Rocephin

Rocephin Contraindications

ceftriaxone

Manufacturer:

Roche

Distributor:

DKSH
Full Prescribing Info
Contraindications
Hypersensitivity: Rocephin is contraindicated in patients with known hypersensitivity to ceftriaxone, any of its excipients or to any other cephalosporin. Patients with previous hypersensitivity reactions to penicillin and other beta lactam agents may be at greater risk of hypersensitivity to ceftriaxone (see General: Hypersensitivity under Precautions).
Lidocaine: Contraindications to lidocaine must be excluded before intramuscular injection of ceftriaxone when lidocaine solution is used as a solvent (see Dosage & Administration). See contraindications section in the prescribing information of lidocaine. Ceftriaxone solutions containing lidocaine should never be administered intravenously.
Use in Children: Premature Neonates: Rocephin is contraindicated in premature neonates up to postmenstrual age of 41 weeks (gestational age + chronological age).
Hyperbilirubinemic newborns: Hyperbilirubinaemic newborns should not be treated with ceftriaxone. In vitro studies have shown that ceftriaxone can displace bilirubin from its binding to serum albumin, leading to a possible risk of bilirubin encephalopathy in these patients.
Neonates and Calcium Containing IV Solutions: Rocephin is contraindicated in neonates (≤28 days) if they require (or are expected to require) treatment with calcium-containing IV solutions, including continuous calcium-containing infusions such as parenteral nutrition because of the risk of precipitation of ceftriaxone-calcium (see Dosage & Administration and Interactions).
A small number of cases of fatal outcomes in which a crystalline material was observed in the lungs and kidneys at autopsy have been reported in neonates receiving Rocephin and calcium-containing fluids. In some of these cases, the same intravenous infusion line was used for both Rocephin and calcium-containing fluids and in some a precipitate was observed in the intravenous infusion line. At least one fatality has been reported in a neonate in whom Rocephin and calcium-containing fluids were administered at different time points via different intravenous lines; no crystalline material was observed at autopsy in this neonate. There have been no similar reports in patients other than neonates (see Post Marketing Experience under Adverse Reactions).
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