EFEXOR XR

국가: 인도네시아

언어: 인도네시아어

출처: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

유효 성분:

VENLAFAXINE HYDROCHLORIDE

제공처:

PFIZER INDONESIA - Indonesia

INN (International Name):

VENLAFAXINE HYDROCHLORIDE

복용량:

84.85 Mg

약제 형태:

KAPSUL PELEPASAN LAMBAT

패키지 단위:

DUS, 2 BLISTER @ 14 KAPSUL PELEPASAN LAMBAT

Manufactured by:

PFIZER IRELAND PHARMACEUTICALS - Ireland

승인 날짜:

2021-01-27

제품 특성 요약

Generic Name: Venlafaxine hydrochloride
Trade Name: Efexor XR
CDS Effective Date: June 09, 2021
Supersedes: July 10, 2019
Approved by BPOM:
2021-0067337
Page 1 of 19
PT. PFIZER INDONESIA
LOCAL PRODUCT DOCUMENT
Generic Name: Venlafaxine hydrochloride
Trade Name: Efexor XR
CDS Effective Date: June 09, 2021
Supersedes: July 10, 2019
1. TRADE NAME OF THE MEDICINAL PRODUCT
Efexor XR 75 mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Efexor XR capsules containing 75 mg of venlafaxine as venlafaxine
hydrochloride.
3. PHARMACEUTICAL FORM
Extended-release capsule
Efexor XR 75 mg capsules are opaque peach capsules printed in red with
“W” and “75”.
4. CLINICAL PARTICULARS
4.1. INDICATIONS
Efexor XR is indicated for the:
-
Treatment of depression, including depression with associated anxiety.
-
For prevention of relapse and prevention of recurrence of depression.
-
Treatment of anxiety or generalized anxiety disorder, including
long-term treatment.
-
Treatment of social anxiety disorder.
-
Treatment of panic disorder.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
The recommended starting dose of venlafaxine extended-release capsules
is 75 mg given once
daily.
Patients not responding to the initial 75 mg/day dose may benefit from
dose increases to a
maximum of 225 mg/day. While the recommended dose for moderately
depressed patients is up to
225 mg/day for immediate-release venlafaxine, more severely depressed
patients in one study
responded to a mean dose of 350 mg/day (range of 150 to 375 mg/day).
Extended-release venlafaxine dosage increases can be made at intervals
of approximately 2 weeks
or more, but not less than 4 days.
Patients treated with venlafaxine immediate-release tablets may be
switched to venlafaxine
extended-release capsules at the nearest equivalent daily dosage. For
example, venlafaxine
immediate-release tablets 37.5 mg twice daily may be switched to
venlafaxine extended-release
capsules 75 mg once daily. Individual dosage adjustments may be
necessary.
DISETUJUI OLEH BPOM : 03/02/2022
ID : EREG100241121