AMOXICILLIN SUGAR-REDUCED GRANULES FOR ORAL SUSPENSION GRANULES FOR SUSPENSION

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE)

Disponibbli minn:

SIVEM PHARMACEUTICALS ULC

Kodiċi ATC:

J01CA04

INN (Isem Internazzjonali):

AMOXICILLIN

Dożaġġ:

250MG

Għamla farmaċewtika:

GRANULES FOR SUSPENSION

Kompożizzjoni:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 250MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

75/100/150ML

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

AMINOPENICILLINS

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0131314003; AHFS:

L-istatus ta 'awtorizzazzjoni:

CANCELLED POST MARKET

Data ta 'l-awtorizzazzjoni:

2016-12-14

Karatteristiċi tal-prodott

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