AMOXICILLIN GRANULES FOR SUSPENSION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE)

Disponibil de la:

SANIS HEALTH INC

Codul ATC:

J01CA04

INN (nume internaţional):

AMOXICILLIN

Dozare:

125MG

Forma farmaceutică:

GRANULES FOR SUSPENSION

Compoziție:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 125MG

Calea de administrare:

ORAL

Unități în pachet:

75/100/150ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

AMINOPENICILLINS

Rezumat produs:

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

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2017-07-31

Caracteristicilor produsului

1
PRODUCT MONOGRAPH
PR AMOXICILLIN
AMOXICILLIN CAPSULES
250 MG AND 500 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
Sanis Health Inc.
333 Champlain Street, Suite 102
Dieppe, New Brunswick
Canada, E1A 1P2
Submission Control No: 167414
Date of Preparation:
September 3, 2013
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 BIOAVAILABITY 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 (
Sanis Health Inc.)
†
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
organisms: H.
influenzae, P. mirabilis and N. gonorrhoeae. Gr