Schedule H

Intravenous (IV), Intramuscular (IM)

• Injection: 250 mg vial (as cefotaxime sodium for reconstitution)

• Injection: 500 mg vial (as cefotaxime sodium for reconstitution)

• Injection: 1 g vial (as cefotaxime sodium for reconstitution)

• Injection: 2 g vial (as cefotaxime sodium for reconstitution)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Community-Acquired Pneumonia (Moderate to Severe) — Adults

Parameter Recommendation

Starting dose 1 g IV/IM every 8 hours

Titration Increase to 2 g every 8 hours if inadequate response

Usual maintenance dose 1–2 g every 8 hours

Maximum dose 12 g/day (in life-threatening infections)

Duration 7–14 days depending on clinical response

Clinical note Covers common CAP pathogens including S. pneumoniae, H. influenzae, K. pneumoniae; add macrolide for atypical coverage if suspected

1. Bacterial Meningitis — Adults

Parameter Recommendation

Starting dose 2 g IV every 6 hours

Titration Not applicable

Usual maintenance dose 2 g IV every 6 hours (8–12 g/day)

Maximum dose 12 g/day

Duration 7–21 days based on pathogen (S. pneumoniae: 10–14 days; N. meningitidis: 7 days; Gram-negative: 21 days)

Clinical note Excellent CSF penetration; empirical choice pending cultures; combine with ampicillin if Listeria suspected (elderly, immunocompromised)

1. Septicaemia / Bacteraemia — Adults

Parameter Recommendation

Starting dose 2 g IV every 8 hours

Titration May increase frequency to every 6 hours in severe sepsis

Usual maintenance dose 2 g IV every 6–8 hours

Maximum dose 12 g/day

Duration Minimum 7 days; guided by source control and clinical response

Clinical note Often combined with aminoglycoside for synergy in gram-negative sepsis; reassess based on culture sensitivity

1. Complicated Urinary Tract Infections / Pyelonephritis / Urosepsis — Adults

Parameter Recommendation

Starting dose 1 g IV every 8–12 hours

Titration Increase to 2 g every 8 hours in urosepsis or severe infection

Usual maintenance dose 1–2 g every 8 hours

Maximum dose 6 g/day (usual); up to 12 g/day in urosepsis

Duration 10–14 days

Clinical note Switch to oral therapy (fluoroquinolone or co-amoxiclav based on sensitivity) once clinically stable

1. Pelvic Inflammatory Disease (PID) — Adults

Parameter Recommendation

Starting dose 1 g IV every 12 hours

Titration Not applicable

Usual maintenance dose 1 g IV every 12 hours

Maximum dose 2 g/day (PID regimen)

Duration Until clinically improved, then switch to oral; total 14 days

Clinical note Must combine with doxycycline 100 mg BD ± metronidazole 500 mg BD for polymicrobial coverage (anaerobes, Chlamydia)

1. Disseminated Gonococcal Infection — Adults

Parameter Recommendation

Starting dose 1 g IV every 8 hours

Titration Not applicable

Usual maintenance dose 1 g IV every 8 hours

Maximum dose 3 g/day

Duration 24–48 hours IV, then switch to oral cefixime 400 mg BD to complete 7 days total

Clinical note Confirm gonococcal infection; treat partner; screen for concurrent STIs

1. Intra-abdominal Infections (Peritonitis, Biliary Sepsis, Post-operative Infections) — Adults

Parameter Recommendation

Starting dose 2 g IV every 8 hours

Titration Not applicable

Usual maintenance dose 2 g IV every 8 hours

Maximum dose 12 g/day

Duration 5–14 days depending on source control and clinical response

Clinical note Must combine with metronidazole 500 mg IV every 8 hours for anaerobic coverage; cefotaxime alone lacks activity against Bacteroides spp.

1. Enteric Fever (Typhoid/Paratyphoid) — Adults

Parameter Recommendation

Starting dose 2 g IV every 8 hours

Titration Not applicable

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

1. Neonatal Sepsis / Meningitis

Age/Weight Dose Frequency Maximum Duration

Preterm (<37 weeks), <7 days 50 mg/kg/dose Every 12 hours 100 mg/kg/day Sepsis: 10–14 days; Meningitis: 14–21 days

Term, <7 days 50 mg/kg/dose Every 12 hours 100 mg/kg/day Sepsis: 10–14 days; Meningitis: 14–21 days

Term, ≥7 days 50 mg/kg/dose Every 8 hours 150 mg/kg/day Sepsis: 10–14 days; Meningitis: 14–21 days

Meningitis (all neonates) 50 mg/kg/dose Every 6 hours (after day 7) 200 mg/kg/day 14–21 days

Clinical note: Preferred over ceftriaxone in neonates due to lower risk of bilirubin displacement and biliary sludge

1. Bacterial Meningitis (>1 month to 12 years)

Parameter Recommendation

Starting dose 50 mg/kg/dose IV every 6 hours

Titration Not applicable

Usual maintenance dose 200 mg/kg/day in 4 divided doses

Maximum dose 12 g/day or 2 g per single dose

Duration S. pneumoniae: 10–14 days; H. influenzae: 7–10 days; N. meningitidis: 5–7 days; Gram-negative: 21 days

1. Paediatric Sepsis / Severe Pneumonia / Complicated UTI (>1 month)

Weight/Age Dose Frequency Maximum Duration

Infants 1–12 months 50 mg/kg/dose Every 8 hours 150 mg/kg/day 7–14 days based on infection

Children 1–12 years 50 mg/kg/dose Every 8 hours 6–8 g/day 7–14 days based on infection

Adolescents >12 years or >40 kg Adult dosing Every 8 hours 12 g/day 7–14 days based on infection

Secondary Indications — Paediatrics (Off-label)

Indication Dose Duration Notes

Enteric fever (quinolone-resistant strains) 75–100 mg/kg/day IV in 3 divided doses (max 4 g/day) 10–14 days OFF-LABEL; Specialist only. First-line for MDR/XDR S. typhi in children. Evidence: IAP guidelines, ICMR surveillance data

Periorbital/Orbital cellulitis 50 mg/kg/dose IV every 8 hours (max 2 g/dose) 7–10 days OFF-LABEL; Specialist only. Ophthalmology consultation required. Evidence: Indian paediatric practice

Minimum age limit: No restriction — safe in neonates (including preterm) under specialist supervision

Safety Monitoring:

• CBC with differential (baseline and weekly in prolonged therapy)

• Renal function tests (especially in neonates)

• Serum bilirubin in neonates (risk of displacement, though lower than ceftriaxone)

• Signs of superinfection (oral thrush, diarrhoea)

• Injection site reactions

50 No adjustment required

30–50 1–2 g every 8–12 hours (reduce frequency)

10–29 1–2 g every 12–24 hours (50–75% of normal dose)

<10 1 g every 24 hours (50% of normal dose)

Haemodialysis 1–2 g post-dialysis (partially dialysable ~50%)

CAPD 1 g every 24 hours; no supplemental dose needed

CRRT 1–2 g every 8–12 hours; consult ID/nephrology

Note: Active metabolite (desacetylcefotaxime) also renally excreted; accumulation contributes to CNS toxicity in severe renal impairment

• Known hypersensitivity to cefotaxime or any cephalosporin

• History of immediate/severe hypersensitivity reaction (anaphylaxis, angioedema) to any penicillin or β-lactam antibiotic

• History of cephalosporin-induced immune-mediated haemolytic anaemia or thrombocytopenia

• History of non-severe penicillin allergy (rash, GI upset) — approximately 1–2% cross-reactivity; monitor closely

• Renal impairment — dose adjustment required; accumulation risk

• Neonates, especially preterm or jaundiced — bilirubin displacement risk (though less than ceftriaxone); monitor bilirubin

• History of seizure disorder or CNS pathology — high-dose or renally accumulated cefotaxime may lower seizure threshold

• History of gastrointestinal disease, especially antibiotic-associated colitis

• Prolonged therapy (>10 days) — risk of superinfection, C. difficile colitis

• Concurrent use of nephrotoxic drugs

• Elderly — reduced renal reserve even with normal serum creatinine

Aspect Recommendation

Overall safety Generally considered safe — extensive use data in pregnancy; crosses placenta in therapeutic concentrations

Risk category US FDA Category B equivalent; no evidence of teratogenicity in animal or human studies

Preferred alternatives None necessary — cefotaxime is among preferred cephalosporins in pregnancy

When to use Appropriate for severe infections during pregnancy including sepsis, pyelonephritis, chorioamnionitis, obstetric sepsis

Monitoring Standard maternal monitoring; fetal wellbeing in severe maternal infection

Aspect Recommendation

Compatibility Compatible with breastfeeding

Drug levels in milk Low (0.14–0.24 mg/L; less than 1% of maternal dose)

Preferred alternatives None necessary — cefotaxime is compatible

Infant monitoring GI disturbance (loose stools, diarrhoea), oral thrush, allergic reaction (rare)

• Starting dose: Lower end of standard range (1 g every 8–12 hours) unless severe infection

• Titration: Increase based on clinical response and renal function

• Special considerations:

• Assess renal function (eGFR) before initiating — serum creatinine alone may underestimate renal impairment

• Increased risk of CNS toxicity (confusion, myoclonus, seizures) especially if renally impaired

• Monitor for C. difficile colitis — higher susceptibility in elderly

• Ensure adequate hydration

• Increased risk of hypokalaemia with prolonged therapy

Drug Interaction Management

Probenecid Inhibits tubular secretion of cefotaxime → increased serum levels and half-life Reduce cefotaxime dose by 50% if probenecid essential; or avoid combination

Warfarin/Acenocoumarol Cephalosporins may enhance anticoagulant effect (gut flora disruption, vitamin K reduction) Monitor INR closely during and after therapy; may need anticoagulant dose reduction

Aminoglycosides (Amikacin, Gentamicin) Additive nephrotoxicity; synergistic antibacterial effect Monitor renal function daily; use for synergy is intentional but requires monitoring

Loop diuretics (Furosemide) Increased nephrotoxicity risk, especially with concurrent aminoglycosides Avoid combination if possible; monitor renal function if unavoidable

Drug Interaction Management

Vancomycin Additive nephrotoxicity Monitor renal function; ensure adequate hydration

Oral contraceptives Theoretical reduction in efficacy due to gut flora disruption Counsel regarding backup contraception during short courses

Live typhoid vaccine (oral) Antibiotics may reduce vaccine efficacy Complete antibiotic course 3 days before vaccination or delay vaccine

Methotrexate Reduced renal clearance of methotrexate → toxicity risk Monitor methotrexate levels and toxicity signs if concurrent use unavoidable

Chloramphenicol Antagonism possible (bacteriostatic vs bactericidal) Avoid combination; use alternative

• Injection site pain, induration, or phlebitis (IV site)

• Diarrhoea and loose stools

• Nausea and vomiting

• Skin rash and pruritus

• Transient eosinophilia

• Transient elevation of hepatic transaminases (ALT, AST)

• Headache

• Positive direct Coombs test (without haemolysis)

• Anaphylaxis and severe hypersensitivity reactions — discontinue immediately; emergency management required

• Stevens-Johnson Syndrome / Toxic Epidermal Necrolysis — rare; discontinue immediately

• Clostridioides difficile colitis (pseudomembranous colitis) — may occur during or after therapy; discontinue and initiate specific treatment

• Seizures — especially with high doses, CNS infection, or renal impairment; discontinue if occurs

• Immune-mediated haemolytic anaemia — rare; discontinue immediately

• Neutropenia / Agranulocytosis — with prolonged therapy (>10 days); reversible on discontinuation

• Thrombocytopenia — rare; monitor if unexplained bleeding

• Interstitial nephritis — rare; presents with fever, rash, eosinophilia, rising creatinine

• Hepatotoxicity — cholestatic hepatitis; rare; discontinue and investigate

During therapy (days 3–5) Clinical response; signs of allergy (rash, fever); diarrhoea; injection site for phlebitis

Prolonged therapy (>7 days) CBC with differential (weekly); LFTs; renal function; neurological assessment in renal impairment

If on anticoagulants INR at days 3–5 and weekly

Neonates Serum bilirubin; CBC

Single-agent Cefotaxime:

• Claforan (Sanofi)

• Taxim (Alkem)

• Omnatax (Dr. Reddy's)

• Biotax (Biochem)

• Cefotax (Ranbaxy/Sun Pharma)

• Oritaxim (Emcure)

• Multiple other branded generics

Fixed-Dose Combinations (Cefotaxime + Sulbactam):

• Magnex (FDC Ltd)

• Taxim-SB (Alkem)

• Supetax (Sun Pharma)

Note: FDCs with sulbactam provide additional β-lactamase inhibitor coverage

Strength Price Range

• NPPA status: Under price control as per NLEM 2022

• Government supply: Available through Jan Aushadhi and public hospital pharmacies at significantly lower prices

• Private sector: Higher end of price range

1. Preferred over ceftriaxone in neonates — does not displace bilirubin from albumin binding sites; lower risk of kernicterus and biliary sludge

1. Every 6–8 hour dosing required for meningitis — shorter half-life than ceftriaxone necessitates more frequent dosing; ensure compliance in inpatient setting

1. Always add metronidazole for intra-abdominal/pelvic infections — cefotaxime has no activity against Bacteroides fragilis and other anaerobes

1. Active metabolite (desacetylcefotaxime) has antibacterial activity — contributes to efficacy but also accumulates in renal impairment; adjust dose accordingly

1. Watch for C. difficile colitis — especially in elderly, prolonged therapy, or ICU patients; new-onset diarrhoea requires stool testing

1. Document penicillin allergy carefully — many reported allergies are non-immune reactions; true IgE-mediated reactions have ~1–2% cross-reactivity with cephalosporins

cefotaxime; cephalosporin; third-generation cephalosporin; injectable antibiotic; meningitis; neonatal sepsis; septicaemia; typhoid; Schedule H; NLEM India; pregnancy-safe; renal-adjustment

RxIndia v1.0 — 05 Jan 2025

• CDSCO Approved Drug Formulations List

• Indian Pharmacopoeia (IP)

• NLEM 2022 (National List of Essential Medicines)

• API Textbook of Medicine (2022)

• AIIMS Standard Treatment Guidelines

• AIIMS NICU Protocols (neonatal dosing)

• IAP Textbook of Pediatrics (paediatric dosing)

• ICMR Guidelines on Antimicrobial Use and Resistance

• Goodman & Gilman's Pharmacological Basis of Therapeutics (supportive)

• Harrison's Principles of Internal Medicine (supportive)

• WHO Model Formulary (supportive for paediatric dosing)