INFORMATION FOR HEALTH PROFESSIONALS
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Cefuroxime Sodium for Injection contains either 250mg, 750mg, or 1.5g of cefuroxime. Each 750mg vial contains 42mg sodium (1.8mEq).
Cefuroxime is a white to faintly yellow powder to which appropriate amounts of water are added to prepare an off-white suspension for intramuscular use or a yellow solution for intravenous administration. Variations in the intensity of this colour do not indicate any change in either the efficacy or safety of the product.
Cefuroxime is a well characterised and effective antibacterial agent which has bactericidal activity against a wide range of common pathogens, including β-lactamase producing strains.
Cefuroxime has good stability to bacterial β-lactamase, and consequently is active against many ampicillin-resistant or amoxycillin-resistant strains.
The bactericidal action of cefuroxime results from inhibition of cell wall synthesis by binding to essential target proteins.
Cefuroxime is usually active against the following organisms in vitro.
Escherichia coli.
Klebsiella sp.
Proteus mirabilis.
Providencia spp
Proteus rettgeri.
Haemophilus influenzae (including ampicillin-resistant strains).
Haemophilus parainfluenzae (including ampicillin-resistant strains).
Moraxella (Branhamella) catarrhalis.
Neisseria gonorrhoeae (including penicillinase and non-penicillinase
producing strains).
Neisseria meningitidis.
Salmonellae spp
Staphylococcus aureus and Staphylococcus epidermidis
(including penicillinase producing strains but excluding methicillin resistant
strains).
Streptococcus pyogenes (and other β-haemolytic streptococci).
Streptococcus pneumoniae.
Streptococcus Group B (Streptococcus agalactiae).
Streptococcus mitis (viridans group).
Bordetella pertussis.
Gram-positive and Gram-negative cocci (including Peptococcus and Peptostreptococcus species).
Gram-positive bacilli (including most Clostridium species) and Gram- negative bacilli (including Bacteroides and Fusobacterium species).
Propionibacterium sp.
Borrelia burgdorferi.
The following organisms are not susceptible to Cefuroxime:-
Clostridium difficile.
Pseudomonas sp.
Campylobacter sp.
Acinetobacter calcoaceticus.
Listeria monocytogenes.
Methicillin resistant strains of Staphylococcus aureus.
Methicillin resistant strains of Staphylococcus epidermidis.
Legionella sp.
Some strains of the following genera are not susceptible to Cefuroxime:-
Enterococcus (Streptococcus) faecalis.
Morganella morganii.
Proteus vulgaris.
Enterobacter sp.
Citrobacter sp.
Serratia sp.
Bacteroides fragilis.
In vitro the activities of cefuroxime and aminoglycoside antibiotics in combination have been shown to be at least additive with occasional evidence of synergy.
Peak levels of cefuroxime are achieved within 30 to 45 minutes after intramuscular administration. The serum half-life after either intramuscular or intravenous injection is approximately 70 minutes.
In the first weeks of life the serum half-life of cefuroxime can be 3 - 5 times that in the adult.
Concurrent administration of probenecid prolongs the excretion of the antibiotic and produces an elevated peak serum level.
Protein binding has been variously stated as 33 - 50% depending on the methodology used.
There is an almost complete recovery (85-90 %) of unchanged cefuroxime in urine within 24 hours of administration. The major part is excreted in the first six hours.
Cefuroxime is not metabolised and is excreted by glomerular filtration and tubular secretion.
Serum levels of cefuroxime are reduced by dialysis.
Concentrations of cefuroxime in excess of the minimum inhibitory levels for common pathogens can be achieved in bone, synovial fluid and aqueous humour. Cefuroxime passes the blood-brain barrier when the meninges are inflamed.
Cefuroxime is a bactericidal cephalosporin antibiotic which is resistant to most β-lactamases and is active against a wide range of Gram-positive and Gram-negative organisms. It is indicated for the treatment of infections before the infecting organism has been identified or when caused by sensitive bacteria.
Respiratory tract infections for example, acute and chronic bronchitis, infected bronchiectasis, bacterial pneumonia, lung abscess and post-operative chest infections.
Ear, nose and throat infections for example, sinusitis, tonsillitis, pharyngitis and otitis media.
Urinary tract infections for example, acute and chronic pyelonephritis, cystitis and asymptomatic bacteriuria.
Soft-tissue infections for example, cellulitis, erysipelas and wound infections.
Bone and joint infections for example, osteomyelitis and septic arthritis.
Obstetric and gynaecological infections, pelvic inflammatory diseases.
Gonorrhoea particularly when penicillin is unsuitable.
Other infections including septicaemia, meningitis and peritonitis.
Prophylaxis against infection in abdominal, pelvic, orthopaedic, cardiac, pulmonary, oesophageal and vascular surgery where there is increased risk from infection.
Usually Cefuroxime Sodium for Injection will be effective alone, but when appropriate it may be used in combination with an aminoglycoside antibiotic, or in conjunction with metronidazole (orally or by suppository or injection), especially for prophylaxis in colonic or gynaecological surgery (see Pharmaceutical Precautions).
Cefuroxime Sodium for Injection is for intravenous and/or intramuscular administration.
Many infections respond to 750mg three times daily by im or iv injection. For more severe infections the dose should be increased to 1.5g three times daily iv. The frequency of administration may be increased to 6-hourly if necessary, giving total daily doses of 3 to 6g.
30 - 100mg/kg/day given as 3 or 4 divided doses. A dose of 60mg/kg/day is appropriate for most infections.
30 - 100mg/kg/day given as 2 or 3 divided doses (see Pharmacokinetics section).
1.5g as a single dose (as 2 x 750mg injections intramuscularly with different sites, e.g. each buttock).
Cefuroxime Sodium for Injection is suitable for sole therapy of bacterial meningitis due to sensitive strains.
Adults - 3g i.v. every eight hours.
Infants and Children - 150-250mg/kg/day i.v. in 3 or 4 divided doses.
Neonates - The dosage should be 100mg/kg/day i.v.
The usual dose is 1.5g i.v. with induction of anaesthesia for abdominal, pelvic and orthopaedic operations. This may be supplemented with two 750mg i.m. doses eight and sixteen hours later.
In cardiac, pulmonary, oesophageal and vascular operations, the usual dose is 1.5g i.v. with induction of anaesthesia, continuing with 750mg i.m. three times daily. for a further 24 to 48 hours.
In total joint replacement, 1.5g cefuroxime powder may be mixed dry with each pack of methyl methacrylate cement polymer before adding the liquid monomer.
Cefuroxime is excreted by the kidneys. Therefore, as with all such antibiotics, in patients with markedly impaired renal function it is recommended that the dosage of Cefuroxime Sodium for Injection should be reduced to compensate for its slower excretion.
It is not necessary to reduce the standard dose (750mg - 1.5g three times daily) until the creatinine clearance falls to 20mL/min or below.
In adults with marked impairment (creatinine clearance 10- 20mL/min) 750mg twice daily is recommended and with severe impairment (creatinine clearance < 10mL/min) 750mg once daily is adequate.
For patients on haemodialysis a further 750mg dose should be given iv or im at the end of each dialysis. In addition to parenteral use, cefuroxime can be incorporated into the peritoneal dialysis fluid (usually 250mg for every 2 litres of dialysis fluid given intravenously).
For patients in renal failure on continuous arteriovenous haemodialysis or high-flux haemofiltration in intensive therapy units a suitable dosage is 750mg twice daily. For low-flux haemofiltration follow the dosage recommended under IMPAIRED RENAL FUNCTION.
Add 1mL Water for Injections to Cefuroxime Sodium for Injection 250 mg or 3mL Water for Injections to Cefuroxime Sodium for Injection 750mg. Shake gently to produce an opaque suspension.
Dissolve Cefuroxime Sodium for Injection in Water for Injections using at least 2mL for 250mg, at least 6mL for 750mg, or 15mL for 1.5g.
For short intravenous infusion (e.g. up to 30 minutes), Cefuroxime Sodium for Injection 1.5g may be dissolved in 50-100mL Water for Injections. These solutions may be given directly into the vein or introduced into the tubing of the giving set if the patient is receiving parenteral fluids.
Hypersensitivity to cephalosporin antibiotics.
Special care is indicated in patients who have experienced an allergic reaction to penicillins or other beta-lactams.
Cephalosporin antibiotics at high dosage should be given with caution to patients receiving concurrent treatment with potent diuretics such as frusemide or aminoglycosides, as renal impairment has been reported with these combinations. Renal function should be monitored in these patients, the elderly, and those with pre-existing renal impairment (see Dosage and Administration).
As with other therapeutic regimens used in the treatment of meningitis, mild-to-moderate hearing loss has been reported in a few paediatric patients treated with cefuroxime sodium. Persistence of positive CSF cultures of Haemophilus influenzae at 18-36 hours has also been noted with cefuroxime sodium injection, as well as with other antibiotic therapies; however, the clinical relevance of this is unknown.
There is no experimental evidence of embryopathic or teratogenic effects attributable to cefuroxime, but, as with all drugs, it should be administered with caution during the early months of pregnancy.
Cefuroxime is excreted in human milk, and consequently caution should be exercised when Cefuroxime Sodium for Injection is administered to a nursing mother.
None reported.
Adverse reactions to cefuroxime have occurred relatively infrequently and have been generally mild and transient in nature.
There have been rare reports of hypersensitivity reactions including skin rashes, urticaria, pruritus, interstitial nephritis, drug fever and very rarely anaphylaxis.
As with other cephalosporins, there have been rare reports of erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis (exanthematic necrolysis).
As with other antibiotics, prolonged use may result in the overgrowth of non-susceptible organisms, e.g. Candida.
Gastro-intestinal disturbance, including, very rarely, symptoms of pseudomembranous colitis may occur during or after treatment.
The principal changes in haematological parameters seen in some patients have been decreased haemoglobin concentration and of eosinophilia, leukopenia, neutropenia and thrombocytopenia.
Cephalosporins as a class tend to be absorbed onto the surface of red cells membranes and react with antibodies directed against the drug to produce a positive Coombs' test (which can interfere with cross-matching of blood) and very rarely haemolitic anaemia.
Although there are sometimes transient rises in serum liver enzymes or serum bilirubin, particularly in patients with pre-existing liver disease, there is no evidence of harm to the liver.
Elevations in serum creatinine and/or blood urea nitrogen and a decreased creatinine clearance have been observed (see Warnings and Precautions).
Transient pain may be experienced at the site of intramuscular injection. This is more likely to occur with higher doses. However it is unlikely to be a cause for discontinuation or treatment.
Occasionally, thrombophlebitis may follow intravenous injection.
Cefuroxime does not interfere in enzyme-based tests for glycosuria.
Slight interference with copper reduction methods (Benedict's, Fehling's, Clinitest) may be observed. However, this should not lead to false - positive results, as may be experienced with some other cephalosporins.
It is recommended that either the glucose oxidase or hexokinase methods are used to determine blood/plasma glucose levels in patients receiving Cefuroxime Sodium for Injection.
This antibiotic does not interfere in the alkaline picrate assay for creatinine.
Overdosage of cephalosporins can cause cerebral irritation leading to convulsions. Serum levels of cefuroxime can be reduced by haemodialysis or peritoneal dialysis.
Cefuroxime Sodium for Injection should not be mixed in the syringe with aminoglycoside antibiotics.
The pH of 2.74% w/v Sodium Bicarbonate Injection BP considerably affects the colour of the solution and therefore this solution is not recommended for the dilution of Cefuroxime Sodium for Injection. However, if required, for patients receiving Sodium Bicarbonate Injection by infusion the Cefuroxime Sodium for Injection may be introduced into the tube of the giving set.
36 months at 25°C, protected from light.
Suspensions of Cefuroxime Sodium for Injection for intramuscular injection and aqueous solutions for direct intravenous injection retain their potency for 24 hours if refrigerated.
1.5g Cefuroxime Sodium for Injection constituted with 15mL Water for Injections may be added to metronidazole injection (500mg/100mL) and both retain their activity for up to 24 hours below 25°C.
1.5g Cefuroxime Sodium for Injection is compatible with azlocillin 1g (in 15mL) or 5g (in 50mL) for up to 24 hours at 4°C or 6 hours below 25°C.
Cefuroxime Sodium for Injection (5mg/mL) in 5% w/v or 10% w/v xylitol injection may be stored for up to 24 hours at 25°C.
Cefuroxime Sodium for Injection is compatible with aqueous solutions containing up to 1% lignocaine hydrochloride.
Cefuroxime Sodium for Injection is compatible with the more commonly used intravenous infusion fluids. It will retain potency for up to 24 hours at room temperature in:-
Sodium Chloride Injection BP 0.9% w/v.
5% Dextrose Injection BP.
0.18% w/v Sodium Chloride plus 4% Dextrose Injection BP.
5% Dextrose and 0.9% Sodium Chloride Injection.
5% Dextrose and 0.45% Sodium Chloride Injection.
5% Dextrose and 0.225% Sodium Chloride Injection.
10% Dextrose Injection.
10% Invert Sugar in Water for Injection.
Ringer's Injection USP.
Lactated Ringer's Injection USP.
M/6 Sodium Lactate Injection.
Compound Sodium Lactate Injection BP (Hartmann's Solution).
The stability of Cefuroxime Sodium for Injection in Sodium Chloride Injection BP 0.9% w/v and in 5% Dextrose Injection is not affected by the presence of hydrocortisone sodium phosphate.
Cefuroxime Sodium for Injection has also been found compatible for 24 hours at room temperature when admixed in intravenous infusion with:
Heparin (10 and 50 units/mL) in 0.9% Sodium Chloride Injection;
Potassium Chloride (10 and 40mEqL) in 0.9% Sodium Chloride Injection.
Prescription Only Medicine
Vials containing 250mg, 750mg and 1.5 g cefuroxime as the sodium salt in packs of 10.
Hospira NZ Limited
23 Haining Street
Te Aro
Wellington
New Zealand
1 October 2007