AMOXICILLIN SUGAR-REDUCED GRANULES FOR ORAL SUSPENSION GRANULES FOR SUSPENSION

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE)

から入手可能:

SIVEM PHARMACEUTICALS ULC

ATCコード:

J01CA04

INN（国際名）:

AMOXICILLIN

投薬量:

125MG

医薬品形態:

GRANULES FOR SUSPENSION

構図:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 125MG

投与経路:

ORAL

パッケージ内のユニット:

75/100/150ML

処方タイプ:

Prescription

治療領域:

AMINOPENICILLINS

製品概要:

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

認証ステータス:

CANCELLED PRE MARKET

承認日:

2018-03-09

製品の特徴

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