Cephalexin 500 mg Capsules — Generic For Keflex — Aurobindo

These highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES

CEPHALEXIN capsules, for oral use

Initial U.S. Approval: 1971

Indications And Usage

Cephalexin capsules are 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 other antibacterial drugs, cephalexin capsules should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (1.6)

Dosage And Administration

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. (2.3)

Dosage Forms And Strengths

Capsules: 250 mg and 500 mg (3)

Contraindications

Patients with known hypersensitivity to cephalexin or other members of the cephalosporin class of antibacterial drugs. (4)

Warnings And Precautions

• Serious hypersensitivity (anaphylactic) reactions: Prior to use, inquire regarding history of hypersensitivity to beta-lactam antibacterial drugs. Discontinue the drug if signs or symptoms of an allergic reaction occur and institute supportive measures. (5.1)
• Clostridium difficile-associated diarrhea (CDAD): Evaluate if diarrhea occurs. (5.2)
• Direct Coombs’ Test Seroconversion: If anemia develops during or after cephalexin therapy, evaluate for drug-induced hemolytic anemia. (5.3)
• Seizure Potential: Use lower dose in patients with renal impairment. (5.4)

• Serious hypersensitivity (anaphylactic) reactions: Prior to use, inquire regarding history of hypersensitivity to beta-lactam antibacterial drugs. Discontinue the drug if signs or symptoms of an allergic reaction occur and institute supportive measures. (5.1)
• Clostridium difficile-associated diarrhea (CDAD): Evaluate if diarrhea occurs. (5.2)
• Direct Coombs’ Test Seroconversion: If anemia develops during or after cephalexin therapy, evaluate for drug-induced hemolytic anemia. (5.3)
• Seizure Potential: Use lower dose in patients with renal impairment. (5.4)

Serious hypersensitivity (anaphylactic) reactions: Prior to use, inquire regarding history of hypersensitivity to beta-lactam antibacterial drugs. Discontinue the drug if signs or symptoms of an allergic reaction occur and institute supportive measures. (5.1)

Clostridium difficile-associated diarrhea (CDAD): Evaluate if diarrhea occurs. (5.2)

Direct Coombs’ Test Seroconversion: If anemia develops during or after cephalexin therapy, evaluate for drug-induced hemolytic anemia. (5.3)

Seizure Potential: Use lower dose in patients with renal impairment. (5.4)

Adverse Reactions

The most common adverse reactions associated with cephalexin include diarrhea, nausea, vomiting, dyspepsia and abdominal pain. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

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)

Use In Specific Populations

Renal Impairment: Monitor patients longer for toxicity and drug interactions due to delayed clearance. (8.6)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 12/2024