Indications
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.
Contraindications
CONTRAINDICATION Cephalexin tablets are contraindicated in patients with known allergy to cephalexin or other members of the cephalosporin class of antibacterial drugs.
Warnings and precautions
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-A ssociated Diarrhea Clostridium difficile-a ssociated 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.
At a glance
- Brand name
- Cephalexin
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Alkem Labs LTD
- Status
- Prescription
- FDA approval
- 27 Sept 2024
- Application
- ANDA218947-002



