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Second-Generation Cephalosporin Pregnancy: §4.6, verbatim. Pregnancy: 'There are limited amounts of data from the use of cefuroxime in pregnant women. Studies in animals have shown no reproductive toxicity (see section 5.3). Zinacef should be prescribed to pregnant women only if the benefit outweighs the risk. Cefuroxime has been shown to cross the placenta and attain therapeutic levels in amniotic fluid and cord blood after intramuscular or intravenous dose to the mother.' Breastfeeding: 'Cefuroxime is excreted in human milk in small quantities. Adverse reactions at therapeutic doses are not expected, although a risk of diarrhoea and fungus infection of the mucous membranes cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from cefuroxime therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.' Fertility: 'There are no data on the effects of cefuroxime sodium on fertility in humans. Reproductive studies in animals have shown no effects on fertility.'

Cefuroxime 1.5g IV

Brand names: Zinacef

Intravenous cefuroxime is a second-generation cephalosporin used in orthopaedics and trauma chiefly as a single-dose surgical antibiotic prophylaxis at induction for clean and clean-contaminated procedures such as joint arthroplasty and internal fixation. The IV route gives reliable tissue and bone concentrations at the time of incision.

Adult dose

Dose: 1.5 g with the induction of anaesthesia. §4.2 Table 1 (Adults and children weighing 40 kg or more), verbatim, for the indication 'Surgical prophylaxis for gastrointestinal, gynaecological surgery (including caesarean section) and orthopaedic operations': '1.5 g with the induction of anaesthesia. This may be supplemented with two 750 mg doses (intramuscularly) after 8 hours and 16 hours'.
Route: Intravenous. §4.2 Method of administration, verbatim: 'Zinacef should be administered by intravenous injection over a period of 3 to 5 minutes directly into a vein or via a drip tube or infusion over 30 to 60 minutes, or by deep intramuscular injection.' Note that the SPC specifies the two supplementary prophylaxis doses INTRAMUSCULARLY. Also §4.2: 'Intramuscular injections should be injected well within the bulk of a relatively large muscle and not more than 750 mg should be injected at one site. For doses greater than 1.5 g intravenous administration should be used.'
Frequency: A single 1.5 g dose given with the induction of anaesthesia, which the SPC states 'may be supplemented with two 750 mg doses (intramuscularly) after 8 hours and 16 hours' - i.e. at most three doses in total for this indication.
SCOPE OF WHAT IS PUBLISHED: the adult/child-40-kg-or-over ORTHOPAEDIC SURGICAL PROPHYLAXIS regimen only, which is this page's primary indication and route. Every figure above is verbatim from §4.2 Table 1 of the Zinacef 1.5 g SPC. || MAXDOSE DELIBERATELY LEFT EMPTY: the SPC states no ceiling for this or any other regimen - the strings 'maximum' and 'not exceed' do not appear anywhere in this bundle (checked). || WHAT ELSE IS NOT SOURCED HERE, and so is not carried: 'Repeat 1.5g IV every 8h for up to 24h post-operatively'; the open-fracture 72-hour course; 'cefuroxime 1.5g IV at scene/ED'; the penicillin-allergy alternative 'teicoplanin 400mg IV + gentamicin 5mg/kg IV'; the ~1% cephalosporin/penicillin cross-reactivity figure; and the 'within 60 minutes of skin incision' timing. These come from BOAST and NICE guidance, not from this SPC - restore them only with a guideline citation, never as SPC content. || RECONSTITUTION: §4.2 defers to §6.6, which was NOT fetched in this bundle - no diluent volume or resulting mg/mL figure is available here (see paedDose.concentration). || TRUNCATION WARNING: §4.4 is cut off mid-sentence at the source-fetch limit ('Intracameral use and eye disorders ... Individual cases'), so the fetched warnings are not the complete set.

Paediatric dose

Route: Intravenous (or, per §4.2, IV infusion over 30 to 60 minutes or deep intramuscular injection)
Frequency: See notes - the SPC gives no paediatric surgical-prophylaxis frequency; a child weighing 40 kg or more takes the adult single-dose-at-induction regimen
THE ONE SOURCED PAEDIATRIC FACT FOR THIS PAGE'S INDICATION IS A WEIGHT THRESHOLD, NOT A PER-KG DOSE. §4.2 Table 1 is headed 'Adults and children >= 40 kg', so a child weighing 40 kg or more receives the adult orthopaedic prophylaxis regimen published above ('1.5 g with the induction of anaesthesia'). || NO SURGICAL PROPHYLAXIS DOSE EXISTS FOR CHILDREN UNDER 40 kg ANYWHERE IN THIS BUNDLE. §4.2 Table 2 ('Children < 40 kg') lists only four TREATMENT indications - community acquired pneumonia, complicated urinary tract infections including pyelonephritis, soft-tissue infections (cellulitis, erysipelas and wound infections) and intra-abdominal infections - for which it gives, verbatim: infants and toddlers over 3 weeks and children under 40 kg, '30 to 100 mg/kg/day (intravenously) given as 3 or 4 divided doses; a dose of 60 mg/kg/day is appropriate for most infections'; infants birth to 3 weeks, '30 to 100 mg/kg/day (intravenously) given as 2 or 3 divided doses'. THAT IS A TREATMENT REGIMEN FOR A DIFFERENT INDICATION AND MUST NOT BE ADMINISTERED AS SURGICAL PROPHYLAXIS. || dosePerKg IS NULL AND MUST STAY NULL for two independent reasons: the only per-kg figures in this SPC are for the wrong indication, and they are DAILY TOTALS in divided doses (30 to 100 mg/kg/day), not a per-dose figure the weight calculator could use. || concentration IS NULL: no mg/mL figure is stated anywhere in the fetched sections; §4.2 refers reconstitution to §6.6, which was not retrieved. || Verify any under-18 dose against a children's formulary and local surgical prophylaxis policy before administration.

Dose adjustments

Renal

§4.2, verbatim: 'Cefuroxime is primarily excreted by the kidneys. Therefore, as with all such antibiotics, in patients with markedly impaired renal function it is recommended that the dosage of Zinacef should be reduced to compensate for its slower excretion.' Table 3 (Recommended doses for Zinacef in renal impairment), quoted by creatinine clearance band with the SPC’s mathematical symbols spelled out: 'greater than 20 mL/min/1.73 m2 - It is not necessary to reduce the standard dose (750 mg to 1.5 g three times daily)'; '10-20 mL/min/1.73 m2 - 750 mg twice daily'; 'less than 10 mL/min/1.73 m2 - 750 mg once daily'; 'Patients on haemodialysis - A further 750 mg dose should be given at the end of each dialysis; in addition to parenteral use, cefuroxime sodium can be incorporated into the peritoneal dialysis fluid (usually 250 mg for every 2 litres of dialysis fluid)'; 'Patients in renal failure on continuous arteriovenous haemodialysis (CAVH) or high-flux haemofiltration (HF) in intensive therapy units - 750 mg twice daily; for low-flux haemofiltration follow the dosage recommended under impaired renal function.' These figures are for the SPC's treatment doses - the SPC gives no renally adjusted surgical-prophylaxis dose.

Hepatic

§4.2, verbatim: 'Cefuroxime is primarily eliminated by the kidney. In patients with hepatic dysfunction this is not expected to affect the pharmacokinetics of cefuroxime.' No dose adjustment is specified.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • §4.3, verbatim: 'Hypersensitivity to cefuroxime or to any of the excipients listed in section 6.1.'
  • §4.3, verbatim: 'Patients with known hypersensitivity to cephalosporin antibiotics.'
  • §4.3, verbatim: 'History of severe hypersensitivity (e.g. anaphylactic reaction) to any other type of beta-lactam antibacterial agent (penicillins, monobactams and carbapenems).'
  • Not a contraindication but a §4.4 stopping rule: 'In case of severe hypersensitivity reactions, treatment with cefuroxime must be discontinued immediately and adequate emergency measures must be initiated.' §4.4 also warns that hypersensitivity reactions have 'progressed to Kounis syndrome (acute allergic coronary arteriospasm that can result in myocardial infarction)'.
  • Not a contraindication but an absolute §4.4 re-challenge bar after a severe cutaneous reaction: 'If the patient has developed a serious reaction such as SJS, TEN or DRESS with the use of cefuroxime, treatment with cefuroxime must not be restarted in this patient at any time.'
  • Not a contraindication but a §4.4 caution: 'Caution should be used if cefuroxime is given to patients with a history of non-severe hypersensitivity to other beta-lactam agents.'
  • Not a contraindication but a §4.2 route restriction: 'Zinacef is not formulated for intracameral use.'

Side effects

  • §4.8 opening statement, verbatim: 'The most common adverse reactions are neutropenia, eosinophilia, transient rise in liver enzymes or bilirubin, particularly in patients with pre-existing liver disease, but there is no evidence of harm to the liver and injection site reactions.'
  • Infections and infestations (§4.8): Candida overgrowth; overgrowth of Clostridioides difficile
  • Blood and lymphatic system disorders (§4.8): neutropenia; eosinophilia; decreased haemoglobin concentration; leukopenia; positive Coomb's test; thrombocytopenia; haemolytic anaemia
  • Cardiac disorders (§4.8): Kounis syndrome
  • Immune system disorders (§4.8): drug fever; interstitial nephritis; anaphylaxis; cutaneous vasculitis
  • Gastrointestinal disorders (§4.8): gastrointestinal disturbance; pseudomembranous colitis
  • Hepatobiliary disorders (§4.8): transient rise in liver enzymes; transient rise in bilirubin
  • Skin and subcutaneous tissue disorders (§4.8): skin rash; urticaria; pruritus; erythema multiforme; toxic epidermal necrolysis and Stevens-Johnson syndrome; angioneurotic oedema; Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
  • Renal and urinary disorders (§4.8): elevations in serum creatinine; elevations in blood urea nitrogen; decreased creatinine clearance
  • General disorders and administration site conditions (§4.8): 'injection site reactions which may include pain and thrombophlebitis'. §4.8 adds: 'Pain at the intramuscular injection site is more likely at higher doses.'
  • Class effect, §4.8 verbatim: 'Cephalosporins as a class tend to be absorbed onto the surface of red cell membranes and react with antibodies directed against the drug to produce a positive Coomb's test (which can interfere with cross matching of blood) and very rarely haemolytic anaemia.'
  • CAVEAT ON FREQUENCIES: the §4.8 table arrived flattened, with its Common / Uncommon / Not known columns collapsed into running text, so the frequency band each individual term sits in cannot be reconstructed reliably. The terms above are verbatim and grouped by system organ class only. §4.8 is also truncated at the source-fetch limit (it stops inside 'Paediatric population'), so this is not the complete adverse-reaction profile.

Monitoring

  • Allergy history BEFORE the first dose, §4.4 verbatim: 'Before beginning treatment, it should be established whether the patient has a history of severe hypersensitivity reactions to cefuroxime, to other cephalosporins or to any other type of beta-lactam agent.'
  • Skin, §4.4 verbatim: 'At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, cefuroxime should be withdrawn immediately and an alternative treatment considered.'
  • Renal function, §4.4 verbatim: 'Renal function should be monitored in the elderly and those with known pre-existing renal impairment.' The same paragraph warns that 'Cephalosporin antibiotics at high dosage should be given with caution to patients receiving concurrent treatment with potent diuretics such as furosemide or aminoglycosides. Renal impairment has been reported during use of these combinations.'
  • Diarrhoea, §4.4 verbatim: 'Antibacterial agent-associated pseudomembranous colitis has been reported with use of cefuroxime and may range in severity from mild to life threatening. This diagnosis should be considered in patients with diarrhoea during or subsequent to the administration of cefuroxime.' It adds that discontinuation and specific C. difficile treatment should be considered and that 'Medicinal products that inhibit peristalsis should not be given.'
  • Overgrowth, §4.4: 'Use of cefuroxime may result in the overgrowth of Candida. Prolonged use may also result in the overgrowth of other non-susceptible microorganisms (e.g. enterococci and Clostridioides difficile), which may require interruption of treatment.'
  • Blood cross-matching, §4.8: a cephalosporin-induced positive Coomb's test 'can interfere with cross matching of blood' - flag this to the laboratory if the patient is being grouped and saved.

Clinical monograph

How it works

It is a beta-lactam that binds penicillin-binding proteins to inhibit bacterial cell-wall peptidoglycan cross-linking, causing cell lysis, with useful activity against meticillin-sensitive staphylococci and many streptococci.

Prescribing in practice

  • Do not give to patients with a history of immediate or severe (anaphylactic) reaction to penicillins or cephalosporins; check allergy status before induction and document a suitable alternative.
  • Timing is critical — administer within the window before knife-to-skin so adequate tissue levels are present, and consider an intra-operative redose for prolonged surgery or major blood loss per local protocol.
  • Reduce frequency in significant renal impairment and review against the SPC and local microbiology guidance.

Monitoring

Routine prophylactic courses need little laboratory monitoring, but observe for hypersensitivity, and review renal function and for antibiotic-associated diarrhoea if therapy is extended.

Counselling the patient

  • Tell the team and patient about any previous penicillin or cephalosporin reaction before surgery.
  • Report rash, swelling or breathing difficulty immediately.
  • Report persistent diarrhoea after antibiotics, as this needs assessment.

Evidence & guidelines

Cephalosporin surgical prophylaxis is supported by NICE and SIGN guidance, which emphasise correct dose timing relative to incision to reduce surgical site infection.

Reference: BOAST Open Fracture Guidelines 2017; NICE NG125 (Surgical Site Infections); Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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