NTP-AMOXICILLIN CAPSULE

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE)

Διαθέσιμο από:

TEVA CANADA LIMITED

Φαρμακολογική κατηγορία (ATC):

J01CA04

INN (Διεθνής Όνομα):

AMOXICILLIN

Δοσολογία:

250MG

Φαρμακοτεχνική μορφή:

CAPSULE

Σύνθεση:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 250MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

100/1000

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

AMINOPENICILLINS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0131314001; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED PRE MARKET

Ημερομηνία της άδειας:

2015-08-06

Αρχείο Π.Χ.Π.

1
PRODUCT MONOGRAPH
NTP-AMOXICILLIN CAPSULES, CHEWABLE TABLETS,
GRANULES FOR ORAL SUSPENSION
and
SUGAR-REDUCED GRANULES FOR ORAL SUSPENSION
(Amoxicillin Trihydrate)
Antibiotic
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
Submission Control No: 165853
Date of Preparation:
July 23, 2013
2
NAME OF DRUG
NTP-AMOXICILLIN
(Amoxicillin Trihydrate)
THERAPEUTIC CLASSIFICATION
Antibiotic
ACTION
NTP-AMOXICILLIN (amoxicillin) exerts its bactericidal action by
interfering with
bacterial cell wall synthesis.
A comparative two-way, single-dose bioavailability study was carried
out in sixteen
healthy, male volunteers on two 250 mg amoxicillin tablet products,
NTP-
AMOXICILLIN 250 mg and Amoxil 250 mg chewable tablets. The
pharmacokinetic data
of fifteen subjects calculated for the NTP-AMOXICILLIN and Amoxil
chewable tablet
formulations is tabulated below:
Geometric Mean
Arithmetic Mean (C.V.)
PARAMETER
NTP-AMOXICILLIN
(1 X 250 MA TABLET)
AMOXIL®
(1 X 250 MG TABLET)
PERCENTAGE OF
AMOXIL ®
AUC
T
(µg• h/mL)
20.3
20.4 (10)
20.5
20.7 (16)
99
AUC
I
(µg• h/mL)
20.5
20.5 (10)
20.5
20.8 (16)
100
C
max
(µg/mL)
7.4
7.5 (13)
7.7
8.0 (26)
96
T
max
*
(h)
1.37 (0.40)
1.43 (0.46)
-
T
1/2
*
(h)
0.95 (0.11)
0.92 (0.09)
-
*For the T
max
and T
1/2
parameters theses are the arithmetic means (standard deviation).
INDICATIONS AND CLINICAL USE
NTP-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. Gram-positive organisms:
Streptococci
(including Streptococcus faecalis and Streptococcus pneumoniae).
3
Amoxicillin is not active against Pseudomonas aeruginosa,
indole-positive Proteus
species, Serratia marcescens, Klebsiella and Enterobacter species.
In emergency cases, where the causative organism is not yet
identified, therapy may be
initiated with amoxicillin on the basis of clinical judgment while
awaiting bacteriologic
tests to determine its antimicrobial sensiti