Schedule H

Oral

• Tablets: 200 mg film-coated tablets (Cefditoren pivoxil)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Acute Exacerbation of Chronic Bronchitis (AECB)

Parameter Details

Starting dose 200 mg orally twice daily

Titration Not applicable

Usual maintenance dose 200 mg twice daily

Maximum dose 400 mg/day (200 mg BD)

Duration 10–14 days

Clinical notes Administer with food. Review local susceptibility data for S. pneumoniae and H. influenzae before empirical use.

1. Community-Acquired Pneumonia (Mild to Moderate)

Parameter Details

Starting dose 200 mg orally twice daily

Titration Not applicable

Usual maintenance dose 200 mg twice daily

Maximum dose 400 mg/day

Duration 10–14 days

Clinical notes Reserved for outpatient management of mild-moderate cases. Not appropriate for severe CAP or atypical pathogen coverage.

1. Pharyngitis / Tonsillitis (Streptococcus pyogenes)

Parameter Details

Starting dose 200 mg orally twice daily

Titration Not applicable

Usual maintenance dose 200 mg twice daily

Maximum dose 400 mg/day

Duration 10 days

Clinical notes Alternative agent in patients with non-type-I penicillin hypersensitivity. Not suitable if history of anaphylaxis to beta-lactams.

1. Uncomplicated Skin and Soft Tissue Infections (SSTIs)

Parameter Details

Starting dose 200 mg orally twice daily

Titration Not applicable

Usual maintenance dose 200 mg twice daily

Maximum dose 400 mg/day

Duration 10–14 days

Clinical notes Effective against methicillin-susceptible S. aureus (MSSA) and Streptococci. Ineffective against MRSA.

Secondary Indications — Adults Only (Off-label)

Indication Dose Duration Evidence Basis Notes

Acute Bacterial Sinusitis 200 mg twice daily 10–14 days International RCTs; Indian specialist practice OFF-LABEL. Consider in penicillin-allergic patients (non-type-I). Specialist supervision advised.

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Approved age: ≥12 years only (Indian formulations)

Age/Weight Indication Dose Duration Clinical Notes

≥12 years (approx. ≥40 kg) Pharyngitis/Tonsillitis 200 mg orally twice daily 10 days Administer with meals

≥12 years AECB 200 mg orally twice daily 10–14 days As per adult dosing

≥12 years Uncomplicated SSTIs 200 mg orally twice daily 10–14 days Monitor for GI tolerability

Children <12 years:

• NOT APPROVED in India

• No paediatric-specific formulations available in India

• Insufficient pharmacokinetic data for weight-based dosing

• Use not recommended outside clinical trial settings

Secondary Indications — Paediatric Doses (Off-label)

Not applicable — No off-label paediatric indications supported by Indian sources or specialist practice.

CrCl (mL/min) Recommendation

50 No dose adjustment required

30–50 Use with caution; consider extending dosing interval to every 12–24 hours

<30 Avoid use — risk of drug accumulation and toxicity

Haemodialysis Not recommended — No pharmacokinetic data available

Peritoneal dialysis Not recommended — No data available

• Known hypersensitivity to cefditoren, other cephalosporins, or any component of the formulation

• History of severe (type-I) hypersensitivity reaction to any beta-lactam antibiotic (penicillins, carbapenems)

• Known carnitine deficiency or inborn errors of carnitine metabolism (cefditoren pivoxil causes carnitine depletion)

• Severe renal impairment (CrCl <30 mL/min)

• History of seizure disorder — cephalosporins may lower seizure threshold

• Pre-existing gastrointestinal disease (especially colitis) — risk of antibiotic-associated diarrhoea or C. difficile colitis

• Lactose intolerance — some formulations may contain lactose as excipient

• Elderly patients with borderline renal function — assess CrCl before prescribing

• Prolonged antibiotic courses — risk of fungal or resistant bacterial superinfection

• Patients on long-term therapy — monitor for carnitine deficiency

Parameter Details

Risk category Not formally assigned by CDSCO; limited human data

Overall safety Avoid in first trimester if possible; may be used in second/third trimester if benefit clearly outweighs risk

Preferred alternatives Amoxicillin-clavulanate, cefixime, cephalexin (better established safety data)

When permissible Only when no safer alternative exists and infection requires treatment

Monitoring Fetal growth monitoring; maternal tolerability and signs of hypersensitivity

Parameter Details

Compatibility Likely compatible — excreted in low concentrations in breast milk

Expected milk levels Low

Preferred alternatives Cephalexin, cefixime (more established lactation data)

Infant monitoring Observe for diarrhoea, rash, oral thrush, feeding difficulties

Parameter Details

Starting dose 200 mg twice daily (same as adults)

Titration Not applicable (fixed dosing)

Special considerations Assess renal function before initiating; increased risk of reduced drug clearance

Risks Heightened susceptibility to GI adverse effects, renal accumulation, and antibiotic-associated colitis

Monitoring Baseline and periodic renal function tests; monitor for diarrhoea and hydration status

Interacting Drug Mechanism Clinical Recommendation

Probenecid Inhibits renal tubular secretion of cefditoren, increasing plasma levels Avoid combination or reduce cefditoren dose; monitor for toxicity

Antacids (aluminium/magnesium hydroxide) Decrease cefditoren absorption by raising gastric pH Avoid co-administration; separate doses by at least 2 hours

H2-receptor antagonists (ranitidine, famotidine) Reduce gastric acidity, impairing drug absorption Avoid concurrent use or administer cefditoren 2 hours before H2-blocker

Proton pump inhibitors (omeprazole, pantoprazole) Reduce absorption due to pH-dependent solubility Avoid concurrent use if possible; significant reduction in bioavailability

Interacting Drug Mechanism Clinical Recommendation

Oral iron supplements May chelate and reduce cefditoren absorption Separate administration by at least 2 hours

Warfarin Cephalosporins may enhance anticoagulant effect via gut flora alteration Monitor INR more frequently during antibiotic course

Combined oral contraceptives Theoretical risk of reduced efficacy via gut flora disruption Advise additional barrier contraception during antibiotic course and for 7 days after

• Diarrhoea

• Nausea

• Abdominal pain/discomfort

• Headache

• Maculopapular rash

Adverse Effect Action Required

Anaphylaxis or severe hypersensitivity reaction Discontinue immediately; administer emergency treatment

Stevens-Johnson Syndrome / Toxic Epidermal Necrolysis Discontinue immediately; urgent dermatology referral

Clostridioides difficile-associated diarrhoea/colitis Stop antibiotic; initiate specific treatment; avoid antiperistaltic agents

Seizures (especially in renal impairment) Discontinue; supportive management

Severe cutaneous adverse reactions (SCAR) Discontinue immediately; specialist referral

During treatment Clinical response, GI symptoms, skin rash, signs of hypersensitivity

If prolonged therapy (>14 days) Complete blood count, liver function tests, symptoms of carnitine deficiency (fatigue, muscle weakness)

• Cefowin® (200 mg tablets)

• Cefpopen® (200 mg tablets)

• Cednir® (200 mg tablets)

• Cefaxin® (200 mg tablets)

• Spectracef® (200 mg tablets)

Note: All available as Cefditoren pivoxil 200 mg film-coated tablets.

• Not included under NLEM/DPCO price control

• Prices vary by brand and location

1. Always administer with meals — food significantly enhances oral absorption of cefditoren pivoxil.

1. Avoid concurrent PPI or antacid use — gastric acid is essential for adequate absorption; bioavailability drops substantially at higher gastric pH.

1. Ineffective against atypical organisms — does not cover Mycoplasma pneumoniae, Chlamydophila pneumoniae, or Legionella; avoid as monotherapy in suspected atypical pneumonia.

1. Not active against MRSA — suitable only for MSSA and streptococcal skin infections; obtain culture if MRSA suspected.

1. Carnitine depletion risk — avoid prolonged courses or use in patients with pre-existing carnitine deficiency; consider carnitine supplementation if extended therapy unavoidable.

1. Check local antibiogram — resistance patterns for respiratory pathogens vary regionally in India; verify susceptibility before empirical use in AECB.

Cefditoren; cephalosporin; respiratory-infection; skin-infection; oral-antibiotic; renal-caution; PPI-interaction; carnitine-depletion; pregnancy-caution; Schedule-H

RxIndia v0.7 — 20 May 2025

• CDSCO (Central Drugs Standard Control Organisation) product information

• Indian Pharmacopoeia / National Formulary of India (IP/NFI)

• AIIMS Drug Formulary

• API Textbook of Medicine

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• Harrison's Principles of Internal Medicine

• ICMR Antimicrobial Resistance Guidelines

• Indian hospital prescribing protocols