Generic name: DIAZEPAM 10mg in 2mL
Dosage form: rectal gel
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(see also Patient/Caregiver Package Insert)
This section is intended primarily for the prescriber; however, the prescriber should also be aware of the dosing information and directions for use provided in the patient package insert.
A decision to prescribe Diazepam rectal gel involves more than the diagnosis and the selection of the correct dose for the patient.
First, the prescriber must be convinced from historical reports and/or personal observations that the patient exhibits the characteristic identifiable seizure cluster that can be distinguished from the patient¹s usual seizure activity by the caregiver who will be responsible for administering Diazepam rectal gel.
Second, because Diazepam rectal gel is only intended for adjunctive use, the prescriber must ensure that the patient is receiving an optimal regimen of standard anti-epileptic drug treatment and is, nevertheless, continuing to experience these characteristic episodes.
Third, because a non-health professional will be obliged to identify episodes suitable for treatment, make the decision to administer treatment upon that identification, administer the drug, monitor the patient, and assess the adequacy of the response to treatment, a major component of the prescribing process involves the necessary instruction of this individual.
Fourth, the prescriber and caregiver must have a common understanding of what is and is not an episode of seizures that is appropriate for treatment, the timing of administration in relation to the onset of the episode, the mechanics of administering the drug, how and what to observe following administration, and what would constitute an outcome requiring immediate and direct medical attention.
Calculating Prescribed Dose
The Diazepam rectal gel dose should be individualized for maximum beneficial effect. The recommended dose of Diazepam rectal gel is 0.2-0.5 mg/kg depending on age. See the dosing table for specific recommendations.
|Age (years)||Recommended Dose|
|2 through 5||0.5 mg/kg|
|6 through 11||0.3 mg/kg|
|12 and older||0.2 mg/kg|
Because Diazepam rectal gel is provided as unit doses of 2.5, 5, 7.5, 10, 12.5, 15, 17.5, and 20 mg, the prescribed dose is obtained by rounding upward to the next available dose. The following table provides acceptable weight ranges for each dose and age category, such that patients will receive between 90% and 180% of the calculated recommended dose. The safety of this strategy has been established in clinical trials.
|2-5 Years||6-11 years||12+ Years|
|0.5 mg/kg||0.3 mg/kg||0.2 mg/kg|
|6 to 10||5||10 to 16||5||14 to 25||5|
|11 to 15||7.5||17 to 25||7.5||26 to 37||7.5|
|16 to 20||10||26 to 33||10||38 to 50||10|
|21 to 25||12.5||34 to 41||12.5||51 to 62||12.5|
|26 to 30||15||42 to 50||15||63 to 75||15|
|31 to 35||17.5||51 to 58||17.5||76 to 87||17.5|
|36 to 44||20||59 to 74||20||88 to 111||20|
The rectal delivery system includes a plastic applicator with a flexible, molded tip available in two lengths. The Diastat® AcuDial™ 10-mg syringe is available with a 4.4 cm tip and the Diastat® AcuDial™ 20 mg syringe is available with a 6.0 cm tip. Diastat® 2.5 mg is also available with a 4.4cm tip.
In elderly and debilitated patients, it is recommended that the dosage be adjusted downward to reduce the likelihood of ataxia or oversedation.
The prescribed dose of Diazepam rectal gel should be adjusted by the physician periodically to reflect changes in the patient¹s age or weight.
The Diastat® 2.5 mg dose may also be used as a partial replacement dose for patients who may expel a portion of the first dose.
The prescriber may wish to prescribe a second dose of Diazepam rectal gel. A second dose, when required, may be given 4-12 hours after the first dose.
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.