Taxim-O/Taxim-O 400/Taxim-O Kids Special Precautions

Taxim-O/Taxim-O 400: General: Cefixime tablets 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 disease, particularly colitis. Cephalosporins may be associated with a fall in prothrombin activity. Those at risk include patients with renal or hepatic 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.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Lifetime studies in animals to evaluate carcinogenic potential have not been conducted. 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 Pregnancy: See Use in Pregnancy & Lactation section for further information.
Use Lactation: See Use in Pregnancy & Lactation section for further information.
Use in Children: Safety and effectiveness of cefixime in children aged less than six months old have not been established.
Taxim-O Kids: Should not be given to patients who are hypersensitive to it or to other cephalosporins. Immunological studies have suggested that up to 20% of penicillin-sensitive patients may also be allergic to cephalosporins although clinical studies indicate a lower frequency and 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 history of allergy.