# Cefalexin ```text 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 ``` --- Dawaa Reference is a reference for prescribers, not a medical device, and does not replace clinical judgement. [Privacy policy](/privacy)