Safety of Diastat®, a rectal gel formulation of diazepam for acute seizure treatment

Drug Safety

Volumn 27, Issue 6, 2004, Pages 383-392

  Pellock, John M ^a,b  

^a VIRGINIA COMMONWEALTH UNIVERSITY   (United States)

^b VIRGINIA COMMONWEALTH UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BENZODIAZEPINE; DIAZEPAM; LORAZEPAM; NORDAZEPAM; OXAZEPAM; PHENOBARBITAL; TEMAZEPAM; VALPROIC ACID; ANTICONVULSIVE AGENT;

ACUTE DISEASE; AGITATION; ANAPHYLAXIS; APNEA; BEHAVIOR DISORDER; BRONCHITIS; CAREGIVER; CHRONIC DRUG ADMINISTRATION; CLINICAL TRIAL; COGNITIVE DEFECT; CONFUSION; CONVULSION; COUGHING; DRUG ABUSE; DRUG ADMINISTRATION ROUTE; DRUG BLOOD LEVEL; DRUG DELIVERY SYSTEM; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG ERUPTION; DRUG FORMULATION; DRUG MECHANISM; DRUG METABOLISM; DRUG OVERDOSE; DRUG SAFETY; DRUG UTILIZATION; DYSPNEA; EPILEPSY; EUPHORIA; FEVER; GASTROINTESTINAL SYMPTOM; GEL; HEART ARRHYTHMIA; HEMOCONCENTRATION; HUMAN; HYPERKINESIA; HYPOTENSION; HYPOVENTILATION; INFECTION; MEDICAL EDUCATION; MORBIDITY; NERVOUSNESS; NEUROLOGIC DISEASE; OTITIS MEDIA; PAIN; PREGNANCY; PRIORITY JOURNAL; PRURITUS; RECTUM DISEASE; RECTUM HEMORRHAGE; RESPIRATION DEPRESSION; RESPIRATORY ARREST; REVIEW; SEDATION; SEIZURE; SIDE EFFECT; SKIN MANIFESTATION; SOMNOLENCE; TACHYPHYLAXIS; TERATOGENICITY; TREATMENT INDICATION; VISUAL DISORDER; VOMITING; RECTAL DRUG ADMINISTRATION;

ACUTE DISEASE; ADMINISTRATION, RECTAL; ANTICONVULSANTS; DIAZEPAM; EPILEPSY; GELS; HUMANS;

EID: 2342532917     PISSN: 01145916     EISSN: None     Source Type: Journal    
DOI: 10.2165/00002018-200427060-00003     Document Type: Review

References (30)

1. Diastat® [package insert]. San Diego (CA): Xcel Pharmaceuticals, 2001
2. Sutula TP, Hagen J, Pitkänen A. Do epileptic seizures damage the brain? Curr Opin Neural 2003; 16: 189-95
3. Shinnar S, Glauser TA. Febrile seizures. J Child Neurol 2002; 17 Suppl. 1: S44-52
4. Cereghino JJ, Cloyd JC, Kuzniecky RI. Rectal diazepam gel for treatment of acute repetitive seizures in adults. Arch Neurol 2002; 59: 1915-20
5. Cereghino JJ, Mitchell WG, Murphy J, et al. Treating repetitive seizures with a rectal diazepam formulation: a randomized study. The North American Diastat Study Group. Neurology 1998; 51: 1274-82
6. Dreifuss FE, Rosman NP, Cloyd JC, et al. A comparison of rectal diazepam gel and placebo for acute repetitive seizures. N Engl J Med 1998; 338: 1869-75
7. Kriel RL, Cloyd JC, Pellock JM, et al. Rectal diazepam gel for treatment of acute repetitive seizures. The North American Diastat Study Group. Pediatr Neural 1999; 20: 282-8
8. Mitchell WG, Conry JA, Crumrine PK, et al. An open-label study of repeated use of diazepam rectal gel (Diastat) for episodes of acute breakthrough seizures and clusters: safety, efficacy, and tolerance. North American Diastat Group. Epilepsia 1999; 40: 1610-7
9. Williams DB, Akabas MH. Benzodiazepines induce a conformational change in the region of the gamma-aminobutyric acid type A receptor alpha(1)-subunit M3 membrane-spanning segment. Mol Pharmacol 2000; 58: 1129-36
10. Williams DB, Akabas MH. Evidence for distinct conformations of the two alpha 1 subunits in diazepam-bound GABA(A) receptors. Neuropharmacology 2001; 41: 539-45
11. Cloyd JC, Lalonde RL, Beniak TE, et al. A single-blind, cross-over comparison of the pharmacokinetics and cognitive effects of a new diazepam rectal gel with intravenous diazepam. Epilepsia 1998; 39: 520-6
12. Kirkwood CK, Melton ST. Anxiety disorders. In: DiPiro JT, Talbert RL, Yee GC, et al., editors. Pharmacotherapy: a pathophysiologic approach. 5th ed. New York (NY): McGraw-Hill, 2002: 1289-310
13. Groves L, Shellenberger K, Franklin J, et al. Safety and tolerability of a single dose administration of Diastat® (diazepam rectal gel) to patients with epilepsy on antiepileptic drugs (AEDs) [abstract]. Epilepsia 1996; 37 Suppl. 5: 154
14. Kriel RL, Cloyd JC, Hadsall RS, et al. Home use of rectal diazepam for cluster and prolonged seizures: efficacy, adverse reactions, quality of life, and cost analysis. Pediatr Neurol 1991; 7: 13-7
15. Alldredge BK, Gelb AM, Isaacs SM, et al. A comparison of lorazepam, diazepam, and placebo for the treatment of out-of-hospital status epelepticus. N Engl J Med 2001; 345: 631-7
16. Appleton R, Sweeney A, Choonara I, et al. Lorazepam versus diazepam in the acute treatment of epileptic seizures and status epilepticus. Dev Med Child Neurol 1995; 37: 682-8
17. Appleton R, Martland T, Phillips B. Drug management for acute tonic-clonic convulsions including convulsive status epilepticus in children (Cochrane review). Cochrane Database Syst Rev 2002; (4): CD001905
18. Camfield CS, Camfield PR, Smith E, et al. Home use of rectal diazepam to prevent status epilepticus in children with convulsive disorders. J Child Neurol 1989; 4: 125-6
19. Hoppu K, Santavuori P. Diazepam rectal solution for home treatment of acute seizures in children. Acta Paediatr Scand 1981; 70: 369-72
20. Elterman RD. Rectal administration of diazepam. J Child Neurol 1994; 9: 340-1
21. Norris E, Marzouk O, Nunn A, et al. Respiratory depression in children receiving diazepam for acute seizures: a prospective study. Dev Med Child Neurol 1999; 41: 340-3
22. Kriel RL, Cloyd JC, Pellock JM. Respiratory depression in children receiving diazepam for acute seizures: a prospective study. Dev Med Child Neurol 2000; 42: 429-30
23. Mackereth S. Use of rectal diazepam in the community [letter]. Dev Med Child Neurol 2000; 42: 785
24. Corny JA, Mitchell WG, Crumrine PK. Diastat® (diazepam rectal gel) treatment of acute repetitive seizures (ARS): a study of long-term, intermittent use [abstract]. Epilepsia 1996; 37 Suppl. 5: 154
25. Laegreid L, Kyllerman M, Hedner T, et al. Benzodiazepine amplification of valproate teratogenic effects in children of mothers with absence epilepsy. Neuropediatrics 1993; 24: 88-92
26. Fitzgerald BJ, Okos AJ, Miller JW. Treatment of out-of-hospital status epilepticus with diazepam rectal gel. Seizure 2003; 12: 52-5
27. Hansen HC, Harboe H, Drenck NE. Local irritation after administration of diazepam in a rectal solution. Br J Anaesth 1989; 63: 287-9
28. Brown L, Bergen DC, Kotagal P, et al. Safety of Diastat when given at larger-than-recommended doses for acute repetitive seizures. Neurology 2001; 56: 1112
29. Brodtkorb E, Aamo T, Henriksen O, et al. Rectal diazepam: pitfalls of excessive use in refractory epilepsy. Epilepsy Res 1999; 35: 123-33
30. Wheless JW, Venkataraman V. New formulations of drugs in epilepsy. Expert Opin Pharmacother 1999; 1: 49-60