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Authoritative Clinical Reference
Schedule H
Oral
Form Strength
Tablet 200 mg (film-coated)
INDICATIONS + DOSING — FOR CLINICIAN USE ONLY
Primary Indications (Approved / Standard in India):
▶ Clostridioides difficile-Associated Diarrhoea (CDAD) in Adults
Parameter Details
Starting dose 200 mg orally twice daily
Titration Not applicable
Usual maintenance dose 200 mg orally twice daily
Maximum dose 400 mg/day
Duration 10 days (fixed course)
Key Clinical Notes:
Secondary Indications – Adults Only (Off-label):
No adequately supported off-label indications established within Indian clinical practice.
PAEDIATRIC DOSING (Specialist Only)
Primary Indications:
▶ Clostridioides difficile Infection (Age ≥6 months)
Weight Category Starting Dose Titration Usual Maintenance Dose Maximum Dose Duration
<12.5 kg 8 mg/kg orally twice daily Not applicable 8 mg/kg twice daily 16 mg/kg/day 10 days
12.5–25 kg 100 mg orally twice daily Not applicable 100 mg twice daily 200 mg/day 10 days
25–50 kg 200 mg orally twice daily Not applicable 200 mg twice daily 400 mg/day 10 days
50 kg 200 mg orally twice daily Not applicable 200 mg twice daily 400 mg/day 10 days
Key Clinical Notes:
Safety Monitoring:
Secondary Indications – Paediatrics (Off-label):
Not recommended for other indications in children due to lack of safety and efficacy data.
Age Restriction Statement:
Not recommended below 6 months of age except under specialist supervision with documented exceptional indication.
| eGFR (ml/min/1.73m²) | Recommendation |
|---|---|
| eGFR (ml/min/1.73m²) | Recommendation |
| Haemodialysis | No dose adjustment required |
| Peritoneal dialysis | No dose adjustment required |
Note: Fidaxomicin is minimally absorbed systemically and not significantly excreted via kidneys.
| Hepatic Impairment | Recommendation |
|---|---|
| Mild impairment (Child-Pugh A) | No dose adjustment required |
| Moderate impairment (Child-Pugh B) | Use with caution; limited pharmacokinetic data available |
| Severe impairment (Child-Pugh C) | Avoid or use only under specialist supervision due to lack of safety data |
Parameter Recommendation
Risk category Not formally classified in India; limited human data available
Overall safety Animal studies show no teratogenicity; minimal systemic absorption expected
Preferred alternatives Oral vancomycin (more safety data in pregnancy for CDI)
When may be used Only if clearly needed and no suitable alternative; specialist consultation preferred
Monitoring Maternal response to therapy; fetal growth surveillance if used in later trimesters
Parameter Recommendation
Excretion in milk Expected to be minimal (negligible systemic absorption)
Compatibility Likely compatible with breastfeeding
Preferred alternatives Oral vancomycin (established safety profile, low milk levels)
Infant monitoring Diarrhoea, feeding intolerance, oral candidiasis
Parameter Recommendation
Starting dose 200 mg orally twice daily (same as adult)
Titration Not applicable
Additional risks No significant increase in adverse events reported in elderly; CDI recurrence risk may be higher in this population
Special considerations Monitor hydration status closely; no dose reduction required solely based on age
Interacting Drug/Class Mechanism / Risk Recommendation
Oral P-glycoprotein inhibitors (cyclosporine, ketoconazole) May increase systemic fidaxomicin and active metabolite (OP-1118) levels Avoid combination or use with close monitoring for adverse effects
Rifampicin (strong P-gp/CYP inducer) May theoretically reduce fidaxomicin levels Avoid combination if not essential
Interacting Drug/Class Mechanism / Risk Recommendation
Anti-diarrhoeal agents (loperamide, diphenoxylate) May mask signs of treatment failure or CDI progression Avoid concurrent use unless specifically indicated
Oral live vaccines (oral typhoid vaccine) Antibiotic may reduce vaccine immunogenicity Defer vaccination during fidaxomicin treatment
Warfarin No direct pharmacokinetic interaction expected; infection resolution may alter warfarin response Monitor INR during and after treatment
Adverse Effect Notes
Hypersensitivity reactions Including rash, angioedema, rare anaphylaxis; requires immediate discontinuation
Haematological effects Anaemia, neutropenia (infrequent); monitor if clinically indicated
Gastrointestinal haemorrhage Rare; monitor in patients with pre-existing GI pathology
Bowel perforation Rare but serious; report immediately if suspected
Hepatic dysfunction Monitor in patients with pre-existing liver disease
| Timing | Parameters |
|---|---|
| Baseline | LFTs (especially in patients with hepatic impairment); stool frequency and consistency; hydration status |
During therapy Clinical response (reduction in diarrhoea frequency); signs of hypersensitivity; hydration and electrolyte status
Post-treatment Monitor for CDI recurrence (particularly within 4 weeks of completing therapy)
Note: Availability may be limited; primarily through hospital-based specialty procurement. Not widely stocked in retail pharmacies.
| Formulation | Approximate Price (per tablet) |
|---|---|
| Tablet 200 mg ₹1,300–₹1,800 per tablet |
NLEM Status: Not included in NLEM 2022; not under price control
Government Supply: Not routinely available through national public health programmes; procurement through tertiary care institutions
fidaxomicin; Clostridioides difficile; CDAD; CDI; macrocyclic antibiotic; GI infection; renal-safe; recurrent diarrhoea; antibiotic-associated diarrhoea; Schedule H
RxIndia v1.0 — 28 May 2025
This platform is designed strictly for healthcare professionals. Data provided is synthesized from authoritative pharmacological sources and clinical registries. Do not use for consumer medical decisions. Always verify critical dosing and contraindications with official institutional protocols and peer-reviewed journals.
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