Here is a complete profile of Safexim (Cefixime):
Safexim (Cefixime)
Brand name: Safexim
Generic name: Cefixime
Drug class: Third-generation oral cephalosporin antibiotic
Available strength: 200 mg tablets (also oral suspension)
Mechanism of Action
Cefixime is a beta-lactam antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), preventing cross-linking of peptidoglycan chains. It is resistant to many narrow-spectrum beta-lactamases, which gives it a broader gram-negative spectrum compared to earlier cephalosporins.
Spectrum of Activity
| Activity | Organisms |
|---|
| Gram-positive | S. pyogenes (but weaker against staphylococci) |
| Gram-negative | E. coli, P. mirabilis, H. influenzae, M. catarrhalis, N. gonorrhoeae |
| Resistant organisms | ESBL/KPC-producing strains - not covered |
Compared to other 3rd-gen cephalosporins, cefixime is less active against gram-positive cocci but provides good gram-negative enteric coverage in an oral formulation.
Approved Indications
- Urinary tract infections (UTI) - caused by E. coli and P. mirabilis
- Otitis media - caused by H. influenzae, M. catarrhalis, S. pyogenes
- Pharyngitis/Tonsillitis - caused by S. pyogenes (though penicillin remains drug of choice)
- Uncomplicated gonorrhea - historically used; however, the CDC no longer recommends cefixime as first-line for gonorrhea due to increasing resistance (intramuscular ceftriaxone is now preferred)
- Typhoid fever - commonly used in the Indian subcontinent (Park's Preventive Medicine)
Dosage
| Population | Dose |
|---|
| Adults | 400 mg once daily OR 200 mg every 12 hours |
| Children 6 months - 12 years (<45 kg) | 8 mg/kg/day in a single dose or divided every 12 hours |
| Duration | 7-14 days depending on infection type |
Pharmacokinetics
| Parameter | Value |
|---|
| Route | Oral only (not parenteral) |
| Plasma half-life (t1/2) | 3-4 hours |
| Excretion | Both renal (urine) and biliary (bile) |
| Bioavailability | ~40-50% (oral suspension slightly higher than tablets) |
Renal dose adjustment:
- GFR 20-50 mL/min: standard dose
- GFR 10-20 mL/min: reduced dose (consult renal dosing table)
Adverse Effects
- GI disturbances (diarrhea, nausea, vomiting) - most common
- Hypersensitivity reactions (rash, urticaria) - cross-reactivity with penicillin (~1-2%)
- Elevated liver enzymes
- Headache
Contraindications
- Known allergy to cephalosporins
- Caution in penicillin-allergic patients (check for cross-reactivity history)
Key Clinical Notes
- Gonorrhea resistance: CDC guidelines moved away from cefixime as preferred therapy due to rising minimum inhibitory concentrations (MICs) in isolates across Asia, Europe, and North America. Ceftriaxone 500 mg IM (single dose) is now the standard. - Goodman & Gilman's Pharmacological Basis of Therapeutics; Smith & Tanagho's General Urology
- Typhoid/MDR typhoid: Used for fluoroquinolone-resistant or multidrug-resistant cases, especially in South Asia. - Park's Textbook of Preventive and Social Medicine
- Cefixime is available as an oral suspension, making it suitable for pediatric use.
- Ceftibuten and cefdinir are oral cephalosporins with similar spectrum and pharmacokinetics to cefixime. - Goodman & Gilman's, p.1177
Summary
Safexim (cefixime) is a convenient once-daily oral 3rd-generation cephalosporin widely used for UTIs, respiratory tract infections, otitis media, and typhoid. Its gram-negative coverage is its key strength. Its role in gonorrhea has diminished due to resistance, and it does not cover Pseudomonas or MRSA.