Prescribing cefixime in the absence of a proven or strongly suspected bacterial infection of a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
The possibility of the emergence of resistant organisms which might result in overgrowth should be kept in mind, particularly during prolonged treatment. In such use, careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken.
The dose of cefixime should be adjusted in patients with renal impairment as well as those undergoing continuous ambulatory peritoneal dialysis (CAPD) and hemodialysis (HD). Patients on dialysis should be monitored carefully. Cefixime should be prescribed with caution in individuals with a history of gastrointestinal (GI) disease, particularly colitis.
Labor and Delivery: Cefixime has not been studied for use during labor and delivery. Treatment should only be given if clearly needed.
Use in pregnancy: Pregnancy category B. Reproduction studies have been performed in mice and rats at doses up to 400 times the human dose and have revealed no evidence of harm to the fetus due to cefixime. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, cefixime should be used during pregnancy only if clearly needed.
Use in lactation: It is not known whether cefixime is excreted in human milk. Consideration should be given to discontinuing nursing temporarily during treatment with cefixime.
Use in children: Safety and effectiveness of cefixime in children <6 months have not been established.
The incidence of GI adverse reactions, including diarrhea and loose stools, in the pediatric patients receiving the suspension, was comparable to the incidence seen in adult patients receiving tablets.