EFFEXOR XR- venlafaxine hydrochloride capsule, extended release

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE - UNII:GRZ5RCB1QG)

Tilgjengelig fra:

Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

INN (International Name):

VENLAFAXINE HYDROCHLORIDE

Sammensetning:

VENLAFAXINE 37.5 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Effexor XR is indicated in adults for the treatment of: Effexor XR is contraindicated in patients: Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including Effexor XR, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/ . Risk Summary Available data from published epidemiologic studies on venlafaxine use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse fetal outcomes (see Data) . Available data from observational studies with venlafaxine have identified a potential increased risk for preeclampsia when used during mid to late pregnancy; exposure to SNRIs near delivery may increase the risk for postpartum hemorrhage (see Clinical Considerations)

Produkt oppsummering:

Effexor XR® is available as: Store at controlled room temperature, 20° to 25°C (68° to 77°F).

Autorisasjon status:

New Drug Application

Informasjon til brukeren

Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
----------
This Medication was approved by the U.S. Food and Drug
Administration.
Revised: 8/2022
MEDICATION GUIDE
EFFEXOR XR (e-fex-or XR)
(venlafaxine extended-release)
capsules
What is the most important information I should know about EFFEXOR XR?
EFFEXOR XR may cause serious side effects, including:
•
Increased risk of suicidal thoughts and actions. EFFEXOR XR and other
antidepressant medicines
may increase suicidal thoughts and actions in some children,
adolescents, and young adults,
especially within the first few months of treatment or when the dose
is changed. EFFEXOR XR 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
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 your healthcare provider right away to report new or sudden
changes in mood, behavior,
thoughts, or feelings.
•
Keep all follow-up visits with your healthcare provider as scheduled.
Call your healthcare
provider between visits as needed, especially if you have concerns
about symptoms.
Call your healthcare provider or get emergency help right away if you
or a family member have any
of the following symptoms, especially if they are new, worse, or worry
you:
•
attempts to commit suicide
•
acting aggressive, being angry, or violent
•
new or worse depression
•
panic attacks
•
new or worse irritability
•
an extreme increase in activity or talking (mania)
•
thoughts about suicide or dying
•
acting on dangerous impulses
•
new or worse anxiety
•
feeling very agitated or restless
•
trouble sleeping
•
other unusual changes in
behavior or mood
What is EFFEXOR XR?
EFFEXOR XR is a prescription medicine used to treat adults wit

Preparatomtale

EFFEXOR XR- VENLAFAXINE HYDROCHLORIDE CAPSULE, 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
EFFEXOR XR SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR EFFEXOR XR.
EFFEXOR XR (VENLAFAXINE EXTENDED-RELEASE) CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
INCREASED RISK OF SUICIDAL THOUGHTS AND BEHAVIOR IN PEDIATRIC PATIENTS
AND YOUNG
ADULTS TAKING ANTIDEPRESSANTS. CLOSELY MONITOR ALL
ANTIDEPRESSANT-TREATED PATIENTS
FOR CLINICAL WORSENING AND EMERGENCE OF SUICIDAL THOUGHTS AND
BEHAVIORS (5.1).
EFFEXOR XR IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS (8.4).
RECENT MAJOR CHANGES
Boxed Warning
8/2022
Dosage and Administration (2.10)
11/2021
Dosage and Administration (2.2, 2.3, 2.6, 2.8, 2.9, 2.11)
8/2022
Warnings and Precautions (5.13)
9/2021
Warnings and Precautions (5.7)
11/2021
Warnings and Precautions (5.1, 5.2, 5.4, 5.5, 5.6, 5.7, 5.8)
8/2022
INDICATIONS AND USAGE
Effexor XR is a serotonin and norepinephrine reuptake inhibitor (SNRI)
indicated for the treatment of adults
with:
Major Depressive Disorder (MDD) (1)
Generalized Anxiety Disorder (GAD) (1)
Social Anxiety Disorder (SAD) (1)
Panic Disorder (PD) (1)
DOSAGE AND ADMINISTRATION
INDICATION
STARTING DOSE
TARGET DOSE
MAXIMUM DOSE
MDD (2.2)
37.5 –75 mg/day
75 mg/day
225 mg/day
GAD (2.3)
37.5 –75 mg/day
75 mg/day
225 mg/day
SAD (2.4)
75 mg/day
75 mg/day
75 mg/day
PD (2.5)
37.5 mg/day
75 mg/day
225 mg/day
Take once daily with food. Capsules should be taken whole; do not
divide, crush, chew, or dissolve (2.1).
When discontinuing treatment, reduce the dose gradually (2.10, 5.7).
Renal impairment: reduce the total daily dose by 25% to 50% in
patients with renal impairment. Reduce
the total daily dose by 50% or more in patients undergoing dialysis or
with severe renal impairment
(2.9).
Hepatic impairment: re