Schedule H

Oral

Tablets: 200 mg, 300 mg

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

⮞ Community-Acquired Pneumonia (Mild to Moderate)

Parameter Recommendation

Starting dose 200 mg orally twice daily

Titration Increase to 300 mg twice or thrice daily for moderate infections

Usual maintenance dose 200–300 mg twice or thrice daily

Maximum dose 900 mg/day

Key Clinical Notes:

• Duration: 5–10 days depending on clinical response

• Covers typical respiratory pathogens including penicillin-resistant pneumococci

• Reserve for cases where beta-lactamase producing organisms suspected

• Not first-line empirical therapy

⮞ Acute Exacerbation of Chronic Bronchitis

Parameter Recommendation

Starting dose 200 mg orally twice daily

Titration Not applicable

Usual maintenance dose 200–300 mg twice daily

Maximum dose 600 mg/day

Key Clinical Notes:

• Duration: 5–7 days

• Consider culture guidance where possible

• Effective against common respiratory pathogens including H. influenzae

⮞ Uncomplicated Urinary Tract Infections (Cystitis)

Parameter Recommendation

Starting dose 200 mg orally twice daily

Titration Not applicable

Usual maintenance dose 200 mg twice daily

Maximum dose 400 mg/day

Key Clinical Notes:

• Duration: 5 days for uncomplicated cystitis

• May extend to 7 days in males or complicated presentations

• Reserve for ESBL-suspected cases where oral step-down required

• Not first-line for simple UTI

⮞ Skin and Soft Tissue Infections (Mild to Moderate)

Parameter Recommendation

Starting dose 200 mg orally twice daily

Titration Increase to 300 mg twice daily for moderate infections

Usual maintenance dose 200–300 mg twice daily

Maximum dose 600 mg/day

Key Clinical Notes:

• Duration: 7–10 days

• Effective against Staphylococcus aureus (MSSA) and Streptococcus species

• Consider for mixed aerobic-anaerobic infections

⮞ Acute Bacterial Sinusitis / Otitis Media

Parameter Recommendation

Starting dose 200 mg orally thrice daily

Titration Not applicable

Usual maintenance dose 200 mg thrice daily

Maximum dose 600 mg/day

Key Clinical Notes:

• Duration: 5–10 days

• Reserve for treatment failures with first-line agents

• Not first-line empirical therapy

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

Indication Dose Duration Notes

Enteric Fever (MDR Salmonella typhi) 200–300 mg twice daily 7–10 days OFF-LABEL; Specialist only; Based on Indian tertiary care clinical experience; Reserve for fluoroquinolone-resistant or MDR cases where oral therapy required

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

⮞ Respiratory Tract Infections, Skin Infections, Uncomplicated UTI

Age-based and Weight-based Dosing:

6 months – <2 years 15–20 mg/kg/day Divided in 2 doses 300 mg/day

2–12 years 10–15 mg/kg/day Divided in 2–3 doses 600 mg/day

12 years Adult dosing Twice or thrice daily 900 mg/day

Dosing Summary:

Parameter Recommendation

Starting dose 10 mg/kg/day in 2 divided doses

Titration Increase to 15–20 mg/kg/day for moderate infections

Usual maintenance dose 10–15 mg/kg/day divided twice or thrice daily

Maximum dose 600 mg/day (or adult maximum)

Key Clinical Notes:

• Duration: 5–10 days based on indication and clinical response

• Administer with or after food to reduce GI upset

Safety Monitoring:

• Monitor for GI disturbances (diarrhoea, nausea, vomiting)

• Watch for signs of hypersensitivity (rash, urticaria)

• Baseline renal function if prolonged therapy planned

Age Restriction Statement:

Not recommended in infants below 6 months of age. Use only under specialist guidance in children.

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

Indication Dose Duration Notes

Enteric Fever (MDR cases) 10–15 mg/kg/day in 2 divided doses 7 days OFF-LABEL; Specialist only; Based on limited Indian tertiary centre data; Reserve for documented MDR Salmonella typhi where oral therapy required

• Known hypersensitivity to faropenem, carbapenems, or any beta-lactam antibiotic (penicillins, cephalosporins)

• History of serious anaphylactic reaction to beta-lactam antibiotics

• Concurrent use with valproic acid or sodium valproate (risk of sub-therapeutic valproate levels and seizure breakthrough)

• History of seizure disorders — beta-lactams may lower seizure threshold (though lower risk than IV carbapenems)

• Renal impairment — increased systemic exposure; dose adjustment may be needed

• History of antibiotic-associated colitis or C. difficile infection

• Cross-reactivity risk with other beta-lactam agents — use with caution in patients with penicillin allergy

• Elderly patients — monitor renal function and hydration status

• Prolonged use — risk of superinfection with resistant organisms

• Not effective against MRSA, Pseudomonas aeruginosa, or Acinetobacter species

Parameter Information

Risk category Category C (animal studies suggest risk; insufficient human data)

Safety statement Limited human pregnancy data; use only if clearly indicated

Preferred alternatives Amoxicillin-clavulanate, Cefixime, Cefuroxime (for mild infections)

When to use Only if benefit clearly outweighs risk and no safer alternatives available; specialist input advised

Monitoring Monitor maternal liver and renal function; routine obstetric surveillance

Parameter Information

Compatibility Use with caution; limited data on excretion

Drug level in milk Likely excreted in small amounts (extrapolated from beta-lactam class)

Preferred alternatives Amoxicillin, Cephalexin, Cefuroxime

Infant monitoring Watch for diarrhoea, oral thrush, skin rash, or feeding difficulties

• Starting dose: 200 mg twice daily

• Titration: Increase cautiously based on clinical response and tolerability

• Additional considerations:

• Assess baseline renal function before initiation

• Increased risk of renal impairment-related accumulation

• Higher susceptibility to GI adverse effects

• Maintain adequate hydration during therapy

• Monitor for CNS effects (confusion, dizziness) particularly in those with renal impairment

Interacting Drug Effect Management

Valproic acid / Sodium valproate Significant reduction in valproate serum levels; risk of breakthrough seizures AVOID concurrent use; if essential, monitor valproate levels frequently and consider alternative antibiotic

Probenecid Increases faropenem serum levels by reducing renal tubular secretion Avoid combination if possible; if used, monitor for toxicity

Interacting Drug Effect Management

Warfarin Possible alteration in INR; increased bleeding risk Monitor PT/INR closely during and after antibiotic course

Other broad-spectrum antibiotics Increased risk of C. difficile-associated diarrhoea Avoid unnecessary combination; monitor for diarrhoea

Oral typhoid vaccine (Ty21a) Reduced vaccine immunogenicity Avoid concurrent administration; complete antibiotic course before vaccination

Metformin Possible altered glycaemic control Monitor blood glucose in diabetic patients

• Diarrhoea

• Nausea

• Abdominal discomfort/pain

• Headache

• Vomiting

• Skin rash

• Dyspepsia

• Dizziness

Adverse Effect Clinical Notes

Anaphylaxis / Angioedema Immediate hypersensitivity; discontinue immediately and provide emergency care

Stevens-Johnson Syndrome / TEN Rare; discontinue immediately and refer urgently

Pseudomembranous colitis (C. difficile) Suspect with severe or persistent diarrhoea; discontinue and treat appropriately

Seizures Rare; more likely in renal impairment or underlying seizure disorders; discontinue if occurs

Hepatotoxicity Rare; monitor LFTs if prolonged therapy; discontinue if significant elevation

Haemolytic anaemia Rare; monitor for symptoms of anaemia

Phase Parameters

Baseline Renal function (especially in elderly); LFTs (if hepatic disease); allergy history; valproate levels (if on concurrent therapy)

During therapy Clinical assessment for GI symptoms, rash, hypersensitivity within first 72 hours; valproate levels if co-administered

Prolonged/repeated courses Periodic renal function; LFTs; CBC; monitor for emergence of resistant organisms or secondary infections

• Farobact (Cipla)

• Faronem (Emcure)

• Faropen (Aristo)

• Farozem (Zuventus)

• Faronova (Glenmark)

• Faropan (Mankind)

• Multiple generic preparations available

Note: Not included in NLEM; not NPPA price-controlled; widely available in private retail; not listed in central government EML.

1. Oral penem, not carbapenem: Faropenem is the only oral penem available in India; it is NOT a true carbapenem and has a narrower spectrum than IV carbapenems (meropenem, imipenem).

1. ESBL coverage advantage: Useful for oral step-down therapy in community-acquired infections caused by ESBL-producing organisms when culture confirms susceptibility.

1. Resistance stewardship: Reserve faropenem for documented resistant infections or treatment failures; indiscriminate use contributes to resistance development.

1. Valproate interaction critical: Avoid concurrent use with valproic acid — can cause significant drop in valproate levels leading to breakthrough seizures.

1. Not for severe infections: Not appropriate for hospital-acquired infections, sepsis, or infections requiring parenteral therapy — use IV carbapenems instead.

1. Limited Pseudomonas/MRSA activity: Unlike IV carbapenems, faropenem has no activity against Pseudomonas aeruginosa, Acinetobacter, or MRSA — do not use empirically for suspected nosocomial infections.

Faropenem; penem; oral beta-lactam; ESBL; community-acquired infections; respiratory infection; UTI; skin infection; valproate-interaction; Schedule H; antimicrobial stewardship

RxIndia v1.0 — 10 Jan 2025

• CDSCO Approved Product List

• Indian Pharmacopoeia

• National Formulary of India (NFI)

• API Textbook of Medicine

• AIIMS Antimicrobial Policy 2023

• ICMR-AMR Guidelines 2022

• Goodman & Gilman's: The Pharmacological Basis of Therapeutics

• Indian observational cohorts (off-label use in enteric fever)

• Product inserts (Cipla, Emcure, Glenmark)