VENLAFAXINE HYDROCHLORIDE capsule, extended release

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Torrent Pharmaceuticals Limited

INN (International Name):

VENLAFAXINE HYDROCHLORIDE

Sammensætning:

VENLAFAXINE 37.5 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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 Effexor XR, duri

Produkt oversigt:

Venlafaxine hydrochloride extended-release capsules, USP are available as :      37.5 mg, size "4" hard gelatin capsule with grey cap and peach body printed with "37.5" on the body and "1018" on the cap with red ink containing white to off white pellets.          Bottles of 30                             NDC 13668-018-30 Bottles of 90                             NDC 13668-018-90 Bottles of 100                           NDC 13668-018-01 Bottles of 500                           NDC 13668-018-05  Bottles of 2600                         NDC 13668-018-45  75 mg, size "1" hard gelatin capsule with pink cap and body printed with "75" on the body and "1019" on the cap with red ink containing white to off white pellets.     Bottles of 30                             NDC 13668-019-30 Bottles of 90                             NDC 13668-019-90  Bottles of 100                           NDC 13668-019-01 Bottles of 500                           NDC 13668-019-05    Bottles of 850                           NDC 13668-019-46 150 mg, size "0" hard gelatin capsule with orange cap and body printed with "150" on the body and "1020" on the cap with white ink containing white to off white pellets.   Bottles of 30                             NDC 13668-020-30 Bottles of 90                             NDC 13668-020-90  Bottles of 100                           NDC 13668-020-01 Bottles of 500                           NDC 13668-020-05     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]. Dispense in a tight container with a child-resistant closure.

Autorisation status:

Abbreviated New Drug Application

Indlægsseddel

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
Torrent Pharmaceuticals Limited
----------
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 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 act

Produktets egenskaber

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
TORRENT 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
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, USP 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
INDICATIONSTARTING DOSE
TARGET DOSE MAXIMUM DOSE
MDD (2.2)
37.5 to 75 mg/day75 mg/day
225 mg/day
GAD (2.3)
37.5 to 75 mg/day75 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