NOVAMOXIN TABLET (CHEWABLE)

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE)

Disponible depuis:

TEVA CANADA LIMITED

Code ATC:

J01CA04

DCI (Dénomination commune internationale):

AMOXICILLIN

Dosage:

125MG

forme pharmaceutique:

TABLET (CHEWABLE)

Composition:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 125MG

Mode d'administration:

ORAL

Unités en paquet:

100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

AMINOPENICILLINS

Descriptif du produit:

Active ingredient group (AIG) number: 0131314009; AHFS:

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2021-07-29

Résumé des caractéristiques du produit

1
PRODUCT MONOGRAPH
PR NOVAMOXIN
AMOXICILLIN CAPSULES, USP
250 MG AND 500 MG AMOXICILLIN (AS AMOXICILLIN TRIHYDRATE)
AMOXICILLIN CHEWABLE TABLETS, USP
125 MG AND 250 MG AMOXICILLIN (AS AMOXICILLIN TRIHYDRATE)
AMOXICILLIN GRANULES FOR ORAL SUSPENSION, USP
125 MG/5 ML AND 250 MG/5 ML AMOXICILLIN (AS AMOXICILLIN TRIHYDRATE)
AFTER RECONSTITUTION
AMOXICILLIN SUGAR-REDUCED GRANULES FOR ORAL
SUSPENSION, TEVA STANDARD
125 MG/5 ML AND 250 MG/5 ML AMOXICILLIN (AS AMOXICILLIN TRIHYDRATE)
AFTER RECONSTITUTION
Antibiotic
Teva Canada Limited
Date of Revision:
30 Novopharm Court
March 20, 2020
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Control # 233622
2
NAME OF DRUG
NOVAMOXIN
(AMOXICILLIN TRIHYDRATE)
THERAPEUTIC CLASSIFICATION
Antibiotic
ACTION AND CLINICAL PHARMACOLOGY
Novamoxin (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,
Novamoxin 250 mg
and Amoxil 250 mg chewable tablets. The pharmacokinetic data of
fifteen subjects
calculated for the Novamoxin 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)
-
* Novamoxin
250 mg Chewable Tablet (Novopharm Ltd.).
†
Amoxil
®
250 mg Chewable Tablet (purchased in Canada).
§
Expressed as the arithmetic mean (standard deviation) only.
3
INDICATIONS AND CLINICAL USE
Novamoxin (amoxicillin) may be indicated in the treatment of
infections due to
susceptible strains of the following m