AMOXICILLIN SUGAR-REDUCED GRANULES FOR ORAL SUSPENSION GRANULES FOR SUSPENSION

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE)

Доступно од:

SIVEM PHARMACEUTICALS ULC

АТЦ код:

J01CA04

INN (Међународно име):

AMOXICILLIN

Дозирање:

125MG

Фармацеутски облик:

GRANULES FOR SUSPENSION

Састав:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 125MG

Пут администрације:

ORAL

Јединице у пакету:

75/100/150ML

Тип рецептора:

Prescription

Терапеутска област:

AMINOPENICILLINS

Резиме производа:

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

Статус ауторизације:

CANCELLED PRE MARKET

Датум одобрења:

2018-03-09

Карактеристике производа

1
PRODUCT MONOGRAPH
PR AMOXICILLIN
AMOXICILLIN CAPSULES
250 MG AND 500 MG AMOXICILLIN (AS AMOXICILLIN TRIHYDRATE)
AMOXICILLIN CHEWABLE TABLETS
125 MG AND 250 MG AMOXICILLIN (AS AMOXICILLIN TRIHYDRATE)
AMOXICILLIN GRANULES FOR ORAL SUSPENSION
125 MG/5ML AND 250 MG/5ML AMOXICILLIN (AS AMOXICILLIN TRIHYDRATE)
AFTER
RECONSTITUTION
AMOXICILLIN SUGAR-REDUCED GRANULES FOR ORAL
SUSPENSION
125 MG/5ML AND 250 MG/5ML AMOXICILLIN (AS AMOXICILLIN TRIHYDRATE)
AFTER
RECONSTITUTION
Antibiotic
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Saint-Laurent, Quebec
H4R 2P7
Control # 174978
Date of Revision:
July 4, 2014
2
NAME OF DRUG
AMOXICILLIN
(AMOXICILLIN TRIHYDRATE)
THERAPEUTIC CLASSIFICATION
Antibiotic
ACTION AND CLINICAL PHARMACOLOGY
AMOXICILLIN (amoxicillin) exerts its bactericidal action by
interfering with bacterial
cell wall synthesis.
COMPARATIVE BIOAVAILABILITY STUDIES - TABLETS
A comparative two-way, single-dose bioavailability study was carried
out in sixteen
healthy, male volunteers on two 250 mg amoxicillin tablet products,
AMOXICILLIN
250 mg and Amoxil 250 mg chewable tablets. The pharmacokinetic data of
fifteen
subjects calculated for the AMOXICILLIN and Amoxil chewable tablet
formulations is
tabulated below:
AMOXICILLIN TRIHYDRATE CHEWABLE TABLETS 250 MG
FROM MEASURED DATA
Geometric Mean
Arithmetic Mean (C.V.%)
PARAMETER
TEST
*
REFERENCE
†
% RATIO OF
GEOMETRIC
MEANS
95%
CONFIDENCE
INTERVAL
AUC
T
(µg*h/mL)
20.3
20.4 (10)
20.5
20.7 (16)
99
91.8 – 108.4
AUC
I
(µg• h/mL)
20.5
20.5 (10)
20.5
20.8 (16)
100
91.8 – 108.5
C
max
(µg/mL)
7.4
7.5 (13)
7.7
8.0 (26)
96
84.8 – 109.1
T
max
§
(h)
1.37 (0.40)
1.43 (0.46)
-
T
1/2
§
(h)
0.95 (0.11)
0.92 (0.09)
-
* AMOXICILLIN
250 mg Chewable Tablet (Sivem Pharmaceuticals ULC)
†
Amoxil® 250 mg Chewable Tablet (purchased in Canada).
§
Expressed as the arithmetic mean (standard deviation) only
3
INDICATIONS AND CLINICAL USE
AMOXICILLIN (amoxicillin) may be indicated in the treatment of
infections due to
susceptible strains of the following micro-organisms: Gram-negative