Cefpodoxime roxetil is an orally administered, extended-spectrum, semi-synthetic, third-generation cephalosporin antibiotic. Like other β-lactam antibiotics, it is a bactericidal drug that acts by inhibiting bacterial cell wall synthesis.
Cefpodoxime is indicated for the treatment of infections caused by susceptible strains of microorganisms, including a wide range of gram-positive and gram-negative bacteria. Its high stability in the presence of β-lactamase enzymes makes it more effective against gram-positive bacteria compared to other third-generation oral cephalosporins.
Gram-positive bacteria: S. aureus (including penicillinase-producing strains), S. saprophyticus, S. pneumoniae, S. pyogenes, S. agalactiae, P. magnus.
Gram-negative bacteria: E. coli, K. pneumoniae, H. influenzae (including β-lactamase-producing and ampicillin-resistant strains), M. catarrhalis, N. gonorrhoeae (including penicillinase-producing strains), P. mirabilis, C. diversus, H. parainfluenzae, K. oxytoca, P. vulgaris, P. rettgeri.
Lower respiratory tract infections: Acute community-acquired pneumonia, acute bacterial exacerbation of chronic bronchitis.
Upper respiratory tract infections: Acute otitis media, acute maxillary sinusitis, pharyngitis, tonsillitis.
Sexually transmitted diseases: Acute uncomplicated urethral and cervical gonorrhea, acute ano-rectal infections in women caused by N. gonorrhoeae.
Uncomplicated urinary tract infections: Cystitis, pyuria.
Skin and soft tissue infections: Furuncle, cellulitis, subcutaneous abscess, infectious atheroma, periproctal abscess.
Roxetil® suspension may be administered without regard to food.
Adults (12 years and older)
Type of Infection Total Daily Dose Dose Frequency Duration
Acute community-acquired pneumonia 400 mg 200 mg 12 hourly 14 days
Acute bacterial exacerbation of chronic bronchitis 400 mg 200 mg 12 hourly 10 days
Uncomplicated gonorrhea (men/women) 200 mg Single dose
Rectal gonococcal infection (women) 200 mg Single dose
Skin & soft tissue infections 800 mg 400 mg 12 hourly 7-14 days
Pharyngitis and/or tonsillitis 200 mg 100 mg 12 hourly 5-10 days
Uncomplicated urinary tract infections 200 mg 100 mg 12 hourly 7 days
Acute maxillary sinusitis 400 mg 200 mg 12 hourly 10 days
Children
15 days - 6 months: 4 mg/kg every 12 hours.
6 months - 2 years: 40 mg every 12 hours.
3 - 8 years: 80 mg every 12 hours.
Over 9 years: 100 mg every 12 hours.
Renal Dysfunction
For severe renal impairment (creatinine clearance < 30 ml/min), the dosing interval should be increased to 24 hours.
Liver Cirrhosis
Cefpodoxime Proxetil pharmacokinetics in cirrhotic patients are similar to those in healthy individuals. Dose adjustment is not necessary in this population.
Cefpodoxime has minimal side effects. Common side effects include:
Gastrointestinal: Diarrhea, nausea, abdominal pain, dyspepsia.
Others: Fungal infections (skin and vaginal), headache, chest pain, myalgia, dizziness, vertigo, cough.
Children: Higher incidence of fungal skin rashes compared to adults.
Precautions
In patients with reduced urinary output due to renal insufficiency, the total daily dose should be reduced.
Use with caution in patients receiving potent diuretics.
Prolonged use may result in the overgrowth of non-susceptible organisms. Regular evaluation of the patient’s condition is essential.
Contraindicated in patients with known allergies to Cefpodoxime or other cephalosporin antibiotics.
Animal studies showed no teratogenic or embryocidal effects. However, there are no adequate studies in pregnant women. Use during pregnancy only if clearly necessary.
Since Cefpodoxime is excreted in human milk, a decision should be made whether to discontinue nursing or discontinue the drug.
Antacids: High doses of sodium bicarbonate or aluminum hydroxide reduce peak plasma levels by 24%-42%.
H2 blockers: Decrease absorption by 27%-32%.
Probenecid: Inhibits renal excretion, increasing AUC by approximately 31%.
Nephrotoxic drugs: Monitor renal function closely when administered concomitantly.
Overdosage may cause toxic reactions such as nausea, vomiting, epigastric distress, and diarrhea.
Directions for Reconstitution
For 50 ml suspension:
Add 30 ml (6 teaspoonfuls or using the provided cup) of cooled, boiled water to the dry powder in the bottle.
Add water in two portions, shaking well after each addition until the powder is fully dissolved.
Shake the suspension well before each use.
Keep the bottle tightly closed and store in a refrigerator.
Discard any unused suspension after 14 days.
Store at a temperature not exceeding 25°C in a dry place.
Keep out of reach of children.
