Product Details
What is this medicine used for?
For the treatment of the following infections caused by susceptible microorganisms:
• Skin and skin structure infections
• Bone and joint infections
• Genitourinary tract infections, including acute prostatitis
• Respiratory tract infections including acute and chronic bronchitis and infected bronchiectasis
• Ear, nose and throat infections including otitis media, mastoiditis, sinusitis, follicular tonsillitis, and pharyngitis
• Dental infections
How much and how often should you use this medicine?
DOSAGE AND ADMINISTRATION
Cefalexin is administered orally.
Usual Adult Dose: 250 mg every 6 hours (Maximum Dose: 4 g/day)
• For streptococcal pharyngitis, skin and skin structure infections and uncomplicated cystitis (in patients > 15
years old): 500 mg every 12 hours
• Larger doses (up to 4 g daily) may be needed for more severe infections or those caused by less susceptible
organisms. If daily doses of cefalexin greater than 4 g are required, initial therapy with parenteral
cephalosporins, in appropriate doses, should be considered.
Contraindications
Known hypersensitivity to cephalosporins, penicillins, or any component of the product.
Warning and Precautions
• Careful inquiry should be made prior to cefalexin therapy to determine whether the patient has had
previous hypersensitivity reactions to cefalexin, cephalosporins, penicillins, or other drugs. Use
with caution in penicillin-sensitive patients since cross-sensitivity among β-lactam antibiotics has
been clearly documented and may occur in up to 10% of patients with a history of allergy to penicillin.
In case of an allergic reaction to cefalexin, the drug should be discontinued. Serious acute
hypersensitivity reactions require immediate emergency treatment with epinephrine. Oxygen,
intravenous antihistamines, corticosteroids, and airway management, including intubation,
should also be instituted.
• -associated diarrhea (CDAD) and colitis have been reported with nearly all antibacterial
agents, including cefalexin, and may range in severity from mild to life threatening. It is important to consider
this diagnosis in patients who present with diarrhea after administration of antibacterial agents.
• Seizures have been reported with several cephalosporins (e.g., ceftazidime, cefuroxime), particularly in
patients with impaired renal function in whom dosage of the drug was not reduced. If seizures occur during
treatment with cephalosporin, the drug should be discontinued and anticonvulsant therapy initiated as
clinically indicated.
• Cephalosporins may be associated with a fall in prothrombin activity particularly in patients with renal or
hepatic impairment, or poor nutritional state, as well as those receiving a protracted course of antibiotic
therapy, and patients stabilized on anticoagulants. Monitoring of prothrombin time in patients at risk and
exogenous vitamin K administration are recommended.
• A false-positive Coombs’ test has been reported during treatment with other cephalosporin antibiotics;
therefore, it should be recognized that a positive Coombs’ test may be due to the drug, e.g., Coombs’ testing
of newborns whose mothers have received cephalosporins before parturition or in hematologic studies or
in transfusion cross-matching procedures when antiglobulin tests are performed.
• Use with caution in patients with renal impairment. Careful clinical and laboratory studies should be made
since safe dosage may be lower than that usually recommended.
• Indicated surgical procedures (e.g., incision and drainage of abscesses) should be performed in conjunction
with antibiotic therapy.
• As with any potent drug, periodic assessment of organ system functions, including renal, hepatic,
hematopoietic, is recommended during prolonged therapy.
• Prescribing cefalexin in the absence of a proven or strongly suspected bacterial infection or a prophylactic
indication is unlikely to provide benefit to the patient and increases the risk of the development of drugresistant
bacteria.
As with other antibacterial drugs, long term or repeated use may result in overgrowth of nonsusceptible organisms, including fungi.
Availability
RM Cefalexin 250 mg box of 100s
