Schedule H

Oral

• Tablets: 250 mg, 500 mg, 1 g

• Capsules: 500 mg

• Oral Suspension: 125 mg/5 mL, 250 mg/5 mL

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

⮞ Acute Pharyngitis / Tonsillitis (Streptococcus pyogenes)

Parameter Recommendation

Starting dose 500 mg orally twice daily

Titration May increase to 1 g twice daily for severe infections

Usual maintenance dose 500 mg–1 g twice daily

Maximum dose 2 g/day

Key Clinical Notes:

• Duration: 10 days mandatory to prevent rheumatic fever

• Complete full course even if symptoms resolve early

• Alternative to penicillin in non-anaphylactic penicillin allergy

⮞ Uncomplicated Urinary Tract Infections (Cystitis)

Parameter Recommendation

Starting dose 500 mg orally twice daily

Titration Increase to 1 g twice daily for moderate infections

Usual maintenance dose 500 mg–1 g twice daily

Maximum dose 2 g/day

Key Clinical Notes:

• Duration: 5–7 days for uncomplicated cystitis

• Extended duration (7–14 days) for complicated UTI or males

• Obtain culture if no response within 48–72 hours

• Covers E. coli, Klebsiella, Proteus (non-ESBL strains)

⮞ Skin and Soft Tissue Infections

(Cellulitis, impetigo, wound infections, furuncles)

Parameter Recommendation

Starting dose 500 mg orally twice daily

Titration Increase to 1 g twice daily for moderate-severe infections

Usual maintenance dose 500 mg–1 g twice daily

Maximum dose 2 g/day

Key Clinical Notes:

• Duration: 7–10 days depending on severity and clinical response

• Effective against Staphylococcus aureus (MSSA) and Streptococcus pyogenes

• Not effective against MRSA

• Review if no improvement within 48–72 hours

⮞ Secondary Bacterial Infections of Dermatitis / Eczema

Parameter Recommendation

Starting dose 500 mg orally twice daily

Titration Not applicable

Usual maintenance dose 500 mg–1 g twice daily

Maximum dose 2 g/day

Key Clinical Notes:

• Duration: 5–10 days

• Review if no improvement in 48–72 hours

• Concurrent topical therapy may be required

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

Indication Dose Duration Notes

Recurrent UTI prophylaxis 500 mg at bedtime Monthly pulsed or continuous; individualised OFF-LABEL; Specialist only; Based on Indian urology/ID practice; Reserve for documented recurrent infections

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

⮞ Pharyngitis / Tonsillitis (Group A Streptococcus)

Weight-based Dosing:

Parameter Recommendation

Starting dose 30 mg/kg/day in 2 divided doses

Titration Not applicable

Usual maintenance dose 30 mg/kg/day divided every 12 hours

Maximum dose Adult dose (2 g/day)

Key Clinical Notes:

• Duration: 10 days mandatory (rheumatic fever prevention)

• Can be given once daily (30 mg/kg as single dose) for compliance in mild cases

• Minimum age: >6 months

⮞ Urinary Tract Infections (Paediatric)

Parameter Recommendation

Starting dose 30 mg/kg/day in 2 divided doses

Titration Increase to 50 mg/kg/day for moderate-severe infections

Usual maintenance dose 30–50 mg/kg/day divided every 12 hours

Maximum dose Adult dose (2 g/day)

Key Clinical Notes:

• Duration: 7–10 days

• Obtain urine culture before initiating therapy

• Minimum age: >6 months

⮞ Skin and Soft Tissue Infections (Paediatric)

Parameter Recommendation

Starting dose 30 mg/kg/day in 2 divided doses

Titration Increase to 50 mg/kg/day for moderate infections

Usual maintenance dose 30–50 mg/kg/day divided every 12 hours

Maximum dose Adult dose (2 g/day)

Key Clinical Notes:

• Duration: 7–10 days

• Minimum age: >6 months

Safety Monitoring:

• Monitor for GI disturbances (diarrhoea, nausea)

• Watch for signs of hypersensitivity (rash, urticaria)

• Baseline renal function in neonates/infants if prolonged therapy

• Monitor for oral thrush with prolonged use

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

Indication Dose Duration Notes

Recurrent tonsillitis prophylaxis 250 mg once daily 3–6 months OFF-LABEL; Specialist only (ENT); Based on Indian ENT practice; Use only after exclusion of surgical indications

Age Restriction Statement:

Not recommended in infants below 6 months of age except under specialist supervision due to immature renal function.

CrCl (mL/min) Recommendation

≥50 No adjustment required

25–49 500 mg every 12 hours

10–24 500 mg every 24 hours

<10 500 mg every 36 hours

Haemodialysis 500 mg post-dialysis; additional dose after each session

Peritoneal dialysis 500 mg every 36 hours

Note: Monitor closely for neurotoxicity (confusion, seizures) in severe renal impairment.

• Known hypersensitivity to cefadroxil or any cephalosporin antibiotic

• History of severe immediate-type hypersensitivity (anaphylaxis) to penicillins or other beta-lactam antibiotics

• Known hypersensitivity to any excipient in the formulation

• History of non-severe penicillin allergy — evaluate cross-reactivity risk (approximately 1–2%); may use with caution

• Renal impairment — dose modification required to prevent accumulation

• History of gastrointestinal disease, particularly antibiotic-associated colitis

• Prolonged use — risk of superinfection with resistant organisms or C. difficile

• History of seizures — risk may be increased with accumulation in renal dysfunction

• Not effective against MRSA, ESBL-producing organisms, or Pseudomonas aeruginosa

Parameter Information

Risk category Generally considered safe (Category B equivalent)

Safety statement No evidence of teratogenicity; crosses placenta but extensive clinical experience supports safety

Preferred use Commonly used in Indian obstetric practice for UTI and SSTI

Preferred alternatives Cephalexin (equally safe first-generation cephalosporin)

When to use When indicated for susceptible infections; preferred cephalosporin when penicillins not suitable

Monitoring Monitor for UTI treatment response; routine obstetric surveillance

Parameter Information

Compatibility Compatible with breastfeeding

Drug level in milk Low (small amounts excreted)

Preferred alternatives Cephalexin also acceptable

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

• Starting dose: Lower end of dose range recommended (500 mg twice daily)

• Titration: Increase based on clinical response and renal function assessment

• Additional considerations:

• Assess baseline renal function before initiation (age-related decline common)

• Adjust dose according to CrCl even if serum creatinine appears normal

• Higher susceptibility to renal-related drug accumulation

• Increased risk of neurotoxicity (confusion, seizures) with accumulation

• Monitor hydration status during therapy

Interacting Drug Effect Management

Probenecid Increases cefadroxil serum levels by inhibiting renal tubular secretion Avoid combination if possible; if used together, monitor for toxicity

Live typhoid vaccine (Ty21a) Diminished vaccine immunogenicity Avoid concurrent administration; complete antibiotic course before vaccination

Interacting Drug Effect Management

Warfarin Rare INR changes reported; possible enhanced anticoagulant effect Monitor INR closely if prolonged antibiotic use

Loop diuretics (furosemide) Increased nephrotoxicity risk Monitor renal function; ensure adequate hydration

Aminoglycosides Additive nephrotoxicity when used together Monitor renal function closely; avoid prolonged combination

Metformin Accumulation risk in renal impairment when combined Monitor blood glucose and renal function

• Diarrhoea

• Nausea

• Vomiting

• Abdominal discomfort/pain

• Skin rash

• Headache

• Dyspepsia

• Oral candidiasis (with prolonged use)

Adverse Effect Clinical Notes

Anaphylaxis / Angioedema Immediate hypersensitivity; discontinue immediately; emergency care required

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

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

Acute interstitial nephritis Rare; presents with fever, rash, eosinophilia, renal impairment

Seizures Rare; associated with accumulation in renal impairment; discontinue if occurs

Haemolytic anaemia Rare; Coombs-positive haemolytic anaemia reported

Phase Parameters

Baseline Renal function (especially in elderly, children, or if prolonged course planned); allergy history

During therapy Clinical assessment for GI symptoms, rash, signs of hypersensitivity

Prolonged therapy (>10 days) LFTs; CBC; renal function

Repeated/long-term courses Periodic renal function; CBC; monitor for superinfection

• Enfexia (Cipla)

• Cefdox (Micro Labs)

• Droxyl (Lupin)

• Cefadure (Alkem)

• Odoxil (Ranbaxy/Sun Pharma)

• Cefadrox (Aristo)

• Multiple generic preparations available

Note: Not included in NLEM; not NPPA price-controlled; generally affordable; widely available.

1. Penicillin alternative for streptococcal pharyngitis: Suitable alternative in patients with non-anaphylactic penicillin allergy; 10-day course mandatory for rheumatic fever prevention.

1. Once-daily dosing option: Due to longer half-life (1.5 hours), once-daily dosing (1 g OD) is possible for mild infections and may improve compliance, especially in children.

1. Interchangeable with cephalexin: Near-interchangeable with cephalexin for most indications; choose based on local availability, price, and dosing convenience.

1. Good paediatric tolerability: Well-tolerated oral suspension with better taste profile; good compliance in children.

1. No MRSA/ESBL coverage: First-generation cephalosporin with no activity against MRSA or ESBL-producing organisms — do not use empirically for suspected resistant infections.

1. Renal dosing critical in elderly: Adjust dose based on calculated CrCl in elderly patients even when serum creatinine appears normal; age-related decline in renal function is common.

Cefadroxil; cephalosporin; first-generation cephalosporin; antibiotic; pharyngitis; tonsillitis; UTI; skin infection; SSTI; renal-adjustment; pregnancy-safe; breastfeeding-compatible; paediatric-appropriate; Schedule H

RxIndia v1.0 — 10 Jan 2025

• CDSCO Approved Formulations List

• Indian Pharmacopoeia / National Formulary of India

• API Textbook of Medicine

• IAP Paediatric Drug Formulary

• AIIMS Paediatric Dosing References

• NCDC National Treatment Guidelines for Antimicrobial Use in Infectious Diseases

• Harrison's Principles of Internal Medicine

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

• Indian hospital paediatric antibiotic protocols