VENLAFAXINE HYDROCHLORIDE capsule, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals Inc.

INN (International Name):

VENLAFAXINE HYDROCHLORIDE

Composition:

VENLAFAXINE 150 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of: Venlafaxine hydrochloride extended-release capsules is contraindicated in patients: Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including venlafaxine hydrochloride extended-release capsules, 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 la

Product summary:

Venlafaxine Hydrochloride Extended-Release Capsules USP, 150 mg are white to off-white free flowing pellets filled in size '0' hard gelatin capsules with dark orange colored cap printed with "ZA-37" in black ink & white body printed with "150 mg" in black ink and are supplied as follows: Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Preferred Pharmaceuticals Inc.
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SPL MEDGUIDE
Medication Guide
Venlafaxine Hydrochloride
(ven" la fax' een hye" droe klor' ide)
Extended-Release Capsules, USP
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 is not
for use in children.
o
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?
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 your healthcare provider right away to report new or sudden
changes in mood, behavior,
thoughts, or feelings.
o
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
• thoughts about suicide or dying
• acting aggressive, being angry, or
violent
• acting on dangerous impulses
• new or worse depression
• new or worse anxiety
• panic attacks
• feeling very agitated or restless
• new or worse irritability
• trouble sleeping
• an extreme increase in activity or
talking (mania)
• other unusual changes in behavior or mo

Summary of Product characteristics

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
PREFERRED 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
ANTIDEPRESSANTS INCREASED THE RISK OF SUICIDAL THOUGHTS AND BEHAVIOR
IN PEDIATRIC AND
YOUNG ADULT PATIENTS IN SHORT-TERM STUDIES. CLOSELY MONITOR ALL
ANTIDEPRESSANT-TREATED
PATIENTS FOR CLINICAL WORSENING AND EMERGENCE OF SUICIDAL THOUGHTS AND
BEHAVIORS _[SEE_
_WARNINGS AND PRECAUTIONS (5.1)]_ .
VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES ARE NOT APPROVED
FOR USE IN
PEDIATRIC PATIENTS _[SEE USE IN SPECIFIC POPULATIONS (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
Venlafaxine hydrochloride extended-release capsules are a serotonin
and norepinephrine reuptake
inhibitor (SNRI) indicated for the treatment of adults with:
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•
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DOSAGE AND ADMINISTRATION
INDICATION
STARTING DOSE
TARGET DOSE
MAXIMUM DOSE
MDD (2.2)
37.5 mg/day to 75 mg/day
75 mg/day
225 mg/day
GAD (2.3)
37.5 mg/day 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
•
•
•
•
Major Depressive Disorder (MDD) (1)
Generalized Anxiety Disorder (GAD) (1)
Social Anxiety Disorder (SAD) (1)
Panic Disorder (PD) (1)
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).
R