Buccal midazolam (Buccolam▼): new authorised medicine for paediatric use
- Medicines and Healthcare products Regulatory Agency
- 13 October 2011
- Therapeutic area:
- Neurology and Paediatrics and neonatology
Care needed when transferring from unlicensed formulations.
Article date: October 2011
Buccolam▼ is a formulation of midazolam suitable for buccal administration in a range of prefilled syringes and doses that are suitable for children aged 3 months to 18 years (2.5 mg in 0.5 mL; 5 mg in 1 mL; 7.5 mg in 1.5 mL; and 10 mg in 2 mL).
Buccolam should only be used by parents or carers where the patient has been diagnosed with epilepsy. For infants aged 3–6 months, treatment should only be in hospital, where monitoring is possible and resuscitation equipment is available.
Transfer to licensed buccal midazolam
Buccal midazolam may be considered as an alternative to rectal diazepam for the treatment of prolonged seizures. Various buccal midazolam preparations have been used in children as unlicensed medicines, including Buccolam prior to authorisation.
Several factors should be considered when transferring patients to the authorised Buccolam product when an unlicensed medicine other than Buccolam has been used previously.
Buccolam is half the strength of some other unlicensed preparations. It contains the hydrochloride salt, whereas some other preparations contain the maleate salt of midazolam. Although there is some suggestion that the maleate salt may be better absorbed in the buccal cavity, there are adequate studies with midazolam hydrochloride to support the dosing schedule authorised for Buccolam. A hospital paediatric unit has recently published its experience of transferring patients to licensed Buccolam (see S Tomlin, The Pharmaceutical Journal 2011; 287: 161).
Other safety information
Hypersensitivity to the midazolam, benzodiazepines, or to any of the excipients may occur.
Midazolam should be used with caution in patients with chronic respiratory insufficiency because it may further depress respiration.
Midazolam may accumulate in patients with chronic renal failure, or impaired hepatic or cardiac function and should therefore be used with caution in these individuals.
The most common adverse reactions in clinical trials of buccal midazolam were sedation, somnolence, depressed levels of consciousness, respiratory depression, and nausea and vomiting.
Report suspected adverse reactions
Suspected adverse reactions to Buccolam should be reported on a Yellow Card at www.yellowcard.gov.uk.
The first paediatric use marketing authorisation
The 2007 European Paediatric Regulation aims to improve the availability of fully authorised medicines for children in suitable dosage forms. As an incentive for the development of existing out-of-patent medicines specifically for use in children, the Regulation introduced a new type of marketing authorisation (licence) known as a PUMA (paediatric use marketing authorisation) with the same exclusivity rights as a completely new medicine. A PUMA needs to be supported by studies that comply with a paediatric investigation plan agreed by the European Paediatric Committee. The studies may relate to formulation development, and to safety or efficacy of the product in children.
Further information from MHRA
BNFC section 4.8.1 Control of the epilepsies
Article citation: Drug Safety Update Oct 2011, vol 5 issue 3: A2.
Published: 13 October 2011