TEVA-CLOXACILLIN CAPSULE

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

CLOXACILLIN (CLOXACILLIN SODIUM)

Доступно од:

TEVA CANADA LIMITED

АТЦ код:

J01CF02

INN (Међународно име):

CLOXACILLIN

Дозирање:

500MG

Фармацеутски облик:

CAPSULE

Састав:

CLOXACILLIN (CLOXACILLIN SODIUM) 500MG

Пут администрације:

ORAL

Јединице у пакету:

100/500/1000

Тип рецептора:

Prescription

Терапеутска област:

PENICILLINASE-RESISTANT PENICILLINS

Резиме производа:

Active ingredient group (AIG) number: 0131306001; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2014-04-24

Карактеристике производа

____________________________________________________________________________________
_TEVA-CLOXACILLIN 1 of 14_
PRODUCT MONOGRAPH
PR
TEVA-CLOXACILLIN
(cloxacillin sodium)
250 and 500 mg Capsules
125 mg/5 mL Granules for Oral Solution
USP
Antibiotic
Teva Canada Limited
Date of Revision:
30 Novopharm Court
March 17, 2020
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Control: 235602
____________________________________________________________________________________
_TEVA-CLOXACILLIN 2 of 14_
STRUCTURAL
FORMULA
AND
CHEMISTRY
Cloxacillin
Sodium
Molecular Formula:
C
19
H
17
ClN
3
NaO
5
S●H
2
O
Molecular
Weight:
475.88 g/mol
Chemical Name:
Monosodium
6-[3-(o-chlorophenyl)-5-methyl-4- isoxazolecarboxamido]-
3,3-dimethyl-7-oxo-4- thia-l-azabicyclo[3.2.0]heptane-2-carboxy-
late
monohydrate.
Description:
Cloxacillin
sodium is a white,
odorless,
crystalline
powder, with an
intensely
bitter taste. Each g represents
2.1
mEq
of sodium. One part
is soluble in
2.5
parts of water, and a 10% aqueous
solution
has a
pH of 5 to
7.
____________________________________________________________________________________
_TEVA-CLOXACILLIN 3 of 14_
NAME OF DRUG
PR
TEVA-CLOXACILLIN
(cloxacillin sodium)
250 and 500 mg Capsules
125 mg/5_ _mL Granules for Oral Solution
THERAPEUTIC CLASSIFICATION
Cloxacillin
sodium is an antibiotic
belonging
to the
semi-synthetic
penicillin
family.
ACTION
TEVA-CLOXACILLIN exhibits a bacterial action against sensitive
organisms during the active
multiplication stage. It acts through the inhibition of biosynthesis
of cell wall mucopeptides.
INDICATIONS AND CLINICAL USE
TEVA-CLOXACILLIN (cloxacillin
sodium) finds use in the treatment
of
infections
caused by
streptococci
when associated
with
sensitive penicillinase-producing
staphylococci;
also in the
treatment
of
all staphylococcal
infections, whether penicillin
G-sensitive
or
resistant.
In infections
suspected
of being caused by
penicillinase-producing
staphylococci,
cloxacillin
may be used for initial treatment
after
appropriate
specimens have been taken fo