Ceftriaxone is contraindicated in patients with known allergy to the cephalosporin class of antibiotics.
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 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.
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.
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