Drug reference

Cefixime

Cephalosporin · Antibiotic

Also known as Cefixime trihydrate

START

400 mg PO once daily OR 200 mg PO BID (or 8 mg/kg/day for peds)

TYPICAL MAX

400 mg/dose; 800 mg/day

STOP IF

Severe hypersensitivity reaction (anaphylaxis, SJS/TEN), CDAD with severe colitis, neutropenia <500/uL

WATCH

Renal function (adjust dose if CrCl <60), signs of C. difficile diarrhea, INR if on warfarin, carbamazepine levels if concurrent use

CDSCO approvedSchedule HJan AushadhiNPPA price-controlledATC J01DD08

Dose laddermg/d

Renal dose adjustmenteGFR mL/min/1.73m²

KDIGO 2024 + manufacturer label

Pharmacokineticsplasma · t hours

ONSET: 1h · 1 h (oral absorption begins)
PEAK: 4h · 2-6 h (oral Cmax)
t½: 3.5h · 3-4 h (prolonged in renal impairment)
DURATION: 12h · 12-24 h (dosing interval)

EXCRETION

~50% renal unchanged · minor hepatic metabolism

route + CYP

INTERACTIONS

—

none in our sources

PREGNANCY

Limited human data; no evidence of fetal harm in animal studies. Use only if clearly needed and potential benefits outweigh potential risks. Avoid in first trimester if alternatives are available.

FDA category + note

Available in India

4,478 branded formulations and 3,790 fixed-dose combinations. Look up specific brands in the Drugs workspace.

Jan Aushadhi — generic available at GoI pharmacies

Mechanism

Cefixime is a bactericidal third-generation cephalosporin antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs). This binding prevents peptidoglycan cross-linking, resulting in defective cell walls, osmotic instability, and bacterial lysis. It is stable against many beta-lactamases.

Indications

Uncomplicated urinary tract infectionsOtitis mediaPharyngitis and tonsillitisAcute exacerbations of chronic bronchitisUncomplicated gonorrhea (cervical/urethral)Uncomplicated urinary tract infections caused by susceptible isolates of Escherichia coli and Proteus mirabilisOtitis media caused by susceptible isolates of Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pyogenesPharyngitis and tonsillitis caused by susceptible isolates of Streptococcus pyogenesAcute exacerbations of chronic bronchitis caused by susceptible isolates of Streptococcus pneumoniae and Haemophilus influenzae

Dosing

Adult: Oral: 400 mg once daily or 200 mg every 12 hours. For uncomplicated gonorrhea: 400 mg as a single dose. For typhoid fever (off-label, India): 200-400 mg twice daily for 10-14 days.
Pediatric: Oral (typically >6 months or >20 kg): 8 mg/kg/day once daily or 4 mg/kg every 12 hours. Maximum 400 mg/day. Children <20 kg or <6 months: 8 mg/kg/day once daily or 4 mg/kg every 12 hours (use suspension).
Renal adjustment: CrCl >60 mL/min: No adjustment. CrCl 21-60 mL/min: 200 mg every 24 hours. CrCl <20 mL/min (including hemodialysis/CAPD): 100 mg every 24 hours. Supplemental dose may be given post-dialysis.
Hepatic adjustment: No dosage adjustment is necessary for patients with hepatic impairment.
Geriatric: No specific dose adjustment required based solely on age, but monitor renal function carefully as impairment is more common in the elderly. Dosing should be adjusted if renal impairment is present.
Max dose: 400 mg/dose; 800 mg/day

Pharmacokinetics

Onset

Rapid absorption with antibacterial effects shortly after oral administration.

Peak effect

2-6 hours (oral); peak plasma concentration reached within 2-6 hours after dosing.

Duration

12-24 hours

Half-life

3-4 hours (range 3.1-4.5 hours; prolonged to 6-11 hours in renal impairment).

Bioavailability

Approximately 40-50% (oral).

Protein binding

Approximately 65%.

Metabolism

Not extensively metabolized; approximately 10% may undergo hepatic metabolism.

Excretion

Primarily renal: approximately 50% excreted unchanged in urine within 24 hours; some biliary excretion (about 10%).

Contraindications

Hypersensitivity to cefixime or other cephalosporins
History of severe hypersensitivity reaction (e.g., anaphylaxis) to any beta-lactam antibiotic

Side effects

Common

DiarrheaNauseaAbdominal painDyspepsiaFlatulenceHeadacheDizzinessLoose or frequent stools

Serious

Clostridioides difficile-associated diarrhea (CDAD)
Severe cutaneous adverse reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis)
Anaphylaxis and other severe hypersensitivity reactions
Acute renal failure
Neutropenia, thrombocytopenia
Neurotoxicity (seizure risk, especially with high doses or renal impairment)
Hepatotoxicity (transient increases in hepatic transaminases)

Pregnancy & lactation

Pregnancy

Limited human data; no evidence of fetal harm in animal studies. Use only if clearly needed and potential benefits outweigh potential risks. Avoid in first trimester if alternatives are available.

Lactation

Cefixime is excreted in breast milk in small amounts. Generally considered compatible with breastfeeding, but infants should be monitored for potential gastrointestinal disturbances (e.g., diarrhea) or candidiasis.

Drug interactions

Azithromycin

Moderate

Textbook-cited

Reduced antibacterial efficacy.

Avoid concurrent use

Source: KDT 7e · p949

Chloramphenicol

Moderate

Textbook-cited