Cefotaxime (AFT)

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Cefotaxime sodium 2096.2mg Equivalent 2 g cefotaxime (+ 5% overage)

Available from:

AFT Pharmaceuticals Ltd

INN (International Name):

Cefotaxime sodium 2096.2 mg (Equivalent 2 g cefotaxime; + 5% overage)

Dosage:

2 g

Pharmaceutical form:

Powder for injection

Composition:

Active: Cefotaxime sodium 2096.2mg Equivalent 2 g cefotaxime (+ 5% overage)

Units in package:

Vial, glass, single dose, 2 g

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Hanmi Fine Chemical Company Ltd

Therapeutic indications:

Cefotaxime is indicated in the treatment of the following infections either before the infecting organism has been identified or when caused by bacteria of established sensitivity. · Septicaemia. · Respiratory tract infections: acute and chronic bronchitis, bacterial pneumonia, infected bronchiectasis, lung abscess and post-operative chest infections. · Urinary tract infections: acute and chronic pyelonephritis, cystitis and asymptomatic bacteriuria. · Soft tissue infections: cellulitis, peritonitis and wound infections. · Bone and joint infections: osteomyelitis, septic arthritis. · Obstetric and gynaecological infections: pelvic inflammatory disease. · Gonorrhoea: particularly if penicillin-resistant. · Other bacterial infections: meningitis and other sensitive infections suitable for parenteral antibiotic therapy. The administration of cefotaxime prophylactically may reduce the incidence of certain post-operative infections in patients undergoing surgical procedures that are classified as contaminated or potentially contaminated or in clean operations where infections would have serious effects. Protection is best ensured by achieving adequate local tissue concentrations at the time contamination is likely to occur. Cefotaxime should therefore be administered immediately prior to surgery and if necessary continued in the immediate post-operative period. Administration should usually be stopped within 24 hours since continuing use of any antibiotic in the majority of surgical procedures does not reduce the incidence of subsequent infections.

Product summary:

Package - Contents - Shelf Life: Vial, glass, single dose, - 2 g - 36 months from date of manufacture stored at or below 25°C protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Authorization date:

1999-02-04

Summary of Product characteristics

CEFOTAXIME
CEFOTAXIME SODIUM, POWDER FOR INJECTION, EQUIVALENT TO CEFOTAXIME 500
MG, 1 G
AND 2 G
PRESENTATION
Cefotaxime is a white to slightly yellowish powder, which, when
dissolved in Water for
Injections B.P., forms a straw coloured solution given by intravenous
or intramuscular
administration.
Each Cefotaxime 500 mg vial contains sterile cefotaxime sodium
equivalent to cefotaxime
500 mg.
Each Cefotaxime 1 g vial contains sterile cefotaxime sodium equivalent
to cefotaxime 1 g.
Each Cefotaxime 2 g vial contains sterile cefotaxime sodium equivalent
to cefotaxime 2 g.
Variations in the intensity of colour of the freshly prepared solution
do not indicate change in
potency or safety.
USES
_ACTIONS _
Cefotaxime is a semi-synthetic broad-spectrum bactericidal
cephalosporin antibiotic. It is a
other β-lactam antibiotic whose mode of action is inhibition of
bacterial cell wall synthesis.
Cefotaxime is exceptionally active _ in vitro_ against Gram-negative
organisms sensitive or
resistant to first or second generation cephalosporins. It is similar
to other cephalosporins in
activity against Gram-positive bacteria.
SUSCEPTIBILITY DATA
Dilution or diffusion techniques – either quantitative minimum
inhibitory concentration (MIC)
or breakpoint, should be used following a regularly updated,
recognised and standardised
method
e.g.
NCCLS.
Standardised
susceptibility
test
procedures
require
the
use
of
laboratory
control
micro-organisms
to
control
the
technical
aspects
of
the
laboratory
procedures.
A report of “Susceptible” indicates that the pathogen is likely to
be inhibited if the microbial
compound in the blood reaches the concentrations usually achievable.
Some strains of
_Pseudomonas aeruginosa_ (approximately 25%) and _Bacteroides_
(approximately 43%) have
_in vitro_ MIC <16 mg/L.A report of “Intermediate” indicates that
the results should be
considered equivocal, and if the micro-organism is not fully
susceptible to alternative,
clinically feasible drugs, the test should be repeated. This category
implies pos