TRIMEBUTINE TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

TRIMEBUTINE MALEATE

Tersedia dari:

AA PHARMA INC

Kode ATC:

A03AA05

INN (Nama Internasional):

TRIMEBUTINE

Dosis:

100MG

Bentuk farmasi:

TABLET

Komposisi:

TRIMEBUTINE MALEATE 100MG

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Prescription

Area terapi:

ANTIMUSCARINICS ANTISPASMODICS

Ringkasan produk:

Active ingredient group (AIG) number: 0115865003; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2010-06-09

Karakteristik produk

_APO-TRIMEBUTINE (Trimebutine Maleate Tablets) _
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_Page 1 of 15 _
PRODUCT MONOGRAPH
PR
APO-TRIMEBUTINE
TRIMEBUTINE MALEATE TABLETS
100 MG AND 200 MG
LOWER GASTROINTESTINAL TRACT MOTILITY REGULATOR
APOTEX INC.
150 SIGNET DRIVE
TORONTO, ONTARIO
M9L 1T9
SUBMISSION CONTROL NUMBER: 284028
DATE OF REVISION:
MAR 14, 2024
_APO-TRIMEBUTINE (Trimebutine Maleate Tablets) _
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_Page 2 of 15 _
PRODUCT MONOGRAPH
Pr
APO-TRIMEBUTINE
Trimebutine Maleate Tablets
100 mg and 200 mg
THERAPEUTIC CLASSIFICATION
Lower gastrointestinal tract motility regulator
CLINICAL PHARMACOLOGY
APO-TRIMEBUTINE (trimebutine maleate) is a noncompetitive spasmolytic
agent. It possesses
moderate opiate receptor affinity and has marked anti-serotonin
activity especially on 'M'
receptors. It induces regulation of spontaneous activity and increases
synchronization between
electrophysiological spikes and contractions in isolated guinea pig
strips of colon and ileum.
However, it does not alter normal motility, but regulates abnormal
intestinal activity.
Comparative Bioavailability
A comparative bioavailability study was performed using healthy human
volunteers. The rate
and extent of absorption of trimebutine was measured and compared
following oral
administration of 1 x 200 mg of Trimebutine or Modulon tablets. The
results from measured data
are summarized as follows:
Summary Table of the Comparative Bioavailability Data
Trimebutine Maleate (Dose: 1 x 200 mg) From Measured Data
Parameter
Geometric Mean
Arithmetic Mean (CV%)
Ratio of Geometric
Means (%)**
Trimebutine
Modulon
®
†
AUC
T
(ng·hr/mL)
AUC
I
(ng·hr/mL)
C
max
(ng/mL)
T
max
(hr)*
55.7
69.6 (61)
59.1
73.8 (63)
36.7
49.3 (77)
0.80 (47.4)
61.4
75.1 (59)
65.3
79.9 (60)
42.1
52.2 (64)
0.70 (28)
90.8
91.8
87.1
-
_APO-TRIMEBUTINE (Trimebutine Maleate Tablets) _
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_Page 3 of 15 _
Summary Table of the Comparative Bioavailability Data
Trimebutine Maleate (Dose: 1 x 200 mg) From Measured Data
Parameter
Geometric Mean
Arithmetic Mean (CV%)
Ratio of Geometric
Means (%