VENLAFAXINE HYDROCHLORIDE capsule extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (International Name):

VENLAFAXINE HYDROCHLORIDE

Composition:

VENLAFAXINE 37.5 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
REFERENCE LABEL SET ID: 28F12FA3-B5EF-41C7-A750-32C80D8881CF
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE
CAPSULES USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR VENLAFAXINE HYDROCHLORIDE EXTENDED-
RELEASE CAPSULES USP.
VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES USP, 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 THINKING AND BEHAVIOR IN CHILDREN,
ADOLESCENTS AND YOUNG ADULTS TAKING
ANTIDEPRESSANTS (5.1)
•MONITOR FOR 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 )
INDICATIONS AND USAGE
Venlafaxine hydrochloride extended-release capsules USP are a
serotonin and norepinephrine reuptake inhibitor (SNRI)
indicated for the treatment of: (1)
•Major Depressive Disorder (MDD)
•Panic Disorder (PD)
DOSAGE AND ADMINISTRATION
INDIC ATIO N
STARTING DOSE
TARGET DOSE
MAXIMUM DOSE
MDD (2.1)
37.5 to 75 mg/day
75 mg/day
225 mg/day
PD (2.4)
37.5 mg/day
75 mg/day
225 mg/day
•Take once daily with food (2). Capsules should be taken whole; do
not divide, crush, chew, or dissolve (2).
•When discontinuing treatment, reduce the dose gradually (2.8, 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 (2.6).
•Hepatic impairment: reduce the daily dose by 50% in patients with
mild to moderate hepatic impairment. In patients
with severe hepatic impairment or hepatic cirrhosis, it may be
necessary to reduce the dose by more than 50% (2.6).
DOSAGE FORMS AND STRENGTHS
•