Ceftriaxone: substantial changes to indication and dose statements and directions for administration to reflect the updated Summary of Product Characteristics (SPC) for Rocephin®

Ceftriaxone has undergone substantial changes which are live in digital versions and will appear in print in BNF for Children 2016-2017 and BNF 72. These changes reflect the updated Summary of Product Characteristics (SPC) for Rocephin® and also advice and feedback from expert opinion and the BNF formulary committees.

Indication and dose

Indications and doses have been separated out. The umbrella term of “Susceptible infections due to sensitive Gram-positive and Gram-negative bacteria” has been removed in preference of individual indications and dosing depending on the indications.

Children 1 month-11 years on mg/kg dosing can get a higher dose than children from 12 years on standard dosing

Doses for the European Summary of Product Characteristics were amended following consultation with the European Medicines Agency. In adults and children over 12 years of age, the recommended dose varies between 1 g and 4 g once daily depending on the indication. In children below 12 years of age, the recommended dose depends on both the body-weight of the patient and the indication. The full details behind these changes are available here: http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Rocephin_30/WC500160112.pdf

Why has the age range Child 911 years (body-weight 50 kg and above) been chosen?

The SPC for Rocephin® states that a child 1 month–12 years with a body-weight over 50 kg should be dosed as for those of 12 years and above. However, the majority of children under 12 years will not weigh over 50 kg, therefore expert advice was taken to determine an appropriate age range of those under 12 years who may weigh above 50 kg. The age range of “Child 9–11 years (body-weight 50 kg and above)” was considered appropriate.

Route and Directions for Administration

The routes of administration have been split out to encourage the use of intravenous infusion as a first choice over other routes. It is important to read the Directions for Administration section before prescribing, clinically checking or administering ceftriaxone by a certain route.

The SPC for Rocephin® states that intravenous doses of 50 mg/kg or more in infants and children up to 12 years of age should be given by infusion only; in the light of this, the ceftriaxone monograph does not give the option of administration by intravenous injection in children 1 month–11 years and body-weight up to 50 kg. Where doses via intravenous infusion are not possible, doses can be given by deep intramuscular injection in the manner described under Directions for Administration.

As patients aged 9–11 years (body-weight 50 kg and above) may rarely receive doses less than 50 mg/kg, the option to administer the dose by intravenous injection is retained.

All children, excluding neonates, can receive ceftriaxone by deep intramuscular injection. The Directions for Administration should be followed when administering deep intramuscular injection in children.