CEPHALEXIN- cephalexin_powder, for suspension

Cephalexin is a cephalosporin antibacterial drug [see Microbiology ( 12. 4 Absorption: Distribution: Excretion: Drug Interactions 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 Morganella morganii Proteus vulgaris Pseudomonas Acinetobacter calcoaceticus Streptococcus pneumoniae Antimicrobial Activity Cephalexin has been shown to be active against most isolates of the following bacteria both in vitro see Indications and Usage ( 1 Gram-positive bacteria Staphylococcus aureus Streptococcus pneumoniae 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.

Cephalexin is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria: Respiratory tract infection ( 1. 1 Otitis media ( 1. 2 Skin and skin structure infections ( 1. 3 Bone infections ( 1. 4 Genitourinary tract infections ( 1. 5 To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, and cephalexin for oral suspension and other antibacterial drugs, cephalexin capsules, and cephalexin for oral suspension should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. 6 Cephalexin is indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae Streptococcus pyogenes. Cephalexin is indicated for the treatment of otitis media caused by susceptible isolates of Streptococcus pneumoniae Haemophilus influenzae Staphylococcus aureus Streptococcus pyogenes Moraxella catarrhalis. Cephalexin is indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus Streptococcus pyogenes Cephalexin is indicated for the treatment of bone infections caused by susceptible isolates of Staphylococcus aureus Proteus mirabilis. Cephalexin is indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of Escherichia coli Proteus mirabilis Klebsiella pneumoniae To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, and cephalexin for oral suspension and other antibacterial drugs, cephalexin capsules, and cephalexin for oral suspension 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.

Adults and patients at least 15 years of age The usual dose is 250 mg every 6 hours, but a dose of 500 mg every 12 hours may be administered ( 2. 1 Pediatric patients (over 1 year of age) Otitis media: 75 to 100 mg/kg in equally divided doses every 6 hours ( 2. 2 All other indications: 25 to 50 mg/kg given in equally divided doses ( 2. 2 In severe infections: 50 to 100 mg/kg may be administered in equally divided doses ( 2. 2 Duration of therapy ranges from 7 to 14 days depending on the infection type and severity. ( 2 Dosage adjustment is required in patients with severe and end stage renal disease (ESRD) defined as creatinine clearance below 30 mL/min. 3 The usual dose of oral cephalexin is 250 mg every 6 hours, but a dose of 500 mg every 12 hours may be administered. Treatment is administered for 7 to 14 days. For more severe infections larger doses of oral cephalexin may be needed, up to 4 grams daily in two to four equally divided doses. The recommended total daily dose of oral cephalexin for pediatric patients is 25 to 50 mg/kg given in equally divided doses for 7 to 14 days. In the treatment of beta-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. Cephalexin Suspension Weight 125 mg/5 mL 250 mg/5 mL 10 kg (22 lb) 1/2 to 1 tsp q. 1/4 to 1/2 tsp q. 20 kg (44 lb) 1 to 2 tsp q. 1/2 to 1 tsp q. 40 kg (88 lb) 2 to 4 tsp q. 1 to 2 tsp q. or Weight 125 mg/5 mL 250 mg/5 mL 10 kg (22 lb) 1 to 2 tsp b. 1/2 to 1 tsp b. d 20 kg (44 lb) 2 to 4 tsp b. 1 to 2 tsp b. 40 kg (88 lb) 4 to 8 tsp b. 2 to 4 tsp b. Directions for Mixing 125 mg per 5 mL (100 mL when mixed): 125 mg per 5 mL (200 mL when mixed): 250 mg per 5 mL (100 mL when mixed): 250 mg per 5 mL (200 mL when mixed): * Administer the following dosing regimens for cephalexin to patients with impaired renal function [see Warnings and Precautions ( 5. Recommended Dose Regimen for Patients with Renal Impairment 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 1 g 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 *There is insufficient information to make dose adjustment recommendations in patients on hemodialysis.

The following serious events are described in greater detail in the Warning and Precautions section: Hypersensitivity reactions [ see Warning and Precautions ( 5. 1 Clostridium difficile see Warnings and Precautions ( 5. 2 Direct Coombs’ Test Seroconversion [ see Warnings and Precautions ( 5. 3 Seizure Potential [ see Warnings and Precautions ( 5. 4 Effect on Prothrombin Activity [ see Warnings and Precautions ( 5. 5 Development of Drug-Resistant Bacteria [ see Warnings and Precautions ( 5. 6 The most common adverse reactions associated with cephalexin include diarrhea, nausea, vomiting, dyspepsia and abdominal pain. ( 6 To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical 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 Altered Laboratory Tests:.

Cephalexin is contraindicated in patients with known hypersensitivity to cephalexin or other members of the cephalosporin class of antibacterial drugs. Patients with known hypersensitivity to cephalexin or other members of the cephalosporin class of antibacterial drugs.

Renal Impairment: Monitor patients longer for toxicity and drug interactions due to delayed clearance. 6 Risk Summary Available data from published epidemiologic studies and pharmacovigilance case reports over several decades with cephalosporin use, including Cephalexin use in pregnant women have not established drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data) Animal reproduction studies with mice and rats using oral doses of cephalexin that are 0. 2-times the maximum recommended human dose (MRHD) based on body surface area during organogenesis revealed no evidence of harm to the fetus (see Data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. general population, the estimated background risk of major birth defects 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. 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. 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. 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. 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 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.

Metformin: increased metformin concentrations. Monitor for hypoglycemia. 1 Probenecid - The renal excretion of cephalexin is inhibited by probenecid. Co-administration of probenecid with cephalexin is not recommended. 2 Administration of cephalexin may result in a false-positive reaction for glucose in the urine. 3 Administration of cephalexin with metformin results in increased plasma metformin concentrations and decreased renal clearance of metformin. Careful patient monitoring and dose adjustment of metformin is recommended in patients concomitantly taking cephalexin and metformin [ see Clinical Pharmacology ( 12. 3 ) The renal excretion of cephalexin is inhibited by probenecid. A false-positive reaction may occur when testing for the presence of glucose in the urine using Benedict’s solution or Fehling’s solution.

OVERDOSAGE
Symptoms of oral overdose may include nausea, vomiting, epigastric distress, diarrhea, and hematuria. In the event of an overdose, institute general supportive measures. Forced diuresis, peritoneal dialysis, hemodialysis, or charcoal hemoperfusion have not been established as beneficial for an overdose of cephalexin.
NONCLINICAL TOXICOLOGY
Lifetime studies in animals have not been performed to evaluate the carcinogenic potential of cephalexin. Tests to determine the mutagenic potential of cephalexin have not been performed. In male and female rats, fertility and reproductive performance were not affected by cephalexin oral doses up to 1. 5 times the highest recommended human dose based upon body surface area.

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