Krajina: Indonézia
Jazyk: indonézština
Zdroj: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
VENLAFAXINE HYDROCHLORIDE
PFIZER INDONESIA - Indonesia
VENLAFAXINE HYDROCHLORIDE
84.85 Mg
KAPSUL PELEPASAN LAMBAT
DUS, 2 BLISTER @ 14 KAPSUL PELEPASAN LAMBAT
PFIZER IRELAND PHARMACEUTICALS - Ireland
2021-01-27
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 Prečítajte si celý dokument