Data from FDA - Curated by EPG Health - Last updated 22 November 2019

Indication(s)

1 INDICATIONS & USAGE 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 and other antibacterial drugs, Cephalexin should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (1.6) 1.1 Respiratory Tract Infections Cephalexin is indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes. 1.2 Otitis Media Cephalexin is indicated for the treatment of otitis media caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella 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 treatment of bone infections caused by susceptible isolates of Staphylococcus aureus and Proteus mirabilis. 1.5 Genitourinary Tract Infections Cephalexin is 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 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.

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Advisory information

contraindications
4 CONTRAINDICATIONS 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. ( 4)
Adverse reactions
6 ADVERSE REACTIONS 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-associated diarrhea [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 Ascend Laboratories, LLC at 1-877-ASC-RX01 (877-272-7901) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience 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: 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.

Usage information

Dosing and administration
2 DOSAGE & ADMINISTRATION Adults and patients at least 15 years of age T he 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 to14 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. ( 2. 3 ) 2.1 Adults and Pediatric Patients at Least 15 Years of Age The usual dose of oral Cephalexin capsule, USP 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 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 dose of oral Cephalexin capsules, USP for pediatric patients is 25 to 50 mg/kg given in equally divided doses for 7 to 14 days. In the treatment of β-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, USP 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 Renal function Dose regimen recommendation Creatinine clearance >60mL/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.
Use in special populations
8 USE IN SPECIFIC POPULATIONS Renal Impairment: Monitor patients longer for toxicity and drug interactions due to delayed clearance. (8.6) 8.1 Pregnancy 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 0.6- 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 (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. In the U.S. 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 0.6 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.

Interactions

7 DRUG INTERACTIONS Metformin: increased metformin concentrations. Monitor for hypoglycemia. ( 7.1) Probenecid- The renal excretion of cephalexin is inhibited by probenecid. Co-administration of probenecid with cephalexin is not recommended. ( 7.2) Administration of cephalexin may result in a false-positive reaction glucose in the urine. ( 7.3 ) 7.1 Metformin 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)] 7.2 Probenecid The renal excretion of cephalexin is inhibited by probenecid. Co-administration of probenecid with cephalexin is not recommended. 7.3 Interaction with Laboratory or Diagnostic Testing A false-positive reaction may occur when testing for the presence of glucose in the urine using Benedict’s solution or Fehling’s solution.

More information

Category Value
Authorisation number ANDA090836
Agency product number OBN7UDS42Y
Orphan designation No
Product NDC 50090-3202,50090-3199
Date Last Revised 09-10-2019
Type HUMAN PRESCRIPTION DRUG
RXCUI 309112
Marketing authorisation holder A-S Medication Solutions