Cefalexin

DRUG INFORMATION

  ADULT
    - Adults and patients at least 15 years of age The usual dose is 250 mg every 6
      hours, but a dose of 500 mg every 12 hours may be administered ( 2.1 ).
      Source: US FDA label for cephalexin (cephalexin), section 'dosage and
      administration', retrieved 2026-08-29
    - ( 2.3 ) 2.1 Adults and Pediatric Patients at Least 15 Years of Age The usual dose
      of oral cephalexin is 250 mg every 6 hours, but a dose of 500 mg every 12 hours
      may be administered.
      Source: US FDA label for cephalexin (cephalexin), section 'dosage and
      administration', retrieved 2026-08-29
    - In severe infections, a total daily dose of 50 to 100 mg/kg may be administered in
      equally divided doses.
      Source: US FDA label for cephalexin (cephalexin), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - The safety and effectiveness of cephalexin in pediatric patients was established
      in clinical trials for the dosages described in the dosage and administration
      section [ see Dosage and Administration ( 2.2 ) ].
      Source: US FDA label for cephalexin (cephalexin), section 'pediatric use',
      retrieved 2026-08-29
    - Adults and patients at least 15 years of age The usual dose is 250 mg every 6
      hours, but a dose of 500 mg every 12 hours may be administered ( 2.1 ).
      Source: US FDA label for cephalexin (cephalexin), section 'dosage and
      administration', retrieved 2026-08-29
    - Pediatric patients (over 1 year of age) • Otitis media: 75 to 100 mg/kg in equally
      divided doses every 6 hours ( 2.2 ) • All other indications: 25 to 50 mg/kg given
      in equally divided doses ( 2.2 ) • In severe infections: 50 to 100 mg/kg may be
      administered in equally divided doses ( 2.2 ) Duration of therapy ranges from 7 to
      14 days depending on the infection type and severity.
      Source: US FDA label for cephalexin (cephalexin), section 'dosage and
      administration', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - ( 2 ) Dosage adjustment is required in patients with severe and end stage renal
      disease (ESRD) defined as creatinine clearance below 30 mL/min.
      Source: US FDA label for cephalexin (cephalexin), section 'dosage and
      administration', retrieved 2026-08-29
    - May be kept for 14 days without significant loss of potency. 2.3 Dosage
      Adjustments in Adult and Pediatric Patients at Least 15 Years of Age with Renal
      Impairment Administer the following dosing regimens for cephalexin for oral
      suspension to patients with impaired renal function [ see Warnings and Precautions
      (5.4) and Use in Specific Populations (8.6) ].
      Source: US FDA label for cephalexin (cephalexin), 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 [ see Warnings and Precautions ( 5.4 ) ]. 8.6
      Renal Impairment Cephalexin should be administered with caution in the presence of
      impaired renal function (creatinine clearance < 30 mL/min, with or without
      dialysis).
      Source: US FDA label for cephalexin (cephalexin), section 'use in specific
      populations', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - Those at risk include patients with renal or hepatic impairment, or poor
      nutritional state, as well as patients receiving a protracted course of
      antibacterial therapy, and patients receiving anticoagulant therapy.
      Source: US FDA label for cephalexin (cephalexin), section 'warnings and cautions',
      retrieved 2026-08-29

  PREGNANCY   [ CAUTION ]
    The label allows it only when the benefit is judged to outweigh the risk. Read the
      quote below.
    - Pregnancy Category B There are no adequate and well-controlled studies in pregnant
      women.
      Source: US FDA label for cephalexin (cephalexin), section 'pregnancy', retrieved
      2026-08-29
    - Because animal reproduction studies are not always predictive of human response,
      this drug should be used during pregnancy only if clearly needed.
      Source: US FDA label for cephalexin (cephalexin), section 'pregnancy', retrieved
      2026-08-29
    - Reproduction studies have been performed on mice and rats using oral doses of
      cephalexin monohydrate 0.6 and 1.5 times the maximum daily human dose (66
      mg/kg/day) based upon body surface area basis, and have revealed no evidence of
      impaired fertility or harm to the fetus.
      Source: US FDA label for cephalexin (cephalexin), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING   [ CAUTION ]
    The label allows it only when the benefit is judged to outweigh the risk. Read the
      quote below.
    - Caution should be exercised when cephalexin is administered to a nursing woman.
      Source: US FDA label for cephalexin (cephalexin), section 'nursing mothers',
      retrieved 2026-08-29
    - Reproduction studies have been performed on mice and rats using oral doses of
      cephalexin monohydrate 0.6 and 1.5 times the maximum daily human dose (66
      mg/kg/day) based upon body surface area basis, and have revealed no evidence of
      impaired fertility or harm to the fetus. 8.3 Nursing Mothers Cephalexin is
      excreted in human milk.
      Source: US FDA label for cephalexin (cephalexin), section 'use in specific
      populations', retrieved 2026-08-29
    - Caution should be exercised when cephalexin is administered to a nursing woman.
      8.4 Pediatric Use The safety and effectiveness of cephalexin in pediatric patients
      was established in clinical trials for the dosages described in the dosage and
      administration section [ see Dosage and Administration ( 2.2 ) ]. 8.5 Geriatric
      Use Of the 701 subjects in 3 published clinical studies of cephalexin, 433 (62%)
      were 65 and over.
      Source: US FDA label for cephalexin (cephalexin), section 'use in specific
      populations', retrieved 2026-08-29