYDROCHLORIDE- fluoxetine hydrochloride capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

INN (International Name):

FLUOXETINE HYDROCHLORIDE

Composition:

FLUOXETINE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fluoxetine capsules, USP are indicated for the treatment of premenstrual dysphoric disorder (PMDD). The efficacy of fluoxetine in the treatment of PMDD was established in three placebo-controlled trials (see CLINICAL TRIALS). The essential features of PMDD, according to the DSM-IV, include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating, and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated b

Product summary:

Fluoxetine Capsules, USP are available containing fluoxetine hydrochloride, USP equivalent to 10 mg or 20 mg of fluoxetine. The 10 mg capsule is a hard-shell gelatin capsule with a blue green opaque cap and a blue green opaque body axially printed with MYLAN over 5410 in black ink on both the cap and the body. The capsule is filled with white to off-white powder. They are available as follows: NDC 0378-5410-28 bottles of 28 capsules The 20 mg capsule is a hard-shell gelatin capsule with a red opaque cap and a red opaque body axially printed with MYLAN over 5420 in black ink on both the cap and the body. The capsule is filled with white to off-white powder. They are available as follows: NDC 0378-5420-28 bottles of 28 capsules 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 using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

FLUOXETINE HYDROCHLORIDE- FLUOXETINE HYDROCHLORIDE CAPSULE
Mylan Pharmaceuticals Inc.
----------
MEDICATION GUIDE
FLUOXETINE CAPSULES, USP
(floo oxʹ e teen)
10 mg and 20 mg
Read the Medication Guide that comes with fluoxetine capsules 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.
Fluoxetine capsules are in a class of drugs called selective serotonin
reuptake inhibitors (SSRIs), which
are often used for the treatment of depression and anxiety disorders.
Although fluoxetine capsules are 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 fluoxetine
capsules?
Fluoxetine capsules and other antidepressant medicines may cause
serious side effects including:
1. Suicidal thoughts or actions:
•
Fluoxetine capsules 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 capsules are
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
•
acti

Summary of Product characteristics

FLUOXETINE HYDROCHLORIDE- FLUOXETINE HYDROCHLORIDE CAPSULE
MYLAN PHARMACEUTICALS INC.
----------
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 CAPSULES 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 NOT
APPROVED FOR USE IN PEDIATRIC PATIENTS WITH MDD AND OBSESSIVE
COMPULSIVE DISORDER
(OCD). (SEE WARNINGS, PRECAUTIONS: INFORMATION FOR PATIENTS AND
PRECAUTIONS: PEDIATRIC USE.)
DESCRIPTION
Fluoxetine hydrochloride is a selective serotonin reuptake inhibitor
(SSRI) for oral administration;
fluoxetine was initially developed and marketed as an antidepressant
(Prozac
, fluoxetine capsules,
USP). It is designated
(±)-_N_-methyl-3-phenyl-3-[(α,α,α-trifluoro-_p_-tolyl)oxy]propylamine
hydrochloride
and has the molecular formula of C
H F NO•HCl. Its molecular weight is 345.79. The structural
formula is:
Fluoxetine hydrochloride, USP is a white to off-white crystalline
powder with a solubility of 14
mg/mL in water.
Each capsule contains fluoxetine hydrochloride, USP equivalent to 10
mg (32.3 µmol) or 20 mg (64.7
µmol) of fl