VENLAFAXINE HYDROCHLORIDE capsule, extended release

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Aurobindo Pharma Limited

INN (Nome Internazionale):

VENLAFAXINE HYDROCHLORIDE

Composizione:

VENLAFAXINE 37.5 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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

Dettagli prodotto:

Venlafaxine Hydrochlorid e 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 15                                       NDC 65862-527-47 Bottles of 30                                       NDC 65862-527-30 Bottles of 90                                       NDC 65862-527-90 Bottles of 100                                     NDC 65862-527-01 Bottles of 1,000                                  NDC 65862-527-99 Bottles of 5,000                                  NDC 65862-527-59 10 x 10 Unit-dose Capsules                NDC 65862-527-10 Venlafaxine Hydrochlorid e 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 15                                       NDC 65862-528-47 Bottles of 30                                       NDC 65862-528-30 Bottles of 90                                       NDC 65862-528-90 Bottles of 100                                     NDC 65862-528-01 Bottles of 1,000                                  NDC 65862-528-99 Bottles of 3,500                                  NDC 65862-528-35 10 x 10 Unit-dose Capsules                NDC 65862-528-10 Venlafaxine Hydrochlorid e 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 15                                      NDC 65862-697-47 Bottles of 30                                      NDC 65862-697-30 Bottles of 90                                      NDC 65862-697-90 Bottles of 100                                    NDC 65862-697-01 Bottles of 500                                    NDC 65862-697-05 Bottles of 2,500                                 NDC 65862-697-26 10 x 10 Unit-dose Capsules               NDC 65862-697-10 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

Aurobindo Pharma Limited
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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
W

Scheda tecnica

VENLAFAXINE HYDROCHLORIDE - VENLAFAXINE HYDROCHLORIDE CAPSULE,
EXTENDED RELEASE
AUROBINDO PHARMA LIMITED
----------
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
Warnings and Precautions (5.2, 5.4) 8/2023
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 daily dose by 50% or more in patients undergoing dialysis or
with severe renal impairment
(2.9).
Hepatic impairment: reduce the daily dose by 50% in patients with mild
to moderate hepatic