Oromucosal midazolam: A review of its use in pediatric patients with prolonged acute convulsive seizures

Pediatric Drugs

Volumn 14, Issue 4, 2012, Pages 251-261

  Garnock Jones, Karly P ^a  

^a ADIS INTERNATIONAL LIMITED   (New Zealand)

Author keywords

Adis Drug Evaluations; Children; Midazolam; Seizures

Indexed keywords

4 AMINOBUTYRIC ACID; 4 AMINOBUTYRIC ACID A RECEPTOR; ALCOHOL; ALPHA HYDROXYMIDAZOLAM; ANTIFUNGAL AGENT; BENZODIAZEPINE; CALCIUM CHANNEL BLOCKING AGENT; CIMETIDINE; DIAZEPAM; FENTANYL; HUMAN IMMUNODEFICIENCY VIRUS PROTEINASE INHIBITOR; LEVODOPA; LORAZEPAM; MACROLIDE; MIDAZOLAM; OPIATE DERIVATIVE; PHENYTOIN; PLACEBO; RIFAMPICIN; XANTHINE;

AMNESIA; ANTICONVULSANT ACTIVITY; ATTENTION DISTURBANCE; CONSCIOUSNESS DISORDER; CONVULSION; DISEASE ACTIVITY; DISEASE DURATION; DRUG ABSORPTION; DRUG ADMINISTRATION ROUTE; DRUG APPROVAL; DRUG BIOAVAILABILITY; DRUG EFFECT; DRUG EFFICACY; DRUG FORMULATION; DRUG HALF LIFE; DRUG MECHANISM; DRUG TOLERABILITY; ELECTROENCEPHALOGRAM; FIRST PASS EFFECT; FOOD DRUG INTERACTION; GRAPEFRUIT; HUMAN; MUSCLE FUNCTION; NAUSEA; NEUROTRANSMISSION; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL (TOPIC); RESPIRATION DEPRESSION; REVIEW; SEDATION; SEIZURE; SIDE EFFECT; SOMNOLENCE; TREATMENT INDICATION; TREATMENT OUTCOME; TREATMENT RESPONSE; VOMITING;

ADMINISTRATION, BUCCAL; ADOLESCENT; ANTICONVULSANTS; CHILD; CHILD, PRESCHOOL; DRUG INTERACTIONS; HUMANS; INFANT; MIDAZOLAM; SEIZURES;

EID: 84862518873     PISSN: 11745878     EISSN: 11792019     Source Type: Journal    
DOI: 10.2165/11209320-000000000-00000     Document Type: Review

References (26)

1. Doshi D. Controlling seizures in children: diazepam or midazolam? Systematic review. Hong Kong J Emerg Med 2010 17 (2): 196-204
2. Offringa M, Newton R. Prophylactic drug management for febrile seizures in children. Cochrane Database Syst Rev 2012 4: CD003031
3. Tomlin S. Medicines tailored for children: the introduction of buccal midazolam. Pharm J 2011 287 (7665-7666): 161-162
4. European Medicines Agency. Buccolam- (buccal midazolam solution): summary of product characteristics [online]. Available from URL: http://www. ema.europa.eu/docs/en-GB/document-library/EPAR-Product-Informa tion/human/002267/WC500112310.pdf [Accessed 2012 Feb 17]
5. European Medicines Agency. European Medicines Agency Committee for Medicinal Products for Human Use assessment report for Buccolam- (buccal midazolam) [EMA/662938/2011] [online]. Available from URL: http://www. ema.europa.eu/docs/en-GB/document-library/EPAR-Public-assessment-report/human/ 002267/WC500112312.pdf [Accessed 2012 Feb 13]
6. Scott RC, Besag FMC, Boyd SG, et al. Buccal absorption of midazolam: pharmacokinetics and EEG pharmacodynamics. Epilepsia 1998 39 (3): 290-294
7. Dundee JW, Halliday NJ, Harper KW, et al. Midazolam: A review of its pharmacological properties and therapeutic use. Drugs 1984 Dec 28 (6): 519-543
8. Reves JG, Fragen RJ, Vinik HR, et al. Midazolam: pharmacology and uses. Anesthesiology 1985 Mar 62 (3): 310-324
9. Olkkola KT, Ahonen J. Midazolam and other benzodiazepines. Handb Exp Pharmacol 2008 (182): 335-360
10. Albrecht S, Krajinovic L, SchneiDer C, et al. Pharmacokinetics of oromucosal midazolam hydrochloride in children [poster]. 2012 World Congress of Anaesthesiologists 2012 Mar 25-30 Buenos Aires 11. Muchohi SN, Kokwaro GO, Ogutu BR, et al. Pharmacokinetics and clinical efficacy of midazolam in children with severe malaria and convulsions. Br J Clin Pharmacol 2008 66 (4): 529-538
11. Riss J, Cloyd J, Gates J, et al. Benzodiazepines in epilepsy: pharmacology and pharmacokinetics. Acta Neurol Scand 2008 118: 69-86
12. McIntyre J, Robertson S, Norris E, et al. Safety and efficacy of buccal midazolam versus rectal diazepam for emergency treatment of seizures in children: A randomised controlled trial. Lancet 2005 366 (9481): 205-210
13. Mpimbaza A, Ndeezi G, Staedke S, et al. Comparison of buccal midazolam with rectal diazepam in the treatment of prolonged seizures in Ugandan children: A randomized clinical trial. Pediatrics 2008 121 (1): e58-64
14. Scott RC, Besag FMC, Neville BGR. Buccal midazolam and rectal diazepam for treatment of prolonged seizures in childhood and adolescence: A randomised trial. Lancet 1999 353 (9153): 623-626
15. Talukdar B, Chakrabarty B. Efficacy of buccal midazolam compared to intravenous diazepam in controlling convulsions in children: A randomized controlled trial. Brain Dev 2009 31 (10): 744-749
16. Trajano MLM, Sanchez BC, Lukban MB, et al. Buccal midazolam compared to rectal diazepam and intravenous midazolam as emergent treatment of acute seizures in children: preliminary study [abstract no. PO18-WE-40]. J Neurol Sci 2009 Oct 285 Suppl. 1: S254-5
17. Baysun S, AydinÖ F, Atmaca E, et al. A comparison of buccal midazolam and rectal diazepam for the acute treatment of seizures. Clin Pediatr 2005 44 (9): 771-776
18. McMullan J, Sasson C, Pancioli A, et al. Midazolam versus diazepam for the treatment of status epilepticus in children and young adults: A meta-Analysis. Acad Emerg Med 2010 17 (6): 575-582
19. European Medicines Agency. Questions and answers on the paediatric use marketing authorisation (PUMA) [online]. Available from URL: http://www. ema.europa.eu/docs/en-GB/document-library/Other/2011/09/WC500112071.pdf [Accessed 2012 Mar 6]
20. National Clinical Guideline Centre. The epilepsies: the diagnosis and management of the epilepsies in adults and children in primary and secondary care (pharmacological update of Clinical Guideline 20) [online]. Available from URL: http://www.nice.org.uk/nicemedia/live/13635/57784/57784.pdf [Accessed 2012 Mar 5]
21. Wilson MT, Macleod S, O'Regan ME. Nasal/buccal midazolam use in the community. Arch Dis Child 2004 89 (1): 50-51
22. Body R, Ijaz M. Best evidence topic report. Buccal midazolam as an alternative to rectal diazepam for prolonged seizures in childhood and adolescence. Emerg Med J 2005 22 (5): 364-365
23. Blumer JL. Clinical pharmacology of midazolam in infants and children. Clin Pharmacokinet 1998 Jul 35 (1): 37-47
24. Wockhardt UK Ltd. Diazepam RecTubes 5 mg rectal solution: summary of product characteristics [online]. Available from URL: http://www.medicines. org.uk/EMC/printfriendlydocument.aspx?documentid=12169&companyid=35 [Accessed 2012Mar 7]
25. Ashrafi MR, Khosroshahi N, Karimi P, et al. Efficacy and usability of buccal midazolam in controlling acute prolonged convulsive seizures in children. Eur J Paediatr Neurol 2010 14 (5): 434-438
26. Scottish Medicines Consortium. Midazolam, 5mg/mL, oromucosal solution (Buccolam-) SMC No. (757/12) [online]. Available from URL: http://www. scottishmedicines.org.uk/files/advice/midazolam-Buccolam-FINAL-Jan-2012-Amended- 310112-for-website.pdf [Accessed 2012 Mar 21]