Cefalexin

What it is and how it works

Mechanism of Action Cephalexin is a cephalosporin antibacterial drug [ see Microbiology ].

Indications

Cephalexin USP is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria: Respiratory tract infection Otitis media Skin and skin structure infections Bone infections Genitourinary tract infections To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, cephalexin for oral suspension should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. Respiratory Tract Infections Cephalexin for oral suspension is indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes . Otitis Media Cephalexin for oral suspension is indicated for the treatment of otitis media caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis.

Dosage and administration (summary)

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 . Pediatric patients (over 1 year of age) • Otitis media: 75 to 100 mg/kg in equally divided doses every 6 hours • All other indications: 25 to 50 mg/kg given in equally divided doses • In severe infections: 50 to 100 mg/kg may be administered in equally divided doses Duration of therapy ranges from 7 to 14 days depending on the infection type and severity. Dosage adjustment is required in patients with severe and end stage renal disease (ESRD) defined as creatinine clearance below 30 mL/min.

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.

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. Clostridium difficile -associated diarrhea (CDAD): Evaluate if diarrhea occurs. Direct Coomb's Test Seroconversion: If anemia develops during or after cephalexin therapy, evaluate for drug-induced hemolytic anemia. Seizure Potential : Use lower dose in patients with renal impairment.

Pregnancy

Pregnancy Pregnancy Category B There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Storage and supply

Product: 50090-6445 NDC: 50090-6445-0 100 mL in a BOTTLE

Source: Cephalexin (Cephalexin) — US FDA prescribing information, 2023-04-26, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.