Buccolam (oromucosal midazolam) is approved for the treatment of prolonged acute convulsive seizures in children aged from 3 months to <18 years. It is the first medicine to be approved under the new Paediatric Use Marketing Authorisation (PUMA) procedure by the European Commission. The aim of this PUMA process is to encourage research into the use of existing medicines in children and was introduced in an attempt to reduce the widespread off-label use of drugs in children.
Buccolam is available in four age-specific, single dose, colour-coded, pre-filled oral syringes. In the community it must only be used by parents/carers where the patient has been diagnosed to have epilepsy. For infants 3 to 6 months of age, treatment should be in a hospital setting where monitoring is possible and resuscitation equipment is available. If you require any further information, please contact Viropharma Ltd on +44 (2075) 721222.
