Xtenda Special Precautions

General: Ceftriaxone is excreted via both biliary and renal excretion. Therefore, patients with renal failure normally require no adjustment in dosage when usual doses of Ceftriaxone are administered but concentrations of drug in the serum should be monitored periodically. If evidence of accumulation exists, dosage should be decreased accordingly.
Dosage adjustments should not be necessary in patients with hepatic dysfunction; however, in patients with both hepatic dysfunction and significant renal disease, Ceftriaxone dosage should not exceed 2 gm daily without close monitoring of serum concentrations.
Prolonged use of Ceftriaxone result in an overgrowth of non-susceptible organism. Careful observation of the patient is essential. If super infection occurs during therapy appropriate measures should be taken.
Ceftriaxone should be prescribed with caution in individuals with a history of gastrointestinal disease, especially colitis.
Carcinogenicity: Considering the maximum duration of treatment and the class of the compound, carcinogenicity studies with ceftriaxone in animals have not been performed.
Mutagenicity: Genetic toxicology tests included the Ames test, a micronucleus test and a test for chromosomal aberrations in human lymphocytes cultured in vitro with ceftriaxone. Ceftriaxone showed no potential for mutagenic activity in these studies.
Use in pregnancy: Reproductive studies have been performed in mice and rats at doses up to 20 times the usual human dose and have no evidence of embryotoxicity, fetotoxicity or teratogenicity. In primates, no embryotoxicity or teratogenicity was demonstrated at a dose approximately 3 times the human dose.
There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Reproduction: Ceftriaxone produced no impairment of fertility when given intravenously to rats at a daily dose up to 586 mg/kg per day, approximately 20 times the recommended clinical dose of 2 gm/day.
Use in lactation: Low concentrations of ceftriaxone are excreted in human milk. Caution should be exercised when Ceftriaxone is administered to a nursing woman.
Use in children: Safety and effectiveness of ceftriaxone in neonates, infants and children have been established for the dosages described in the dosage and administration section. In vitro studies have shown that ceftriaxone like some other cephalosporins, can displace bilirubin from serum albumin. Ceftriaxone should not be administered to hyperbilirubinemic neonates, especially prematures.
Use in elderly: Due to high protein binding the dosage should be adjusted based upon the creatinine clearance.
Effects on ability to drive and use machines: Since this drug does not cause somnolence it is not contraindicated in drivers or people who use machines.