SUMMARY
Diastat®
(diazepam rectal gel)
Rectal Delivery System
128486
Diastat® AcuDial™ C-IV
(diazepam rectal gel)
Diazepam rectal gel rectal delivery system is a non-sterile diazepam gel provided in a prefilled, unit-dose, rectal delivery system. Diazepam rectal gel contains 5 mg/mL diazepam, propylene glycol, ethyl alcohol (10%), hydroxypropyl methylcellulose, sodium benzoate, benzyl alcohol (1.5%), benzoic acid and water. Diazepam rectal gel is clear to slightly yellow and has a pH between 6.5 -7.2. Diazepam, the active ingredient of diazepam rectal gel, is a benzodiazepine anticonvulsant with the chemical name 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2 H -1,4-benzodiazepin-2-one.
Diastat AcuDial (diazepam RECTAL) is indicated for the following:
Diazepam rectal gel is a gel formulation of diazepam intended for rectal administration in the management of selected, refractory, patients with epilepsy, on stable regimens of AEDs, who require intermittent use of diazepam to control bouts of increased seizure activity.
Evidence to support the use of diazepam rectal gel was adduced in two controlled trials (see CLINICAL PHARMACOLOGY, CLINICAL STUDIES subsection) that enrolled patients with partial onset or generalized convulsive seizures who were identified jointly by their caregivers and physicians as suffering intermittent and periodic episodes of markedly increased seizure activity, sometimes heralded by nonconvulsive symptoms, that for the individual patient were characteristic and were deemed by the prescriber to be of a kind for which a benzodiazepine would ordinarily be administered acutely. Although these clusters or bouts of seizures differed among patients, for any individual patient the clusters of seizure activity were not only stereotypic but were judged by those conducting and participating in these studies to be distinguishable from other seizures suffered by that patient. The conclusion that a patient experienced such unique episodes of seizure activity was based on historical information.
|
NEWS HIGHLIGHTS
Published Studies Related to Diastat Acudial (Diazepam Rectal)
Comparison of buccal midazolam with rectal diazepam in the treatment of prolonged seizures in Ugandan children: a randomized clinical trial. [2008.01]
OBJECTIVE: Our goal was to compare the efficacy and safety of buccal midazolam with rectal diazepam in the treatment of prolonged seizures in Ugandan children... CONCLUSION: Buccal midazolam was as safe as and more effective than rectal diazepam for the treatment of seizures in Ugandan children, although benefits were limited to children without malaria.
Effectiveness of intermittent diazepam prophylaxis in febrile seizures: long-term prospective controlled study. [2006.12]
The efficacy of intermittent rectal diazepam prophylaxis is assessed in the prevention of febrile seizures. In a prospective randomized cohort trial, 139 children (77 girls, 62 boys) who experienced a first febrile seizure were allocated to two groups: group A, which received intermittent diazepam (n = 68), and group B, which received no prophylaxis (n = 71)...
[Indications for intermittent diazepam prophylaxis in febrile seizures] [2006.09]
BACKGROUND: In a prospective controlled study we evaluated the efficacy of intermittent diazepam prophylaxis in the recurrence rate of febrile seizures (FS). PATIENTS: A total of 139 children aged between 6 and 36 months, who had a first FS, were enrolled in the study and were randomly allocated to two groups: group (A) that received diazepam prophylaxis and group (B) without prophylaxis... CONCLUSION: The intermittent prophylaxis with rectal diazepam during febrile episodes lead to a reduction of febrile seizure recurrence, especially in high-risk patients. The results of our study set the indication for the use of intermittent diazepam prophylaxis in this subgroup.
Intranasal midazolam vs rectal diazepam in acute childhood seizures. [2006.05]
One hundred eighty-eight seizure episodes in 46 children were randomly assigned to receive treatment with rectal diazepam and intranasal midazolam with doses of 0.3 mg/kg body weight and 0.2 mg/kg body weight, respectively. Efficacy of the drugs was assessed by drug administration time and seizure cessation time...
Safety and efficacy of buccal midazolam versus rectal diazepam for emergency treatment of seizures in children: a randomised controlled trial. [2005.07.16]
BACKGROUND: Rectal diazepam and buccal midazolam are used for emergency treatment of acute febrile and afebrile (epileptic) seizures in children. We aimed to compare the safety and efficacy of these drugs... INTERPRETATION: Buccal midazolam was more effective than rectal diazepam for children presenting to hospital with acute seizures and was not associated with an increased incidence of respiratory depression.
Clinical Trials Related to Diastat Acudial (Diazepam Rectal)
A Comparison of Lorazepam and Diazepam in the Treatment of Alcohol Withdrawal [Completed]
The purpose of this study is to compare the efficacy of two commonly used medications in the
treatment of alcohol withdrawal, diazepam and lorazepam.
Exploring the Effects of Diazepam and Lorazepam [Recruiting]
Aims :
- exploring lorazepam (0. 038 mg/kg)effects, after a single oral intake, in healthy
volunteers, on the neural correlates of encoding and retrieval of information during a
word-stem completion task (implicit memory), using fMRI
- comparing lorazepam effects to diazepam (0. 3 mg/kg)effects
- exploring benzodiazepines effects, after a single oral intake, on the neural correlates
of successful encoding of information within explicit memory using fMRI
Hypothesis :
- both diazepam and lorazepam will impair explicit memory performance, but lorazepam only
will impair perceptual priming
- lorazepam and diazepam will modify the normal correlates of information encoding wthin
explicit memory
- lorazepam only will alter the neural corraltes of perceptual priming
Intranasal Midazolam Versus Rectal Diazepam for Treatment of Seizures [Recruiting]
The investigators will conduct a randomized controlled trial comparing the use of nasal
midazolam, using a Mucosal Atomization Devise, to rectal diazepam for the treatment of acute
seizure activity in children under the age of 18 years with epilepsy in the community
setting. The primary hypothesis is that nasal midazolam will be more effective and have
shorter seizure time compared to rectal diazepam in the community. The secondary hypotheses
are that patients treated with nasal midazolam will have fewer respiratory complications,
emergency department visits, and admissions.
Efficacy and Safety Study Comparing Lorazepam and Diazepam for Children in the Emergency Department With Seizures [Recruiting]
Children with seizures are frequently seen in the emergency department. The drug lorazepam,
which is commonly used, is not labeled by the US Food and Drug Administration for children
for this use. The FDA, under the Best Pharmaceuticals for Children Act, has requested that
a study comparing diazepam, a drug that is labeled by the FDA for this indication, with
lorazepam be performed. The study will show whether one drug is more effective and safe than
the other.
A Study on the Effectiveness and Safety of Diazepam Injection (Vanquix™) for Patients With Epilepsy That Receive Antiepileptic Drugs, But Still Experience Acute Repetitive Seizures (Bouts or Clusters of Seizures) That Require Treatment [Recruiting]
|
|
|
|
Page last updated: 2008-03-26
|
