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.

eNewsletters

In a recent survey we asked for your feedback about the BNF eNewsletter, and in response to your comments we have redesigned the June edition. We hope you’ll find it clearer, more succinct and easier to find the information you need. Let us know what you think at enewsletter@bnf.org.

This month’s issue contains a useful case study on managing chronic asthma, along with the latest guidance and content updates to the BNF and BNFC.

June 2016

Previous newsletters can be found below:

May 2016

April 2016

March 2016

Print editions: flags and drug-class monographs

In the print editions of BNF Publications, where there is common information relating to a class of drugs, the shared properties are contained in a drug-class monograph.  Drug-class monographs are highlighted by a circled flag symbol beside the title of the drug-class monograph.  The corresponding individual drug monographs usually follow the drug-class monograph, and are highlighted by a non-circled flag symbol.

BNF Beta-adrenoceptor blockers

BNF Atenolol

For example, the monograph for atenolol will display a flag, indicating that the drug-class monograph for Beta-adrenoceptor blockers (systemic), should be consulted in tandem.  For more information, see How to use BNF publications in print in the preface of the current print publications.

Update and clarification of ceftriaxone in the BNF for Children 2015-2016

Following feedback about the ceftriaxone monograph in BNFC 2015-2016 and online, we would like to provide an update and clarification:

In the current BNFC, the dosage and route of ceftriaxone remains unchanged from BNFC legacy. Although the routes for the dosing statement include intramuscular injection, this was never intended as a recommendation for child under 12 years with body-weight under 50kg, as doses of 50mg/kg and over were advised to be given by intravenous infusion only. Children over 50kg do have the option in this dosing statement to have ceftriaxone by intramuscular injection. However, since this information has been published, the SPC for Rocephin has been updated.

Over the last few months, we have been processing the updated SPC and we have also taken the opinion of expert advisers, the Paediatric Formulary Committee, and now are awaiting evidence from the manufacturer. This is to ensure the content we publish is clinically appropriate for paediatrics.

We appreciate the need to update the monograph based on the SPC as soon as possible, but we also want to ensure the dose and route are safe and appropriate before the monograph will be published.

 

Update for Valproic Acid in BNF and BNF for Children

The following sections in the Valproic acid monograph in BNF Publications will be updated for the next print edition/digital update to bring the content in line with the Sodium valproate monograph. The content will be updated in BNF 72 (September 2016) and BNF for Children 2016-2017. Digital versions will be updated at the next scheduled release date – April 2016.

The updated content will read as follows:

Contra-indications: Acute porphyrias p.864; personal or familial history of severe hepatic dysfunction; known or suspected mitochondrial disorders (higher rate of acute liver failure and liver-related deaths)

Breastfeeding: Present in milk – risk of haematological disorders in breast-fed newborns and infants

A downloadable version of this update can be found here:

Update to Valproic acid monograph