’s solution.

, staphylococcus aureus , streptococcus pyogenes , and moraxella catarrhalis. 1.3 skin and skin structure infections cephalexin capsules are indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following gram-positive bacteria: staphylococcus aureus and streptococcus pyogenes . 1.4 bone infections cephalexin capsules are indicated for the treatment of bone infections caused by susceptible isolates of staphylococcus aureus and proteus mirabilis. 1.5 genitourinary tract infections cephalexin capsules are indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of escherichia coli , proteus mirabilis , and klebsiella pneumoniae . 1.6 usage to reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules and other antibacterial drugs, cephalexin capsules should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information is available, this information should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

her drugs. cross-hypersensitivity among beta-lactam antibacterial drugs may occur in up to 10% of patients with a history of penicillin allergy. if an allergic reaction to cephalexin occurs, discontinue the drug and institute appropriate treatment. 5.2 clostridium difficile -associated diarrhea clostridium difficile - associated diarrhea (cdad) has been reported with use of nearly all antibacterial agents, including cephalexin, and may range in severity from mild diarrhea to fatal colitis. treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of c. difficile . c. difficile produces toxins a and b, which contribute to the development of cdad. hypertoxin-producing strains of c. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. cdad must be considered in all patients who present with diarrhea following antibiotic use. careful medical history is necessary since cdad has been reported to occur over two months after the administration of antibacterial agents. if cdad is suspected or confirmed, ongoing antibiotic use not directed against c. difficile may need to be discontinued. appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of c. difficile , and surgical evaluation should be instituted as clinically indicated. 5.3 direct coombs’ test seroconversion positive direct coombs’ tests have been reported during treatment with the cephalosporin antibacterial drugs including cephalexin. acute intravascular hemolysis induced by cephalexin therapy has been reported. if anemia develops during or after cephalexin therapy, perform a diagnostic work-up for drug-induced hemolytic anemia, discontinue cephalexin and institute appropriate therapy. 5.4 seizure potential several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced. if seizures occur, discontinue cephalexin. anticonvulsant therapy can be given if clinically indicated. 5.5 prolonged prothrombin time cephalosporins may be associated with prolonged prothrombin time. those at risk include patients with renal or hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antibacterial therapy, and patients receiving anticoagulant therapy. monitor prothrombin time in patients at risk and manage as indicated. 5.6 development of drug-resistant bacteria prescribing cephalexin in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. prolonged use of cephalexin may result in the overgrowth of nonsusceptible organisms. careful observation of the patient is essential. if superinfection occurs during therapy, appropriate measures should be taken.

may be needed, up to 4 grams daily in two to four equally divided doses. 2.2 pediatric patients (over 1 year of age) the recommended total daily dose of oral cephalexin capsules for pediatric patients is 25 to 50 mg/kg given in equally divided doses for 7 to 14 days. in the treatment of ?-hemolytic streptococcal infections, duration of at least 10 days is recommended. in severe infections, a total daily dose of 50 to 100 mg/kg may be administered in equally divided doses. for the treatment of otitis media, the recommended daily dose is 75 to 100 mg/kg given in equally divided doses. 2.3 dosage adjustments in adult and pediatric patients at least 15 years of age with renal impairment administer the following dosing regimens for cephalexin capsules to patients with renal impairment [see warnings and precautions (5.4) and use in specific populations (8.6) ] . table 1. recommended dose regimen for patients with renal impairment *there is insufficient information to make dose adjustment recommendations in patients on hemodialysis. renal function dose regimen recommendation creatinine clearance > 60 ml/min no dose adjustment creatinine clearance 30 to 59 ml/min no dose adjustment; maximum daily dose should not exceed 1g creatinine clearance 15 to 29 ml/min 250 mg, every 8 hours or every 12 hours creatinine clearance 5 to 14 ml/min not yet on dialysis* 250 mg, every 24 hours creatinine clearance 1 to 4 ml/min not yet on dialysis* 250 mg, every 48 hours or every 60 hours

ctly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. in clinical trials, the most frequent adverse reaction was diarrhea. nausea and vomiting, dyspepsia, gastritis, and abdominal pain have also occurred. as with penicillins and other cephalosporins, transient hepatitis and cholestatic jaundice have been reported. other reactions have included hypersensitivity reactions, genital and anal pruritus, genital candidiasis, vaginitis and vaginal discharge, dizziness, fatigue, headache, agitation, confusion, hallucinations, arthralgia, arthritis, and joint disorder. reversible interstitial nephritis has been reported. eosinophilia, neutropenia, thrombocytopenia, hemolytic anemia, and slight elevations in aspartate transaminase (ast) and alanine transaminase (alt) have been reported. in addition to the adverse reactions listed above that have been observed in patients treated with cephalexin, the following adverse reactions and other altered laboratory tests have been reported for cephalosporin class antibacterial drugs: other adverse reactions : fever, colitis, aplastic anemia, hemorrhage, renal dysfunction, and toxic nephropathy. altered laboratory tests : prolonged prothrombin time, increased blood urea nitrogen (bun), increased creatinine, elevated alkaline phosphatase, elevated bilirubin, elevated lactate dehydrogenase (ldh), pancytopenia, leukopenia, and agranulocytosis.

’s solution.

fects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data human data while available studies cannot definitively establish the absence of risk, published data from epidemiologic studies and postmarketing case reports over several decades have not identified a consistent association with cephalosporin use, including cephalexin, during pregnancy, and major birth defects, miscarriage, or other adverse maternal or fetal outcomes. available studies have methodologic limitations, including small sample size, retrospective data collection, and inconsistent comparator groups. animal data in animal reproduction studies, pregnant mice and rats administered oral cephalexin doses of 250 or 500 mg/kg/day (approximately 0.6 and 1.2 times the mrhd) based on body surface area, respectively during the period of organogenesis showed no adverse effects on embryofetal development. in a pre-and post-natal developmental toxicity study, pregnant rats that received oral doses of 250 or 500 mg/kg/day of cephalexin from day 15 of pregnancy to litter day 21 showed no adverse effects on parturition, litter size, or growth of offspring. 8.2 lactation risk summary data from a published clinical lactation study reports that cephalexin is present in human milk. the relative infant dose (rid) is considered to be <1% of the maternal weight adjusted dose. there are no data on the effects of cephalexin on the breastfed child or on milk production. the development of health benefits of breastfeeding should be considered along with the mother’s clinical need for cephalexin and any potential adverse effects on the breastfed child from cephalexin or from the underlying maternal condition. 8.4 pediatric use the safety and effectiveness of cephalexin in pediatric patients was established in clinical trials for the dosages described in the dosage and administration section [see dosage and administration (2.2) ]. 8.5 geriatric use of the 701 subjects in 3 published clinical studies of cephalexin, 433 (62%) were 65 and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. this drug is substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection [see warnings and precautions (5.4) ]. 8.6 renal impairment cephalexin should be administered with careful monitoring in the presence of renal impairment (creatinine clearance < 30 ml/min, with or without dialysis). under such conditions, careful clinical observation and laboratory studies renal function monitoring should be conducted because safe dosage may be lower than that usually recommended [see dosage and administration (2.3) ] . monitor patients longer for toxicity and drug interactions due to delayed clearance.

s cannot definitively establish the absence of risk, published data from epidemiologic studies and postmarketing case reports over several decades have not identified a consistent association with cephalosporin use, including cephalexin, during pregnancy, and major birth defects, miscarriage, or other adverse maternal or fetal outcomes. available studies have methodologic limitations, including small sample size, retrospective data collection, and inconsistent comparator groups. animal data in animal reproduction studies, pregnant mice and rats administered oral cephalexin doses of 250 or 500 mg/kg/day (approximately 0.6 and 1.2 times the mrhd) based on body surface area, respectively during the period of organogenesis showed no adverse effects on embryofetal development. in a pre-and post-natal developmental toxicity study, pregnant rats that received oral doses of 250 or 500 mg/kg/day of cephalexin from day 15 of pregnancy to litter day 21 showed no adverse effects on parturition, litter size, or growth of offspring.

ormin mean c max and auc increased by an average of 34% and 24%, respectively, and metformin mean renal clearance decreased by 14%. no information is available about the interaction of cephalexin and metformin following multiple doses of either drug. 12.4 microbiology mechanism of action cephalexin is a bactericidal agent that acts by the inhibition of bacterial cell-wall synthesis. resistance methicillin-resistant staphylococci and most isolates of enterococci are resistant to cephalexin. cephalexin is not active against most isolates of enterobacter spp., morganella morganii , and proteus vulgaris . cephalexin has no activity against pseudomonas spp., or acinetobacter calcoaceticus . penicillin-resistant streptococcus pneumoniae is usually cross-resistant to beta-lactam antibacterial drugs. antimicrobial activity cephalexin has been shown to be active against most isolates of the following bacteria both in vitro and in clinical infections [ see indications and usage (1) ]. gram-positive bacteria staphylococcus aureus (methicillin-susceptible isolates only) streptococcus pneumoniae (penicillin-susceptible isolates) gram-negative bacteria escherichia coli haemophilus influenzae klebsiella pneumoniae moraxella catarrhalis proteus mirabilis susceptibility testing for specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by fda for this drug, please see: https://www.fda.gov/stic.

4%. no information is available about the interaction of cephalexin and metformin following multiple doses of either drug.

ommon to feel better early in the course of therapy, the medication should be taken exactly as directed. skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by cephalexin or other antibacterial drugs in the future. distributed by: aurobindo pharma usa, inc. 279 princeton-hightstown road east windsor, nj 08520 manufactured by: aurobindo pharma limited hyderabad-500 032, india revised: 10/2021