PRISTIQ EXTENDED-RELEASE- desvenlafaxine succinate tablet, extended release

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

DESVENLAFAXINE SUCCINATE (UNII: ZB22ENF0XR) (DESVENLAFAXINE - UNII:NG99554ANW)

Tilgjengelig fra:

Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

INN (International Name):

DESVENLAFAXINE SUCCINATE

Sammensetning:

DESVENLAFAXINE 50 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

PRISTIQ is indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14)] . Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185. Risk Summary Based on data from published observational studies, exposure to SNRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see Warnings and Precautions (5.4) and Clinical Considerations] . There are no published studies on PRISTIQ in pregnant women; however published epidemiologic studies of pregnant women exposed to venlafaxine, the parent compound, have not reported a clear association with adverse developmental outcomes (see Data) . There are risks associated with untreated depression in pregnancy and with expos

Produkt oppsummering:

PRISTIQ® (desvenlafaxine) extended-release tablets are available as follows: 25 mg, tan, square pyramid tablet debossed with "W" (over) "25" on the flat side 50 mg, light pink, square pyramid tablet debossed with "W" (over) "50" on the flat side 100 mg, reddish-orange, square pyramid tablet debossed with "W" (over) "100" on the flat side Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] . Each tablet contains 38 mg, 76 mg or 152 mg of desvenlafaxine succinate equivalent to 25 mg, 50 mg or 100 mg of desvenlafaxine, respectively.

Autorisasjon status:

New Drug Application

Informasjon til brukeren

Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
----------
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Revised: 8/2023
MEDICATION GUIDE
PRISTIQ® (pris-TEEK)
(desvenlafaxine)
extended-release tablets
What is the most important information I should know about PRISTIQ?
PRISTIQ can cause serious side effects, including:
•
Increased risk of suicidal thoughts or actions in some children and
young adults within the first few
months of treatment. PRISTIQ is not for use in children.
•
Depression or other serious mental illnesses are the most important
causes of suicidal thoughts or
actions.
How can I watch for and try to prevent suicidal thoughts and actions?
o
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.
o
Call the healthcare provider right away to report new or sudden
changes in mood, behavior,
thoughts, or feelings.
o
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 your healthcare provider right away if you have any of the
following symptoms,
especially if they are new, worse, or worry you:
o
thoughts about suicide or dying
o
attempts to commit suicide
o
new or worse depression
o
new or worse anxiety
o
feeling very agitated or restless
o
panic attacks
o
trouble sleeping (insomnia)
o
new or worse irritability
o
acting aggressive, being angry, or violent
o
acting on dangerous impulses
o
an extreme increase in activity and talking (mania)
o
other unusual changes in behavior or mood
What is PRISTIQ?
•
PRISTIQ is a prescription medicine used to treat adults with a certain
type of depression called
major depressive disorder (MDD). PRISTIQ belongs to a class of
medicines known as serotonin
and norepinephrine reuptake inhibitors (SNRIs).
Do not take PRISTIQ if you:
•
are allergic to desvenlafax

Preparatomtale

PRISTIQ EXTENDED-RELEASE- DESVENLAFAXINE SUCCINATE TABLET, EXTENDED
RELEASE
WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PRISTIQ SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PRISTIQ.
PRISTIQ (DESVENLAFAXINE) EXTENDED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2008
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
•
RECENT MAJOR CHANGES
Warnings and Precautions (5.2, 5.4)
8/2023
INDICATIONS AND USAGE
PRISTIQ is a serotonin and norepinephrine reuptake inhibitor (SNRI)
indicated for the treatment of adults
with major depressive disorder (MDD) (1).
DOSAGE AND ADMINISTRATION
•
•
•
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
•
•
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
®
INCREASED THE RISK OF SUICIDAL THOUGHTS AND BEHAVIORS IN CHILDREN,
ADOLESCENTS AND
YOUNG ADULTS TAKING ANTIDEPRESSANTS (5.1).
CLOSELY MONITOR FOR CLINICAL WORSENING AND EMERGENCE OF SUICIDAL
THOUGHTS AND
BEHAVIORS (5.1).
PRISTIQ IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS (8.4).
Recommended dose: 50 mg once daily with or without food (2.1).
There was no evidence that doses greater than 50 mg per day confer any
additional benefit (2.1).
The 25 mg per day dose is intended for a gradual reduction in dose
when discontinuing treatment or
dosing in severe renal and end-stage renal disease patients (2.1).
Discontinuation: Reduce dose gradually whenever possible (2.1).
Take tablets whole; do not divide, crush, chew, or dissolve (2.1).
Moderate renal impairment: Maximum dose 50 mg per day (2.2).
Severe renal impairment and end-stage renal disease: Maximum dose 25
mg per day or 50 mg every
other day (2.2).
Moderate to severe hepatic impairment: Maximum dose 100 mg per day
(2.3).
PRISTIQ extended-release tablets: 25 mg, 50 mg and 100 mg (3).
Each tablet contains 38 mg, 76 mg or 152 mg of desvenlafaxine
succinate equivalent to