Cefixime Uses, Dosage, Side Effects & Price | DrugsAtlas
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Therapeutic Class
Antibacterial
Subclass
Third-generation oral cephalosporin
Speciality
Infectious Diseases
Schedule (India)
Schedule H
Routes
Oral
Formulations
| Form | Strengths |
|---|---|
| Tablets | 100 mg, 200 mg |
| Dispersible tablets | 100 mg, 200 mg |
| Oral suspension (dry syrup) | 50 mg/5 mL, 100 mg/5 mL |
Adult indications
INDICATIONS + DOSING ā FOR CLINICIAN USE ONLY
Primary Indications (Approved / Standard in India)
1. Typhoid Fever (Enteric Fever ā Salmonella Typhi)
| Parameter | Details |
|---|---|
| Starting dose | 200 mg orally twice daily OR 400 mg once daily |
| Titration | Not applicable |
| Usual maintenance dose | 400 mg/day (in single or divided doses) |
| Maximum dose | 400 mg/day |
| Duration | 10ā14 days |
Clinical Notes:
- First-line oral option for uncomplicated typhoid in Indian settings
- Culture-guided therapy preferred where feasible
- Monitor for clinical response by day 5ā7
- Watch for relapse 7ā14 days after completing therapy
- Consider alternatives if fluoroquinolone-resistant or MDR strains prevalent locally
2. Acute Uncomplicated Urinary Tract Infection (Cystitis)
| Parameter | Details |
|---|---|
| Starting dose | 200 mg orally twice daily OR 400 mg once daily |
| Titration | Not applicable |
| Usual maintenance dose | 400 mg/day |
| Maximum dose | 400 mg/day |
| Duration | 5ā7 days |
Clinical Notes:
- Reserve for culture-confirmed susceptible organisms
- Increasing resistance among uropathogens in India; not empiric first-line in many centres
- Consider nitrofurantoin or fosfomycin as alternatives for uncomplicated cystitis
3. Acute Bacterial Exacerbation of Chronic Bronchitis
| Parameter | Details |
|---|---|
| Starting dose | 200 mg orally twice daily OR 400 mg once daily |
| Titration | Not applicable |
| Usual maintenance dose | 400 mg/day |
| Maximum dose | 400 mg/day |
| Duration | 7ā10 days |
Clinical Notes:
- Obtain sputum culture if recurrent exacerbations
- Effective against common respiratory pathogens (H. influenzae, M. catarrhalis, S. pneumoniae)
4. Community-Acquired Pneumonia (Mild to Moderate)
| Parameter | Details |
|---|---|
| Starting dose | 200 mg orally twice daily OR 400 mg once daily |
| Titration | Not applicable |
| Usual maintenance dose | 400 mg/day |
| Maximum dose | 400 mg/day |
| Duration | 7ā10 days |
Clinical Notes:
- Suitable for outpatient management of mild-to-moderate CAP
- Consider combination with macrolide if atypical pathogens suspected
- Not effective against atypical organisms (Mycoplasma, Chlamydia, Legionella)
5. Acute Pharyngitis / Tonsillitis (Group A Streptococcus)
| Parameter | Details |
|---|---|
| Starting dose | 200 mg orally twice daily |
| Titration | Not applicable |
| Usual maintenance dose | 400 mg/day in divided doses |
| Maximum dose | 400 mg/day |
| Duration | 5ā10 days |
Clinical Notes:
- Second-line agent; penicillin V or amoxicillin remain first-line
- Reserve for documented penicillin allergy (non-immediate type)
- Full 10-day course recommended to prevent rheumatic fever
6. Acute Otitis Media
| Parameter | Details |
|---|---|
| Starting dose | 200 mg orally twice daily OR 400 mg once daily |
| Titration | Not applicable |
| Usual maintenance dose | 400 mg/day |
| Maximum dose | 400 mg/day |
| Duration | 7ā10 days |
Clinical Notes:
- Second-line option when amoxicillin fails or contraindicated
- Assess clinical improvement by day 3ā5
Secondary Indications ā Adults (Off-label, if any)
| Indication | Dose | Duration | Notes |
|---|---|---|---|
| Uncomplicated Gonorrhoea (cervical/urethral/rectal) ā OFF-LABEL | 400 mg single oral dose | Single dose | Specialist only. Use only when local antimicrobial surveillance confirms susceptibility. High rates of cefixime resistance reported in many Indian cities; injectable ceftriaxone preferred. Evidence: WHO/CDC STI guidelines; limited current use in Indian STI practice due to resistance. |
Paediatric indications
PAEDIATRIC DOSING (Specialist Only)
Primary Indications (Approved / Standard in India)
1. Typhoid Fever (Enteric Fever)
Age: ≥6 months
| Parameter | Details |
|---|---|
| Starting dose | 8 mg/kg/day orally in two divided doses |
| Titration | May increase to 10ā20 mg/kg/day based on severity and response |
| Usual maintenance dose | 10ā15 mg/kg/day in two divided doses |
| Maximum dose | 400 mg/day |
| Duration | 10ā14 days |
Clinical Notes:
- First-line oral option for uncomplicated paediatric typhoid in India
- Culture-guided therapy preferred
- Monitor for clinical response; observe for relapse post-treatment
- Oral suspension should be reconstituted properly and shaken well before each dose
2. Acute Pharyngitis / Tonsillitis (Penicillin Allergy)
Age: ≥6 months
| Parameter | Details |
|---|---|
| Starting dose | 8 mg/kg/day orally in two divided doses |
| Titration | Not applicable |
| Usual maintenance dose | 8 mg/kg/day in two divided doses |
| Maximum dose | 400 mg/day |
| Duration | 10 days |
Clinical Notes:
- Second-line for GAS pharyngitis when penicillin contraindicated
- Complete 10-day course for rheumatic fever prevention
3. Acute Otitis Media
Age: ≥6 months
| Parameter | Details |
|---|---|
| Starting dose | 8 mg/kg/day orally (once daily or in two divided doses) |
| Titration | Not applicable |
| Usual maintenance dose | 8 mg/kg/day |
| Maximum dose | 400 mg/day |
| Duration | 7ā10 days |
Clinical Notes:
- Assess clinical improvement by day 3ā5
- May use once-daily dosing for improved compliance
4. Urinary Tract Infection (Paediatric)
Age: ≥6 months
| Parameter | Details |
|---|---|
| Starting dose | 8 mg/kg/day orally in two divided doses |
| Titration | Not applicable |
| Usual maintenance dose | 8 mg/kg/day |
| Maximum dose | 400 mg/day |
| Duration | 7ā14 days (depending on upper vs lower UTI) |
Clinical Notes:
- Culture and sensitivity essential
- Consider parenteral therapy for pyelonephritis or toxic-appearing child
Secondary Indications ā Paediatrics (Off-label, if any)
Not applicable. No well-documented off-label paediatric indications in Indian practice.
Age Restriction:
Not recommended in infants below 6 months of age except under paediatric infectious diseases specialist supervision with documented clinical necessity.
Not recommended in infants below 6 months of age except under paediatric infectious diseases specialist supervision with documented clinical necessity.
Safety Monitoring (All Paediatric Patients):
- Monitor for diarrhoea, rash, and hypersensitivity reactions
- Assess clinical response within 48ā72 hours
- Reconstitute suspension as per manufacturer instructions; shake well before use
- Maintain adequate hydration
Renal Adjustments
| eGFR (mL/min) | Dose Adjustment |
|---|---|
| >60 | No adjustment required |
| 21ā60 | Reduce to 75% of usual daily dose |
| ≤20 | Reduce to 50% of usual daily dose |
| Dialysis Status | Recommendation |
|---|---|
| Haemodialysis | Give 50% of standard dose after dialysis session |
| Peritoneal dialysis | Not significantly dialysed; use 50% dose with caution |
Hepatic adjustment
Contraindications
- Known hypersensitivity to cefixime or any cephalosporin antibiotic
- History of immediate-type (Type I) hypersensitivity reaction to penicillins (anaphylaxis, angioedema, urticaria occurring within 1 hour) ā cross-reactivity risk approximately 1ā2%
- Known hypersensitivity to any excipient in the formulation
Cautions
- History of non-immediate penicillin allergy ā use with caution; monitor closely
- History of antibiotic-associated colitis or Clostridioides difficile infection
- Renal impairment ā dose adjustment required
- History of seizure disorder or CNS pathology ā cephalosporins may rarely lower seizure threshold
- Prolonged use may result in superinfection with resistant organisms or fungi
- Monitor for emergence of resistance, especially in recurrent infections
Pregnancy
| Parameter | Details |
|---|---|
| Overall safety | Generally considered safe; limited human data but no evidence of teratogenicity |
| Risk category | Comparable to FDA former Category B |
| Preferred alternatives | Amoxicillin or amoxicillin-clavulanate preferred when susceptibility confirmed |
| When to use | May be used when benefit clearly outweighs risk, particularly for UTI or respiratory infections unresponsive to first-line agents |
| Monitoring | Maternal renal function; GI tolerance; clinical response |
Lactation
| Parameter | Details |
|---|---|
| Compatibility | Compatible with breastfeeding |
| Milk levels | Very low; minimal excretion into breast milk |
| Preferred alternatives | Amoxicillin preferred when appropriate |
| Infant monitoring | Observe for rash, loose stools, oral candidiasis (all rare) |
Elderly
| Parameter | Recommendation |
|---|---|
| Starting dose | Same as adult dose (400 mg/day) |
| Titration | Not applicable |
| Special considerations | Renal function assessment mandatory ā estimate eGFR and adjust dose accordingly. Increased risk of Clostridioides difficile-associated diarrhoea. Monitor hydration status. More susceptible to adverse GI effects. |
Major drug interactions
| Interacting Drug | Mechanism / Effect | Recommendation |
|---|---|---|
| Warfarin | Altered gut flora reduces vitamin K synthesis; potential increase in INR and bleeding risk | Monitor INR closely when initiating or discontinuing cefixime; adjust warfarin dose as needed |
| Carbamazepine | Cefixime may increase serum carbamazepine levels | Monitor for carbamazepine toxicity (ataxia, nystagmus, drowsiness); consider level monitoring |
Moderate drug interactions
| Interacting Drug | Effect | Recommendation |
|---|---|---|
| Probenecid | Decreases renal tubular secretion of cefixime, increasing serum levels | Clinical monitoring; dose adjustment usually not required |
| Oral contraceptives | Theoretical reduction in efficacy due to altered gut flora | Counsel regarding backup contraception during antibiotic course (precautionary) |
| Antacids (aluminium/magnesium-containing) | May slightly reduce cefixime absorption | Administer cefixime 2 hours before or after antacids |
| Live oral typhoid vaccine (Ty21a) | Antibiotics may reduce vaccine efficacy | Avoid concurrent use; complete antibiotic course at least 3 days before administering live vaccine |
Common Adverse effects
- Diarrhoea (most common)
- Nausea
- Abdominal pain / dyspepsia
- Flatulence
- Headache
- Skin rash
Serious Adverse effects
| Adverse Effect | Clinical Notes |
|---|---|
| Anaphylaxis / severe hypersensitivity | Immediate discontinuation required; emergency management with adrenaline |
| Stevens-Johnson Syndrome (SJS) / Toxic Epidermal Necrolysis (TEN) | Rare; discontinue immediately and hospitalise |
| Clostridioides difficile-associated diarrhoea (CDAD) | Suspect if persistent or severe diarrhoea develops during or after therapy; discontinue and treat appropriately |
| Hepatotoxicity | Rare; may present as transaminase elevation; discontinue if significant |
| Haematological toxicity | Rare; thrombocytopenia, leucopenia, pancytopenia reported ā investigate unexplained bleeding or recurrent infections |
| Seizures | Rare; more likely in patients with pre-existing CNS disorders or renal impairment |
Monitoring requirements
Baseline:
- Renal function (serum creatinine, eGFR) ā especially in elderly or those with comorbidities
- Liver function tests if prolonged course anticipated
- Allergy history (penicillin, cephalosporin)
After initiation:
- Clinical response assessment within 48ā72 hours
- Monitor for hypersensitivity reactions (rash, urticaria, respiratory distress)
- Watch for diarrhoea ā especially antibiotic-associated or Clostridioides difficile-related
Long-term (if extended course):
- Repeat renal and hepatic function if therapy exceeds 14 days
- Monitor for superinfection (oral/vaginal candidiasis)
- In typhoid: observe for clinical relapse 7ā14 days post-treatment
Brands in India'
| Brand Name | Manufacturer |
|---|---|
| Taxim-O | Alkem |
| Zifi | FDC Ltd |
| Mahacef | Mankind |
| Ceftas | Intas |
| Cefix | Cipla |
| Topcef | Lupin |
| Gramocef-O | Glenmark |
Common Fixed-Dose Combinations (FDCs):
- Cefixime + Ofloxacin (e.g., Taxim-OF, Zifi-OZ)
- Cefixime + Clavulanic acid (e.g., Taxim-CL, Mahacef-CV)
- Cefixime + Azithromycin (e.g., Zifi-AZ)
Price range (INR)
| Formulation | Approximate Price |
|---|---|
| Tablet 200 mg (per tablet) | ā¹7ā20 |
| Dispersible tablet 100 mg (per tablet) | ā¹4ā10 |
| Oral suspension 50 mg/5 mL (30 mL bottle) | ā¹25ā50 |
| Oral suspension 100 mg/5 mL (30 mL bottle) | ā¹40ā70 |
Regulatory status: Cefixime is included in NLEM 2022; ceiling prices regulated by NPPA for scheduled formulations.
Clinical pearls
- Typhoid mainstay in India ā Cefixime remains a key oral option for uncomplicated typhoid fever in Indian settings, particularly for outpatient management and step-down therapy.
- Resistance awareness ā Rising resistance among uropathogens and gonococci limits empiric use in UTI and gonorrhoea; always prefer culture-guided therapy when feasible.
- Twice-daily dosing may be superior ā Although once-daily dosing is convenient, divided dosing (200 mg BD) may provide better pharmacodynamic coverage for certain infections.
- Not for serious infections ā Cefixime has no activity against Pseudomonas aeruginosa, MRSA, Enterococcus, or ESBL-producing organisms. Do not use for nosocomial or complicated infections.
- Monitor for CDAD ā Any patient developing persistent diarrhoea during or after cefixime therapy should be evaluated for Clostridioides difficile infection.
- FDC caution ā Fixed-dose combinations (particularly with fluoroquinolones) should be used judiciously to prevent resistance; monotherapy preferred when organism susceptibility is known.
Version
RxIndia v1.0 ā 25 Apr 2025
Reference
-
- CDSCO approved product inserts (Form 46)
- National Formulary of India (NFI) 2021
- NLEM 2022
- Indian Pharmacopoeia
- API Textbook of Medicine
- ICMR Treatment Guidelines for Antimicrobial Use in Common Syndromes (2019)
- IAP Guidelines ā Typhoid and Fever Management
- AIIMS Delhi Antibiotic Formulary (hospital protocol)
- WHO Essential Medicines List (supportive reference for paediatrics)
- CDC/WHO STI Guidelines (supporting off-label gonorrhoea indication)
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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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