Label: CEPHALEXIN tablet

Cephalexin tablets, USP contain the active ingredient cephalexin, which is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-α-amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid, monohydrate.

Cephalexin has the molecular formula C16H17N3O4S•H2O and the molecular weight is 365.41.

Cephalexin has the following structural formula:

The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5.

The crystalline form of cephalexin which is available is a monohydrate. It is a white to off white crystalline powder. Slightly soluble in water, practically insoluble alcohol, in chloroform and in ether.

The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position.

Each tablet contains cephalexin monohydrate equivalent to 250 mg or 500 mg of cephalexin. The tablets also contain the inactive ingredients: hypromellose, hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium starch glycolate, talc and titanium dioxide.

FDA approved dissolution test specifications differ from USP

Human Pharmacology

Cephalexin tablets are acid stable and may be given without regard to meals. It is rapidly absorbed after oral administration. Following doses of 250 mg, 500 mg, and 1g, average peak serum levels of approximately 9, 18, and 32 mcg/mL, respectively, were obtained at 1 hour. Serum levels were detectable 6 hours after administration (at a level of detection of 0.2 mcg/mL). Cephalexin is approximately 10% to 15% bound to plasma proteins. Cephalexin is excreted in the urine by glomerular filtration and tubular secretion. Studies showed that over 90% of the drug was excreted unchanged in the urine within 8 hours. During this period, peak urine concentrations following the 250-mg, 500-mg, and 1-g doses were approximately 1000, 2200, and 5000 mcg/mL, respectively.

In healthy subjects given single 500 mg doses of cephalexin and metformin, plasma metformin 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.

Microbiology

Cephalexin is a bactericidal agent that acts by the inhibition of 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 vulqaris. Cephalexin has no activity against Pseudomonas spp., or Acinetobacter calcoaceticus. Penicillinresistant Streptococcus pneumoniae is usually cross-resistant to beta-lactam

antibacterial drugs.

Antimicrobial Activity - Cephalexin is active against most isolates of the following bacteria both in vitro and in clinical infections [see INDICATIONS and USAGE]:

Gram-positive bacteria

Staphylococci aureus (methicillin-susceptible isolates only),

Streptococcus pneumoniae (penicillin-susceptible isolates)

Streptococcus pyogenes

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.

Cephalexin tablets are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms:

Respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes

Otitis media due to susceptible isolates of Streptococcu.. pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and  Moraxella Catarrhalis.

Skin and skin structure infections caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus, and Streptococcus pyogenes

Bone infections caused by susceptible isolates of Staphylococcus aureus and Proteus Mirabilis

Genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniare

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin tablets and other antibacterial drugs, cephalexin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they 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.

Cephalexin tablets are contraindicated in patients with known allergy to cephalexin or other members of the cephalosporin class of antibacterial drugs.

Hypersensitivity Reactions

Allergic reactions in the form of rash, urticaria, angioedema, anaphylaxis, erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis have been reported with the use of cephalexin tablets. Before therapy with cephalexin tablets are instituted, inquire whether the patient has a history of hypersensitivity reactions to cephalexin, cephalosporins, penicillins, 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 tablets occurs, discontinue the drug and institute appropriate treatment.

Clostridium difficile-Associated Diarrhea

Clostridium difficile-associated diarrhea (CDAD)has been reported with use of nearly all antibacterial agents, including cephalexin tablets, 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

Direct Coomb’s 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.

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 tablets. Anticonvulsant therapy can be given if clinically indicated.

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.

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. 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 tablets, 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. 

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.

Cephalexin tablets are administered orally.

Adults and Pediatric 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. Treatment is administered for 7 to 14 days. For more severe infections larger doses of oral cephalexin may be needed, up to 4 grams in two to four equally divided doses.

Pediatric Patients (over 1 year of age)

The recommended total daily dose of oral cephalexin for pediatric patients is 25 to 50 mg/kg 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.

In the treatment of otitis media, the recommended daily dose is 75 to 100 mg/kg/day in equally divided doses.

Dosage adjustments in Adults and Pediatric Patients at Least 15 years of

Age with Renal Impairment

Administer the following dosing regimens for cephalexin tablets to patients with renal impairment [see PRECAUTIONS].

Table 1. Recommended Dose Regimen for Patients with Renal Impairment

*There is insufficient information to make dose adjustment recommendations in patients on hemodialysis.

Cephalexin tablets USP—

250 mg: white to off white, capsule-shaped coated tablet, debossed “250” on one side with score between the “2” and “5” and “CEP” on the reverse side. They are available as follows:

Bottles of 30                                                                 NDC 67877-891-30

Bottles of 100                                                               NDC 67877-891-01 

Bottles of 500                                                               NDC 67877-891-05 

Carton of 30 Tablets (3 x 10 Unit-dose)                       NDC 67877-891-84

500 mg: white to off white, capsule-shaped coated tablet, debossed “500” on one side with score between the “5” and “0” and “CEP” on the reverse side. 

Bottles of 30                                                                 NDC 67877-892-30

Bottles of 100                                                               NDC 67877-892-01 

Bottles of 500                                                               NDC 67877-892-05 

Carton of 30 Tablets (3 x 10 Unit-dose)                       NDC 67877-892-84

Store at 20°C to 25°C (68°F to77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

 Manufactured by:

 Alkem Laboratories Ltd., 
 Mumbai - 400 013, INDIA.

 Distributed by:

 Ascend Laboratories, LLC

 Parsippany, NJ 07054                                                                                                                                               

 Revised: 5/2024

PT9166

Cephalexin Tablets, USP 250 mg

NDC 67877-891-30
30 Tablets Container Pack
Rx Only

Cephalexin Tablets, USP 250 mg

NDC 67877-891-01
100 Tablets Container Pack
Rx Only

Cephalexin Tablets, USP 250 mg

NDC 67877-891-05
500 Tablets Container Pack
Rx Only 

Cephalexin Tablets, USP 250 mg

NDC 67877-891-84
30 Tablets Carton Pack
Rx Only

Cephalexin Tablets, USP 500 mg
NDC 67877-892-30
30 Tablets Container Pack
Rx Only

Cephalexin Tablets, USP 500 mg
NDC 67877-892-01
100 Tablets Container Pack
Rx Only

Cephalexin Tablets, USP 500 mg
NDC 67877-892-05
500 Tablets Container Pack
Rx Only

Cephalexin Tablets, USP 500 mg

NDC 67877-892-84
30 Tablets Carton Pack
Rx Only