DETRUSITOL

Country: Ինդոնեզիա

language: ինդոնեզերեն

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

active_ingredient:

TOLTERODINE

MAH:

PFIZER INDONESIA - Indonesia

INN:

TOLTERODINE

dosage:

2 MG

pharmaceutical_form:

TABLET SALUT SELAPUT

units_in_package:

DUS, 2 BLISTER @ 14 TABLET SALUT SELAPUT

manufactured_by:

PFIZER ITALIA S.R.L - Italy

authorization_date:

2016-06-13

SPC

Product Document Title: Tolterodine L-TartrateTolterodine
Trade Name : DETRUSITOL
Product Document No.:756
Date: April 11, 2008
Supercedes: February 23, 2007
Approved by BPOM: June 13, 2016
2020-0061491
1
[PFI1]
PT. PFIZER INDONESIA
LOCAL PRODUCT DOCUMENT
Product Document Title: Tolterodine L-TartrateTolterodine
[PFI2]
Trade Name: DETRUSITOL
Product Document No.:756
Date: April 11, 2008
Supercedes: February 23, 2007
[FN3]
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tolterodine L-tartrate 2 mg corresponding 1.37 mg tolterodine (rINN)
respectively.
[FN4]
PHARMACEUTICAL FORM
Film Coated Tablet
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
For the treatment of overactive bladder with symptoms of urinary
urgency, frequency, or urge
incontinence.
POSOLOGY AND METHODS OF ADMINISTRATION
The recommended dose is 2 mg b.i.d. The dose may be reduced from 2 mg
to 1 mg b.i.d., based on
individual tolerability.
Safety and effectiveness in children have not yet been established.
Therefore, Detrusitol is not
recommended for children until more information is available.
Use in Impaired Renal Function
The recommended total daily dose is 2 mg (i.e., tolterodine tablets 1
mg twice daily) for patients with
impaired renal function (see Section – SPECIAL WARNINGS AND
PRECAUTIONS FOR USE).
Use in Impaired Hepatic Function
The recommended total daily dose is 2 mg (i.e., tolterodine tablets 1
mg twice daily) for patients with
impaired hepatic function (see Section – SPECIAL WARNINGS AND
PRECAUTIONS FOR USE).
Use with Potent CYP3A4 Inhibitors
The recommended total daily dose is 2 mg (i.e., tolterodine tablets 1
mg twice daily) for patients
receiving concomitant ketoconazole or other potent CYP3A4 inhibitors
(see Section – SPECIAL
WARNINGS AND PRECAUTIONS FOR USE, CYP3A4 INHIBITORS, and Section –
INTERACTIONS WITH OTHER
MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION).
After 6 months the need for further treatment should be considered.
PADA PROSES PEMBUATANNYA BERSINGGUNGAN DENGAN BAHAN BERSUMBER BABI
DISETUJUI OLEH BPOM : 02/10/2020
I