Schedule H

Oral

Formulation Strengths Available

Tablets (as Cefpodoxime Proxetil) 100 mg, 200 mg

Dispersible Tablets 50 mg, 100 mg

Dry Syrup (for reconstitution) 25 mg/5 mL, 50 mg/5 mL, 100 mg/5 mL

Oral Suspension 50 mg/5 mL

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Acute Pharyngitis and Tonsillitis (Streptococcal)

Parameter Recommendation

Starting dose 100 mg twice daily

Titration Not applicable

Usual maintenance dose 100 mg twice daily

Maximum dose 200 mg/day

Duration 5–10 days

Key Clinical Notes:

• Confirm Group A Streptococcus by rapid antigen test or culture before initiating

• Penicillin V or amoxicillin preferred as first-line if organism susceptible

1. Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB)

Parameter Recommendation

Starting dose 200 mg twice daily

Titration Not applicable

Usual maintenance dose 200 mg twice daily

Maximum dose 400 mg/day

Duration 5–10 days

Key Clinical Notes:

• Alternative to respiratory fluoroquinolones

• Consider local antibiogram for H. influenzae, M. catarrhalis resistance patterns

1. Community-Acquired Pneumonia (Mild to Moderate)

Parameter Recommendation

Starting dose 200 mg twice daily

Titration Not applicable

Usual maintenance dose 200 mg twice daily

Maximum dose 400 mg/day

Duration 7–14 days

Key Clinical Notes:

• Suitable for low-risk outpatients (CURB-65 score 0–1)

• May be used as step-down therapy after IV antibiotics

• Add macrolide if atypical pathogen coverage needed

1. Uncomplicated Urinary Tract Infections

Parameter Recommendation

Starting dose 100 mg twice daily

Titration Not applicable

Usual maintenance dose 100 mg twice daily

Maximum dose 200 mg/day

Duration 3–7 days (women: 3 days; men/complicated: 7 days)

Key Clinical Notes:

• Second-line option; prefer nitrofurantoin or fosfomycin for uncomplicated cystitis per ICMR guidelines

• Obtain urine culture in recurrent or treatment-failure cases

1. Skin and Soft Tissue Infections (Uncomplicated)

Parameter Recommendation

Starting dose 200 mg twice daily

Titration Not applicable

Usual maintenance dose 200 mg twice daily

Maximum dose 400 mg/day

Duration 7–10 days

Key Clinical Notes:

• Effective against S. aureus (MSSA) and Streptococcus pyogenes

• Not effective against MRSA

1. Acute Bacterial Sinusitis

Parameter Recommendation

Starting dose 200 mg twice daily

Titration Not applicable

Usual maintenance dose 200 mg twice daily

Maximum dose 400 mg/day

Duration 7–10 days

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Indications: Pharyngitis, Tonsillitis, Acute Otitis Media, Bronchitis, Mild Community-Acquired Pneumonia, Uncomplicated UTI

General Dosing Principle:

• Starting dose: 8–10 mg/kg/day divided into two doses (every 12 hours)

• Titration: Not applicable

• Usual maintenance dose: 8–10 mg/kg/day in two divided doses

• Maximum dose: 400 mg/day (or 200 mg per dose)

Weight-Based Dosing Table

Weight (kg) Total Daily Dose Dose per Administration (every 12 hours) Suggested Formulation

5–10 50–100 mg/day 25–50 mg Dry syrup 50 mg/5 mL

10–15 100–150 mg/day 50–75 mg Dry syrup 50 mg/5 mL

15–20 150–200 mg/day 75–100 mg Dry syrup 100 mg/5 mL

20–30 200–300 mg/day 100–150 mg Dispersible tablet 100 mg

30 300–400 mg/day 150–200 mg Tablet 100 mg or 200 mg

Duration: 5–10 days for most respiratory and soft tissue infections; 3–7 days for UTI

Safety Monitoring:

• Monitor for diarrhoea, rash, and oral candidiasis

• Watch for signs of allergic reaction during first few doses

Age Restriction:

• Minimum age: >2 months

• Not recommended below 2 months except under paediatric infectious disease specialist supervision

Secondary Indications — Paediatrics (Off-label)

No documented off-label paediatric indications supported in Indian guidance.

• Known hypersensitivity to cefpodoxime or any cephalosporin

• History of immediate-type (Type I) hypersensitivity reaction to penicillins or other beta-lactams (anaphylaxis, angioedema, urticaria)

• History of severe allergic reaction (e.g., anaphylaxis) to any beta-lactam antibiotic

• History of delayed-type (non-immediate) beta-lactam allergy — evaluate severity and consider skin testing if needed

• Severe renal impairment (increased risk of accumulation and neurotoxicity)

• Prolonged antibiotic use — risk of Clostridioides difficile-associated diarrhoea (CDAD)

• History of seizure disorders — use with caution, especially in renal impairment

• History of gastrointestinal disease, particularly colitis

• Concurrent use with nephrotoxic agents

Aspect Details

Safety status Generally considered safe; no evidence of teratogenicity in human studies

Risk category Category B (US FDA historical classification)

When to use Can be used for UTI, respiratory infections, and skin infections when indicated

Preferred alternatives Amoxicillin, Cephalexin (if narrower spectrum suffices)

Monitoring Monitor maternal renal function during prolonged courses

Aspect Details

Compatibility Compatible with breastfeeding

Drug levels in milk Low (minimal excretion)

Preferred alternatives Amoxicillin, Cephalexin (if narrower spectrum suffices)

Infant monitoring Monitor for gastrointestinal disturbances (loose stools, diarrhoea) and oral/nappy candidiasis

Aspect Recommendation

Starting dose Same as adult dose if renal function is normal

Titration Not applicable

Renal assessment Mandatory baseline eGFR assessment; adjust dose if eGFR <30 mL/min

Extra risks Higher risk of diarrhoea, C. difficile infection, and drug accumulation due to reduced renal reserve

Monitoring Monitor hydration status and renal function during therapy

Interacting Drug Effect Management

Probenecid Inhibits renal tubular secretion → increased cefpodoxime levels and prolonged half-life Avoid combination unless specifically intended; if used, monitor for toxicity

Antacids (aluminium/magnesium-based) Significantly reduces cefpodoxime absorption Administer cefpodoxime at least 2 hours before or after antacids

H2-receptor antagonists (ranitidine, famotidine) Reduces absorption due to increased gastric pH Separate administration by at least 2 hours; monitor clinical response

Proton pump inhibitors May reduce absorption Administer cefpodoxime with food; monitor clinical efficacy

Interacting Drug Effect Management

Warfarin Possible enhanced anticoagulant effect (mechanism unclear; possibly altered vitamin K synthesis by gut flora) Monitor INR closely during and after antibiotic course

Loop diuretics (furosemide) Potential additive nephrotoxicity Monitor renal function, especially in elderly or dehydrated patients

Oral iron preparations Chelation may reduce cefpodoxime absorption Separate doses by at least 2 hours

Oral contraceptives Theoretical reduction in efficacy if significant diarrhoea occurs Advise additional contraceptive precautions if experiencing diarrhoea or vomiting

Aminoglycosides Potential additive nephrotoxicity Monitor renal function if concomitant use is necessary

• Diarrhoea (most common)

• Nausea

• Vomiting

• Abdominal pain/discomfort

• Headache

• Skin rash

• Vulvovaginal candidiasis

Adverse Effect Clinical Action

Pseudomembranous colitis (C. difficile-associated diarrhoea) Discontinue immediately; initiate specific treatment (oral vancomycin/fidaxomicin)

Anaphylaxis Immediate discontinuation; emergency management with adrenaline, airway support

Stevens-Johnson syndrome / Toxic epidermal necrolysis Rare; immediate discontinuation; dermatology referral; may require hospitalisation

Seizures More likely in renal impairment or high doses; discontinue and evaluate

Severe haemolytic anaemia Rare; discontinue and investigate

During therapy Monitor for rash, GI symptoms (especially diarrhoea), signs of allergic reaction

If on warfarin Repeat INR within 3–5 days of starting and after completing course

Long-term Not applicable for typical short-course therapy; if prolonged use (>14 days), monitor for superinfection and C. difficile

Brand Name Manufacturer

Cefoprox Cipla

Cefpod Sun Pharma

Omnicef-O Abbott

Ceff Indoco Remedies

Tax-O Alkem

Zedocef Hetero

Cepodem Ranbaxy/Sun Pharma

Mahacef Mankind

Fixed-Dose Combinations (FDCs) available:

NLEM Status: Included (Dry syrup 50 mg/5 mL and Tablets 100 mg) — subject to price control by NPPA

1. Food enhances absorption: Administer cefpodoxime after meals for improved bioavailability (up to 50% increase compared to fasting state)

1. Antacid timing critical: Do not co-administer with antacids, H2 blockers, or PPIs; maintain at least 2-hour gap to ensure adequate absorption

1. Antibiotic stewardship: Prefer narrower-spectrum agents (amoxicillin, cephalexin) when organism is susceptible; reserve cefpodoxime for beta-lactamase producing organisms

1. C. difficile vigilance: Monitor for persistent diarrhoea, especially in elderly patients or those with prolonged courses; discontinue and test for C. difficile toxin if suspected

1. Not effective against MRSA: Do not use for suspected MRSA skin infections; consider alternative agents

1. Complete the course: Ensure patients complete prescribed duration to prevent resistance development, even if symptoms improve

cefpodoxime; antibiotic; third-generation cephalosporin; oral cephalosporin; respiratory infections; UTI; pharyngitis; otitis media; paediatric-safe; NLEM India; renal-adjust; pregnancy-safe; Schedule H

RxIndia v1.0 — 10 May 2025

• CDSCO product information and approved prescribing information

• Indian Pharmacopoeia (IP)

• National Formulary of India (NFI)

• National List of Essential Medicines (NLEM) 2022

• ICMR Treatment Guidelines for Antimicrobial Use in Common Syndromes 2019

• ICMR Antimicrobial Resistance Guidelines 2023

• API Textbook of Medicine

• AIIMS Delhi Antibiotic Policy and Guidelines 2022

• Indian Academy of Pediatrics (IAP) Guidelines for Rational Antibiotic Use 2021

• Harrison's Principles of Internal Medicine (supportive reference for mechanism and spectrum)