PRO-AMOX-500 CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE)

Available from:

PRO DOC LIMITEE

ATC code:

J01CA04

INN (International Name):

AMOXICILLIN

Dosage:

500MG

Pharmaceutical form:

CAPSULE

Composition:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 500MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

AMINOPENICILLINS

Product summary:

Active ingredient group (AIG) number: 0131314006; AHFS:

Authorization status:

APPROVED

Authorization date:

2019-09-13

Summary of Product characteristics

_PAGE 1 OF 23_
PRODUCT MONOGRAPH
PR
PRO-AMOX-250
PR
PRO-AMOX-500
Amoxicillin Capsules BP
250 mg & 500 mg amoxicillin
(as amoxicillin trihydrate)
Antibiotic
PRO DOC LTÉE
Date of Revision:
2925 boul. Industriel
March 11, 2021.
Laval, Québec
H7L 3W9
Submission Control No: 249475
_PAGE 2 OF 23_
PRODUCT MONOGRAPH
PR
PRO-AMOX-250
PR
PRO-AMOX-500
Amoxicillin Capsules BP
250 mg & 500 mg amoxicillin
(as amoxicillin trihydrate)
THERAPEUTIC CLASSIFICATION
Antibiotic
ACTIONS AND CLINICAL PHARMACOLOGY
Amoxicillin exerts its bactericidal action by interfering with
bacterial cell wall synthesis.
CLINICAL TRIALS
COMPARATIVE BIOAVAILABILITY DATA
A double blind, randomized, two treatment, two sequence, two period,
crossover, single dose
comparative oral bioavailability study of PRO-AMOX capsules
(amoxicillin trihydrate) 500 mg
capsules (Pro Doc Ltée) and Apo-Amoxi (amoxicillin trihydrate) 500mg
capsules (Apotex Inc.)
was conducted in 26 healthy, adult, human Asian male subjects under
fasting conditions.
SUMMARY TABLE OF THE COMPARATIVE BIO-AVAILABILITY DATA
AMOXICILLIN
(1 X 500 mg)
From measured data
Geometric Mean
Arithmetic Mean (CV %)
PARAMETER
TEST*
REFERENCE
†
% RATIO OF
GEOMETRIC
MEANS
#
90%
CONFIDENCE
INTERVAL
#
AUC
T
(hr.ng/mL)
27554.36
28467.18 (22.9)
26519.07
27339.12 (23.6)
103.90
96.00-112.46
AUC
I
(hr.ng/mL)
27833.34
28763.40 (23.1)
26791.54
27631.25 (23.9)
103.89
96.00-112.42
C
max
(ng/mL)
8004.72
8328.68 (23.4)
7896.32
8276.50 (27.8)
101.37
92.75-110.79
T
max
§
(h)
2.13 (1.25-3.50)
2.25 (1.00-4.00)
T
½
$
(h)
1.66 (15.4)
1.62 (15.3)
_PAGE 3 OF 23_
* PRO-AMOX (Amoxicillin trihydrate) 500 mg (Pro Doc Ltée)
†
APO-AMOXI 500 mg Capsules (Apotex Inc) were purchased in Canada.
§
Expressed as Median (Range).
$
Expressed as arithmetic mean (CV %) only
INDICATIONS AND CLINICAL USE
PRO-AMOX may be indicated in the treatment of infections due to
susceptible strains of the
following micro-organisms: Gram-negative organisms: H. influenzae, P.
mirabilis and N.
gonorrhoeae. Gram-positive organisms: Streptococci (including