Schedule H

Oral

• Capsules: 400 mg

• Oral Suspension (dry syrup for reconstitution): 90 mg/5 mL

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB)

Parameter Details

Starting dose 400 mg orally once daily

Titration Not applicable

Usual maintenance dose 400 mg once daily

Maximum dose 400 mg/day

Duration 10 days

Clinical notes Avoid if Pseudomonas or MDR pathogens suspected. Effective against S. pneumoniae, H. influenzae, M. catarrhalis.

1. Acute Otitis Media

Parameter Details

Starting dose 400 mg orally once daily

Titration Not applicable

Usual maintenance dose 400 mg once daily

Maximum dose 400 mg/day

Duration 10 days

Clinical notes Consider when amoxicillin treatment has failed or in penicillin-allergic patients (non-Type I).

1. Pharyngitis / Tonsillitis (Streptococcus pyogenes)

Parameter Details

Starting dose 400 mg orally once daily

Titration Not applicable

Usual maintenance dose 400 mg once daily

Maximum dose 400 mg/day

Duration 10 days

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

1. Uncomplicated Urinary Tract Infections (Lower UTI)

Parameter Details

Starting dose 400 mg orally once daily

Titration Not applicable

Usual maintenance dose 400 mg once daily

Maximum dose 400 mg/day

Duration 7–10 days

Clinical notes Consider when local E. coli sensitivity to oral cephalosporins is favourable. Not preferred when fluoroquinolone resistance is low in the region.

1. Community-Acquired Pneumonia (Mild to Moderate)

Parameter Details

Starting dose 400 mg orally once daily

Titration Not applicable

Usual maintenance dose 400 mg once daily

Maximum dose 400 mg/day

Duration 10–14 days

Clinical notes Suitable when S. pneumoniae and H. influenzae are likely pathogens. Limited anaerobic coverage. Not for severe CAP or atypical pathogens.

Secondary Indications — Adults Only (Off-label)

Not applicable — No commonly documented off-label indications in Indian practice.

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

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

Weight-based dosing:

Indication Age Dose Maximum Dose Duration Clinical Notes

Acute Otitis Media ≥6 months 9 mg/kg orally once daily 400 mg/day 10 days Use calibrated measuring device for suspension

Pharyngitis/Tonsillitis ≥6 months 9 mg/kg orally once daily 400 mg/day 10 days Complete full course; prefer penicillin if no allergy

Mild CAP / Lower RTI ≥6 months 9 mg/kg orally once daily 400 mg/day 10–14 days Limited data; specialist supervision advised

Practical dosing examples (90 mg/5 mL suspension):

Body Weight Daily Dose Volume of Suspension

10 kg 90 mg 5 mL once daily

15 kg 135 mg 7.5 mL once daily

20 kg 180 mg 10 mL once daily

30 kg 270 mg 15 mL once daily

≥45 kg 400 mg Use 400 mg capsule

Safety monitoring: GI tolerability, skin rash, signs of hypersensitivity

Secondary Indications — Paediatric Doses (Off-label)

Not applicable — No routinely used off-label paediatric indications in Indian practice.

Age restriction: Not recommended in children <6 months except under infectious disease specialist supervision. Avoid in neonates due to lack of safety and pharmacokinetic data.

CrCl (mL/min) Recommendation

50 No dose adjustment required

30–49 200 mg once daily OR 400 mg once every 48 hours

<30 100 mg once daily OR 400 mg once every 72 hours

Haemodialysis 400 mg after each dialysis session

Peritoneal dialysis Limited data — 100 mg once daily; specialist supervision advised

• Known hypersensitivity to ceftibuten or any other cephalosporin antibiotic

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

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

• Renal impairment — dose adjustment required to prevent drug accumulation

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

• Suspected anaerobic infections — ceftibuten has limited anaerobic coverage

• Suspected Pseudomonas aeruginosa infection — not effective against Pseudomonas

• Nosocomial infections — not suitable for empirical treatment

• Meningitis — inadequate CSF penetration; not indicated

• Children below 6 months — safety and efficacy not established

Parameter Details

Risk category Not formally assigned by CDSCO; generally considered safe (no known teratogenicity)

Overall safety Cephalosporins are generally compatible with pregnancy; limited specific data for ceftibuten

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

When permissible When clinically indicated and benefits outweigh risks

Monitoring Maternal GI symptoms, signs of hypersensitivity; fetal growth if prolonged course

Parameter Details

Compatibility Compatible with breastfeeding

Expected milk levels Low — cephalosporins are excreted minimally in breast milk

Preferred alternatives Cephalexin, cefixime (larger lactation experience)

Infant monitoring Diarrhoea, oral thrush, rash, feeding difficulties

Parameter Details

Starting dose 400 mg once daily (same as adults)

Titration Not applicable

Special considerations Assess renal function (eGFR/CrCl) before initiating; dose adjust based on renal status

Increased risks Reduced renal clearance with age leading to drug accumulation; higher susceptibility to GI adverse effects

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

Interacting Drug Mechanism Clinical Recommendation

Probenecid Inhibits renal tubular secretion, increasing ceftibuten plasma concentrations Avoid combination or use with close monitoring; dose reduction may be required

Live typhoid vaccine (Ty21a) Antibiotics may reduce vaccine efficacy by killing attenuated bacteria Avoid concurrent use; complete antibiotic course at least 3 days before vaccine administration

Interacting Drug Mechanism Clinical Recommendation

Antacids (aluminium/magnesium hydroxide) May reduce ceftibuten absorption Administer ceftibuten at least 2 hours before or after antacid

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

Warfarin Possible alteration of gut flora affecting vitamin K synthesis Monitor INR during concurrent therapy, especially with prolonged antibiotic courses

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

H2-receptor antagonists May slightly reduce absorption Generally clinically insignificant; no dose adjustment needed

• Diarrhoea

• Nausea

• Abdominal pain/discomfort

• Dyspepsia

• Headache

• Dizziness

• Loose stools

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 Stop antibiotic; initiate specific treatment (oral vancomycin/metronidazole); may require hospitalisation

Neutropenia (with prolonged use) Discontinue; check CBC; haematology referral if severe

Seizures (rare, especially in renal impairment with overdose) Discontinue; supportive management

During treatment (first 72 hours) Clinical response, GI symptoms, skin rash, signs of hypersensitivity

If prolonged course (>10 days) Complete blood count (watch for neutropenia, eosinophilia), signs of C. difficile infection

Long-term Not recommended for prolonged use; reassess if therapy exceeds 14 days

• Cedax® (Shionogi/MSD)

• Ceftib® (various manufacturers)

• Tibutin® (Zydus)

• Butacef® (Mankind)

Note: Brand availability may vary by region. Verify WHO-GMP certification for generics.

• Not included under NLEM/DPCO price control

• Prices vary by brand and location

1. Once-daily oral third-generation cephalosporin — Convenient dosing improves compliance; useful alternative when parenteral therapy is not required but extended gram-negative coverage needed.

1. Poor anaerobic and Pseudomonas coverage — Avoid in diabetic foot infections, intra-abdominal infections, or any condition where anaerobes or Pseudomonas are likely pathogens.

1. Cost consideration — Significantly costlier than amoxicillin or cotrimoxazole; reserve for situations with documented resistance or when first-line agents have failed.

1. Suspension preparation — Shake well before use; use calibrated measuring device for accurate dosing in children; refrigerate after reconstitution; discard after 14 days.

1. Check local antibiogram — Ceftibuten susceptibility varies across Indian states; verify local resistance patterns before empirical use, especially for UTIs.

1. Renal dosing critical — Always assess renal function before prescribing in elderly patients; significant dose adjustment needed when CrCl <50 mL/min.

Ceftibuten; cephalosporin; third-generation; oral-cephalosporin; otitis-media; pharyngitis; UTI; ABECB; paediatric-antibiotic; renal-adjustment; 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 2022

• AIIMS Antimicrobial Policy 2023

• AIIMS Drug Formulary

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• Manufacturer prescribing information (WHO-GMP certified Indian brands)