{
 "query": "cefpodoxime",
 "ingredient": "cefpodoxime",
 "slug": "cefpodoxime",
 "rxcui": "20489",
 "brands": [],
 "names": [
  "cefpodoxime",
  "cefpodoxime proxetil"
 ],
 "classes": [
  {
   "id": "J01DD",
   "name": "Third-generation cephalosporins"
  }
 ],
 "alternatives": [
  "cefdinir",
  "cefditoren",
  "cefetamet",
  "cefixime",
  "cefodizime",
  "cefoperazone",
  "cefotaxime",
  "cefsulodin",
  "ceftazidime",
  "ceftibuten",
  "ceftizoxime",
  "ceftriaxone",
  "moxalactam"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 14
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS AND USAGE 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. Please see DOSAGE AND ADMINISTRATION for specific recommendations. Acute otitis media caused by Streptococcus pneumoniae (excluding penicillin-resistant strains), Streptococcus pyogenes, Haemophilus influenzae (including beta-lactamase-producing strains), or Moraxella (Branhamella) catarrhalis (including beta-lactamase-producing strains). Pharyngitis and/or tonsillitis caused by Streptococcus pyogenes . NOTE: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Cefpodoxime proxetil is generally effective in the eradication of streptococci from the oropharynx. However, data establishing the efficacy of cefpodoxime proxetil for the prophylaxis of subsequent rheumatic fever are not available. Community-acquired pneumonia caused by S.pneumoniae or H.influenzae (including beta-lactamase-producin...",
  "contraindications": "CONTRAINDICATIONS Cefpodoxime proxetil is contraindicated in patients with a known allergy to cefpodoxime or to the cephalosporin group of antibiotics.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS 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, USP, 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 ...",
  "adverse_reactions": "ADVERSE REACTIONS Clinical Trials Film-coated Tablets (Multiple dose) In clinical trials using multiple doses of cefpodoxime proxetil filmcoated 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 receiv...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Information for Patients Patients should be counseled that antibacterial drugs including cefpodoxime proxetil tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When cefpodoxime proxetil tablets is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by cefpodoxime proxetil tablets or other antibacterial drugs in the future. Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.",
  "spl_medguide": "",
  "clinical_studies": "CLINICAL TRIALS Cystitis In two double-blind, 2:1 randomized, comparative trials performed in adults in the United States, cefpodoxime proxetil was compared to other beta-lactam antibiotics. In these studies, the following bacterial eradication rates were obtained at 5 to 9 days after therapy: Pathogen Cefpodoxime Comparator E. coli 200/243 (82%) 99/123 (80%) Other pathogens 34/42 (81%) 23/28 (82%) K.pneumoniae P.mirabilis S.saprophyticus TOTAL 234/285 (82%) 122/151 (81%) In these studies, clinical cure rates and bacterial eradication rates for cefpodoxime proxetil were comparable to the comparator agents; however, the clinical cure rates and bacteriologic eradication rates were lower than those observed with some other classes of approved agents for cystitis. Acute Otitis Media Studies In controlled studies of acute otitis media performed in the United States, where significant rates of beta-lactamase-producing organisms were found, cefpodoxime proxetil was compared to cefixime. In these studies, using very strict evaluability criteria and microbiologic and clinical response criteria at the 4 to 21 day post-therapy follow-up, the following presumptive bacterial eradication/clinica...",
  "brand_name": "Cefpodoxime Proxetil",
  "manufacturer": "Sandoz Inc",
  "application_number": "ANDA065462",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260730",
  "set_id": "8519a9d8-7106-4545-bc58-859ee9a6708e",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 2477,
  "serious": 2071,
  "death": 265,
  "hospitalization": 1406,
  "primary_suspect": 2471,
  "top_reactions": [
   [
    "Pneumonia",
    191
   ],
   [
    "Diarrhoea",
    153
   ],
   [
    "Pyrexia",
    152
   ],
   [
    "Fatigue",
    150
   ],
   [
    "Nausea",
    124
   ],
   [
    "Acute Kidney Injury",
    120
   ],
   [
    "Off Label Use",
    108
   ],
   [
    "Dyspnoea",
    107
   ],
   [
    "Urinary Tract Infection",
    102
   ],
   [
    "Death",
    96
   ],
   [
    "Drug Ineffective",
    88
   ],
   [
    "Vomiting",
    82
   ],
   [
    "Dizziness",
    80
   ],
   [
    "Headache",
    75
   ],
   [
    "Cough",
    74
   ]
  ],
  "by_year": {
   "2019": 239,
   "2020": 285,
   "2021": 220,
   "2022": 183,
   "2023": 150,
   "2024": 190,
   "2025": 190,
   "2026": 132
  },
  "by_year_primary": {
   "2019": 239,
   "2020": 284,
   "2021": 220,
   "2022": 182,
   "2023": 150,
   "2024": 188,
   "2025": 189,
   "2026": 131
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20140522",
   "reason": "Presence of Foreign Substance: Presence of stainless steel particles.",
   "firm": "Sandoz, Inc",
   "status": "Terminated"
  }
 ],
 "recall_total": 1,
 "drugsfda": {
  "applications": 12,
  "nda": 4,
  "anda": 8,
  "first_approval": "19920807",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 34,
  "labeling_recent": 0,
  "sponsors": [
   "ALKEM LABS LTD",
   "ANDA REPOSITORY",
   "AUROBINDO PHARMA",
   "AUROBINDO PHARMA LTD",
   "CHARTWELL RX",
   "PFIZER",
   "SANDOZ",
   "SANKYO"
  ],
  "unapproved": false,
  "first_approval_fmt": "08/07/1992"
 },
 "trials": {
  "total": 17,
  "completed": 12,
  "terminated": 2,
  "with_results": 3,
  "industry": 4,
  "phase3": 2,
  "results_share": 0.25,
  "terminated_share": 0.11764705882352941
 },
 "pubmed": {
  "rct": 49,
  "meta": 2,
  "recent_rct": 0,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "cefpodoxime"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 528117,
  "beneficiaries": 434299,
  "spend": 25519165.71,
  "by_brand": [
   {
    "brand": "Cefpodoxime Proxetil",
    "claims": 528117,
    "per_claim": 48.321045734,
    "is_generic": true
   }
  ],
  "per_claim": 48.321045734183905
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": null,
  "name": "cefpodoxime",
  "matched": "cefpodoxime",
  "stewardship": [
   "WatchGroup"
  ]
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 508,
  "fills": 528117,
  "per_million": 961.9080620392829,
  "ratio": 0.3473909415374974,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "962 FDA reports naming it as the suspect drug per million Medicare fills, 0.3x the median drug on this site",
    "Death share in reports is near or below the FAERS average (1.2x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 27,
   "letter": "F",
   "why": [
    "49 randomized trials and 2 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 25% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 100,
   "letter": "A",
   "why": [
    "No recalls on record since 2016"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $0 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (8 applications)",
    "13 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 82,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are pneumonia, diarrhoea, pyrexia, fatigue. How would we recognize and handle those?",
  "Why this one over cefdinir, cefditoren, cefetamet? What would make you pick one of those instead?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}