Drugs List

Therapeutic Indications

Uses

Prophylaxis against post-operative infections, including abdominal, pelvic, orthopaedic, cardiac, pulmonary, oesophageal, and vascular surgery where there is an increased risk of infection.

Treatment of infections caused by sensitive bacteria, or before the infecting organism has been identified.
Types of infection include:

Respiratory tract infections: acute and chronic bronchitis, infected bronchiectasis, bacterial pneumonia, lung abscess, postoperative chest infections and aspiration pneumonia

Ear, nose and throat infections: sinusitis, tonsillitis, and pharyngitis.

Urinary tract infection: acute and chronic pyelonephritis, cystitis, and asymptomatic bacteriuria.

Soft tissue infections: cellulitis, erysipelas, peritonitis, and wound infections.

Bone and joint infections: osteomyelitis and septic arthritis.

Obstetric and gynaecological infections: pelvic inflammatory disease and pelvic abscess.

Gonorrhoea: particularly if penicillin is unsuitable.

Other infections: brain abscess,septicaemia and meningitis

The susceptibility to treatment of the causative organism should be tested (when possible) although therapy may be initiated before the results are available.

Administration

After reconstitution, the solution may be administered by intramuscular or intravenous injection, or by intravenous infusion.

For intravenous administration, the solution may be given directly into a vein or into the tubing of the giving set if the patient is receiving parenteral fluids.

Handling

After reconstitution, the product should be used immediately. If this is not possible, the diluted product may be stored at 2 to 8 degrees C for no longer than 24 hours.

Reconstitution

Follow manufacturer's guidance for reconstitution advice, displacement volumes etc.

Intramuscular injection
Add 1ml of water for injections to 250mg cefuroxime or 3ml water for injections to 750mg cefuroxime. Shake gently to produce an opaque suspension.

Intravenous administration
Dissolve the powder in water for injections using at least 2ml for 250mg cefuroxime, at least 6ml for 750mg cefuroxime or 15ml for 1.5g cefuroxime. For short intravenous infusion (e.g. up to 30 minutes), 1.5g may be dissolved in 50ml water for injections.

Compatibilities

For intravenous use, the reconstituted solution may be diluted with:
5% or 10% dextrose
5% glucose containing 0.2%, 0.225%, 0.45% or 0.9% sodium chloride injection.
5% glucose containing 20mEq potassium chloride.
0.9% sodium chloride injection.
Sodium lactate M/6 injection.
Ringer's injection.
Lactated Ringer's injection.
Heparin 10 units/ml in 0.9% sodium chloride injection.
Heparin 50 units/ml in 0.9% sodium chloride injection.
10mEq potassium chloride in 0.9% sodium chloride injection.

Incompatibilities

Cefuroxime should not be mixed with aminoglycoside antibiotics.

Contraindications

None known

Precautions and Warnings

Consideration should be given to the official guidance on the appropriate use of antibacterial agents.

Renal impairment - see Dosage; Renal Impairment.
Monitor renal function in the elderly and in patients with renal impairment. There may be some variation on the results of biochemical tests of renal function, but these do not appear to be of clinical importance. Some manufacturers recommend, as a precaution, monitoring renal function if this is already impaired.

Use with caution in patients who have experienced an allergic reaction to penicillins or other beta-lactams.

Cefuroxime may interfere with some laboratory tests. See Effects on Laboratory Tests.

Delayed sterilisation of the cerebrospinal fluid (CSF) in patients with Haemophilus influenzae meningitis may result in deafness or other neurological sequelae. Persistent positive H. influenzae CSF cultures have been found in some patients at 18 to 36 hours. Hearing loss has been reported in some children.

If there is no improvement in the clinical condition of the patient after 72 hours of parenteral therapy, then treatment should be reviewed.

As with other antibiotics, prolonged use of cefuroxime may result in the overgrowth of non-susceptible organisms (e.g. Candida , enterococci, Clostridium difficile ), which may require interruption of treatment.

There is conflicting information concerning the use of cefuroxime in porphyria.There is some evidence of 'non-porphyrinogenicity' but some manufacturers contraindicate use in acute porphyria.

Use in Porphyria

There is conflicting information concerning the use of cefuroxime in porphyria.

There is some evidence of 'non-porphyrinogenicity' but some manufacturers contraindicate use in acute porphyria.

Pregnancy and Lactation

Pregnancy

Cefuroxime readily crosses the placenta in late pregnancy and labour, achieving therapeutic concentrations in foetal serum and amniotic fluid.

There is no evidence of embryopathic or teratogenic effects attributable to cefuroxime.

Schaefer (2007) concludes that cephalosporins may be safely used during pregnancy if needed.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use with caution in women who are breast-feeding as cefuroxime is excreted in human milk.

At the time of writing, limited information suggests that maternal doses by injection produce low levels in milk that are not expected to cause severe adverse effects in the breastfed infant. Occasionally, disruption of the infant's gastrointestinal flora, causing diarrhoea or thrush have been reported with cephalosporins but these effects have not been adequately evaluated.

Schaefer (2007) recommends that second generation cephalosporins such as cefuroxime are the antibiotics of choice during breastfeeding.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Hypersensitivity reactions
Rash
Maculopapular rash
Urticaria
Pruritus
Interstitial nephritis
Drug fever
Anaphylaxis
Serum sickness-like reactions
Arthralgia
Overgrowth by non-susceptible organisms
Candidiasis
Erythema multiforme
Stevens-Johnson syndrome
Toxic epidermal necrolysis
Gastro-intestinal disturbances
Abdominal discomfort
Nausea
Vomiting
Diarrhoea
Pseudomembranous colitis
Antibiotic-associated colitis
Blood disorders
Aplastic anaemia
Haemolytic anaemia
Eosinophilia
Leucopenia
Neutropenia
Thrombocytopenia
Agranulocytosis
False positive Coombs test
Increases in hepatic enzymes
Serum bilirubin increased
Hepatitis (transient)
Cholestatic jaundice
Alterations in renal function tests
Local pain (injection site)
Thrombophlebitis (injection site)
Burning pain at injection site
Hearing loss
Dizziness
Headache
Hyperactivity
Nervousness
Sleep disturbances
Confusion
Hypertonia
Decrease in haemoglobin
Serum creatinine increased
Increase in blood urea nitrogen
Decrease in creatinine clearance
Cutaneous vasculitis
Glossitis
Azotaemia

Presentation

Powder for solution for injection or infusion containing 250mg of cefuroxime (as the sodium salt)
Powder for solution for injection or infusion containing 750mg of cefuroxime (as the sodium salt)
Powder for solution for injection or infusion containing 1.5g of cefuroxime (as the sodium salt)

Drugs List

Therapeutic Indications

Uses

Prophylaxis against post-operative infections, including abdominal, pelvic, orthopaedic, cardiac, pulmonary, oesophageal, and vascular surgery where there is an increased risk of infection.

Treatment of infections caused by sensitive bacteria, or before the infecting organism has been identified.
Types of infection include:

Respiratory tract infections: acute and chronic bronchitis, infected bronchiectasis, bacterial pneumonia, lung abscess, postoperative chest infections and aspiration pneumonia

Ear, nose and throat infections: sinusitis, tonsillitis, and pharyngitis.

Urinary tract infection: acute and chronic pyelonephritis, cystitis, and asymptomatic bacteriuria.

Soft tissue infections: cellulitis, erysipelas, peritonitis, and wound infections.

Bone and joint infections: osteomyelitis and septic arthritis.

Obstetric and gynaecological infections: pelvic inflammatory disease and pelvic abscess.

Gonorrhoea: particularly if penicillin is unsuitable.

Other infections: brain abscess,septicaemia and meningitis

The susceptibility to treatment of the causative organism should be tested (when possible) although therapy may be initiated before the results are available.

Dosage

Consideration should be given to the official guidance on the appropriate use of antibacterial agents.

Adults

Children

Neonates

Patients with Renal Impairment

Administration

After reconstitution, the solution may be administered by intramuscular or intravenous injection, or by intravenous infusion.

For intravenous administration, the solution may be given directly into a vein or into the tubing of the giving set if the patient is receiving parenteral fluids.

Handling

After reconstitution, the product should be used immediately. If this is not possible, the diluted product may be stored at 2 to 8 degrees C for no longer than 24 hours.

Reconstitution

Follow manufacturer's guidance for reconstitution advice, displacement volumes etc.

Intramuscular injection
Add 1ml of water for injections to 250mg cefuroxime or 3ml water for injections to 750mg cefuroxime. Shake gently to produce an opaque suspension.

Intravenous administration
Dissolve the powder in water for injections using at least 2ml for 250mg cefuroxime, at least 6ml for 750mg cefuroxime or 15ml for 1.5g cefuroxime. For short intravenous infusion (e.g. up to 30 minutes), 1.5g may be dissolved in 50ml water for injections.

Compatibilities

For intravenous use, the reconstituted solution may be diluted with:
5% or 10% dextrose
5% glucose containing 0.2%, 0.225%, 0.45% or 0.9% sodium chloride injection.
5% glucose containing 20mEq potassium chloride.
0.9% sodium chloride injection.
Sodium lactate M/6 injection.
Ringer's injection.
Lactated Ringer's injection.
Heparin 10 units/ml in 0.9% sodium chloride injection.
Heparin 50 units/ml in 0.9% sodium chloride injection.
10mEq potassium chloride in 0.9% sodium chloride injection.

Incompatibilities

Cefuroxime should not be mixed with aminoglycoside antibiotics.

Contraindications

None known

Precautions and Warnings

Consideration should be given to the official guidance on the appropriate use of antibacterial agents.

Renal impairment - see Dosage; Renal Impairment.
Monitor renal function in the elderly and in patients with renal impairment. There may be some variation on the results of biochemical tests of renal function, but these do not appear to be of clinical importance. Some manufacturers recommend, as a precaution, monitoring renal function if this is already impaired.

Use with caution in patients who have experienced an allergic reaction to penicillins or other beta-lactams.

Cefuroxime may interfere with some laboratory tests. See Effects on Laboratory Tests.

Delayed sterilisation of the cerebrospinal fluid (CSF) in patients with Haemophilus influenzae meningitis may result in deafness or other neurological sequelae. Persistent positive H. influenzae CSF cultures have been found in some patients at 18 to 36 hours. Hearing loss has been reported in some children.

If there is no improvement in the clinical condition of the patient after 72 hours of parenteral therapy, then treatment should be reviewed.

As with other antibiotics, prolonged use of cefuroxime may result in the overgrowth of non-susceptible organisms (e.g. Candida , enterococci, Clostridium difficile ), which may require interruption of treatment.

There is conflicting information concerning the use of cefuroxime in porphyria.There is some evidence of 'non-porphyrinogenicity' but some manufacturers contraindicate use in acute porphyria.

Use in Porphyria

There is conflicting information concerning the use of cefuroxime in porphyria.

There is some evidence of 'non-porphyrinogenicity' but some manufacturers contraindicate use in acute porphyria.

Pregnancy and Lactation

Pregnancy

Cefuroxime readily crosses the placenta in late pregnancy and labour, achieving therapeutic concentrations in foetal serum and amniotic fluid.

There is no evidence of embryopathic or teratogenic effects attributable to cefuroxime.

Schaefer (2007) concludes that cephalosporins may be safely used during pregnancy if needed.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use with caution in women who are breast-feeding as cefuroxime is excreted in human milk.

At the time of writing, limited information suggests that maternal doses by injection produce low levels in milk that are not expected to cause severe adverse effects in the breastfed infant. Occasionally, disruption of the infant's gastrointestinal flora, causing diarrhoea or thrush have been reported with cephalosporins but these effects have not been adequately evaluated.

Schaefer (2007) recommends that second generation cephalosporins such as cefuroxime are the antibiotics of choice during breastfeeding.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Effects on Ability to Drive and Operate Machinery

There is no known effect on the ability to drive or operate machinery.

Side Effects

Hypersensitivity reactions
Rash
Maculopapular rash
Urticaria
Pruritus
Interstitial nephritis
Drug fever
Anaphylaxis
Serum sickness-like reactions
Arthralgia
Overgrowth by non-susceptible organisms
Candidiasis
Erythema multiforme
Stevens-Johnson syndrome
Toxic epidermal necrolysis
Gastro-intestinal disturbances
Abdominal discomfort
Nausea
Vomiting
Diarrhoea
Pseudomembranous colitis
Antibiotic-associated colitis
Blood disorders
Aplastic anaemia
Haemolytic anaemia
Eosinophilia
Leucopenia
Neutropenia
Thrombocytopenia
Agranulocytosis
False positive Coombs test
Increases in hepatic enzymes
Serum bilirubin increased
Hepatitis (transient)
Cholestatic jaundice
Alterations in renal function tests
Local pain (injection site)
Thrombophlebitis (injection site)
Burning pain at injection site
Hearing loss
Dizziness
Headache
Hyperactivity
Nervousness
Sleep disturbances
Confusion
Hypertonia
Decrease in haemoglobin
Serum creatinine increased
Increase in blood urea nitrogen
Decrease in creatinine clearance
Cutaneous vasculitis
Glossitis
Azotaemia

Effects on Laboratory Tests

Slight interference with copper reduction tests for glycosuria may be observed. The reliability of enzymatic tests for glycosuria or the alkaline picrate method for creatinine are not affected by cefuroxime.

It is recommended that the glucose oxidase or hexokinase methods are used to determine blood glucose levels in patients receiving cefuroxime sodium.

Cephalosporins have been reported to cause false-positive results with the Coombs test.

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Shelf Life and Storage

Store below 25 degrees C and protect from light.

After reconstitution, the products should be used immediately. If this is not possible, the diluted product may be stored at 2 to 8 degrees C for no longer than 24 hours.

Further Information

Last Full Review Date: June 2012

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Summary of Product Characteristics: Cefuroxime Sodium 250mg, 750mg, 1.5g Injection. Stravencon. Revised March 2012.
Summary of Product Characteristics: Cefuroxime Sodium Injection. Flynn Pharma Ltd. Revised January 2009.
Summary of Product Characteristics: Zinacef. GlaxoSmithKline UK. Revised July 2015.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 07 September 2017

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Cefuroxime Last revised: 7 December 2010
Last accessed: June 14 2012