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Cephalexin, Cephalexin Hydrochloride

Cephalexin is a semisynthetic, first generation cephalosporin antibiotic.

Administration

Cephalexin is administered orally.

Dosage

Dosage of cephalexin, which is commercially available as monohydrates, is expressed in terms of cephalexin.

Cephalexin Hydrochloride

Adult Dosage

The usual adult dosage of cephalexin is 250 mg every 6 hours.

For streptococcal pharyngitis, skin and skin structure infections, or uncomplicated cystitis in patients older than 15 years of age, 500 mg of cephalexin may be given every 12 hours.

A minimum of 10 days of therapy is recommended in infections caused by Streptococcus pyogenes. 100, 101 The manufacturer suggests that therapy for cystitis be continued for 7-14 days.

For severe infections or those caused by less susceptible organisms, higher dosages may be needed (up to 4 g daily in adults). If a dosage greater than 4 g daily is required, initial therapy with a parenteral cephalosporin should be considered.

Pediatric Dosage

The usual dosage of cephalexin for children is 25-50 mg/kg daily. For severe infections, these dosages may be doubled. Although the daily dosage is usually administered in 3-4 equally divided doses, the manufacturers state that daily dosage may be given in 2 equally divided doses at 12-hour intervals for the treatment of streptococcal pharyngitis in patients older than 1 year of age or for the treatment of skin and skin structure infections in children.

Alternatively, some clinicians recommend a pediatric dosage of 0.75-1. g/m2 daily administered in 4 equally divided doses. A minimum of 10 days of therapy is recommended in infections caused by Streptococcus pyogenes. 100, 101

For the treatment of otitis media, the manufacturers recommend a pediatric dosage of 75-100 mg/kg daily in 4 divided doses. Prevention of Bacterial Endocarditis If cephalexin is used as an alternative to amoxicillin or ampicillin for prevention of a-hemolytic (viridans group) streptococcal endocarditis in penicillin-allergic individuals considered to be at risk for bacterial endocarditis following certain dental or upper respiratory tract procedures, adults should receive a single 2-g dose and pediatric patients should receive a single 50-mg/kg dose (no more than 2 g) administered 1 hour prior to the procedure. C

ephalexin should not be used for such prophylaxis in individuals with a history of immediate-type hypersensitivity reactions to penicillin (e.g., urticaria, angioedema, anaphylaxis). For information regarding indications for prophylaxis against bacterial endocarditis, see Uses: Prevention of Bacterial Endocarditis, in the Aminopenicillins General Statement 8:12.16.08.

Dosage in Renal Impairment

In patients with impaired renal function, the initial dose of cephalexin may be the same as in patients with normal renal function; subsequent doses and/or frequency of administration must be modified in response to the degree of renal impairment, severity of the infection, susceptibility of the causative organism, and serum concentrations of the drug.

Various dosage regimens have been recommended for these patients.

The drug has been administered in 250-mg doses at 12- to 24-hour intervals in adults with creatinine clearances less than 5 mL/minute; 250-mg doses every 12 hours in adults with creatinine clearances of 5-10 mL/minute; and 500-mg doses every 8-12 hours in adults with creatinine clearances of 11-40 mL/minute. Modification of usual dosage does not appear to be necessary in patients with creatinine clearances greater than 40 mL/minute.

Cautions

Cephalexin shares the toxic potentials of other cephalosporins, and the usual cautions, precautions, and contraindications associated with cephalosporin therapy should be observed. (See Cautions in the Cephalosporins General Statement 8:12.06.)

Pediatric Precautions

Cephalexin is labeled for use in pediatric patients.

Acute Toxcicity

The oral LD50 of cephalexin is 5 g/kg in rats. Overdosage of cephalexin may cause nausea, vomiting, epigastric distress, diarrhea, and hematuria. If other symptoms are present, they probably are secondary to an underlying disease state, an allergic reaction, or toxicity related to ingestion of another medication.

The manufacturer states that, in the event of cephalexin overdosage, GI decontamination is not necessary unless 5-10 times the usual cephalexin dose has been ingested. The benefits of forced diuresis, peritoneal dialysis, hemodialysis, or charcoal hemoperfusion in treating cephalexin overdosage have not been established. Spectrum Based on its spectrum of activity, cephalexin is classified as a first generation cephalosporin.

For information on the classification of cephalosporins and closely related b-lactam antibiotics based on spectra of activity, see Spectrum in the Cephalosporins General Statement 8:12.06. Like other first generation cephalosporins (e.g., cefadroxil, cefazolin, cephradine), cephalexin is active in vitro against many gram-positive aerobic cocci but has limited activity against gram-negative bacteria.

Pharmacokinetics

Absorption

Cephalexin (as the monohydrate) is acid-stable and is rapidly and completely absorbed from the GI tract. Following oral administration in healthy, fasting adults with normal renal function of a single 250- or 500-mg dose of cephalexin, peak serum cephalexin concentrations are attained within 1 hour and average 9 or 15-18 mcg/mL respectively; serum concentrations 3 hours after the dose average 1.6 or 3.4 mcg/mL, respectively.

Serum concentrations of cephalexin were still detectable 6 hours after the dose.

Following oral administration of a single 1-g dose of cephalexin in healthy, fasting adults, peak serum cephalexin concentrations were attained within 1 hour and averaged 32-39 mcg/mL. Peak serum concentrations are slightly lower and are attained later when cephalexin is administered with food, although the total amount of drug absorbed is unchanged.

Following oral administration of cephalexin in healthy, fasting adults, serum concentrations 15 and 30 minutes after a single 500-mg dose averaged about 0.2 and 12 mcg/mL, respectively.

Absorption of cephalexin is delayed in young children and may be decreased up to 50% in neonates.

Peak serum concentrations of the drug have been reported to occur within 3 hours in infants younger than 6 months of age, within 2 hours in children 9-12 months of age, and within 1 hour in older children.

Elimination

The serum half-life of cephalexin is 0.5-1. hours in adults with normal renal function. The serum half-life of the drug is reported to be about 5 hours in neonates and 2.5 hours in children 3-12 months of age.

In one study, the serum half-life was 7.7 hours in adults with creatinine clearances of 13. mL/minute, 10. hours in adults with creatinine clearances of 9.2 mL/minute, and 13. hours in adults with creatinine clearances of 4 mL/minute.

Cephalexin is excreted in urine as unchanged drug via both glomerular filtration and tubular secretion. Approximately 70-90% of a single 250- or 500-mg oral dose is excreted within 8-12 hours in adults with normal renal function.

Cephalexin concentrations of 0.2 (range: 0.054-0.) or 0.11-4 mg/mL have been reported in urine collected over a 6-hour period following a single 250- or 500-mg dose, respectively, in adults with normal renal function. Peak urine concentrations of the drug averaging about 2 mg/mL occur 2 hours after a single 500-mg oral dose of cephalexin.

Chemistry and Stability

Chemistry

cephalexin Cephalexin is a semisynthetic cephalosporin antibiotic. Cephalexin is commercially available as the monohydrate. Cephalexin (as the monohydrate) occurs as a white to off-white, crystalline powder and is slightly soluble in water and practically insoluble in alcohol.

Stability

Cephalexin capsules, tablets, and powder for oral suspension should be stored in tight containers at 15-30°C. After reconstitution, cephalexin oral suspensions should be stored in tight containers at 2-8°C and discarded if not used within 2 weeks.

For further information on chemistry, mechanism of action, spectrum, resistance, pharmacokinetics, uses, cautions, drug interactions, laboratory test interferences, and dosage and administration of cephalexin, see the Cephalosporins General Statement 8:12.06.

Preparations

Cephalexin Oral Capsules 250 mg Keflex® Pulvules®, Lilly 500 mg Keflex® Pulvules®, Lilly For suspension 125 mg/5 mL 250 mg/5 mL Tablets, film- 250 mg coated 500 mg

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