Schedule H

Oral

Form Strengths

Tablets 100 mg, 200 mg

Dispersible tablets 100 mg, 200 mg

Oral suspension (dry syrup) 50 mg/5 mL, 100 mg/5 mL

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Typhoid Fever (Enteric Fever — Salmonella Typhi)

Parameter Details

Starting dose 200 mg orally twice daily OR 400 mg once daily

Titration Not applicable

Usual maintenance dose 400 mg/day (in single or divided doses)

Maximum dose 400 mg/day

Duration 10–14 days

Clinical Notes:

• First-line oral option for uncomplicated typhoid in Indian settings

• Culture-guided therapy preferred where feasible

• Monitor for clinical response by day 5–7

• Watch for relapse 7–14 days after completing therapy

• Consider alternatives if fluoroquinolone-resistant or MDR strains prevalent locally

1. Acute Uncomplicated Urinary Tract Infection (Cystitis)

Parameter Details

Starting dose 200 mg orally twice daily OR 400 mg once daily

Titration Not applicable

Usual maintenance dose 400 mg/day

Maximum dose 400 mg/day

Duration 5–7 days

Clinical Notes:

• Reserve for culture-confirmed susceptible organisms

• Increasing resistance among uropathogens in India; not empiric first-line in many centres

• Consider nitrofurantoin or fosfomycin as alternatives for uncomplicated cystitis

1. Acute Bacterial Exacerbation of Chronic Bronchitis

Parameter Details

Starting dose 200 mg orally twice daily OR 400 mg once daily

Titration Not applicable

Usual maintenance dose 400 mg/day

Maximum dose 400 mg/day

Duration 7–10 days

Clinical Notes:

• Obtain sputum culture if recurrent exacerbations

• Effective against common respiratory pathogens (H. influenzae, M. catarrhalis, S. pneumoniae)

1. Community-Acquired Pneumonia (Mild to Moderate)

Parameter Details

Starting dose 200 mg orally twice daily OR 400 mg once daily

Titration Not applicable

Usual maintenance dose 400 mg/day

Maximum dose 400 mg/day

Duration 7–10 days

Clinical Notes:

• Suitable for outpatient management of mild-to-moderate CAP

• Consider combination with macrolide if atypical pathogens suspected

• Not effective against atypical organisms (Mycoplasma, Chlamydia, Legionella)

1. Acute Pharyngitis / Tonsillitis (Group A Streptococcus)

Parameter Details

Starting dose 200 mg orally twice daily

Titration Not applicable

Usual maintenance dose 400 mg/day in divided doses

Maximum dose 400 mg/day

Duration 5–10 days

Clinical Notes:

• Second-line agent; penicillin V or amoxicillin remain first-line

• Reserve for documented penicillin allergy (non-immediate type)

• Full 10-day course recommended to prevent rheumatic fever

1. Acute Otitis Media

Parameter Details

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

1. Typhoid Fever (Enteric Fever)

Age: ≥6 months

Parameter Details

Starting dose 8 mg/kg/day orally in two divided doses

Titration May increase to 10–20 mg/kg/day based on severity and response

Usual maintenance dose 10–15 mg/kg/day in two divided doses

Maximum dose 400 mg/day

Duration 10–14 days

Clinical Notes:

• First-line oral option for uncomplicated paediatric typhoid in India

• Culture-guided therapy preferred

• Monitor for clinical response; observe for relapse post-treatment

• Oral suspension should be reconstituted properly and shaken well before each dose

1. Acute Pharyngitis / Tonsillitis (Penicillin Allergy)

Age: ≥6 months

Parameter Details

Starting dose 8 mg/kg/day orally in two divided doses

Titration Not applicable

Usual maintenance dose 8 mg/kg/day in two divided doses

Maximum dose 400 mg/day

Duration 10 days

Clinical Notes:

• Second-line for GAS pharyngitis when penicillin contraindicated

• Complete 10-day course for rheumatic fever prevention

1. Acute Otitis Media

Age: ≥6 months

Parameter Details

Starting dose 8 mg/kg/day orally (once daily or in two divided doses)

Titration Not applicable

Usual maintenance dose 8 mg/kg/day

Maximum dose 400 mg/day

Duration 7–10 days

Clinical Notes:

• Assess clinical improvement by day 3–5

• May use once-daily dosing for improved compliance

1. Urinary Tract Infection (Paediatric)

Age: ≥6 months

Parameter Details

Starting dose 8 mg/kg/day orally in two divided doses

Titration Not applicable

Usual maintenance dose 8 mg/kg/day

Maximum dose 400 mg/day

Duration 7–14 days (depending on upper vs lower UTI)

Clinical Notes:

• Culture and sensitivity essential

• Consider parenteral therapy for pyelonephritis or toxic-appearing child

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

Not applicable. No well-documented off-label paediatric indications in Indian practice.

Age Restriction:

Not recommended in infants below 6 months of age except under paediatric infectious diseases specialist supervision with documented clinical necessity.

Safety Monitoring (All Paediatric Patients):

• Monitor for diarrhoea, rash, and hypersensitivity reactions

• Assess clinical response within 48–72 hours

• Reconstitute suspension as per manufacturer instructions; shake well before use

• Maintain adequate hydration

60 No adjustment required

21–60 Reduce to 75% of usual daily dose

≤20 Reduce to 50% of usual daily dose

Dialysis Status Recommendation

Haemodialysis Give 50% of standard dose after dialysis session

Peritoneal dialysis Not significantly dialysed; use 50% dose with caution

• Known hypersensitivity to cefixime or any cephalosporin antibiotic

• History of immediate-type (Type I) hypersensitivity reaction to penicillins (anaphylaxis, angioedema, urticaria occurring within 1 hour) — cross-reactivity risk approximately 1–2%

• Known hypersensitivity to any excipient in the formulation

• History of non-immediate penicillin allergy — use with caution; monitor closely

• History of antibiotic-associated colitis or Clostridioides difficile infection

• Renal impairment — dose adjustment required

• History of seizure disorder or CNS pathology — cephalosporins may rarely lower seizure threshold

• Prolonged use may result in superinfection with resistant organisms or fungi

• Monitor for emergence of resistance, especially in recurrent infections

Parameter Details

Overall safety Generally considered safe; limited human data but no evidence of teratogenicity

Risk category Comparable to FDA former Category B

Preferred alternatives Amoxicillin or amoxicillin-clavulanate preferred when susceptibility confirmed

When to use May be used when benefit clearly outweighs risk, particularly for UTI or respiratory infections unresponsive to first-line agents

Monitoring Maternal renal function; GI tolerance; clinical response

Parameter Details

Compatibility Compatible with breastfeeding

Milk levels Very low; minimal excretion into breast milk

Preferred alternatives Amoxicillin preferred when appropriate

Infant monitoring Observe for rash, loose stools, oral candidiasis (all rare)

Parameter Recommendation

Starting dose Same as adult dose (400 mg/day)

Titration Not applicable

Special considerations Renal function assessment mandatory — estimate eGFR and adjust dose accordingly. Increased risk of Clostridioides difficile-associated diarrhoea. Monitor hydration status. More susceptible to adverse GI effects.

Interacting Drug Mechanism / Effect Recommendation

Warfarin Altered gut flora reduces vitamin K synthesis; potential increase in INR and bleeding risk Monitor INR closely when initiating or discontinuing cefixime; adjust warfarin dose as needed

Carbamazepine Cefixime may increase serum carbamazepine levels Monitor for carbamazepine toxicity (ataxia, nystagmus, drowsiness); consider level monitoring

Interacting Drug Effect Recommendation

Probenecid Decreases renal tubular secretion of cefixime, increasing serum levels Clinical monitoring; dose adjustment usually not required

Oral contraceptives Theoretical reduction in efficacy due to altered gut flora Counsel regarding backup contraception during antibiotic course (precautionary)

Antacids (aluminium/magnesium-containing) May slightly reduce cefixime absorption Administer cefixime 2 hours before or after antacids

Live oral typhoid vaccine (Ty21a) Antibiotics may reduce vaccine efficacy Avoid concurrent use; complete antibiotic course at least 3 days before administering live vaccine

• Diarrhoea (most common)

• Nausea

• Abdominal pain / dyspepsia

• Flatulence

• Headache

• Skin rash

Adverse Effect Clinical Notes

Anaphylaxis / severe hypersensitivity Immediate discontinuation required; emergency management with adrenaline

Stevens-Johnson Syndrome (SJS) / Toxic Epidermal Necrolysis (TEN) Rare; discontinue immediately and hospitalise

Clostridioides difficile-associated diarrhoea (CDAD) Suspect if persistent or severe diarrhoea develops during or after therapy; discontinue and treat appropriately

Hepatotoxicity Rare; may present as transaminase elevation; discontinue if significant

Haematological toxicity Rare; thrombocytopenia, leucopenia, pancytopenia reported — investigate unexplained bleeding or recurrent infections

Seizures Rare; more likely in patients with pre-existing CNS disorders or renal impairment

Baseline:

• Renal function (serum creatinine, eGFR) — especially in elderly or those with comorbidities

• Liver function tests if prolonged course anticipated

• Allergy history (penicillin, cephalosporin)

After initiation:

• Clinical response assessment within 48–72 hours

• Monitor for hypersensitivity reactions (rash, urticaria, respiratory distress)

• Watch for diarrhoea — especially antibiotic-associated or Clostridioides difficile-related

Long-term (if extended course):

• Repeat renal and hepatic function if therapy exceeds 14 days

• Monitor for superinfection (oral/vaginal candidiasis)

• In typhoid: observe for clinical relapse 7–14 days post-treatment

Brand Name Manufacturer

Taxim-O Alkem

Zifi FDC Ltd

Mahacef Mankind

Ceftas Intas

Cefix Cipla

Topcef Lupin

Gramocef-O Glenmark

Common Fixed-Dose Combinations (FDCs):

Regulatory status: Cefixime is included in NLEM 2022; ceiling prices regulated by NPPA for scheduled formulations.

1. Typhoid mainstay in India — Cefixime remains a key oral option for uncomplicated typhoid fever in Indian settings, particularly for outpatient management and step-down therapy.

1. Resistance awareness — Rising resistance among uropathogens and gonococci limits empiric use in UTI and gonorrhoea; always prefer culture-guided therapy when feasible.

1. Twice-daily dosing may be superior — Although once-daily dosing is convenient, divided dosing (200 mg BD) may provide better pharmacodynamic coverage for certain infections.

1. Not for serious infections — Cefixime has no activity against Pseudomonas aeruginosa, MRSA, Enterococcus, or ESBL-producing organisms. Do not use for nosocomial or complicated infections.

1. Monitor for CDAD — Any patient developing persistent diarrhoea during or after cefixime therapy should be evaluated for Clostridioides difficile infection.

1. FDC caution — Fixed-dose combinations (particularly with fluoroquinolones) should be used judiciously to prevent resistance; monotherapy preferred when organism susceptibility is known.

cephalosporin; third-generation; typhoid; enteric fever; UTI; respiratory infection; oral antibiotic; paediatric; renal-adjustment; NLEM India; antimicrobial stewardship

RxIndia v1.0 — 25 Apr 2025

• CDSCO approved product inserts (Form 46)

• National Formulary of India (NFI) 2021

• NLEM 2022

• Indian Pharmacopoeia

• API Textbook of Medicine

• ICMR Treatment Guidelines for Antimicrobial Use in Common Syndromes (2019)

• IAP Guidelines — Typhoid and Fever Management

• AIIMS Delhi Antibiotic Formulary (hospital protocol)

• WHO Essential Medicines List (supportive reference for paediatrics)

• CDC/WHO STI Guidelines (supporting off-label gonorrhoea indication)