hi my daughter just been given buccolam, due to her fits getting worse is this bad sign

[piggy935]

[willyoung]

Hi Piggy, is not quite the salutation I like to greet someone?

But, having had epilepsy for 44 years this is not a drug that I am aware of until I saw the Medicines and Healthcare Products Regulatory Agency (MHRA) for the following;

Buccal midazolam (Buccolam▼): new authorised medicine for paediatric use—care needed when transferring from unlicensed formulationsArticle date: October 2011

Summary

Buccal midazolam (Buccolam▼) is a new authorised treatment for prolonged acute convulsive seizures. It is now available on the UK market. Buccal midazolam may be considered as an alternative to rectal diazepam for the treatment of prolonged seizures. 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 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.

Reporting of suspected adverse reactions

Suspected adverse reactions to Buccolam should be reported on a Yellow Card at 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.

The European Commission has granted the first ever PUMA to Buccolam.

Further information from the MHRA:

Drug Safety Update article on the European Paediatric Regulation

Drug Safety Update article on prescribers’ responsibilities for off-label or unlicensed use of medicines

MHRA press release for Buccolam

Other information:

Buccolam product information from the European Medicines Agency

NICE guidance for treatment of epilepsy

BNFC section 4.8.1 Control of the epilepsies

Article citation: Drug Safety Update Oct 2011, vol 5 issue 3: A2.

Kind regards,

Bill

[piggy935 in reply to willyoung]

thanks bill

[timsgirl]

Ive been put on that despite it being for under 18s That is what they they tested it for it is just to stop taking me into hospital every time My fits last over 10 mins this tends to get me out of it & send me to sleep my hubby does it!