VENLAFAXINE HYDROCHLORIDE capsule, extended release

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Zydus Pharmaceuticals USA Inc.

INN (Isem Internazzjonali):

VENLAFAXINE HYDROCHLORIDE

Kompożizzjoni:

VENLAFAXINE 37.5 mg

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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 is 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-rele

Sommarju tal-prodott:

Venlafaxine Hydrochloride Extended-Release Capsules USP, 37.5 mg are white to off-white free flowing pellets filled in size '3' hard gelatin capsules with grey colored cap printed with "ZA-35" in black ink & white body printed with "37.5 mg" in black ink and are supplied as follows: NDC 68382-034-06 in bottle of 30 capsules with child-resistant closure NDC 68382-034-16 in bottle of 90 capsules with child-resistant closure NDC 68382-034-10 in bottle of 1,000 capsules Venlafaxine Hydrochloride Extended-Release Capsules USP, 75 mg are white to off-white free flowing pellets filled in size '1' hard gelatin capsules with peach colored cap printed with "ZA-36" in black ink & white body printed with "75 mg" in black ink and are supplied as follows: NDC 68382-035-06 in bottle of 30 capsules with child-resistant closure NDC 68382-035-16 in bottle of 90 capsules with child-resistant closure NDC 68382-035-10 in bottle of 1,000 capsules 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: NDC 68382-036-06 in bottle of 30 capsules with child-resistant closure NDC 68382-036-16 in bottle of 90 capsules with child-resistant closure NDC 68382-036-10 in bottle of 1,000 capsules Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container.

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Fuljett ta 'informazzjoni

Zydus Pharmaceuticals USA 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.
•
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
• 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 behavi

Karatteristiċi tal-prodott

VENLAFAXINE HYDROCHLORIDE - VENLAFAXINE HYDROCHLORIDE CAPSULE,
EXTENDED RELEASE
ZYDUS PHARMACEUTICALS USA INC.
----------
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:
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 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
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 tot