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Cefuroxime axetil

AEMPS

Second-generation oral cephalosporin

ATC code: J01DC02

Brand names: Zinnat, Ceftin, Cefuracet

Updated · Methodology

Indications

B

Acute otitis media in children

Second line

Used in acute otitis media in children and adults as an alternative to amoxicillin/clavulanate when penicillins are intolerable without anaphylaxis. 2013 and the Spanish 2024 pediatric consensus set amoxicillin 80–90 mg/kg/day or amoxicillin/clavulanate (with suspected resistance) as first-line. Cefuroxime axetil in children: 30 mg/kg/day in 2 doses for 5–10 days. In children over 2 without severe disease, delayed antibiotic prescription over 48–72 hours is an option.

Sources

  1. AEMPS: Ficha técnica de Cefuroxima axetilo (2024)
  2. AEPED: Update of the consensus document on the aetiology, diagnosis and treatment of acute otitis media and sinusitis. (2023)

ICD-10: H66.0 · ICD-11: AB00

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

F

Common cold

Not recommended

Cefuroxime axetil is prescribed for upper respiratory infections, acute bronchitis and uncomplicated pharyngitis without group A streptococcal confirmation. 2024 AWaRe limits outpatient oral cephalosporin use. NG191 2020 does not recommend antibiotics for acute bronchitis in immunocompetent adults. Use in viral infections is irrational.

Sources

  1. AEMPS: Ficha técnica de Cefuroxima axetilo (2024)
  2. Cochrane (Hemila and Chalker): Vitamin C for preventing and treating the common cold (2013)

ICD-10: J00 · ICD-11: CA00

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

A bactericidal antibiotic that binds penicillin-binding proteins and disrupts cell-wall synthesis. Spectrum covers Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Streptococcus pyogenes, methicillin-susceptible Staphylococcus aureus, and some Escherichia coli and Klebsiella pneumoniae strains. Cefuroxime axetil is a prodrug converted to active cefuroxime by intestinal esterases. In Spain it is widely prescribed under the brand Zinnat – among the most prescribed oral cephalosporins.

Safety

Contraindications

  • Cephalosporin hypersensitivity
  • History of penicillin anaphylaxis
  • Age under 3 months

Serious adverse effects

  • Anaphylaxis
  • Pseudomembranous colitis
  • Hematologic disorders (eosinophilia, thrombocytopenia)
  • Hepatotoxicity
  • Stevens–Johnson syndrome (rare)

Common adverse effects

  • Diarrhea
  • Nausea
  • Abdominal pain
  • Headache
  • Skin rash
  • Candidiasis

Pregnancy: can you take Cefuroxime axetil?

AEMPS summary of product characteristics (section 4.6): there are limited data on the use of cefuroxime in pregnant women. Animal studies have shown no harmful effects on pregnancy, embryonic or fetal development, parturition or postnatal development. Cefuroxime should be prescribed to pregnant women only if the benefit outweighs the risk.

Breastfeeding: can you take Cefuroxime axetil?

Compatible with breastfeeding. Milk concentrations are low; transient infant diarrhea is possible.

Calculate RIDFull profile on NIH LactMed ↗

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Timing and administration

Take with or immediately after food – meals raise bioavailability from 37% to 52%. Do not break or chew the tablet (bitter taste). With eGFR under 30, extend interval to 24 hours. Complete the course – early discontinuation on subjective improvement raises relapse and resistance risk.
Label mentions4 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

  • antacidsclass named in the label
    «Drugs that Reduce Gastric Acidity: Drugs that reduce gastric acidity may result in a lower bioavailability of cefuroxime axetil compared with administration in the fasting state. Administration of…»

    FDA, section 7 · Open on DailyMed

  • anticoagulantesclass named in the label
    «La administración concomitante con anticoagulantes orales puede dar lugar a un aumento del Ratio Internacional Normalizado (International Normalized Ratio – INR).»

    AEMPS, section 4.5 · Open on CIMA

  • Copper
    «Drug/Laboratory Test Interactions: A false-positive reaction for glucose in the urine may occur with copper reduction tests (e.g., Benedict's or Fehling's solution), but not with enzyme-based tests…»

    FDA, section 7 · Open on DailyMed

  • proton pump inhibitorsclass named in the label
    «Drugs that Reduce Gastric Acidity: Drugs that reduce gastric acidity may result in a lower bioavailability of cefuroxime axetil compared with administration in the fasting state. Administration of…»

    FDA, section 7 · Open on DailyMed

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Frequently asked

What is Cefuroxime axetil used for?

Cefuroxime axetil is evaluated for the following indications with varying evidence strength: Acute otitis media in children (evidence tier B), COPD exacerbation (evidence tier B), Community-acquired pneumonia (evidence tier B). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Cefuroxime axetil?

Common side effects of Cefuroxime axetil (≥ 1 in 100): Diarrhea, Nausea, Abdominal pain, Headache, Skin rash, Candidiasis. See the Safety section for uncommon and serious reactions.

Is Cefuroxime axetil safe during pregnancy?

AEMPS summary of product characteristics (section 4.6): there are limited data on the use of cefuroxime in pregnant women. Animal studies have shown no harmful effects on pregnancy, embryonic or fetal development, parturition or postnatal development. Cefuroxime should be prescribed to pregnant women only if the benefit outweighs the risk.

Is Cefuroxime axetil compatible with breastfeeding?

Compatible with breastfeeding. Milk concentrations are low; transient infant diarrhea is possible.

Who should not take Cefuroxime axetil?

Cefuroxime axetil is contraindicated in: Cephalosporin hypersensitivity; History of penicillin anaphylaxis; Age under 3 months. Full list in the Safety section.

Official sources

Direct links to regulator labels. Open in a new tab.

Other drugs in this group

Chloramphenicol, Ciprofloxacin, Clarithromycin, Clindamycin, Co-trimoxazole, Fosfomycin, Metronidazole, Amoxicillin