VENLAFAXINE HYDROCHLORIDE capsule, extended release

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

ACETRIS HEALTH, LLC

INN (International Adı):

VENLAFAXINE HYDROCHLORIDE

Kompozisyon:

VENLAFAXINE 37.5 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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 extended-r

Ürün özeti:

Venlafaxine Hydrochloride Extended-Release Capsules USP , 37.5 mg  are white to off white spherical to oval pellets filled in empty hard gelatin capsule shell (size ‘3’) of opaque grey color cap and opaque peach color body imprinted with “E” on cap and “73” on the body with edible black ink. Bottles of 30                                       NDC 52343-131-30 Bottles of 90                                       NDC 52343-131-90 Venlafaxine Hydrochloride Extended-Release Capsules USP , 75 mg   are white to off white spherical to oval pellets filled in empty hard gelatin capsule shell (size ‘1’) of opaque peach color cap and opaque peach color body imprinted with “E” on cap and “74” on the body with edible black ink.   Bottles of 30                                       NDC 52343-132-30 Bottles of 90                                       NDC 52343-132-90 Venlafaxine Hydrochloride Extended-Release Capsules USP , 150 mg  are white to off white spherical to oval pellets filled in empty hard gelatin capsule shell (size ‘0’) of opaque dark orange color cap and opaque dark orange color body imprinted with “E” on cap and “89” on the body with edible black ink. Bottles of 30                                       NDC 52343-133-30 Bottles of 90                                       NDC 52343-133-90 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Yetkilendirme durumu:

Abbreviated New Drug Application

Bilgilendirme broşürü

ACETRIS HEALTH, LLC
----------
MEDICATION GUIDE
Venlafaxine Hydrochloride Extended-Release Capsules USP
(ven'' la fax' een hye'' droe klor' ide)
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 restless
•
trouble sleeping
•
other unusual changes in behavior or mood
What ar

Ürün özellikleri

VENLAFAXINE HYDROCHLORIDE - VENLAFAXINE HYDROCHLORIDE CAPSULE,
EXTENDED RELEASE
ACETRIS HEALTH, LLC
----------
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 total da