Buccolam is approved for the treatment of prolonged acute convulsive seizures in children aged between 3 months and 18 years of age.
For infants between 3 and 6 months of age, treatment should be provided under the supervision of a healthcare professional in a hospital setting where resuscitation equipment is available.
First paediatric use marketing authorisation
Buccolam is the first medicine to be approved under the Paediatric Use Marketing Authorisation (PUMA) procedure. The aim of the PUMA process is to encourage research into the use of existing medicines in children by affording the same exclusivity rights as completely new medicines. It was introduced in an attempt to reduce the widespread off-label use of drugs in children.
In 4 studies using rectal diazepam as control, buccal midazolam was effective in stopping seizures within 10 minutes in 65% to 78% of children compared with 41% to 85% of children for rectal diazepam.
The Medicines and Healthcare products Regulatory Agency Drug Safety Update (October 2011) has highlighted safety issues for consideration when switching patients from unlicensed products to the licensed product, including noting that Buccolam is half the strength of some other unlicensed products.
Although there is some suggestion that the maleate salt used in some other products is better absorbed by buccal adminstration, there are adequate studies to support the licensed doses of Buccolam, which contains midazolam hydrochloride.
MHRA Drug Safety update – October 2011