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Home > Martindale: The Complete Drug Reference > Drugs and Ancillary Substances > By therapeutic use > Antibacterials > Drug Monographs Cefalexin Sub-sections Cefalexin Cefalexin Hydrochloride Adverse Effects and Precautions Interactions Antimicrobial Action Pharmacokinetics Uses and Administration Preparations Cefalexin Date of monograph review: 24-Mar-1997; 20-Jul-1998; 06-Oct-1999; 02Oct-2001; 12-Nov-2003; 28-May-2004; 25-Jul-2006; 10-Sep-2008; 20-Nov2009; 20-Aug-2010; (latest modification: 30-Jan-2013) Drug Nomenclature (Latest modification: 30-Jan-2013) Synonyms: 66873; Κεφαλεξίνη; Cefaleksinas monohidratas; Cefaleksyna; Cefalexin monohydrát; Cefalexina; Céfalexine monohydratée; Cefalexinmonohydrat; Cefalexinum; Cefalexinum Monohydricum; Cephalexin; Kefaleksiini; Kefaleksiinimonohydraatti; Sefaleksin; セファレキシン BAN: Cefalexin USAN: Cephalexin INN: Cefalexin [pINN (en)] INN: Cefalexina [pINN (es)] INN: Céfalexine [pINN (fr)] INN: Cefalexinum [pINN (la)] INN: Цефалексин [pINN (ru)] INN: [ ال ي ك س ين س يفpINN (ar)] INN: 头孢氨苄 [pINN (cn)] Chemical name: (7R)-3-Methyl-7-(α-D-phenylglycylamino)-3-cephem4-carboxylic acid monohydrate Molecular formula: C16H17N3O4S,H2O =365.4 CAS: 15686-71-2 (anhydrous cefalexin); 23325-78-2 (cefalexin monohydrate) ATC code: J01DB01 ATC code (veterinary): QJ01DB01; QJ51DA01 UNII code: OBN7UDS42Y (cefalexin); 5SFF1W6677 (anhydrous cefalexin) Chemical Structure of Cefalexin Pharmacopoeias: In Chin., Eur. (see ), Jpn, US, and Viet. Ph. Eur. 7 (Cefalexin Monohydrate). A white or almost white crystalline powder. Sparingly soluble in water; practically insoluble in alcohol. A 0.5% solution in water has a pH of 4.0 to 5.5. Protect from light. USP 36 (Cephalexin). A white to off-white crystalline powder. Slightly soluble in water; practically insoluble in alcohol, in chloroform, and in ether. pH of a 5% suspension in water is between 3.0 and 5.5. Store in airtight containers. Cefalexin Hydrochloride Date of monograph review: 24-Mar-1997; 20-Jul-1998; 06-Oct-1999; 02Oct-2001; 12-Nov-2003; 28-May-2004; 25-Jul-2006; 10-Sep-2008; 20-Nov2009; 20-Aug-2010; (latest modification: 30-Jan-2013) Drug Nomenclature (Latest modification: 30-Jan-2013) Synonyms: Cefalexina, hidrocloruro de; Cephalexin Hydrochloride; LY061188; 塩酸セファレキシン BAN: Cefalexin Hydrochloride [BANM] USAN: Cephalexin Hydrochloride INN: Cefalexin Hydrochloride [pINNM (en)] INN: Hidrocloruro de cefalexina [pINNM (es)] INN: Céfalexine, Chlorhydrate de [pINNM (fr)] INN: Cefalexini Hydrochloridum [pINNM (la)] INN: Цефалексина Гидрохлорид [pINNM (ru)] Molecular formula: C16H17N3O4S,HCl,H2O =401.9 CAS: 105879-42-3 ATC code: J01DB01 ATC code (veterinary): QJ01DB01 UNII code: 6VJE5G3D98 Pharmacopoeias: In US. USP 36 (Cephalexin Hydrochloride). A white to off-white crystalline powder. Soluble 1 in 100 in water, in acetone, in acetonitrile, in alcohol, in dimethylformamide, and in methyl alcohol; practically insoluble in chloroform, in ether, in ethyl acetate, and in isopropyl alcohol. pH of a 1% solution in water is between 1.5 and 3.0. Store in airtight containers. Adverse Effects and Precautions (Latest modification: 25-Mar-2004) As for Cefalotin Sodium, . The most common adverse effects of cefalexin and other oral cephalosporins are generally gastrointestinal disturbances and hypersensitivity reactions. Pseudomembranous colitis has been reported. (last reviewed 2010-08-20; last modified 2004-03-25) References. (last reviewed 2010-08-20; last modified 2009-09-05) 1. 1. Dave J, et al. Cephalexin induced toxic epidermal necrolysis. J Antimicrob Chemother 1991; 28: 477–8. PubMed 2. 2. Baran R, Perrin C. Fixed-drug eruption presenting as an acute paronychia. Br J Dermatol 1991; 125: 592–5. PubMed 3. 3. Clark RF. Crystalluria following cephalexin overdose. Pediatrics 1992; 89: 672–4. PubMed 4. 4. Murray KM, Camp MS. Cephalexin-induced Stevens-Johnson syndrome. Ann Pharmacother 1992; 26: 1230–3. PubMed 5. 5. Czechowicz RT, et al. Bullous pemphigoid induced by cephalexin. Australas J Dermatol 2001; 42: 132–5. PubMed 6. 6. Longstreth KL, et al. Cephalexin-induced acute tubular necrosis. Pharmacotherapy 2004; 24: 808–11. PubMed 7. 7. Skoog SM, et al. Cephalexin-induced cholestatic hepatitis. J Clin Gastroenterol 2004; 38: 833. PubMed 8. 8. Chan AL, et al. Fatal anaphylactic reaction to intravenous cephalexin. Clin Drug Invest 2005; 25: 675–8. PubMed 9. 9. Penttilä J, et al. Delirium in an adolescent patient during treatment with cephalexin. J Adolesc Health 2006; 39: 782–3. PubMed Porphyria (Latest modification: 01-Nov-2011) The Drug Database for Acute Porphyria, compiled by the Norwegian Porphyria Centre (NAPOS) and the Porphyria Centre Sweden, classifies cefalexin as probably not porphyrinogenic; it may be used as a drug of first choice and no precautions are needed.1 (last reviewed 2010-08-20; last modified 2011-11-01) 1. 1. The Drug Database for Acute Porphyria. Available at: online (accessed 18/10/11) Interactions (Latest modification: 27-Aug-2009) The renal excretion of cefalexin, and many other cephalosporins, is delayed by probenecid. (last reviewed 2010-08-20; last modified 2009-08-27) Hormonal contraceptives (Latest modification: 04-May-2011) There have been isolated reports of cefalexin decreasing the efficacy of oestrogen-containing oral contraceptives.1 However, evidence does not generally support an interaction between broad-spectrum antibacterials and hormonal contraceptives (see ). (last reviewed 2010-08-20; last modified 2011-05-04) 1. 1. Friedman M, et al. Cephalexin and Microgynon-30 do not go well together. J Obstet Gynaecol 1982; 2: 195–6. Antimicrobial Action (Latest modification: 25-Mar-2004) As for Cefalotin Sodium, , although cefalexin is generally less potent. Some strains of Gram-negative bacteria may be inhibited only by the high concentrations achievable in the urinary tract. Haemophilus influenzae is moderately resistant to cefalexin. (last reviewed 2010-08-20; last modified 2004-03-25) Pharmacokinetics (Latest modification: 27-Jul-2010) Cefalexin is almost completely absorbed from the gastrointestinal tract and a peak plasma concentration of about 18 micrograms/mL occurs 1 hour after a 500-mg oral dose. If cefalexin is taken with food, absorption may be delayed, but the total amount absorbed is not appreciably altered. Up to 15% of a dose is bound to plasma proteins. The plasma half-life is about 1 hour; it increases with reduced renal function. Cefalexin is widely distributed in the body but does not enter the CSF in significant quantities. It crosses the placenta and small quantities are found in breast milk. Cefalexin is not metabolised. About 80% or more of a dose is excreted unchanged in the urine in the first 6 hours by glomerular filtration and tubular secretion; urinary concentrations greater than 1 mg/mL have been achieved after a dose of 500 mg. Probenecid delays urinary excretion. Therapeutically effective concentrations may be found in the bile and some may be excreted by this route. Cefalexin is removed by haemodialysis and peritoneal dialysis. (last reviewed 2010-08-20; last modified 2010-07-27) References. (last reviewed 2010-08-20; last modified 2004-03-25) 1. 1. Wise R. The pharmacokinetics of the oral cephalosporins—a review. J Antimicrob Chemother 1990; 26 (suppl E): 13–20. PubMed Uses and Administration (Latest modification: 04-Aug-2010) Cefalexin is a first-generation oral cephalosporin antibacterial for the treatment of infections caused by susceptible Gram-positive and Gramnegative bacteria including infections of the respiratory and genito-urinary tracts, bones, and skin. For details of these infections and their treatment, see under Choice of Antibacterial, . Cefalexin is usually given as the monohydrate although the hydrochloride is sometimes used. Doses are expressed in terms of the equivalent amount of anhydrous cefalexin; 1.05 g of cefalexin monohydrate and 1.16 g of cefalexin hydrochloride are each equivalent to about 1 g of anhydrous cefalexin. It is given in doses ranging from 1 to 4 g daily in divided doses; 250 to 500 mg every 6 to 8 hours is typical. For skin and soft tissue infections, streptococcal pharyngitis, and uncomplicated urinary-tract infections a dose of 250 mg every 6 hours or 500 mg every 12 hours may be given. If daily doses greater than 4 g are needed, parenteral cephalosporins should be considered. For the prophylaxis of recurrent urinary-tract infection, cefalexin may be given in a dose of 125 mg at night. For details of doses in children, see . The dose of cefalexin may need to be reduced in renal impairment, see . Cefalexin sodium or cefalexin lysine have been used parenterally. (last reviewed 2010-08-20; last modified 2010-08-04) Administration in children (Latest modification: 04-Aug-2010) Cefalexin may be given orally to children for the treatment of infections caused by susceptible Gram-positive and Gram-negative bacteria. The usual recommended dose is 25 to 50 mg/kg daily in 2 or 3 divided doses. In severe infections the dose may be doubled and for otitis media a dose of 75 to 100 mg/kg daily in 4 divided doses is recommended. Alternative doses recommended by the BNFC 2010/11 are: children over 1 month of age: 12.5 mg/kg twice daily; dose should be doubled in severe infection (to a maximum dose of 1 g 4 times daily) or children 1 month to 1 year of age: 125 mg twice daily children 1 to 5 years of age: 125 mg 3 times daily children more than 5 years of age: 250 mg 3 times daily Although not licensed in the UK for neonates, the BNFC 2010/11 suggests a dose of 25 mg/kg (to a maximum of 125 mg) may be given twice daily for neonates less than 7 days old, 3 times daily for those aged 7 to 21 days, and 4 times daily for those aged 21 to 28 days. For the prophylaxis of recurrent urinary-tract infection the BNFC 2010/11 recommends that children over 1 month of age be given 12.5 mg/kg orally at night (to a maximum dose of 125 mg). (last reviewed 2010-08-20; last modified 2010-08-04) Administration in renal impairment (Latest modification: 16-Aug-2010) Oral doses of cefalexin may need to be reduced in patients with renal impairment. The BNF 59 recommends the following maximum daily doses according to creatinine clearance (CC): CC 40 to 50 mL/minute per 1.73 m2: maximum 3 g daily CC 10 to 40 mL/minute per 1.73 m2: maximum 1.5 g daily CC less than 10 mL/minute per 1.73 m2: maximum 750 mg daily (last reviewed 2010-08-20; last modified 2010-08-16) Preparations (Latest modification: 01-Jul-2013) Single-ingredient Preparations (Latest modification: 01-Jul-2013) The symbol ¤ denotes a preparation which is discontinued or no longer actively marketed. Argentina: Beliam; Butefina¤; Cefagrand; Cefalexi¤; Cefapoten¤; Cefarinol¤; Cefasporina; Cefosporen; Ceporexin Duo; Ceporexin; Fabotop; Keforal; Lafexina; Lars; Lexin; Lorbicefax; Novalexin¤; Ospexin; Pectorina¤; Permvastat; Sanibiotic; Septilisin Duo; Septilisin; Trexina; Triblix; Velexina; Australia: Ceflin¤; Cephatrust; Ceporex¤; Cilex; Ialex; Ibilex; Keflex; Rancef; Sporahexal¤; Austria: Cepexin¤; Cephalobene; Keflex; Ospexin; Sanaxin; Belgium: Ceporex¤; Keforal; Brazil: Betacef¤; Cefaben; Cefacimed; Cefagel; Cefagon¤; Cefagran; Cefalen¤; Cefalexan¤; Cefalexol; Cefanal; Cefanid; Cefaporex¤; Cefaxon; Cefexina; Ceflexin¤; Celen¤; Celexin¤; Celinax¤; Ceporexin¤; Falexin¤; Kefalexin¤; Keflaxina; Keflex; Keforal¤; Kiflexin¤; Lexin; Lifalexin¤; Neo Ceflex; Neoceflex; Primacef; Profalexina¤; Todexin¤; Valflex; Canada: Apo-Cephalex; Ceporex¤; Keflex; Novo-Lexin; Nu-Cephalex; China: Bei Dun; Fulin; Meifeng; Shen Jia; Sporidex; Czech Republic: Cefaclen¤; Oracef¤; Ospexin¤; Sporidex¤; Denmark: Keflex; Finland: Kefalex; Kefexin; Orakef¤; France: Cefacet; Ceporexine¤; Keforal; Germany: Cephalex; Ceporexin¤; Oracef¤; Greece: Kefalospes; Kefaxin; Keflex; Keflogen; Kekrinal; Medalexine; Neptolin; Nylichlor; Sinthecillin; Tricylamil; Zabytrex; Hong Kong: Anxer¤; ApoCepalex¤; Apo-Cephalex¤; Cefacapxin¤; Cefacin; Cefacure¤; Cephalexyl¤; Cephin¤; Ceporex¤; Felexin; Keflex¤; Medolexin; Ora-C¤; Ospexin; Sofilex; Solulexin¤; Syntolexin¤; Hungary: Keflex¤; Pyassan; Servispor¤; India: Alcephin; Alexin; Allsafe; Anphexin; Axin-LA; Bactocep; Betaspore; Biolex; Blucef; C-Lex; Cefacin; Cefact; Cefacure; Cefalex; Cefalin; Cefamax; Cefax; Cefbact; Cefcidal; Cefel; Ceff; Cefmix; Ceftop RM; Celexin; Cephadex; Cephal; Cephalex; Cephalkem; Cephalpet; Cephamax; Cepharil; Cephaxin; Cephaxtar; Cexin; Ciphlenat; Citaceph; Cucef; Culexin; DT LX-Kid; E CefOD; Emceph; Equitrol; Faxe; Fex; Gencef; Gexin; Halexin; Hycef; Keflex; Lecef; Lexa; Lexillin; Lexipil; LX; Mepycep; Mexef; Monacef; Neocef; Niphex; Nufex; Oralex; Oriphex; Phexin; Rofex; Sepexin; Sporidex; Indonesia: Cefabiotic; Madlexin; Ospexin; Pralexin¤; Sofaxin; Tepaxin; Theralexin¤; Ireland: Ceporex¤; Kefexin¤; Keflex; Israel: Cefalin¤; Ceforal; Cefovit; Keflex¤; Italy: Abiocef¤; Cefadros¤; Cepo¤; Ceporex; Coliceflor¤; Domucef¤; Ibilex¤; Keforal; Lafarin¤; Latoral¤; Lorexina¤; Sintolexyn¤; Zetacef-lis¤; Zetacef¤; Japan: Larixin; Malaysia: Cefax¤; Celexin¤; Cephanmycin; Ceporex¤; Felexin; Kefexin¤; Medolexin; Ospexin; Refex¤; Sofilex; Solulexin; Sporidex; Uphalexin; Mexico: Acacin¤; Ancetev¤; Arlexen; Capxin; Cefalver; Ceporex; Facelit¤; Falexol¤; Fleximin¤; Flextinol; Keflex; Meta-K¤; Nafacil; Naxifelar; Nixelaf-C; Optocef; Paferxin; Quimosporina; Servicef; Sporicef; Netherlands: Ceporex¤; Keforal; Norway: Keflex; New Zealand: Keflex¤; Philippines: Airex; Bacilexin; Bandax; Benlexin; Bloflex; Canelin; Cefalin; Cendalex; Ceporex; CFA; Civalex; Clephin¤; Difalex; Edexin; Eliphorin; Exel; Fablex; Falex; Falteria; Forexine; Halcepin¤; Infexin; Ivynall; Keflex¤; Lewimycin; Lexum; Lonarel¤; Lyceplix; Madexin; Medilexin; Medoxine; Mefolex; Mexin; Montralex¤; Nefadon; Neolecsin; Nerfalex; Oneflex; Pediaflex; Respinal; Selzef; Servispor¤; Sorlex; Sporidex¤; Xeface; Xinflex; Zepharyl; Zeporin; Zepotex; Zexanta¤; Zinace; Zucoflaxin¤; Poland: Keflex; Portugal: Ceflax¤; Ceporex¤; Keflex¤; South Africa: Belex; Betacef¤; Ceporex¤; Cerexin¤; Fexin¤; Keflex; Lenocef¤; Ranceph; Singapore: Apo-Cephalex; Celexin; Cephalen¤; Cephanmycin; Ceporex; Felexin; Ospexin; Sofilex; Solulexin; Sporidex; Uphalexin; Spain: Bioporina¤; Bioscefal¤; Cefadina¤; Cefaleh Ina¤; Cefalexgobens; Cefalival¤; Cefalorex¤; Cefamiso¤; Ceferran¤; Cefibacter¤; Ceporex¤; Cilicef¤; Defaxina¤; Efemida¤; Erifalecin¤; Fergon¤; Janocilin¤; Karilexina¤; Kefloridina; Lensafrend¤; Lerporina¤; Lexibiotico¤; Lexincef¤; Libesporal¤; Sporol¤; Sulquipen; Talinsul¤; Torlasporin¤; Ultralexin¤; Valesporin¤; Sweden: Keflex; Switzerland: Ceporex¤; Keflex¤; Servispor¤; Thailand: Anxer¤; Cefexin¤; Cefute; Cefxin¤; Celex; Celexin¤; Cephalexyl; Cephin; Ceporex¤; Farmalex; Felexin; Ibilex; Keflex; Mycef; Neolexin¤; Pondnacef¤; Sefasin¤; Servispor¤; Sialexin; Sporicef; Sporidex¤; Sporidin; Suphalex; Teplexin; Toflex; Ulflex; Vataceph¤; Zeplex; Turkey: Maksipor; Sef; United Arab Emirates: Cefrin; United Kingdom: Ceporex; Keflex-C¤; Keflex; Kiflone¤; Ukraine: Lexin (Лексин); Ospexin (Оспексин)¤; United States: Biocef¤; Cefanex; Keflet¤; Keflex; Keftab¤; Zartan¤; Venezuela: Bidocef; Cefaloga¤; Keforal; Stricef; Multi-ingredient Preparations (Latest modification: 25-Jan-2012) The symbol ¤ denotes a preparation which is discontinued or no longer actively marketed. China: Pixian; Xindabao; India: Alcephin-LA; Caceff; Carbicef; Cecarb; Cefalong-DS; Cefel-B; Ceff-LA; Cep-Bro; Cephadex LB; Italy: Foce¤; Fosfolexin¤; Kufaprim¤; Mexico: Arlexen B; Cefabroxil; Cepobrom; Mucocef; Rombox; Spain: Kefloridina Mucolitico¤; Mucobiotina¤; Prindex Mucolitico¤; Pharmacopoeial Preparations (Latest modification: 06-Dec-2011) BP 2013: Cefalexin Capsules; Cefalexin Oral Suspension; Cefalexin Tablets; USP 36: Cephalexin Capsules; Cephalexin for Oral Suspension; Cephalexin Tablets for Oral Suspension; Cephalexin Tablets; Martindale: The Complete Drug Reference © 2013 The Pharmaceutical Press. MedicinesComplete © The Pharmaceutical Press 2013