VENLAFAXINE HYDROCHLORIDE capsule, extended release

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

RPK Pharmaceuticals, Inc.

INN (International Name):

VENLAFAXINE HYDROCHLORIDE

Sammensætning:

VENLAFAXINE 150 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of: -   Major Depressive Disorder (MDD) [see Clinical Studies (14.1)] - Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)] -   Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)] -   Panic Disorder (PD) [see Clinical Studies (14.4)] Venlafaxine hydrochloride extended-release capsules are contraindicated in patients: - with known hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate or to any excipients in the formulation [see Adverse Reactions (6.2)]. - taking, or within 14 days of stopping, MAOIs (including the MAOIs linezolid and intravenous methylene blue) because of the risk of serotonin syndrome [see Dosage and Administration (2.11), Warnings and Precautions (5.2), and Drug Interactions (7.1)]. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including venlafaxine hydrochloride exten

Produkt oversigt:

Product: 53002-1361 NDC: 53002-1361-3 30 CAPSULE, EXTENDED RELEASE in a BOTTLE NDC: 53002-1361-9 90 CAPSULE, EXTENDED RELEASE in a BOTTLE Product: 53002-1365 NDC: 53002-1365-3 30 CAPSULE, EXTENDED RELEASE in a BOTTLE NDC: 53002-1365-9 90 CAPSULE, EXTENDED RELEASE in a BOTTLE Product: 53002-1366 NDC: 53002-1366-3 30 CAPSULE, EXTENDED RELEASE in a BOTTLE NDC: 53002-1366-9 90 CAPSULE, EXTENDED RELEASE in a BOTTLE

Autorisation status:

Abbreviated New Drug Application

Indlægsseddel

RPK Pharmaceuticals, Inc.
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Dispense with Medication Guide available at: www.tevausa.com/medguides
MEDICATION GUIDE
Venlafaxine Hydrochloride (ven′′ la fax′ een hye′′ droe
klor′ ide)
Extended-Release Capsules
What is the most important information I should know about venlafaxine
hydrochloride extended-release capsules?
Venlafaxine hydrochloride extended-release capsules may cause serious
side effects, including:
•
Increased risk of suicidal thoughts and actions Venlafaxine
hydrochloride extended-release capsules 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. Venlafaxine hydrochloride extended-release
capsules are 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

Produktets egenskaber

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
RPK PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VENLAFAXINE
HYDROCHLORIDE EXTENDED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING
INFORMATION FOR VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES.
VENLAFAXINE HYDROCHLORIDE 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).
• VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES ARE 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 (5.7) 11/2021
Warnings and Precautions (5.1, 5.2, 5.4, 5.5, 5.6, 5.7, 5.8) 8/2022
INDICATIONS AND USAGE
Venlafaxine hydrochloride extended-release capsules are 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 to 75 mg/day
75 mg/day
225 mg/day
GAD (2.3)
37.5 to 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 tot