Hypersensitivity to penicillins; pseudomembranous colitis; renal failure; pregnancy and lactation.
Lactation: Drug excreted in breast milk; use with caution
FDA has not yet classified the drug into a specified pregnancy category.
Mode of Action
Cefalexin binds to one or more of the penicillin-binding proteins (PBPs) which inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell wall, thus inhibiting biosynthesis and arresting cell wall assembly resulting in bacterial cell death.
Interaction
Concurrent use w/ metfromin may result to fatal lactic acidosis. May enhance the anticoagulant effect of vit K antagonists (e.g. warfarin). Increased risk of nephrotoxicity w/ potent diuretics (e.g. ethacrynic acid, furosemide) and other potentially nephrotoxic antibiotics (e.g. aminoglycosides, polymyxin, colistin). Prothrombin time may be prolonged when used concomitantly w/ oral anticoagulants. May reduce the effects of OCs. Hypokalaemia may result from concomitant use of cefalexin and cytotoxic drugs for leukaemia. Uricosuric drugs (e.g. probenecid) may suppress renal excretion, resulting to increased plasma levels of cefalexin. May diminish the therapeutic effect of Na picosulfate, BCG and typhoid vaccine. May reduce serum level w/ multivitamins/minerals.
Pregnancy Category Note
Pregnancy
There are no adequate and well-controlled studies
Available data from published epidemiologic studies and pharmacovigilance case reports over several decades with cephalosporin use, use in pregnant women have not established drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes
Animal data
Animal reproduction studies with mice and rats using oral doses of cephalexin that are 0.6- and 1.2-times the maximum recommended human dose (MRHD) based on body surface area during organogenesis revealed no evidence of harm to the fetus; estimated background risk of major birth defects and miscarriage for indicated population is unknown
Lactation
Data from a published clinical lactation study reports that cephalexin is present in human milk; relative infant dose (RID) is considered to be <1% of maternal weight adjusted dose; there are no data on effects of cephalexin on breastfed child or on milk production
Development of health benefits of breastfeeding should be considered along with mother?s clinical need for therapy and any potential adverse effects on breastfed child from therapy or from underlying maternal condition
Adult Dose
Oral
Bone and joint infections; Respiratory tract infections, Genitourinary Tract Infections, Otitis Media
Adults
1 to 4 g/day in divided doses.
Usual dose is 250 mg every 6 hours.
Streptococcal pharyngitis, skin and skin structure infections, uncomplicated cystitis, cellulitis and mastitis
>15 years 500 mg every 12 hours.
Child Dose
Children
25 to 50 mg/kg/day q12h
For streptococcal pharyngitis in patients >1year old and for skin and skin structure infections, divide total daily dose and give every 12 hours.
In sever infections, 75?100 mg/kg/day for bone and joint, otitis media or severe infections q6?8h
Beta-hemolytic streptococcal infections: Continue treatment for at least 10 days.
Renal Dose
Renal impairment:
CrCl (ml/min)
40-50 Max: 3 g daily.
10-40 Max: 1.5 g daily.
<10 Max: 750 mg daily.
Administration
May be taken with or without food. May be taken w/ meals to reduce GI discomfort.
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