Cephalexin monohydrate

[sef-ah-LEX-in] Pregnancy Category: B

Apo-Cephalex M, Biocef, Dom-Cephalexin M, Keflex, Novo-Lexin M, Nu-Cephalex M, PMS-Cephalexin M, STCC-Cephalexin M [Rx] Classification: Cephalosporin, firstgeneration

See also Anti-Infectives and Cephalo-sporins.

Action/Kinetics: Peak serum levels:

PO, 9-39 mcg/mL after 1 hr. tVi, PO: 30-72 min. Absorption delayed in children. The HCl monohydrate does not require conversion in the stomach before absorption. Ninety percent of drug excreted unchanged in urine within 8 hr. Uses: Respiratory tract infections caused by Streptococcus pneumoniae and group A ß-hemolytic streptococci. Otitis media due to S. pneumoni-ae, Hemophilus influenzae, Moraxella catarrhalis (use monohydrate only), staphylococci, and streptococci. Genitourinary tract infections (including acute prostatitis) due to Esche-richia coli, Proteus mirabilis, and Klebsiella. Bone infections caused by P. mirabilis and staphylococci. Skin and skin structure infections due to staphylococci and streptococci. Bacterial endocarditis prophylaxis. Contraindications: Hypersensitiv-ity to cephalosporins.

Special Concerns: Safety and effectiveness of the HCl monohydrate have not been determined in children. Hypersensitivity to penicillins. Use in patients with renal impairment.

Side Effects: See also Cephalosporins. Additional Side Effects: Nephrotoxicity, cholestatic jaundice. Drug Interactions: See also Cepha-losporins.

How Supplied: Cephalexin hydrochloride monohydrate: Tablet: 500 mg. Cephalexin monohydrate: Capsule: 250 mg, 500 mg; Powder for reconstitution: 125 mg/5 mL, 250 mg/5 mL; Tablet: 250 mg, 500 mg


• Capsules, Oral Suspension, Tablets

General infections. Adults, usual: 250 mg q 6 hr up to 4 g/day. Pediatric: Monohydrate, 25—50 mg/kg/day in four equally divided doses.

Infections of skin and skin structures, streptococcal pharyngitis, uncomplicated cystitis, over 15years. Adults: 500 mg q 12 hr. Large doses may be needed for severe infections or for less susceptible organisms. For streptococcal pharyngitis in children over 1 year and for skin and skin structure infections, the total daily dose should be divided and given q 12 hr. In severe infections, the dose should be doubled.

Otitis media. Pediatric: 75-100 mg/kg/day in four divided doses.

Bacterial endocarditis prophylaxis. Adults: 2 g 1 hr before procedure for patients unable to take amoxicil-lin. Pediatric: 20 mg/kg of body weight 1 hr before procedure. Note: Should not be used in patients with immediate-type hypersensitivity reactions to penicillins.

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