Schedule H

Oral

• Tablets: 250 mg, 500 mg

• Dry Syrup (for reconstitution): 125 mg/5 mL, 250 mg/5 mL

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Acute Pharyngitis / Tonsillitis (Streptococcus pyogenes)

Parameter Details

Starting dose 500 mg orally once daily OR 250 mg twice daily

Titration Not applicable

Usual maintenance dose 500 mg once daily or 250 mg twice daily

Maximum dose 500 mg/day

Duration 10 days

Clinical notes Alternative to penicillin in patients tolerant to beta-lactams. Complete full course to prevent rheumatic fever.

1. Acute Otitis Media

Parameter Details

Starting dose 500 mg orally twice daily

Titration Not applicable

Usual maintenance dose 500 mg twice daily

Maximum dose 1 g/day

Duration 10 days

Clinical notes Not first-line therapy. Consider for recurrent cases or treatment failures with amoxicillin. Provides coverage against beta-lactamase producing H. influenzae.

1. Acute Bacterial Sinusitis

Parameter Details

Starting dose 250 mg orally twice daily

Titration Not applicable

Usual maintenance dose 250–500 mg twice daily

Maximum dose 1 g/day

Duration 10–14 days

Clinical notes Reserve for mild-to-moderate cases. Avoid in severe sinusitis with complications. Consider local resistance patterns.

1. Uncomplicated Skin and Soft Tissue Infections

Parameter Details

Starting dose 250 mg orally twice daily

Titration Not applicable

Usual maintenance dose 250–500 mg twice daily (based on severity)

Maximum dose 1 g/day

Duration 7–10 days

Clinical notes Effective against MSSA and Streptococci. Not effective against MRSA.

Secondary Indications — Adults Only (Off-label)

Indication Dose Duration Evidence Basis Notes

Acute Exacerbation of Chronic Bronchitis 500 mg orally twice daily 7–10 days International RCTs; Indian hospital practice OFF-LABEL. Consider when amoxicillin-clavulanate not suitable. Specialist discretion advised.

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Minimum age: ≥6 months (Safety not established below 6 months)

Indication Age/Weight Dose Maximum Dose Duration Clinical Notes

Acute Pharyngitis/Tonsillitis ≥6 months 7.5 mg/kg orally twice daily 500 mg/day 10 days Complete full course

Acute Otitis Media ≥6 months 15 mg/kg orally twice daily 1 g/day 10 days Use higher dose range for resistant cases

Uncomplicated SSTIs ≥6 months 10 mg/kg orally twice daily 1 g/day 7–10 days Based on severity

Age-based practical dosing (oral suspension):

6 months – 2 years 62.5–125 mg Twice daily

2–6 years 125 mg Twice daily

6–12 years 250 mg Twice daily

12 years Use adult dosing —

Safety monitoring: GI tolerability, rash, signs of hypersensitivity

Secondary Indications — Paediatric Doses (Off-label)

Indication Dose Duration Evidence Basis Notes

Acute Bacterial Sinusitis 15–20 mg/kg/day in 2 divided doses 10–14 days IAP specialist practice; international paediatric studies OFF-LABEL. Specialist supervision advised. Max 1 g/day.

Age restriction: Not recommended in children <6 months except under specialist supervision with close monitoring.

• Known hypersensitivity to cefprozil or any other cephalosporin antibiotic

• History of severe immediate-type (Type I) hypersensitivity reaction to penicillins or carbapenems (anaphylaxis, angioedema, urticaria)

• History of non-severe penicillin allergy — assess cross-reactivity risk (approximately 1–2%)

• Renal impairment — requires dose adjustment when eGFR <30 mL/min

• History of gastrointestinal disease, particularly colitis — increased risk of C. difficile-associated diarrhoea

• Prolonged antibiotic use — risk of superinfection with resistant organisms or fungi

• Children below 6 months — safety and efficacy not established

• Patients on sodium-restricted diets — check sodium content of formulations

Parameter Details

Risk category Generally considered safe (FDA Category B equivalent); no teratogenic effects reported

Overall safety Can be used when clinically indicated; crosses placenta

Preferred alternatives Amoxicillin, cefixime, cephalexin (more extensive pregnancy data)

When permissible When benefit outweighs risk and alternative agents not suitable

Monitoring Maternal GI symptoms, signs of hypersensitivity

Parameter Details

Compatibility Compatible with breastfeeding

Expected milk levels Low — minimal transfer into breast milk

Preferred alternatives Amoxicillin, cephalexin (larger lactation experience)

Infant monitoring Diarrhoea, oral thrush, rash, feeding difficulties

Parameter Details

Starting dose Use lower end of dose range (250 mg twice daily)

Titration Not applicable

Special considerations Assess renal function (eGFR) before initiating therapy

Increased risks Drug accumulation if renal impairment present; GI intolerance more common

Monitoring Renal function, hydration status, signs of C. difficile colitis

Interacting Drug Mechanism Clinical Recommendation

Probenecid Inhibits renal tubular secretion, increasing cefprozil plasma concentrations Avoid combination or use with caution; monitor for toxicity

Aminoglycosides (concurrent use) Potential additive nephrotoxicity Avoid combination if possible; if unavoidable, monitor renal function closely

Interacting Drug Mechanism Clinical Recommendation

Warfarin Possible enhancement of anticoagulant effect (rare) Monitor INR during initiation and discontinuation of cefprozil

Loop diuretics (furosemide) Theoretical additive nephrotoxicity risk Monitor renal function with concurrent use

Combined oral contraceptives Theoretical reduced efficacy via gut flora alteration Advise barrier contraception during antibiotic course and for 7 days after completion

Antacids (aluminium/magnesium) May reduce absorption slightly Separate administration by 2 hours if possible

• Diarrhoea

• Nausea

• Vomiting

• Abdominal discomfort/pain

• Maculopapular rash

• Headache

• Vulvovaginal candidiasis

Adverse Effect Action Required

Anaphylaxis / severe hypersensitivity Discontinue immediately; administer emergency treatment

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

Clostridioides difficile-associated colitis (pseudomembranous colitis) Stop antibiotic; initiate specific treatment (oral vancomycin/metronidazole); may require hospitalisation

Seizures (especially at high doses in renal impairment) Discontinue; supportive management

Severe haemolytic anaemia (rare) Discontinue; haematology referral

During treatment Clinical response by 48–72 hours, GI symptoms, skin rash, signs of hypersensitivity

If prolonged/repeated courses Complete blood count, signs of C. difficile infection (fever, diarrhoea), eosinophilia

• Cefzil® (Abbott)

• Prozil® (Cipla)

• Cefpro® (Alkem)

• Refzil® (Ranbaxy/Sun Pharma)

• Orzil® (Mankind)

Note: Availability of specific brands may vary by region.

• Not included under NLEM/DPCO price control

• Prices vary by brand and location

1. Second-generation advantage — Better coverage against H. influenzae and M. catarrhalis compared to first-generation cephalosporins; preferred for respiratory infections with suspected beta-lactamase producers.

1. Not first-line for pharyngitis — Penicillin V or amoxicillin remain first-choice for Group A streptococcal pharyngitis; reserve cefprozil for penicillin-allergic patients (non-Type I).

1. Suspension reconstitution — Instruct caregivers to shake well before each use; refrigerate after reconstitution; discard after 14 days.

1. Ineffective against atypicals — Does not cover Mycoplasma, Chlamydophila, or Legionella; avoid as monotherapy if atypical pneumonia suspected.

1. Complete the course — Emphasize importance of completing full 10-day course in streptococcal pharyngitis to prevent rheumatic fever and glomerulonephritis.

1. Local antibiogram matters — Resistance patterns vary regionally; consult local data before empirical use in sinusitis or otitis media.

Cefprozil; cephalosporin; second-generation; otitis-media; pharyngitis; sinusitis; URTI; paediatric-antibiotic; oral-antibiotic; pregnancy-compatible; Schedule-H

RxIndia v1.0 — 20 May 2025

• CDSCO (Central Drugs Standard Control Organisation) product information

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

• API Textbook of Medicine

• IAP Guidelines for Respiratory Infections

• AIIMS Drug Formulary

• AIIMS Paediatric Dosing Protocols

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• International meta-analyses (off-label bronchitis indication)