A thorough inquiry about the patient's previous hypersensitivity history should be made. Cefixime, like other cephalosporins, penicillins and other drugs, may cause serious hypersensitivity reactions and should be used with caution in any patient who has demonstrated some allergy to any drug. Although it has not been established, allergic reactions to antibiotics may occur more frequently in atopic individuals. Serious acute hypersensitivity reactions may require treatment with Epinephrine and other emergency measures including oxygen, intravenous fluids and intravenous antihistamines, corticosteroids, pressor amines, and airway management as clinically indicated.
Clostridium difficile-associated diarrhea (CDAD) and colitis have been reported with the use of nearly all antibacterial agents, including cefixime, and may range in severity from mild to life threatening. It is important to consider this diagnosis in patients who present with diarrhea following administration of antibacterial agents.
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.
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 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.
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.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies have not been performed to date to evaluate the carcinogenic potential of cefixime. Cefixime did not cause point mutations in bacteria or mammalian cells, DNA damage, or chromosome damage in vitro and did not exhibit clastogenic potential in vivo in the mouse micronucleus test. In rats, fertility and reproductive performance were not affected by cefixime at doses up to 125 times the adult therapeutic dose.
Use in Patients with Renal Impairment: Experience in children with renal impairment is very limited.
Use in Pregnancy: (Pregnancy Category B). Reproduction studies performed in mice and rats up to 400 times the human dose have not revealed evidence of harm to the fetus. There are no adequate and well-controlled studies in pregnant women, and the drug should be used during pregnancy only when clearly needed.
Labor and Delivery: The effect of cefixime in labor and delivery is unknown.
Use in Lactation: It is not known whether cefixime is excreted in human milk. Consideration should be given to discontinuing breastfeeding temporarily during treatment with cefixime.
Use in Children: The safety and efficacy of cefixime in children less than six (6) months old have not been established. The incidence of GI adverse reactions such as diarrhea and loose stools, in children receiving cefixime suspension, was comparable to the incidence seen in adults receiving cefixime tablets.