Diazepam Rectal Gel is a Schedule IV controlled drug substance and should be administered no more frequently than every 5 days and no more than 5 times a month.
Diazepam Rectal gel is contraindicated in patients with acute narrow angle glaucoma.
Diazepam rectal gel should only be administered by caregivers who, in the opinion of the prescribing physician, (1) can identify the difference between cluster of seizures (and/or the events that precipitate the onset of seizures) from ordinary seizure activity, (2) are judged to be able to use product as instructed, (3) understand which seizures may or may not be treated with diazepam rectal gel, and (4) monitor the effect of diazepam rectal gel and know when to seek professional medical help.
Patients must be cautioned that diazepam rectal gel causes Central Nervous System (CNS) depression. Patients need to be advised against operating machinery, driving a motor vehicle, or riding a bike until they no longer feel the effects of the medication. Diazepam should not be used with alcohol or other CNS products that cause respiratory or CNS depressant effects. Prolonged CNS depression has been observed in neonates treated with diazepam; therefore diazepam rectal gel is not recommended for use in children under 6 months of age.
Because of general concerns about benzodiazepines, diazepam rectal gel should be used in pregnant women only after the physician considers the risk to the fetus.
Tonic status epilepticus has been precipitated in patients treated with IV diazepam for petit mal status or petit mal variant status.
Diazepam rectal gel should be used with caution in patients with compromised respiratory function, in patients with kidney or liver disease, in the elderly, and in nursing women. Although diazepam rectal gel is indicated only intermittently, the potential for synergistic CNS depressant effects and drug interactions should be considered.
The most frequent adverse event reported with the use of diazepam rectal gel in clinical trials was somnolence (23%). Less frequent adverse events reported (≤5%) were dizziness, headache, pain, vasodilation, diarrhea, ataxia, euphoria, incoordination, asthma, rash, abdominal pain, nervousness and rhinitis.
Please see full DIASTAT AcuDial Prescribing Information.