Briefing Note: midazolam (Buccolam oromucosal solution)

SMC accepted midazolam for the treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents (from 3 months to < 18 years).

• A seizure occurs when the brain functions abnormally, leading to a change in consciousness and movement. Seizures can occur in children for a variety of reasons in different parts of the brain. A convulsive seizure involves a large portion of the brain and causes uncontrollable muscle jerking lasting for a few minutes, followed by a period of drowsiness. Often the child will not remember the seizure itself but may have an injury such as a bitten tongue or broken bone caused by the jerking.
• Midazolam belongs to a group of medicines known as benzodiazepines. It can be used to stop a prolonged, convulsive seizure and also causes drowsiness and induces sleep. It is given buccally, meaning that it is administered into the space between the cheek and the gum. Buccolam® is a new formulation of midazolam in a pre-filled syringe for buccal administration in children.
• Studies have shown that midazolam given buccally was as effective at stopping convulsive seizures as another benzodiazepine given rectally, but it was not possible to determine if midazolam worked better.
• A side effect of benzodiazepines can be difficulty breathing. In studies, the occurrence of breathing problems was similar among patients given buccal midazolam compared with patients given the other medicine.
• SMC accepted midazolam oromucosal solution for use in NHSScotland because it is the first formulation of midazolam that can be administered buccally, and provides an alternative, more tolerable method of administration for this medicine at an acceptable cost.

13 February 2012