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Manufacturer
ORCHIDPHARMA, I
SKU
42043014005

cephalexin 250 mg capsule

Generic
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Uses

Acute Otitis Media

Oral cephalexin is used for the treatment of acute otitis media (AOM) caused by susceptible Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, staphylococci, or streptococci.

When anti-infective therapy is indicated for the treatment of AOM, the American Academy of Pediatrics (AAP) recommends high-dose amoxicillin or amoxicillin and clavulanate potassium as the drugs of first choice for initial treatment. These experts recommend certain cephalosporins (cefdinir, cefpodoxime, cefuroxime, ceftriaxone) as alternatives for initial treatment in penicillin-allergic patients who do not have a history of severe and/or recent penicillin-allergic reactions.

For additional information regarding treatment of AOM, including information on diagnosis and management strategies, anti-infectives for initial treatment, duration of initial treatment, and anti-infectives after initial treatment failure, see .

Pharyngitis and Tonsillitis

Oral cephalexin is used for the treatment of pharyngitis and tonsillitis caused by S. pyogenes (group A β-hemolytic streptococci). Although cephalexin generally is effective in eradicating S. pyogenes from the nasopharynx, efficacy of the drug in prevention of subsequent rheumatic fever has not been established to date.

Selection of an anti-infective for the treatment of S. pyogenes pharyngitis and tonsillitis should be based on the drug's spectrum of activity, bacteriologic and clinical efficacy, potential adverse effects, ease of administration, patient compliance, and cost. No regimen has been found to date that effectively eradicates group A β-hemolytic streptococci in 100% of patients.

Because the drugs have a narrow spectrum of activity, are inexpensive, and generally are effective with a low frequency of adverse effects, the AAP, Infectious Diseases Society of America (IDSA), American Heart Association (AHA), and others recommend a penicillin regimen (i.e., 10 days of oral penicillin V or oral amoxicillin or single dose of IM penicillin G benzathine) as the treatment of choice for S. pyogenes pharyngitis and tonsillitis and prevention of initial attacks (primary prevention) of rheumatic fever. Other anti-infectives (e.g., oral cephalosporins, oral macrolides, oral clindamycin) are recommended as alternatives in penicillin-allergic individuals.

If an oral cephalosporin is used for the treatment of S. pyogenes pharyngitis and tonsillitis, a 10-day regimen of a first generation cephalosporin (cefadroxil, cephalexin) is preferred instead of other cephalosporins with broader spectrums of activity (e.g., cefaclor, cefdinir, cefixime, cefpodoxime, cefuroxime).

Bone and Joint Infections

Oral cephalexin is used for the treatment of bone and joint infections caused by susceptible staphylococci or Proteus mirabilis.

Respiratory Tract Infections

Oral cephalexin is used for the treatment of mild to moderate respiratory tract infections caused by susceptible S. pneumoniae.

Skin and Skin Structure Infections

Oral cephalexin is used for the treatment of mild to moderate skin and skin structure infections caused by susceptible staphylococci or streptococci.

Urinary Tract Infections

Oral cephalexin is used for the treatment of mild to moderate urinary tract infections, including acute prostatitis, caused by susceptible Escherichia coli, Klebsiella pneumoniae, or P. mirabilis.

Prevention of Bacterial Endocarditis

Oral cephalexin is used as an alternative for prevention of α-hemolytic (viridans group) streptococcal endocarditis in penicillin-allergic individuals undergoing certain dental or upper respiratory tract procedures who have underlying cardiac conditions that put them at highest risk of adverse outcomes from endocarditis. Cephalexin should not be used for such prophylaxis in those with a history of immediate-type hypersensitivity to penicillins (e.g., urticaria, angioedema, anaphylaxis).

For information on which cardiac conditions are associated with highest risk of endocarditis and which procedures require prophylaxis, see . When selecting anti-infectives for prophylaxis of bacterial endocarditis, the current recommendations published by AHA should be consulted.

Dosage and Administration

Reconstitution and Administration

Cephalexin is administered orally.

Although food may decrease the rate of absorption of cephalexin (see Pharmacokinetics: Absorption), the manufacturers state that the drug may be administered without regard to meals.

Reconstitution

Cephalexin powder for oral suspension should be reconstituted at the time of dispensing by adding the amount of water specified on the container to provide a suspension containing 125 or 250 mg of cephalexin per 5 mL. The water should be added in 2 equal portions and the bottle shaken after each addition.

The oral suspension should be shaken well prior to administration of each dose.

Dosage

Cephalexin is commercially available as the monohydrate; dosage is expressed in terms of cephalexin.

Adult Dosage

General Adult Dosage

The usual adult dosage of cephalexin ranges from 1-4 g daily given in divided doses. Dosage usually is 250 mg every 6 hours or 500 mg every 12 hours. For severe infections or those caused by less susceptible organisms, higher dosage may be needed (up to 4 g daily in adults).

If dosage greater than 4 g daily is required, initial therapy with a parenteral cephalosporin should be considered.

Pharyngitis and Tonsillitis

For the treatment of group A β-hemolytic streptococcal pharyngitis and tonsillitis in patients older than 15 years of age, the usual dosage is 500 mg of cephalexin every 12 hours given for at least 10 days.

Bone and Joint Infections

For the treatment of bone and joint infections in patients older than 15 years of age, the manufacturer recommends 250 mg every 6 hours. Higher dosages may be needed for severe infections or those caused by less susceptible bacteria.

Respiratory Tract Infections

For the treatment of respiratory tract infections in patients older than 15 years of age, the manufacturer recommends 250 mg every 6 hours for mild to moderate infections. Higher dosages may be needed for more severe infections or those caused by less susceptible bacteria.

Skin and Skin Structure Infections

For the treatment of skin and skin structure infections in patients older than 15 years of age, the usual dosage is 500 mg of cephalexin every 12 hours.

Urinary Tract Infections

For the treatment of uncomplicated cystitis in patients older than 15 years of age, the usual dosage is 500 mg of cephalexin every 12 hours given for 7-14 days.

Prevention of Bacterial Endocarditis

If cephalexin is used as an alternative to amoxicillin or ampicillin for prevention of α-hemolytic (viridans group) streptococcal endocarditis in penicillin-allergic individuals considered to be at highest risk for bacterial endocarditis following certain dental or upper respiratory tract procedures, adults should receive a single 2-g dose administered 0.5-1 hour prior to the procedure.

Pediatric Dosage

General Pediatric Dosage

The manufacturers state that the usual dosage of cephalexin for children is 25-50 mg/kg daily in divided doses; however, these dosages may be doubled for severe infections.

The American Academy of Pediatrics (AAP) recommends that pediatric patients beyond the neonatal period receive cephalexin in a dosage of 25-50 mg/kg daily in 2 or 4 equally divided doses for the treatment of mild or moderate infections and 75-100 mg/kg daily in 3 or 4 equally divided doses for the treatment of severe infections.

Acute Otitis Media

For the treatment of otitis media, the manufacturers recommend a pediatric dosage of 75-100 mg/kg daily in 4 equally divided doses.

Pharyngitis and Tonsillitis

The usual dosage of cephalexin for the treatment of group A β-hemolytic streptococcal pharyngitis in children older than 1 year of age is 25-50 mg/kg daily in equally divided doses every 12 hours given for at least 10 days.

Skin and Skin Structure Infections

For the treatment of skin and skin structure infections in pediatric patients, the usual dosage of cephalexin is 25-50 mg/kg daily in equally divided doses every 12 hours.

Prevention of Bacterial Endocarditis

If cephalexin is used as an alternative to amoxicillin or ampicillin for prevention of α-hemolytic (viridans group) streptococcal endocarditis in penicillin-allergic individuals considered to be at highest risk for bacterial endocarditis following certain dental or upper respiratory tract procedures, pediatric patients should receive a single 50-mg/kg dose (no more than 2 g) administered 0.5-1 hour prior to the procedure.

Dosage in Renal Impairment

The manufacturers state that cephalexin should be used with caution in patients with markedly impaired renal function, and close clinical observation and laboratory studies are recommended in such patients because safe dosage may be lower than usual dosages.

Some clinicians state that modification of the usual dosage does not appear to be necessary in patients with creatinine clearances greater than 40 mL/minute. These clinicians suggest that the usual adult dosage be used for the initial dose. Then, for subsequent doses, adults with creatinine clearances of 11-40 mL/minute should receive 500 mg every 8-12 hours, those with creatinine clearances of 5-10 mL/minute should receive 250 mg every 12 hours, and those with creatinine clearances less than 5 mL/minute should receive 250 mg every 12-24 hours.

Cautions

Cephalexin shares the toxic potentials of other cephalosporins, and the usual cautions, precautions, and contraindications associated with cephalosporin therapy should be observed.

Pediatric Precautions

Cephalexin is labeled for use in pediatric patients; safety and efficacy were established based on clinical trials using recommended dosages of the drug administered as capsules or oral suspension.

Cephalexin capsules should only be used in children and adolescents who are able to ingest capsules.

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-mg, 500-mg, or 1-g dose of cephalexin, peak serum cephalexin concentrations are attained within 1 hour and average 9, 18, or 32 mcg/mL, respectively. Serum concentrations of cephalexin were still detectable 6 hours after the dose.

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 0.5-1.2 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 13.5 mL/minute, 10.8 hours in adults with creatinine clearances of 9.2 mL/minute, and 13.9 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: 0.054-0.67) 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.

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