FLUOXETINE HYDROCHLORIDE capsule, delayed release pellets

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Dr.Reddy's Laboratories Limited

INN (International Name):

Fluoxetine hydrochloride

Composition:

Fluoxetine 90 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fluoxetine delayed-release capsules are indicated for the treatment of: • Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)] . The use of MAOIs intended to treat psychiatric disorders with fluoxetine or within 5 weeks of stopping treatment with fluoxetine is contraindicated because of an increased risk of serotonin syndrome. The use of fluoxetine within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated [see Dosage and Administration (2.9) and Warnings and Precautions (5.2) ]. Starting fluoxetine 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 (2.10) and Warnings and Precautions (5.2) ]. The use of fluoxetine is contraindicated with the following: - Pimozide [see Warnings and Precautions (5.11) and Drug Interactions (7.7, 7.8) ]. - Thioridazine [see Warnings and Precautions (

Product summary:

Fluoxetine delayed release capsules USP, 90 mg are white to off-white, elliptical to spherical pellets filled in size ‘0el’ hard gelatin capsule shell with brown opaque colored cap and white opaque colored body imprinted “RDY” on cap and “284” on body with black ink and are supplied in unit-dose packages of 4 (1 x 4). Unit-dose packages of 4 (1 x 4)                                              NDC 55111-284-48 Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

FLUOXETINE HYDROCHLORIDE- FLUOXETINE HYDROCHLORIDE CAPSULE, DELAYED
RELEASE PELLETS
Dr.Reddy's Laboratories Limited
----------
Medication Guide
Fluoxetine (floo ox’ e teen) Delayed-Release Capsules, USP
(Once-Weekly)
Read the Medication Guide that comes with fluoxetine delayed-release
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
want to learn more about.
What is the most important information I should know about fluoxetine
delayed-release capsules?
Fluoxetine delayed-release capsules and other antidepressant medicines
may cause serious side effects,
including:
1. Suicidal thoughts or actions:
•
Fluoxetine delayed-release 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
delayed-release 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
•
acting on dangerous impulses
•
acting aggressive or violent
•
thoughts about suicide or dying
•
new or worse depression
•
new or worse anxiety or panic attacks
•
feeling agitated, restless, angry or irri

Summary of Product characteristics

FLUOXETINE HYDROCHLORIDE- FLUOXETINE HYDROCHLORIDE CAPSULE, DELAYED
RELEASE PELLETS
DR.REDDY'S LABORATORIES LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUOXETINE DELAYED-
RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR FLUOXETINE
DELAYED-RELEASE CAPSULES.
FLUOXETINE DELAYED-RELEASE CAPSULES (ONCE-WEEKLY), FOR ORAL USE
INITIAL U.S. APPROVAL: 2001
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
INCREASED RISK OF SUICIDAL THINKING AND BEHAVIOR IN CHILDREN,
ADOLESCENTS, AND
YOUNG ADULTS TAKING ANTIDEPRESSANTS (5.1).
MONITOR FOR WORSENING AND EMERGENCE OF SUICIDAL THOUGHTS AND BEHAVIORS
(5.1).
RECENT MAJOR CHANGES
Warnings and Precautions, Serotonin Syndrome (5.2) 07/2023
Warnings and Precautions (5.7) 07/2023
INDICATIONS AND USAGE
Fluoxetine delayed-release capsules are selective serotonin reuptake
inhibitor indicated for:
Acute and maintenance treatment of Major Depressive Disorder (MDD) (1)
DOSAGE AND ADMINISTRATION
INDICATION
ADULT
PEDIATRIC
MDD (2.1)
20 mg/day in am (initial dose)
10 to 20 mg/day (initial dose)
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)
Dosing with fluoxetine weekly capsules - initiate 7 days after the
last daily dose of fluoxetine 20 mg (2.1)
DOSAGE FORMS AND STRENGTHS
Weekly capsules: 90 mg (3)
CONTRAINDICATIONS
Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat
psychiatric disorders with
fluoxetine or within 5 weeks of stopping treatment with fluoxetine. Do
not use fluoxetine within 14 days
of stopping an MAOI intended to treat psychiatric disorders. In
addition, do not start fluoxetine in a
patient who is being treated with linezolid or intravenous methylene
blue (4.1)
Pimozide: Do not use. Risk of QT prolongation and drug interaction
(4.2, 5.11, 7.7, 7.8)
Thioridazine: Do not u