TRIMEBUTINE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TRIMEBUTINE MALEATE

Available from:

AA PHARMA INC

ATC code:

A03AA05

INN (International Name):

TRIMEBUTINE

Dosage:

200MG

Pharmaceutical form:

TABLET

Composition:

TRIMEBUTINE MALEATE 200MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

ANTIMUSCARINICS ANTISPASMODICS

Product summary:

Active ingredient group (AIG) number: 0115865004; AHFS:

Authorization status:

APPROVED

Authorization date:

2010-06-09

Summary of Product characteristics

_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
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_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 (%