Schedule H

Oral, Intravenous, Intramuscular

• Tablets: 125 mg, 250 mg, 500 mg (as cefuroxime axetil)

• Dry syrup/Suspension: 125 mg/5 mL (as cefuroxime axetil)

• Injection: 750 mg, 1.5 g vials (as cefuroxime sodium, for IM/IV use)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India):

1. Community-Acquired Pneumonia

Oral (Cefuroxime axetil):

Parameter Dose Clinical Notes

Starting dose 500 mg orally twice daily Administer with food for optimal absorption

Titration Not applicable Fixed dosing regimen

Usual maintenance dose 500 mg twice daily

Maximum dose 500 mg twice daily

Duration 5–7 days (uncomplicated); up to 10 days (severe) Step-down from IV after clinical improvement

Parenteral (Cefuroxime sodium):

Parameter Dose Clinical Notes

Starting dose 750 mg IV/IM every 8 hours For moderate severity

Titration Not applicable May escalate to 1.5 g every 8 hours if severe

Usual maintenance dose 750 mg–1.5 g every 8 hours Depending on severity

Maximum dose 1.5 g every 6 hours (6 g/day) For severe infections

Duration 5–10 days Switch to oral when clinically stable

1. Acute Bacterial Sinusitis

Parameter Dose Clinical Notes

Starting dose 250 mg orally twice daily For mild to moderate cases

Titration Not applicable Increase to 500 mg twice daily if inadequate response

Usual maintenance dose 250–500 mg twice daily

Maximum dose 500 mg twice daily

Duration 7–10 days Complete full course to prevent resistance

1. Acute Otitis Media

Parameter Dose Clinical Notes

Starting dose 250 mg orally twice daily For adults

Titration Not applicable

Usual maintenance dose 250 mg twice daily

Maximum dose 500 mg twice daily For treatment failures

Duration 5–10 days

1. Skin and Soft Tissue Infections

Oral:

Parameter Dose Clinical Notes

Starting dose 250 mg orally twice daily For mild infections

Titration Not applicable Increase to 500 mg twice daily for moderate infections

Usual maintenance dose 250–500 mg twice daily

Maximum dose 500 mg twice daily

Duration 7–14 days Based on clinical response

Parenteral:

Parameter Dose Clinical Notes

Starting dose 750 mg IV/IM every 8 hours

Titration Not applicable Increase to 1.5 g every 8 hours if severe

Usual maintenance dose 750 mg–1.5 g every 8 hours

Maximum dose 1.5 g every 6 hours

Duration 7–14 days Step-down to oral when appropriate

1. Urinary Tract Infections

Uncomplicated UTI (Oral):

Parameter Dose Clinical Notes

Starting dose 250 mg orally twice daily

Titration Not applicable

Usual maintenance dose 250 mg twice daily

Maximum dose 500 mg twice daily

Duration 5–7 days

Complicated UTI / Pyelonephritis (Parenteral):

Parameter Dose Clinical Notes

Starting dose 750 mg IV/IM every 8 hours

Titration Not applicable Increase to 1.5 g every 8 hours if severe

Usual maintenance dose 750 mg–1.5 g every 8 hours

Maximum dose 1.5 g every 8 hours

Duration 10–14 days Switch to oral after improvement

PAEDIATRIC DOSING (Specialist Only)

Primary Indications:

1. Acute Otitis Media

Age/Weight Oral Dose Comments

3 months to 2 years 10–15 mg/kg/dose twice daily Use suspension formulation

2–12 years 15 mg/kg/dose twice daily Maximum 250 mg per dose

12 years 250 mg twice daily Adult dosing

Dosing Summary:

• Starting dose: 20–30 mg/kg/day in 2 divided doses

• Titration: Not applicable

• Usual maintenance dose: 20–30 mg/kg/day in 2 divided doses

• Maximum dose: 500 mg twice daily (1 g/day)

• Duration: 5–10 days

1. Acute Bacterial Sinusitis

Parameter Dose Comments

Starting dose 15 mg/kg/dose orally twice daily

Titration Not applicable

Usual maintenance dose 30 mg/kg/day in 2 divided doses

Maximum dose 500 mg twice daily

Duration 10–14 days

1. Pharyngitis/Tonsillitis (Group A Streptococcal)

Parameter Dose Comments

Starting dose 10 mg/kg/dose orally twice daily

Titration Not applicable

Usual maintenance dose 20 mg/kg/day in 2 divided doses

Maximum dose 250 mg twice daily

Duration 10 days Complete course to prevent rheumatic fever

1. Skin and Soft Tissue Infections

Oral:

Parameter Dose Comments

Starting dose 10–15 mg/kg/dose orally twice daily

Titration Not applicable

Usual maintenance dose 20–30 mg/kg/day in 2 divided doses

Maximum dose 500 mg twice daily

Duration 7–14 days

Parenteral:

Parameter Dose Comments

Starting dose 25–50 mg/kg/dose IV every 8 hours For moderate to severe infections

Titration Not applicable

Usual maintenance dose 75–150 mg/kg/day in 3 divided doses

Maximum dose 6 g/day

1. Urinary Tract Infections

Parameter Dose Comments

Starting dose (oral) 10–15 mg/kg/dose twice daily For uncomplicated UTI

Starting dose (IV) 25–50 mg/kg/dose every 8 hours For complicated/febrile UTI

Titration Not applicable

Usual maintenance dose 20–30 mg/kg/day (oral); 75–150 mg/kg/day (IV)

Maximum dose 500 mg twice daily (oral); 6 g/day (IV)

Duration 7–14 days

1. Community-Acquired Pneumonia

Parameter Dose Comments

Starting dose (IV) 50 mg/kg/dose every 8 hours For hospitalized children

Titration Not applicable

Usual maintenance dose 100–150 mg/kg/day in 3 divided doses

Maximum dose 6 g/day

Oral step-down 15 mg/kg/dose twice daily After clinical improvement

Duration 7–10 days total

Secondary Indications — Paediatrics (Off-label, if any)

Not applicable. No established off-label paediatric indications in routine Indian practice.

Not recommended below 3 months of age except under specialist paediatric infectious disease supervision. Third-generation cephalosporins (ceftriaxone, cefotaxime) preferred for neonatal infections.

30 No adjustment No adjustment

10–30 250 mg every 12–24 hours 750 mg every 12 hours

<10 250 mg every 24 hours 750 mg every 24 hours

Haemodialysis Dose after dialysis 750 mg after each dialysis session

CAPD 250 mg every 24 hours 750 mg twice weekly (specialist guidance)

Note: Monitor for CNS toxicity (seizures, encephalopathy) in severe renal impairment, especially with high doses.

Cefuroxime is primarily renally excreted; hepatic impairment does not significantly affect pharmacokinetics.

• Known hypersensitivity to cefuroxime or any cephalosporin antibiotic

• History of severe allergic reaction (anaphylaxis, angioedema, severe urticaria) to any beta-lactam antibiotic (penicillins, carbapenems)

• Cefuroxime axetil suspension in patients with hereditary fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency (due to sucrose content in some formulations)

• History of non-severe penicillin allergy (rash only) — approximately 1–2% cross-reactivity risk; may use with caution and monitoring

• Renal impairment — dose adjustment required; increased risk of accumulation and neurotoxicity

• Seizure disorder or CNS pathology — high doses can lower seizure threshold

• History of gastrointestinal disease, especially colitis — increased risk of Clostridioides difficile-associated diarrhoea

• Prolonged use — risk of superinfection with resistant organisms or fungal overgrowth

• Oral formulation (cefuroxime axetil) — administer with food to enhance absorption

Aspect Recommendation

Risk category Generally considered safe; extensive human use data without evidence of teratogenicity

Use in pregnancy Preferred beta-lactam for susceptible infections during pregnancy

Preferred alternatives Amoxicillin, amoxicillin-clavulanate for common infections

When to use Can be used when clinically indicated throughout pregnancy

Monitoring Standard maternal monitoring; renal function if prolonged parenteral course

Aspect Recommendation

Compatibility Compatible with breastfeeding

Drug levels in milk Low (milk:plasma ratio <0.1)

Preferred alternatives None required; cefuroxime is a preferred choice during lactation

Recommendations May breastfeed while on cefuroxime therapy

Infant monitoring Observe for diarrhoea, oral thrush, or feeding difficulties with prolonged maternal use

Aspect Recommendation

Starting dose Standard adult doses if renal function normal

Titration Not applicable

Special considerations Age-related decline in renal function common — assess eGFR and adjust dose accordingly

Extra risks Increased risk of C. difficile colitis; CNS effects (confusion, encephalopathy) more likely if renally impaired

Monitoring Baseline and periodic renal function; observe for confusion or seizures

Drug Interaction Management

Probenecid Inhibits renal tubular secretion → increased cefuroxime levels (up to 50%) Avoid combination or reduce cefuroxime dose; use only if clinically necessary

Live attenuated typhoid vaccine (Ty21a) Antibiotics may reduce vaccine immunogenicity Complete cefuroxime course at least 3 days before starting oral typhoid vaccine

Aminoglycosides Additive nephrotoxicity when used concurrently Use with caution; monitor renal function and aminoglycoside levels if combined

Drug Interaction Management

Warfarin Possible increased INR due to gut flora alteration affecting vitamin K synthesis Monitor INR; particularly with prolonged cefuroxime courses

Loop diuretics (furosemide) Theoretical increased nephrotoxicity risk Monitor renal function if concurrent use

Metformin No direct interaction, but monitor renal function in diabetic patients Standard monitoring

Oral contraceptives Theoretical reduction in efficacy (gut flora alteration) — clinical significance unclear Counsel on backup contraception during prolonged antibiotic use if desired

Antacids, H2 blockers, PPIs May reduce absorption of cefuroxime axetil Administer cefuroxime with food; separate from antacids by 2 hours

• Diarrhoea (most common — 3–10%)

• Nausea and vomiting

• Abdominal discomfort

• Headache

• Rash (maculopapular, non-allergic)

• Injection site pain/phlebitis (parenteral use)

• Transient elevation of liver enzymes (AST, ALT)

• Positive direct Coombs' test (without haemolysis)

• Eosinophilia (transient)

Adverse Effect Clinical Notes

Anaphylaxis Rare but life-threatening; discontinue immediately; manage as anaphylactic emergency

Stevens-Johnson Syndrome / TEN Rare; discontinue immediately if mucocutaneous lesions develop

Clostridioides difficile-associated diarrhoea (CDAD) May occur during or after therapy; discontinue if confirmed; treat with metronidazole or vancomycin orally

Seizures Risk increased in renal impairment and high doses; discontinue and manage supportively

Haemolytic anaemia Rare; Coombs-positive haemolysis reported; discontinue if occurs

Interstitial nephritis Rare; may present as fever, rash, eosinophilia, rising creatinine

Severe neutropenia / Agranulocytosis Very rare with prolonged use; obtain CBC if unexplained fever or infections

During treatment Clinical response (fever curve, inflammatory markers); observe for hypersensitivity reactions; monitor for diarrhoea (especially C. difficile)

Prolonged therapy (>14 days) CBC, LFTs, renal function weekly; Coombs' test if haemolysis suspected

Parenteral therapy Inspect IV site for phlebitis; rotate sites every 48–72 hours

• Ceftum (GSK/Alkem)

• Zinacef (GSK) — injectable

• Supacef (Sun Pharma)

• Cefakind (Mankind)

• Altacef (Unichem)

• Xorimax (Sandoz)

• Cefu (Cipla)

• Furocef (Aristo)

• Zocef (FDC)

NLEM status: Listed in NLEM 2022 (injectable form); not currently under NPPA price ceiling for all formulations.

1. Food enhances absorption — cefuroxime axetil (oral prodrug) has significantly better bioavailability when administered with food; always counsel to take with meals.

1. Good bone penetration — useful in orthopaedic surgical prophylaxis and osteomyelitis step-down therapy; commonly used in India for this indication.

1. Not effective against atypical pathogens — lacks activity against Mycoplasma, Chlamydia, and Legionella; combine with macrolide for CAP if atypical coverage needed.

1. Step-down therapy — excellent IV-to-oral bioequivalence makes it suitable for early oral switch in pneumonia and SSTIs once patient is afebrile and clinically improving.

1. Avoid in confirmed ESBL producers — second-generation cephalosporins are ineffective against ESBL-producing Enterobacteriaceae; obtain culture sensitivity before initiating therapy for complicated UTIs.

1. Suspension dosing accuracy — ensure caregivers understand proper reconstitution and measurement; use calibrated measuring device rather than household spoons.

cefuroxime; cephalosporin; beta-lactam; respiratory infection; CAP; UTI; surgical prophylaxis; SSTI; pregnancy-safe; paediatric; renal-adjustment; NLEM India; Schedule H

RxIndia v1.0 — 06 May 2025

• CDSCO approved prescribing information

• Indian Pharmacopoeia

• NLEM 2022

• API Textbook of Medicine

• AIIMS Antimicrobial Guidelines

• ICMR Treatment Guidelines for Antimicrobial Use in Common Syndromes

• IAP Guidelines on Rational Antibiotic Use in Children

• WHO Model List of Essential Medicines (supportive for paediatric dosing)

• Manufacturer prescribing information (India-specific)