Cefalin Capsule Special 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 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 steroids, and airway management, including intubation, should also be instituted.
Clostridium difficile-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., ceftazidine, 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 cephalosporin 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 abcesses) 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 drug-resistant bacteria.
As with other antibacterial drugs, long term or repeated use may result in overgrowth of non-susceptible organisms, including fungi.
Renal Impairment: In patients with impaired renal function, decreases in doses and/or frequency of administration of cefalexin may be required and should be based on the degree of renal impairment, severity of infection, susceptibility of the causative organism, and serum concentrations of cefalexin.