VENLAFAXINE HYDROCHLORIDE capsule, extended release

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Macleods Pharmaceuticals Limited

DCI (Dénomination commune internationale):

VENLAFAXINE HYDROCHLORIDE

Composition:

VENLAFAXINE 37.5 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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 hydr

Descriptif du produit:

• Venlafaxine hydrochloride extended-release capsules, USP are available as follows:  37.5 mg capsules:  Grey cap/peach body, size ‘3’ capsules containing white to off white extended release beads with ‘L 86’ on cap and ‘37.5’ on body imprinted with red ink and are available as follows:  Bottles of 30 capsules NDC 33342-194-07 Bottles of 90 capsules NDC 33342-194-10 Bottles of 100 capsules NDC 33342-194-11 Bottles of 500 capsules NDC 33342-194-15 Unit-Dose Blister Packages of 100 capsules NDC 33342-194-12 75 mg capsules:  Peach cap/peach body, size ‘1’ capsules containing white to off white extended release beads with ‘L 87’ on cap and ‘75’ on body imprinted with red ink and are available as follows: Bottles of 30 capsules NDC 33342-195-07 Bottles of 90 capsules NDC 33342-195-10 Bottles of 100 capsules NDC 33342-195-11 Bottles of 500 capsules NDC 33342-195-15 Unit-Dose Blister Packages of 140 capsules NDC 33342-195-56 150 mg capsules:  Dark orange cap/ dark orange body, size ‘0el’ capsules containing white to off white extended release beads with ‘L 88’ on cap and ‘150’ on body imprinted with white ink and are available as follows: Bottles of 30 capsules NDC 33342-196-07 Bottles of 90 capsules NDC 33342-196-10 Bottles of 100 capsules NDC 33342-196-11 Bottles of 500 capsules NDC 33342-196-15 Unit-Dose Blister Packages of 140 capsules NDC 33342-196-56 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Preserve in well-closed containers.

Statut de autorisation:

Abbreviated New Drug Application

Notice patient

Macleods Pharmaceuticals Limited
----------
SPL MEDGUIDE SECTION
MEDICATION GUIDE
Venlafaxine Hydrochloride Extended-Release Capsules
(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.
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

Résumé des caractéristiques du produit

VENLAFAXINE HYDROCHLORIDE - VENLAFAXINE HYDROCHLORIDE CAPSULE,
EXTENDED RELEASE
MACLEODS PHARMACEUTICALS 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