or fehling’s solution.

mo raxella catarrhalis. 1.3 skin and skin structure infections cephalexin is 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 is indicated for the treat ment of bone infections caused by susceptible isolates of staphylococcusaureus and proteus mi rabilis. 1.5 genitourinary tract infections cephalexin is indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of escheric hia c oli, proteus mirabilis, and klebsiella pneumonia e. 1.6 usage to reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, cephalexin 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.

, or other 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.

ephalexin capsules, usp 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 doseof oral cephalexin capsules, usp for pediatric patients is 25 to 50 mg/kg givenin equally divided doses for 7 to 14 days. in the treatment of β-hemolyticstreptococcal infections, duration of at least 10 days is recommended. insevere infections, a total daily dose of 50 to 100 mg/kg may be administered inequally divided doses. for thetreatment of otitis media, the recommended daily dose is 75 to 100 mg/kg givenin 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, usp to patients with impaired renal function [see war nin gsand precautions (5.4) and use inspecific populations (8.6 ) ] . table 1. recommended dose regimen for patients with renal impairment renal function dose regimen recommendation creatinine cleartance ≥ 60ml/min. no dose adjustment creatinine clearance 30 to 59 ml / min no dose adjustment; maximum daily dose should not exceed 1 g creati nine clearance 15 to 29 ml / min 250 mg, every 8 hours or every 12 hours creati nine clearance 5 to 14 ml / min not yet on dialysis* 250 mg, every 24 hours creati nine clearance 1 to 4 ml / min not yet on dialysis* 250 mg, every 48 hours or every 60 hours *there is insufficient information to make dose adjustment recommendations in patients on hemodialysis.

trials of a drug cannot be directly 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.

or fehling’s solution.

xin, 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 caution in the presence of impaired renal function (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 ) ] .

ormin mean cmax 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) streptococcus pyogenes gram-negative bacteria escheric h ia coli haemophilusinfl uenzae klebsiellapneumoniae moraxella catarrhalis proteusmi rabilis susceptibility tests methods when available, the clinical microbiology laboratory should provide the results of in vitro susceptibility test results for antimicrobial drug products used in resident hospitals to the physician as periodic reports that describe the susceptibility profile of nosocomial and community-acquired pathogens. these reports should aid the physician in selecting an antibacterial drug product for treatment. in cases of uncomplicated urinary tract infection only, susceptibility of e. coli, k. pneumoniae, and p. mirabilis to cephalexin may be inferred by testing cefazolin2. dilution techniques quantitative methods are used to determine antimicrobial minimal inhibitory concentrations (mics). these mics provide estimates of the susceptibility of bacteria to antimicrobial compounds. the mics should be determined using a standardized test methods (broth or agar)1,2. diffusion techniques quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. the zone size provides an estimate of the susceptibility of bacteria to antimicrobial compounds. the zone size should be determined using a standardized test method2,3. a report of susceptible (s) indicates that the antimicrobial drug is likely to inhibit growth of the pathogen if the antimicrobial drug reaches the concentration usually achievable at the site of infection. a report of intermediate (i) indicates that the result should be considered equivocal, and if the microorganism is not fully susceptible to alternative clinically feasible drugs, the test should be repeated. this category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where a high dosage of the drug can be used. this category also provides a buffer zone that prevents small uncontrolled technical factors from causing major discrepancies in interpretation. a report of resistant (r) indicates that the antimicrobial drug is not likely to inhibit growth of the pathogen if the antimicrobial drug reaches the concentrations usually achievable at the infection site; other therapy should be selected. qualit y co n t r ol standardized susceptibility test procedures require the use of laboratory controls to monitor and ensure the accuracy and precision of supplies and reagents used in the assay, and the techniques of the individual performing the test 1 ,2,3 ,.

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

he 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. manufactured by: alkem laboratories ltd. mumbai - 400 013, india distributed by: ascend laboratories, llc parsippany, nj 07054 revised: july 2016 pt 1199-08