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Diastat Acudial (Diazepam Rectal) - Summary

 
 



SUMMARY

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.


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NEWS HIGHLIGHTS

Published Studies Related to Diastat Acudial (Diazepam Rectal)

Diazepam pharmacokinetics after nasal drop and atomized nasal administration in dogs. [2011.02]
The standard of care for emergency therapy of seizures in veterinary patients is intravenous (i.v.) administration of benzodiazepines, although rectal administration of diazepam is often recommended for out-of-hospital situations, or when i.v...

Pharmacokinetics of diazepam administered intramuscularly by autoinjector versus rectal gel in healthy subjects: a phase I, randomized, open-label, single-dose, crossover, single-centre study. [2011]
BACKGROUND AND OBJECTIVE: Acute repetitive seizures (ARS) are a debilitating part of episodic seizure activity that can sometimes progress to status epilepticus. Currently approved treatment that can be administered by non-medical personnel to patients with ARS is a diazepam rectal gel. While effective, rectal administration can be difficult, inconvenient and objectionable. A diazepam autoinjector has been developed to deliver diazepam via an intramuscular (IM) injection. This study evaluated the dose proportionality of the diazepam autoinjector and the consequent diazepam bioavailability relative to an equivalent dose of diazepam administered rectally as a commercial gel... CONCLUSION: Results of the present study indicated that diazepam can be safely and reliably administered IM using a diazepam autoinjector.

Intranasal midazolam vs rectal diazepam for the home treatment of acute seizures in pediatric patients with epilepsy. [2010.08]
OBJECTIVE: To compare intranasal midazolam, using a Mucosal Atomization Device (IN-MMAD), with rectal diazepam (RD) for the home treatment of seizures in children with epilepsy... CONCLUSIONS: There was no detectable difference in efficacy between IN-MMAD and RD as a rescue medication for terminating seizures at home in pediatric patients with epilepsy. Ease of administration and overall satisfaction was higher with IN-MMAD compared with RD. Trial Registration clinicaltrials.gov Identifier: NCT00326612.

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)...

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Clinical Trials Related to Diastat Acudial (Diazepam Rectal)

Comparison of Absorption of Vaginal Diazepam Using Different Delivery Systems [Terminated]
The purpose of this study is to determine which of three delivery systems of vaginal diazepam have the best systemic absorption, measured by serum diazepam levels. The three delivery systems are: moistened tablet, suppository or cream. Additionally the study will compare the side effects and absorption of vaginal diazepam with oral diazepam. Vaginal diazepam is used off-label vaginally to relax pelvic floor muscles and reduce pelvic pain caused from pelvic floor dysfunction.

A Study of Diazepam After Intranasal and Intravenous Administration to Healthy Volunteers [Completed]
The purpose of this clinical research study is to assess the bioavailability and pharmacokinetics of two formulations of diazepam after intranasal (nasal spray) and injectable diazepam after intravenous (I. V.) administration

A Study to Determine the Bioavailability, Safety and Tolerability of Diazepam Nasal Spray Versus Diazepam Rectal Gel (Diastat®) [Recruiting]
This is a multi-center, open-label, crossover, pharmacokinetic, bioavailability study involving adolescents and adults with refractory (drug-resistant) epilepsy

Intranasal Midazolam Versus Rectal Diazepam for Treatment of Seizures [Completed]
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.

Prevention of Posttraumatic Stress Disorder (PTSD) With Diazepam [Active, not recruiting]

PTSD is a pervasive and frequent disorder. Early psychological treatment - but not

pharmacology - effectively prevent PTSD.

Current pharmacological studies did not include treatment given immediately after trauma exposure. However, a recent study of opiates suggests that their early administration may reduce the

likelihood of developing PTSD - possibly by mitigating early post-traumatic distress (UCR) -

within an adequate window of time.

Benzodiazepines are often used to reduce anxiety and agitation during stressful situations -

including traumatic event. These compounds may increase the likelihood of developing PTSD when administered few days

after the traumatic event - but their effect as an immediate intervention has not been

studied - despite their frequent and uninformed use at this stage.

This work will evaluate the effect of diazepam - a BZ compound - on PTSD symptom trajectory

following traumatic event in a randomized controlled design. Following the studies of opiates it is hoped that diazepam, administered within hours of the traumatic event, and before the first night sleep (a memory consolidating condition) will reduce the likelihood of developing PTSD. However, an adverse effect cannot be excluded, and thus the investigators posit a bidirectional hypothesis. The importance of this work is that it will provide the necessary evidence to sanction a frequently practiced use of benzodiazepines.

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Page last updated: 2011-12-09

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