Drug profile
Cefuroxime
Adult, child, renal, hepatic, pregnancy and breastfeeding information, with the source named on every line.
DRUG INFORMATION
ADULT
- 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
CHILD
- 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
RENAL IMPAIRMENT
- 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
- 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
- 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
HEPATIC IMPAIRMENT
- 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
PREGNANCY
- 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
- 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
- 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
BREASTFEEDING
- 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
- 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
- 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