Ceftriaxone (Paediatric)

PAEDIATRIC DOSING IS RECORDED IN THE paedDose FIELD AND MUST BE VERIFIED AGAINST A CHILDREN'S FORMULARY. 'The dose depends on the severity, susceptibility, site and type of infection and on the age and hepato-renal function of the patient... In particularly severe cases, doses at the higher end of the recommended range should be considered.' 'In documented bacteraemia, the higher end of the recommended dose range should be considered.' ADULT / OVER-12 INDICATIONS REQUIRING SPECIFIC SCHEDULES: acute otitis media - a single intramuscular dose of 1 to 2 g, and where the patient is severely ill or previous therapy has failed, 1 to 2 g intramuscularly daily for 3 days; pre-operative prophylaxis of surgical site infections - 2 g as a single pre-operative dose; gonorrhoea - 500 mg as a single intramuscular dose; syphilis - 500 mg to 1 g once daily, increased to 2 g once daily for neurosyphilis, for 10 to 14 days; disseminated Lyme borreliosis (early Stage II and late Stage III) - 2 g once daily for 14 to 21 days. National or local guidance should be taken into consideration for syphilis and Lyme borreliosis. DURATION: 'The duration of therapy varies according to the course of the disease. As with antibiotic therapy in general, administration of ceftriaxone should be continued for 48 - 72 hours after the patient has become afebrile or evidence of bacterial eradication has been achieved.' OLDER PEOPLE: no modification required provided renal and hepatic function is satisfactory. HEPATIC IMPAIRMENT: no dose adjustment needed in mild or moderate liver impairment provided renal function is not impaired; no study data in severe hepatic impairment. PRE-OPERATIVE TIMING: ceftriaxone should be administered 30 to 90 minutes prior to surgery. CALCIUM INCOMPATIBILITY (critical in neonates): ceftriaxone is contraindicated in neonates 28 days or younger if they require or are expected to require treatment with calcium-containing intravenous solutions, including continuous calcium-containing infusions such as parenteral nutrition, because of the risk of precipitation of ceftriaxone-calcium. Diluents containing calcium (e.g. Ringer's or Hartmann's solution) must not be used to reconstitute vials or to dilute a reconstituted vial for intravenous administration. In patients of ANY age ceftriaxone must not be mixed or administered simultaneously with any calcium-containing intravenous solution, even via different lines or sites; in patients older than 28 days they may be given sequentially if lines at different sites are used, or if the lines are replaced or thoroughly flushed with physiological saline between infusions. Fatal reactions with calcium-ceftriaxone precipitates in lungs and kidneys have been described in premature and full-term neonates aged less than 1 month. SOURCE COMPLETENESS: eMC section 4.5 (interactions) was NOT captured in this bundle, and sections 4.4 and 4.8 were truncated at the source-fetch limit.

dosePerKg is left null because the SPC gives DIFFERENT per-kg ranges by indication AND by age band - a single number would be unsafe. VERBATIM SPC section 4.2 paediatric tables. NEONATES, INFANTS AND CHILDREN 15 DAYS TO 12 YEARS OF AGE (under 50 kg): '50-80 mg/kg once daily' for intra-abdominal infections, complicated urinary tract infections including pyelonephritis, community acquired pneumonia and hospital acquired pneumonia; '50-100 mg/kg (Max 4 g) once daily' for complicated skin and soft tissue infections, infections of bones and joints, and management of neutropenic patients with fever suspected to be due to a bacterial infection; '80-100 mg/kg (max 4 g) once daily' for bacterial meningitis; '100 mg/kg (max 4 g) once daily' for bacterial endocarditis. Specific schedules in this age band: acute otitis media - a single intramuscular dose of 50 mg/kg for initial treatment, and where the child is severely ill or initial therapy has failed, 50 mg/kg intramuscularly daily for 3 days; pre-operative prophylaxis of surgical site infections - 50 to 80 mg/kg as a single pre-operative dose; syphilis - 75 to 100 mg/kg (max 4 g) once daily for 10 to 14 days, based on very limited data; disseminated Lyme borreliosis (early Stage II and late Stage III) - 50 to 80 mg/kg once daily for 14 to 21 days. 'For children with bodyweight of 50 kg or more, the usual adult dosage should be given.' NEONATES 0 TO 14 DAYS: 'Ceftriaxone is contraindicated in premature neonates up to a postmenstrual age of 41 weeks (gestational age + chronological age).' '20-50 mg/kg once daily' for intra-abdominal infections, complicated skin and soft tissue infections, complicated urinary tract infections including pyelonephritis, community acquired pneumonia, hospital acquired pneumonia, infections of bones and joints, and management of neutropenic patients with fever suspected to be due to a bacterial infection; '50 mg/kg once daily' for bacterial meningitis and bacterial endocarditis. 'A maximum daily dose of 50 mg/kg should not be exceeded.' Specific schedules for neonates 0 to 14 days: acute otitis media - a single intramuscular dose of 50 mg/kg for initial treatment; pre-operative prophylaxis of surgical site infections - 20 to 50 mg/kg as a single pre-operative dose; syphilis - 50 mg/kg once daily for 10 to 14 days, based on very limited data. In documented bacteraemia, the higher end of the recommended dose range should be considered. See the contraindications and the calcium-incompatibility note in adultDose.notes - both are critical in neonates. Verify against a children's formulary before use.