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Pharmacology of DIASTAT® AcuDial™ (diazepam rectal gel)

Rapid seizure termination

Warnings

Treatment frequency

Chronic use

Precautions

Drug interactions

Rapid Seizure Termination
  • Rapid onset of action, begins working within 15 minutes.1


* This study was conducted with diazepam solution, not diazepam gel.

Rectal administration of diazepam is significantly faster than IM, tablet, and suppository and allows for rapid absorption without the danger of aspiration inherent in oral/buccal administration.2


* This study was conducted with diazepam solution, not diazepam gel.

The absolute bioavailability of diazepam rectal gel relative to diazepam injection is 90%3.

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Warnings: DIASTAT AcuDial should only be administered by caregivers who, in the opinion of the prescribing physician, i) can distinguish between a cluster seizures and the patient's ordinary seizure patterns, ii) have been instructed on how to administer DIASTAT AcuDial and judged to be competent to do so, iii) understand explicitly which seizures may or may not be treated with DIASTAT AcuDial, and iv) are able to monitor clinical response and recognize when the response mandates immediate professional medical evaluation.

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Treatment Frequency:

It is recommended that Diazepam rectal gel be used to treat no more than five episodes per month and no more than one episode every five days.

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Chronic Use:

Diazepam rectal gel is not recommended for chronic, daily use as an anticonvulsant because of the potential for development of tolerance to diazepam. Chronic daily use of diazepam may increase the frequency and/or severity of tonic clonic seizures, requiring an increase in the dosage of standard anticonvulsant medication. In such cases, abrupt withdrawal of chronic diazepam may also be associated with a temporary increase in the frequency and/or severity of seizures.

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Precautions:
  • Caution in renally impaired patients
  • Caution in hepatically impaired patients
  • Caution in use with patients with compromised respiratory function
  • Caution in use in elderly.

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Drug Interactions:
  • Potential for synergistic CNS-depressant effect when used simultaneously with alcohol or other CNS-depressant
  • Careful consideration if combined with other psychotropic agents
  • Clearance of diazepam and certain other benzodiazepines can be delayed in association with cimetidine administration
  • Valproate may potentiate the CNS-depressant effects of diazepam.

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Learn More About:

References:
  1. Cloyd JC, Lalonde RL, Beniak TE,Novack GD.A single-blind, crossover comparison of the pharmacokinetics and cognitive effects of a new diazepam rectal gel with intravenous diazepam. Epilepsia. 1998;39:520-526.
  2. Moolenaar F, Bakker S, Visser J, Huizinga T. Biopharmaceutics of rectal administration of drugs in man IX. Comparative biopharmaceutics of diazepam after single rectal, oral, intramuscular and intravenous administration in man. Int J Pharmaceut. 1980;5:127-137.
  3. DIASTAT AcuDial package insert. Aliso Viejo,Calif: Valeant Pharmaceuticals NA; Nov 2006.
 
IMPORTANT SAFETY INFORMATION

DIASTAT® AcuDial™ (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 for patients 2 years and older.

In clinical trials with DIASTAT®, the most frequent side effect was somnolence (23%). Less frequent adverse events reported were dizziness, headache, pain, vasodilation, diarrhea, ataxia, euphoria, incoordination, asthma, rash, abdominal pain, nervousness and rhinitis (1%-5%). Please see full DIASTAT AcuDial Prescribing Information.