PRO-AMOX-125 POWDER FOR SUSPENSION

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE)

Tillgänglig från:

PRO DOC LIMITEE

ATC-kod:

J01CA04

INN (International namn):

AMOXICILLIN

Dos:

125MG

Läkemedelsform:

POWDER FOR SUSPENSION

Sammansättning:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 125MG

Administreringssätt:

ORAL

Enheter i paketet:

100

Receptbelagda typ:

Prescription

Terapiområde:

AMINOPENICILLINS

Produktsammanfattning:

Active ingredient group (AIG) number: 0131314002; AHFS:

Bemyndigande status:

APPROVED

Tillstånd datum:

2019-10-24

Produktens egenskaper

PRODUCT MONOGRAPH
PR
PRO-AMOX-125
PR
PRO-AMOX-250
AMOXICILLIN FOR ORAL SUSPENSION
USP
125 MG / 5 ML AND 250 MG / 5 ML AMOXICILLIN (AS AMOXICILLIN
TRIHYDRATE)
ANTIBIOTIC
PRO DOC LTÉE
2925, boul. Industriel
Laval, Quebec
H7L 3W9
SUBMISSION
CONTROL
NUMBER: 249590
Date
of
Revision:
March 26, 2021
PR
PRO-AMOX-125
PR
PRO-AMOX-250
AMOXICILLIN FOR ORAL SUSPENSION
USP
125 MG / 5 ML AND 250 MG / 5 ML AMOXICILLIN (AS AMOXICILLIN
TRIHYDRATE)
THERAPEUTIC CLASSIFICATION
ANTIBIOTIC
ACTION AND CLINICAL PHARMACOLOGY
Amoxicillin exerts its bactericidal action by interfering with
bacterial cell wall synthesis.
COMPARATIVE BIOAVAILABILITY STUDIES
A double blind, randomized, two-treatment, two-sequence, two-period,
crossover, single-dose
comparative oral bioavailability study of PRO-AMOX (amoxicillin
trihydrate) 250 mg/5 mL
powder for oral suspension (Pro Doc Ltée) versus APO-AMOXI
(amoxicillin trihydrate) 250
mg/5 mL powder for oral suspension (Apotex Inc.) was conducted in 28
healthy, adult human
male subjects under fasting conditions. A summary of the
bioavailability data of 27 subjects who
completed the study is presented in the following table.
SUMMARY TABLE OF THE COMPARATIVE BIOAVAILABILITY DATA
AMOXICILLIN
(5 ML X 250 MG/5 ML)
FROM MEASURED DATA
GEOMETRIC MEAN
ARITHMETIC MEAN (CV %)
PARAMETER
TEST
*
REFERENCE
†
% RATIO OF
GEOMETRIC
MEANS
90% CONFIDENCE
INTERVAL
AUC
0→t
(hr.ng/mL)
17625.3
17906.5 (18.5)
18064.7
18322.7 (17.2)
97.6
94.5-100.8
AUC
0
→
∞
(hr.ng/mL)
17785.2
18066.1 (18.4)
18232.6
18486.8 (17.0)
97.6
94.5-100.7
C
max
(ng/mL)
6558.9
6846.2 (29.0)
7114.4
7345.2 (24.6)
92.2
85.8-99.1
T
max
§
(hr)
1.25 (0.75-2.75)
1.00 (0.75-2.75)
T
½
$
(hr)
1.4 (17.6)
1.4 (23.1)
*PRO-AMOX (amoxicillin trihydrate) 250 mg/5 mL powder for oral
suspension (Pro Doc Ltée).
† APO-AMOXI (amoxicillin trihydrate) 250 mg/5 mL powder for oral
suspension (Apotex Inc.) was purchased
from Canada.
§ Expressed as the median (range) only.
$ Expressed as arithmetic mean (CV%) only.
A double blind, randomized, two-treatment, two-sequence,