{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "cefuroxime",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Tablets and oral suspension are not bioequivalent and are therefore not substitutable on a milligram-per-milligram basis. ( 2.1 ) Administer tablets with or without food. ( 2.2 ) Administer cefuroxime axetil tablets as described in the dosage guidelines. ( 2.2 ) Dosage adjustment is required for patients with impaired renal function.",
        "source": "US FDA label for cefuroxime (Cefuroxime Axetil), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/cefuroxime.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Tablets and oral suspension are not bioequivalent and are therefore not substitutable on a milligram-per-milligram basis. ( 2.1 ) Administer tablets with or without food. ( 2.2 ) Administer cefuroxime axetil tablets as described in the dosage guidelines. ( 2.2 ) Dosage adjustment is required for patients with impaired renal function.",
        "source": "US FDA label for cefuroxime (Cefuroxime Axetil), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/cefuroxime.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "Therefore, patients who cannot swallow the tablet whole should receive the oral suspension. 2.5 Dosage in Patients with Impaired Renal Function A dosage interval adjustment is required for patients whose creatinine clearance is less than 30 mL/min, as listed in Table 4 below, because cefuroxime is eliminated primarily by the kidney [see Clinical Pharmacology (12.3) ].",
        "source": "This line points to a numbered table that this card does not show - read that table in the label before you dose. US FDA label for cefuroxime (Cefuroxime Axetil), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/cefuroxime.json",
        "verbatim": true
      },
      {
        "text": "Dosing in Adults with Renal Impairment Creatinine Clearance (mL/min) Recommended Dosage ≥30 No dosage adjustment 10 to <30 Standard individual dose given every 24 hours <10 (without hemodialysis) Standard individual dose given every 48 hours Hemodialysis A single additional standard dose should be given at the end of each dialysis",
        "source": "US FDA label for cefuroxime (Cefuroxime Axetil), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/cefuroxime.json",
        "verbatim": true
      },
      {
        "text": "Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. 8.6 Renal Impairment Reducing the dosage of cefuroxime axetil is recommended for adult patients with severe renal impairment (creatinine clearance <30 mL/min) [see Dosage and Administration (2.5) , Clinical Pharmacology (12.3) ] .",
        "source": "US FDA label for cefuroxime (Cefuroxime Axetil), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/cefuroxime.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "No liver-impairment dose in this label. Not a statement that none is needed.",
        "source": "Read and found silent: the US FDA label for cefuroxime (Cefuroxime Axetil), retrieved 2026-08-29",
        "cached_file": "labels/cefuroxime.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary Available data from published epidemiologic studies, case series, and case reports over several decades with cephalosporin use, including cefuroxime axetil, in pregnant women have not established drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data) .",
        "source": "US FDA label for cefuroxime (Cefuroxime Axetil), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/cefuroxime.json",
        "verbatim": true
      },
      {
        "text": "In studies in pregnant mice and rats administered oral cefuroxime axetil during organogenesis at 14 and 9 times the maximum recommended human dose (MRHD) based on body surface area, respectively, there were no adverse developmental outcomes (see Data).",
        "source": "US FDA label for cefuroxime (Cefuroxime Axetil), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/cefuroxime.json",
        "verbatim": true
      },
      {
        "text": "The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown.",
        "source": "US FDA label for cefuroxime (Cefuroxime Axetil), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/cefuroxime.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Risk Summary Based on several published case reports describing multiple lactating women who received cefuroxime via intravenous, intramuscular, and oral routes, cefuroxime is present in human milk.",
        "source": "US FDA label for cefuroxime (Cefuroxime Axetil), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/cefuroxime.json",
        "verbatim": true
      },
      {
        "text": "The highest maternal milk concentration described occurred in lactating women 8 hours after an intramuscular administration of cefuroxime 750 mg.",
        "source": "US FDA label for cefuroxime (Cefuroxime Axetil), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/cefuroxime.json",
        "verbatim": true
      },
      {
        "text": "Allowing for an infant milk consumption of 150 mL/kg/day, the estimated breastfed infant dose would be less than 1% of the adult dose .",
        "source": "US FDA label for cefuroxime (Cefuroxime Axetil), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/cefuroxime.json",
        "verbatim": true
      }
    ]
  }
}