Generic name: CEPHALEXIN 333mg
Dosage form: capsule
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Adults and Pediatric Patients at Least 15 Years of Age
The usual dose of oral DaxbiaTM (Cephalexin capsule, USP) is 333 mg and should be administered such that the daily dose is within 1 to 4 grams per day.
For more severe infections larger doses of oral Cephalexin capsules, USP may be needed, up to 4 grams daily in two to four equally divided doses.
Pediatric Patients (over 1 year of age)
The recommended total daily dose of oral Daxbia™ (cephalexin capsules, USP) for pediatric patients is 25 to 50 mg/kg given in equally divided doses for 7 to 14 days. In the treatment of β-hemolytic streptococcal infections, duration of at least 10 days is recommended. In severe infections, a total daily dose of 50 to 100 mg/kg may be administered in equally divided doses.
For the treatment of otitis media, the recommended daily dose is 75 to 100 mg/kg given in equally divided doses.
Dosage Adjustments in Adult and Pediatric Patients at Least 15 Years of Age With Renal Impairment
Administer the following dosing regimens for DaxbiaTM (cephalexin capsule, USP) to patients with impaired renal function [see Warnings and Precautions (5.4)and Use in Specific Populations (8.6)].
Table 1. Recommended Dose Regimen for Patients with Renal Impairment
||Dose regimen recommendation
|Creatinine clearance ≥60 mL/min
||No dose adjustment
|Creatinine clearance 30 to 59 mL/min
||No dose adjustment; maximum daily dose should not exceed 1 g
|Creatinine clearance 15 to 29 mL/min
||250 mg, every 8 hours or every 12 hours
|Creatinine clearance 5 to 14 mL/min not yet on dialysis*
||250 mg, every 24 hours
|Creatinine clearance 1 to 4 mL/min not yet on dialysis*
||250 mg, every 48 hours or every 60 hours
*There is insufficient information to make dose adjustment recommendations in patients on hemodialysis.
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