Product Name
ORACEF (dry powder)
Chemical Name
Cefpodoxime (Proxetil)
Therapeutic Category
Pharmacologic Category
Antibiotic, Cephalosporin (Third Generation)
Pharmaceutical Form
Dry powder
Cefpodoxime (Proxetil) 50mg / 100mg
Dosing: Adult
Acute community-acquired pneumonia and bacterial exacerbations of chronic bronchitis: Oral: 200 mg every 12 hours for 14 days and 10 days, respectively
Acute maxillary sinusitis: Oral: 200 mg every 12 hours for 10 days
Pharyngitis/tonsillitis: Oral: 100 mg every 12 hours for 5-10 days
Skin and skin structure: Oral: 400 mg every 12 hours for 7-14 days
Uncomplicated gonorrhea (male and female) and rectal gonococcal infections (female): Oral: 200 mg as a single dose
Uncomplicated urinary tract infection: Oral: 100 mg every 12 hours for 7 days

Dosing: Pediatric
Acute maxillary sinusitis: Oral: Children: 2 months to 12 years: 10 mg/kg/day divided every 12 hours for 10 days (maximum: 200 mg/dose)
Acute otitis media: Oral: Children:
2 months to 12 years: 10 mg/kg/day divided every 12 hours (400 mg/day) for 5 days (maximum: 200 mg/dose)
≥12 years: Refer to adult dosing.
Pharyngitis/tonsillitis: Oral: Children:
2 months to 12 years: 10 mg/kg/day in 2 divided doses for 5-10 days (maximum: 100 mg/dose)
≥12 years: Refer to adult dosing.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment

Clcr <30 mL/minute: Administer every 24 hours.
Hemodialysis: Dose 3 times/week following dialysis.

Dosing: Hepatic Impairment

Dose adjustment is not necessary in patients with cirrhosis.
Treatment of susceptible acute, community-acquired pneumonia caused by S. pneumoniae or nonbeta-lactamase producing H. influenzae; acute uncomplicated gonorrhea caused by N. gonorrhoeae; uncomplicated skin and skin structure infections caused by S. aureus or S. pyogenes; acute otitis media caused by S. pneumoniae, H. influenzae, or M. catarrhalis; pharyngitis or tonsillitis; and uncomplicated urinary tract infections caused by E. coli, Klebsiella, and Proteus
Adverse Reactions
Dermatologic: Diaper rash (12.1%)
Gastrointestinal: Diarrhea in infants and toddlers (15.4%)
1% to 10%:
Central nervous system: Headache (1.1%)
Dermatologic: Rash (1.4%)
Gastrointestinal: Diarrhea (7.2%), nausea (3.8%), abdominal pain (1.6%), vomiting (1.1% to 2.1%)
Genitourinary: Vaginal infection (3.1%)
<1% (Limited to important or life-threatening): Anaphylaxis, anxiety, appetite decreased, chest pain, cough, dizziness, epistaxis, eye itching, fatigue, fever, flatulence, flushing, fungal skin infection, hypotension, insomnia, malaise, nightmares, pruritus, pseudomembranous colitis, purpuric nephritis, salivation decreased, taste alteration, tinnitus, vaginal candidiasis, weakness
Reactions reported with other cephalosporins: Agranulocytosis, aplastic anemia, cholestasis, colitis, erythema multiforme, hemolytic anemia, hemorrhage, interstitial nephritis, toxic nephropathy, pancytopenia, renal dysfunction, seizure, serum-sickness reactions, Stevens-Johnson syndrome, superinfection, toxic epidermal necrolysis, urticaria, vaginitis
Hypersensitivity to cefpodoxime, any component of the formulation, or other cephalosporins
Warnings / Precautions Drug
Concerns related to adverse effects:
• Penicillin allergy: Use with caution in patients with a history of penicillin allergy, especially IgE-mediated reactions (eg, anaphylaxis, angioedema, urticaria).
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.
Disease-related concerns:
• Renal impairment: Use with caution in patients with renal impairment; modify dosage in severe impairment.
Antacids: May decrease the serum concentration of Cefpodoxime. Risk C: Monitor therapy
BCG: Antibiotics may diminish the therapeutic effect of BCG. Risk X: Avoid combination
H2-Antagonists: May decrease the absorption of Cefpodoxime. Separate oral doses by at least 2 hours. Risk C: Monitor therapy
Probenecid: May increase the serum concentration of Cephalosporins. Risk C: Monitor therapy
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 24 hours after cessation of antibacterial agents. Risk D: Consider therapy modification
Ethanol/Nutrition/Herb Interactions
Food: Food delays absorption; cefpodoxime serum levels may be increased if taken with food.
Pregnancy Implications
Teratogenic events were not observed in animal studies; therefore, cefpodoxime is classified as pregnancy category B. It is not known if cefpodoxime crosses the human placenta. Other cephalosporins cross the placenta and are considered safe in pregnancy.
Enters breast milk (small amounts)/not recommended
Breast-Feeding Considerations
Very small amounts of cefpodoxime are excreted in breast milk. Breast-feeding is not recommended by the manufacturer. Other cephalosporins are considered safe during breast-feeding. Nondose-related effects could include modification of bowel flora.
Mechanism of Action
Inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs) which in turn inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis. Bacteria eventually lyse due to ongoing activity of cell wall autolytic enzymes (autolysins and murein hydrolases) while cell wall assembly is arrested.
Pharmacodynamics / Kinetics
Absorption: Rapid and well absorbed (50%), acid stable; enhanced in the presence of food or low gastric pH
Distribution: Good tissue penetration, including lung and tonsils; penetrates into pleural fluid
Protein binding: 18% to 23%
Metabolism: De-esterified in GI tract to active metabolite, cefpodoxime
Half-life elimination: 2.2 hours; prolonged with renal impairment
Time to peak: Within 1 hour
Excretion: Urine (80% as unchanged drug) in 24 hours