Treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents (from 3 months to <18 years). BUCCOLAM must only be used by parents/carers where the patient has been diagnosed to have 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.
3 to 6 months hospital setting*
> 6 months to <1 year
2.5 mg in 0.5 ml
1 to < 5 years
5 mg in 1 ml
5 to <10 years
7.5 mg in 1.5 ml
10 to <18 years
10 mg in 2 ml
BUCCOLAM is available in four unit-dose, age-specific, colour-coded, pre-filled oral syringes.
The appropriate dose for an individual patient should be prescribed by the patient’s clinician/epilepsy specialist nurse. BUCCOLAM must only be administered by parents/carers to a patient who has been diagnosed to have epilepsy.
*IMPORTANT: Treatment should be in a hospital setting where monitoring is possible and resuscitation equipment is available
Carers should only administer a single dose of midazolam. 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.
Mechanism Of Action
Midazolam is a derivative of the imidazobenzodiazepine group. The free base is a lipophilic substance with low solubility in water. The basic nitrogen in position 2 of the imidazobenzodiazepine ring system enables midazolam to form the hydrochloride salt with acids. These produce a stable solution suitable for oromucosal administration.1
BUCCOLAM consists of the active ingredient, midazolam hydrochloride, and the following excipients sodium chloride, water for injections, hydrochloric acid and sodium hydroxide.
Contains no sugar, sweeteners, preservatives, flavourings, colorants or ethanol. Target pH is 2.9 to 3.7.
The shelf life for BUCCOLAM 2.5 mg is 18 months and BUCCOLAM 5 mg, 7.5 mg and 10 mg is 2 years.
Pre-filled syringes, which allow for specific dosing. Appearance: Unit-dose, age-specific, colour-coded, pre-filled oral syringes, supplied in a clear plastic tube, packed in boxes with four tubes per carton, plus a patient information leaflet.
Clinical Efficacy And Safety Information
Clinical Efficacy Information1
In 4 rectal diazepam-controlled studies and one study versus intravenous diazepam, in a total of 688 children, cessation of visible signs of seizures within 10 minutes was observed in 65% to 78% of children receiving oromucosal midazolam*. Additionally, in 2 of the studies, cessation of visible signs of seizures within 10 minutes without recurrence within 1 hour after administration was observed in 56% to 70% of children.
The frequency and severity of adverse drug reactions reported for oromucosal midazolam* during published clinical trials were similar to the adverse drug reactions reported in the comparative group using rectal diazepam.
*BUCCOLAM is licensed for oromucosal administration only
Clinical Safety Information1
Summary of the safety profile
Published clinical studies show thatoromucosal midazolam was administered to approximately 443 children with seizures. Respiratory depression occurs at a rate of up to 5%, although this is a known complication of convulsive seizures as well as being related to midazolam use. One episode of pruritus was possibly attributed to the use of buccal midazolam.
Common adverse events
Nervous system disorders
Common: Sedation, somnolence, depressed levels of consciousness, respiratory depression
Common: Nausea and vomiting
Skin and subcutaneous tissue disorders
Uncommon: Pruritus, rash and urticaria
Common: ≥1/100 to <1/10,
Uncommon: ≥1/1,000 to <1/100
For the full list of adverse events, please refer to the BUCCOLAM SmPC.
Reporting Of Adverse Events
- BUCCOLAM SmPC. Available from: https://www.medicines.org.uk/emc/product/7460 (accessed 03 Apr 2020)
- Campo‐Soria C, Chang Y, Weiss DS. Mechanism of action of benzodiazepines on GABAA receptors. British Journal of Pharmacology. 2006 Aug;148(7):984-90
- Knoflach F, Hernandez MC, Bertrand D. GABAA receptor-mediated neurotransmission: Not so simple after all. Biochemical Pharmacology. 2016 Sep 1;115:10-7
- Bialer M, White HS. Key factors in the discovery and development of new antiepileptic drugs. Nature reviews Drug discovery. 2010 Jan;9(1):68
This information is provided as a resource to HCP’s who prescribe or administer Buccolam.
Reporting of adverse events (Healthcare Professionals in the UK)