MHRA: Transferring patients to the new licensed buccal midazolam preparation
13th October 2011
The UK Medicines and Healthcare Regulatory Agency (MHRA) have highlighted that care is needed on transferring patients from unlicensed buccal midazolam preparations to the new licensed buccal midazolam preparation (Buccolam, ViroPharma).
Buccolam is oral midazolam 5mg/mL provided in age-specific, individual doses of 2.5mg, 5mg, 7.5mg or 10mg, in pre-filled syringes for buccal delivery (see our news item 14-09-2011). The NHS list price of 4 dose units is £82, £85.50, £89 and £91.50 respectively. It is licensed for patients diagnosed with epilepsy from age 3months to <18years.
Buccolam is half the strength of some of the unlicensed preparations that have been used and is also a different salt; it contains the hydrochloride salt, whereas some other preparations contain the maleate salt of midazolam. MHRA state that 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 authorized for Buccolam in the SPC. It also references a publication of the experience of a hospital paediatric unit transferring its patients to licensed Buccolam.
- Care of the dying: NICE guideline consultation
- Legislation changes for the availability of parenteral naloxone
- MHRA further measures to minimise risk of ONJ with denosumab and IV bisphosphonates
- Cochrane review: Antidepressants for the treatment of depression in people with cancer
- Ketamine 50mg/mL injection back in stock
- Phenobarbital 200mg/mL injection shortage
- Co-danthramer and strong co-danthramer capsules discontinued
- Ketamine supply update
- Cochrane review: Palliative interventions for controlling vaginal bleeding in advanced cervical cancer
- Temazepam prescriptions now need to meet requirements for Schedule 3 CDs