Cefpodoxime

Mechanism-of-action class: Enzyme Inhibitors.

• Cefpodoxime proxetil is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Recommended dosages, durations of therapy, and applicable patient populations vary among these infections.

• Cefpodoxime proxetil is contraindicated in patients with a known allergy to cefpodoxime or to the cephalosporin group of antibiotics.contraindicated

(See INDICATIONS AND USAGE for indicated pathogens.) Film-coated Tablets Cefpodoxime Proxetil Tablets, USP should be administered orally with food to enhance absorption. ( See CLINICAL PHARMACOLOGY .) The recommended dosages, durations of treatment, and applicable patient population are as described in the following chart: Adults and Adolescents (age 12 years and older) Type of Infection Total Daily Dose Dose Frequency Duration Pharyngitis and/or tonsillitis 200 mg 100 mg Q 12 hours 5 to 10 days Acute community acquired - pneumonia 400 mg 200 mg Q 12 hours 14 days Acute bacterial exacerbations of chronic bronchitis 400 mg 200 mg Q 12 hours 10 days Uncomplicated gonorrhea (men and women) and rectal gonococcal infections (women) 200 mg single dose Skin and skin structure 800 mg 400 mg Q 12 hours 7 to 14 days Acute maxillary sinusitis 400 mg 200 mg Q 12 hours 10 days Uncomplicated urinary tract infection 200 mg 100 mg Q 12 hours 7 days Patients with Renal Dysfunction For patients with severe renal impairment (<30 mL/min creatinine clearance), the dosing intervals should be increased to Q 24 hours. In patients maintained on hemodialysis, the dose frequency should be 3 times/week after hemodialysis. When only the serum creatinine level is available, the following formula (based on sex, weight, and age of the patient) may be used to estimate creatinine clearance (mL/min). For this estimate to be valid, the serum creatinine level should represent a steady state of renal function.

BEFORE THERAPY WITH CEFPODOXIME PROXETIL IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFPODOXIME, OTHER CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF CEFPODOXIME IS TO BE ADMINISTERED TO PENICILLIN SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS HYPERSENSITIVITY AMONG BETA-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO CEFPODOXIME PROXETIL OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINE, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cefpodoxime proxetil tablets, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use.

Clinical Trials Film-coated Tablets (Multiple dose) In clinical trials using multiple doses of cefpodoxime proxetil film-coated tablets, 4696 patients were treated with the recommended dosages of cefpodoxime (100 to 400 mg Q 12 hours). There were no deaths or permanent disabilities thought related to drug toxicity. One-hundred twenty-nine (2.7%) patients discontinued medication due to adverse events thought possibly or probably related to drug toxicity. Ninety-three (52%) of the 178 patients who discontinued therapy (whether thought related to drug therapy or not) did so because of gastrointestinal disturbances, nausea, vomiting, or diarrhea. The percentage of cefpodoxime proxetil-treated patients who discontinued study drug because of adverse events was significantly greater at a dose of 800 mg daily than at a dose of 400 mg daily or at a dose of 200 mg daily. Adverse events thought possibly or probably related to cefpodoxime in multiple-dose clinical trials (N=4696 cefpodoxime-treated patients) were: Incidence Greater Than 1 % Diarrhea 7 % Diarrhea or loose stools were dose-related: decreasing from 10.4% of patients receiving 800 mg per day to 5.7% for those receiving 200 mg per day. Of patients with diarrhea, 10% had C.

Pregnancy Teratogenic Effects Pregnancy Category B Cefpodoxime proxetil was neither teratogenic nor embryocidal when administered to rats during organogenesis at doses up to 100 mg/kg/day (2 times the human dose based on mg/m2) or to rabbits at doses up to 30 mg/kg/day (1 to 2 times the human dose based on mg/m2). There are, however, no adequate and well-controlled studies of cefpodoxime proxetil use in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

In acute rodent toxicity studies, a single 5 g/kg oral dose produced no adverse effects. In the event of serious toxic reaction from overdosage, hemodialysis or peritoneal dialysis may aid in the removal of cefpodoxime from the body, particularly if renal function is compromised. The toxic symptoms following an overdose of beta-lactam antibiotics may include nausea, vomiting, epigastric distress, and diarrhea.

• Jun 8, 2007ANDAANDA065409Aurobindo Pharma Ltd
• Jun 11, 2007ANDAANDA065370Aurobindo Pharma
• May 28, 2008ANDAANDA065462Sandoz
• May 18, 2022ANDAANDA210568Alkem Labs Ltd

1. 1Diarrhoea798.3%
2. 2Pyrexia757.9%
3. 3Pneumonia677.1%
4. 4Dyspnoea495.2%
5. 5Cough464.8%
6. 6Fatigue434.5%
7. 7Nausea434.5%
8. 8Death404.2%
9. 9Vomiting404.2%
10. 10Asthenia363.8%
11. 11Pain363.8%
12. 12Off Label Use353.7%
13. 13Rash353.7%
14. 14Headache333.5%
15. 15Urinary Tract Infection333.5%

Recent PubMed references pinned to Cefpodoxime as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Elucidating the mechanism of cefpodoxime-BSA interaction via a combination of multi-spectroscopic methods and molecular docking simulations.
  Scientific reports · 2026 · El Gammal RN, Elmansi H, El-Emam AA, et al.
  PMID 41765909DOI 10.1038/s41598-026-39137-8
• Complete genome and comparative genomic analysis of cefpodoxime resistant Pantoea septica strain GABEPS69 isolated from saliva of a patient diagnosed with treatment resistant schizophrenia.
  International journal of medical microbiology : IJMM · 2025 · McDonagh F, Kovarova A, Tumeo A, et al.
  PMID 41192073DOI 10.1016/j.ijmm.2025.151681
• What Makes Cefpodoxime an Empiric Drug of Choice to Treat Lower Respiratory Tract Infections, including Acute Exacerbation of Chronic Obstructive Pulmonary Disease, in the Real-world Setting in India?
  The Journal of the Association of Physicians of India · 2025 · Talwar D, Vora A, Tarke C, et al.
  PMID 41100340DOI 10.59556/japi.73.1181
• A Study of Expert Perspectives on the Administration of Cefpodoxime and its Combinations in Respiratory Infections: PERCEPT Survey.
  The Journal of the Association of Physicians of India · 2025 · Jain A, Thacker H, Singh J, et al.
  PMID 40836725DOI 10.59556/japi.73.1054
• Re-evaluation of penicillin and ceftriaxone MIC results to predict susceptibility to the oral cephalosporin, cefpodoxime, in Streptococcus pneumoniae clinical isolates from the United States according to CLSI guidelines (2019-2021).
  Journal of clinical microbiology · 2025 · Mendes RE, Pierce JV, Wright K, et al.
  PMID 40552822DOI 10.1128/jcm.00027-25
• Clinical pharmacokinetics of cefpodoxime: a systematic review.
  Expert opinion on drug metabolism & toxicology · 2024 · Farooq A, Zamir A, Imran I, et al.
  PMID 39120118DOI 10.1080/17425255.2024.2391389

The 10 most recently updated of 17 ClinicalTrials.gov registrations naming Cefpodoxime as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Optimizing the Diagnostic Approach to Cephalosporin Allergy Testing
  Recruiting · Phase 2 · Interventional · 300 enrolled · Massachusetts General Hospital
  NCT06406114updated 2026-05-26
• Comparing Oral Versus Parenteral Antimicrobial Therapy
  Terminated · Phase 4 · Interventional · 94 enrolled · West Virginia University
  NCT05977868updated 2025-08-26
• Endourology Disease Group Excellence (EDGE) Consortium: Antibiotics (Abx) for Percutaneous Nephrolithotomy (PCNL) Part 2
  Completed · Interventional · 330 enrolled · University of California, San Diego
  NCT02829060updated 2025-03-06
• Efficacy and Safety of Modified Release Cefpodoxime Formulation in the Treatment of Acute Sinusitis.
  Unknown · Phase 3 · Interventional · 100 enrolled · Neutec Ar-Ge San ve Tic A.Ş
  NCT03729258updated 2023-01-05
• Enhanced Versus Extended Preoperative Antibiotic Prophylaxis Regimens for Retrograde Intrarenal Surgery in High Infectious Risk Patients
  Unknown · Phase 3 · Interventional · 280 enrolled · Mansoura University
  NCT05384197updated 2022-11-14
• Healthy Patients & Effect of Antibiotics
  Completed · Interventional · 20 enrolled · Washington University School of Medicine
  NCT03098485updated 2022-11-10
• Patients Response to Early Switch To Oral:Osteomyelitis Study
  Terminated · Early phase 1 · Interventional · 11 enrolled · Julio Ramirez
  NCT02099240updated 2021-04-06
• A Pilot Study of the Addition of Bevacizumab to VOIT Regimen for Relapsed/Refractory Pediatric Solid Tumors
  Completed · Phase 1 · Interventional · 13 enrolled · Children's Hospital Medical Center, Cincinnati
  NCT00786669updated 2021-02-10
• Efficacy and Cost Analysis of Steroids in Treatment of Otitis Media With Effusion
  Completed · Phase 4 · Interventional · 160 enrolled · Lumbini Medical College
  NCT03590912updated 2020-06-19
• A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK, the Measure of How the Human Body Processes a Substance) of ETX0282 When Administered Orally to Healthy Participants
  Completed · Phase 1 · Interventional · 99 enrolled · Entasis Therapeutics
  NCT03491748updated 2020-01-14

Frequently asked questions

How does Cefpodoxime work?

Mechanism-of-action class: Enzyme Inhibitors.

What is Cefpodoxime used for?

According to FDA labeling, Cefpodoxime carries indications including: Cefpodoxime proxetil is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Recommended dosages, durations of therapy, and applicable patient populations vary among these infections.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Cefpodoxime?

Cefpodoxime is classified as Third-generation cephalosporins, Cephalosporin Antibacterial, Enzyme Inhibitors, Decreased Cell Wall Synthesis & Repair.

What are the brand names for Cefpodoxime?

Cefpodoxime is marketed under brand names including Cefpoderm, Dermaceph, Simplicef.

What are the contraindications for Cefpodoxime?

Cefpodoxime labeling lists contraindications including: Cefpodoxime proxetil is contraindicated in patients with a known allergy to cefpodoxime or to the cephalosporin group of antibiotics.. Always consult the full prescribing information and a clinician.