This promotional website is intended for GB healthcare professionals.

BUCCOLAM® (midazolam) is indicated for the treatment of prolonged, acute, convulsive seizures in adults, adolescents, children and infants aged 3 months and above.1
BUCCOLAM® must only be used by parents/caregivers where the patient has been diagnosed to have epilepsy.1-4
For infants between 3-6 months of age treatment should be in a hospital setting where monitoring is possible and resuscitation equipment is available.1-4

Be prepared when seizure strikes

Be prepared when seizure strikes

Adverse events should be reported. Healthcare professionals are asked to report any suspected adverse reactions. UK reporting forms and information can be found via the Yellow Card Scheme www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in Google Play or Apple App Store. Adverse events should also be reported to Neuraxpharm UK Ltd by emailing pv-uk@neuraxpharm.com

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where leading experts in epilepsy care regularly join us to discuss their experience, best practices, and the difference BUCCOLAM® (midazolam) can make when prolonged, acute, convulsive seizures (PACS) strike

Help patients, family and friends to be prepared for when a seizure strikes

This educational video is intended for healthcare professionals and provides guidance on training patients, their families and friends on the appropriate use of BUCCOLAM® to ensure they are prepared to handle PACS. This video is not for patient viewing; educational videos designed specifically for patients are available.

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Rapidz

Rapid

Studies have demonstrated cessation of PACS within 10 minutes in the majority of adults (range 74–92%)5–7

Cessation of visible signs of seizures within 10 minutes has been observed in the majority of children (range 65–78%)1–4

Reliable

Reliable

No documented supply shortages in GB8,9

The first buccal midazolam authorised as rescue medication for PACS across Europe in 201110

Simple

Age-based, colour-coded dosing1–4

Supplied in ready-to-use packs of 4 pre-filled syringes to be available whenever and wherever needed1–4

Age rangeDose
(single pre-filled syringe)		Label colour
3 to 6 months hospital setting2.5 mgYellow
>6 months to <1 year2.5 mgYellow
1 year to <5 years5 mgBlue
5 years to <10 years7.5 mgPurple
10 years and above (including adults)10 mgOrange

Prescribing considerations1-4

Contraindications:

  • Hypersensitivity to the active substance, benzodiazepines or to any of the excipients listed below:
  • Sodium chloride
  • Water for injections
  • Hydrochloric acid 
  • Sodium hydroxide 
  • Myasthenia gravis
  • Severe respiratory insufficiency
  • Sleep apnoea syndrome
  • Severe hepatic impairment

Special Warnings and Precautions:

  • Midazolam should be used with caution in patients with chronic respiratory insufficiency because midazolam may further depress respiration
  • Paediatric patients aged 3 to 6 months
  • Midazolam should be used with caution in elderly patients and patients with chronic renal failure, impaired hepatic or cardiac function. Midazolam may accumulate in patients with chronic renal failure or impaired hepatic function whilst in patients with impaired cardiac function it may cause decreased clearance of midazolam
  • Debilitated patients are more prone to the central nervous system (CNS) effects of benzodiazepines and, therefore, lower doses may be required
  • Midazolam should be avoided in patients with a medical history of alcohol or drug abuse
  • Midazolam may cause anterograde amnesia

Undesirable effects1-4

Common (≥1/100 to <1/10):

  • Sedation
  • Somnolence
  • Depressed levels of consciousness 
  • Respiratory depression
  • Nausea and vomiting

Other serious undesirable effects:

  • Angioedema and anaphylactic reaction

Please refer to the Summary of Product Characteristics for additional information

References

  1. BUCCOLAM® oromucosal solution 10 mg Summary of Product Characteristics.
  2. BUCCOLAM® oromucosal solution 2.5 mg Summary of Product Characteristics.
  3. BUCCOLAM® oromucosal solution 5 mg Summary of Product Characteristics.
  4. BUCCOLAM® oromucosal solution 7.5 mg Summary of Product Characteristics.
  5. Nakken KO, Lossius M. Buccal midazolam or rectal diazepam for treatment of residential adult patients with serial seizures or status epilepticus. Acta Neurol Scand. 2011:124(2):99-103.
  6. Kadel J, et al. Use of Emergency Medication in Adult Patients with Epilepsy: A Multicentre Cohort Study from Germany. CNS Drugs. 2018;32(8):771-781.
  7. Shankar R, et al. Oromucosal midazolam maleate: use and effectiveness in adults with epilepsy in the UK. Epilepsy Behav. 2021;123:108242.
  8. European Medicines Agency. Buccolam (midazolam) supply shortage. March 2015. Available at: https://www.ema.europa.eu/en/documents/shortage/buccolam-midazolam-supply-shortage_en.pdf (accessed: November 2024). 
  9. Community Pharmacy England. Search results for Medicine Supply Notification: Midazolam. Available at: https://cpe.org.uk/?s=Medicine+Supply+Notification%3A+Midazolam&post_type=all (accessed: November 2024).
  10. European Medicines Agency. Buccolam. July 2024. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/buccolam (accessed November 2024).

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NXUK/0824/05 v2 | November 2024