Refix Special Precautions

Capsule: Hypersensitivity Reactions: Careful inquiry should be made prior to cefixime therapy to determine whether the patient has had previous hypersensitivity reactions to cephalosporins, penicillins or other drugs. Use with caution in penicillin-sensitive patients since cross-hypersensitivity among beta-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 cefixime, the drug should be discontinued. Serious acute hypersensitivity reactions may require treatment with epinephrine and other emergency measures including oxygen, intravenous (IV) fluids, IV antihistamines, corticosteroids, pressor amines and airway management as clinically indicated.
Severe Cutaneous Adverse Reactions: Severe cutaneous adverse reactions including toxic epidermal necrolysis, Stevens-Johnson syndrome and drug rash with eosinophilia and systemic symptoms (DRESS) have been reported in some patients on cefixime. When severe cutaneous adverse reactions occur, cefixime should be discontinued and appropriate treatment and/or measures should be taken.
Clostridium difficile-associated diarrhea (CDAD): This has been reported with the use of nearly all antibacterial agents, including cefixime, and may range in severity from mild diarrhea to fatal colitis. It is important to consider this diagnosis in patients who present with diarrhea following administration of antibacterial agents.
Hemolytic Anemia: Cefixime should not be used in patients with a history of cephalosporin-associated hemolytic anemia since the recurrence of hemolysis is much more severe.
An immune-mediated hemolytic anemia has been observed in patients receiving cephalosporin antibiotics, including cefixime. Severe cases of hemolytic anemia including fatalities, have been reported with cephalosporins in both adults and children if a patient develops anemia anytime during or within 2 to 3 weeks following the administration of cefixime. The diagnosis of a cephalosporin-associated anemia should be considered and the drug discontinued until the etiology is determined.
Periodic monitoring of signs and symptoms of hemolytic anemia, including measurement of hematological parameters or drug-induced antibody testing, where appropriate is recommended.
Acute Renal Failure: As with other cephalosporins, cefixime may cause acute renal failure including tubulointerstitial nephritis. In case of renal failure, cefixime should be discontinued and appropriate therapy instituted.
Prothrombin Time: Cephalosporins may be associated with a fall in prothrombin activity. Patients who are at risk are those with kidney or liver impairment or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy. Prothrombin time should be monitored in patients at risk and exogenous Vitamin K administered as indicated.
Seizures: These have been reported with several cephalosporins (e.g., cefuroxime, ceftazidime), particularly in patients with renal impairment in whom dosage of the drug was not reduced. If seizures occur during treatment with a cephalosporin, the drug should be discontinued and anticonvulsant therapy initiated as clinically indicated.
Other Precautions: As with other broad-spectrum antibiotics, cefixime should be given with caution in individuals with a history of colitis. The safety and efficacy of cefixime have not been established in patients with gastrointestinal malabsorption.
Prescribing cefixime 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 antibiotic resistance.
As with other antibacterial drugs, long term or repeated use may result in overgrowth of non-susceptible organisms, including fungi.
Abnormal Laboratory Tests: Positive Coombs' test, pancytopenia, transient increase in gamma-glutamyl transferase, decreased serum albumin and/or total protein.
Granules for oral suspension: Should not be given to patients who are hypersensitive to it or to other cephalosporins. About 10% of penicillin-sensitive patients may also be allergic to cephalosporins although the true incidence is uncertain; great care should be taken if cefixime is to be given to such patients. Care is also necessary in patients with a history of allergy.