NeLM news service
Midazolam oromucosal solution (Buccolam®) for prolonged, acute, convulsive seizures in children licensed in UK

Source: ViroPharma Limited

Date published: 09/12/2011 19:41

Summary
by: Yuet Wan

Until recently, midazolam oromucosal solution ® was an unlicensed specials product for the treatment of prolonged, acute, convulsive seizures in children. It has now been licensed in the UK under the trade name Buccolam® for use in infants, toddlers, children and adolescents (from 3 months to < 18 years). It is the first licensed oromucosal midazolam product in the UK and also the first to receive a paediatric-use marketing authorisation (PUMA).

 

Buccolam must only be used by parents/carers where the patient has been diagnosed with epilepsy. For infants between 3-6 months of age treatment should be in a hospital setting where monitoring is possible and resuscitation equipment is available. Dosing us based on age (see SPC). Carers should only administer a single dose; if the seizure has not stopped within 10 minutes after administration of midazolam, emergency medical assistance must be sought and the empty syringe given to the healthcare professional to provide information on the dose received by the patient. A second or repeat dose when seizures re-occur after an initial response should not be given without prior medical advice.

 

The NHS list price of 4 dose units is as follows:

 

• 2.5mg £82
• 5.0mg £85.50
• 7.5mg £89
• 10mg £91.50

 

Link to 2.5mg SPC below, for other strengths, go to http://www.medicines.org.uk/emc/ and type brand name into search box.

Preview your comment

Add new comment

Comment text:

Comments

There are no comments yet. You could be the first! You must be Logged In to comment.