APO CLOXI FOR ORAL SOLN 125MG/5ML POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CLOXACILLIN SODIUM

Available from:

APOTEX INC

ATC code:

J01CF02

INN (International Name):

CLOXACILLIN

Dosage:

125MG

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

CLOXACILLIN SODIUM 125MG

Administration route:

ORAL

Units in package:

60/100/200ML

Prescription type:

Prescription

Therapeutic area:

PENICILLINASE-RESISTANT PENICILLINS

Product summary:

Active ingredient group (AIG) number: 0105904003; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2019-12-03

Summary of Product characteristics

PRESCRIBING INFORMATION
PR
APO-CLOXI
(Cloxacillin Sodium)
250 AND 500 MG CAPSULES
125 MG/5 ML POWDER FOR ORAL SOLUTION
USP
ANTIBIOTIC
APOTEX INC.
DATE OF PREPARATION:
150 SIGNET DRIVE
July 26, 2000
WESTON, ONTARIO
DATE OF REVISION:
M9L 1T9
May 16, 2019
Control No.: 221440
1
PHARMACEUTICAL INFORMATION
Drug Substance
Proper/Common Name:
Cloxacillin Sodium
Chemical Names:
1) 4-Thia-1-azabicyclol[3.2.0]heptane-2-carboxylic acid, 6-[[[3-
(2- chlorophenyl)-5-methyl-4-isoxazolyl]carbonyl]amino]-3,3-
dimethyl-7- oxo-, monosodium salt, monohydrate, [2_S_-
(2

,5

,6

)]-
2) Monosodium (2_S, _5_R, _6_R_)-6-[3-(_o_-chlorophenyl)-5-
methyl-4- isoxazolecarboxamido]-3,3-dimethyl-7-oxo-4-thia-
1-azabicyclo [3.2.0]heptane-2-carboxylate monohydrate
Structural Formula:
Molecular Formula:
C
19
H
17
ClN
3
NaO
5
S

H
2
O
Molecular Weight:
475.88 g/mol
Description:
Cloxacillin sodium is a white, odorless, crystalline powder. It is
freely soluble in water, soluble in alcohol and slightly soluble in
chloroform.
Composition
In addition to cloxacillin sodium, APO-CLOXI capsules also contain the
non-medicinal
ingredients colloidal silicon dioxide, stearic acid, and talc (as an
antistatic agent). The capsule
shells, imprinted with edible white ink, contain the non-medicinal
ingredients D&C yellow #10,
FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, silicon dioxide,
sodium lauryl sulfate
and titanium dioxide.
In addition to cloxacillin sodium, APO-CLOXI powder for oral solution
also contains the non-
medicinal ingredients FD&C red #40, sodium benzoate, sodium citrate
(anhydrous), sodium
cyclamate, sucrose, and artificial cherry flavour.
2
PRESCRIBING INFORMATION
PR
APO-CLOXI
(Cloxacillin Sodium)
250 mg and 500 mg Capsules
125 mg/5 mL Powder for Oral Solution
USP
THERAPEUTIC CLASSIFICATION
Cloxacillin sodium is an antibiotic belonging to the semi-synthetic
penicillin family.
ACTION
APO-CLOXI exhibits a bacterial action against sensitive organisms
during the active
multiplication stage. It acts through the inhibition of biosyn