Diastat Acudial (Diazepam Rectal) - Indications and Dosage

INDICATIONS AND USAGE

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.

DOSAGE AND ADMINISTRATION

(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
Weight	Dose	Weight	Dose	Weight	Dose
(kg)	(mg)	(kg)	(mg)	(kg)	(mg)
6 to10	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^® 2.5mg 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.

Additional 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.

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.

Pharmacist Instructions

HOW SUPPLIED

Diazepam rectal gel rectal delivery system is a non-sterile, prefilled, unit dose, rectal delivery system. The rectal delivery system includes a plastic applicator with a flexible, molded tip available in two lengths, designated for convenience as 10 mg Delivery System and 20 mg Delivery System. The available doses from 20 mg delivery system are 12.5 mg, 15 mg, 17.5 mg, and 20 mg. The available doses from 10 mg delivery system are 5 mg, 7.5 mg, and 10 mg. The Diazepam rectal gel delivery system is available in the following three presentations:

Diastat ®	Rectal Tip Size	NDC
2.5 mg Twin Pack	4.4 cm	NDC 66490-650-20
Diastat ® AcuDial ™	Rectal Tip Size	NDC
10 mg Delivery	4.4 cm	NDC 0187-0658-20
System Twin Pack
20 mg Delivery	6.0 cm	NDC 0187-0659-20
System Twin Pack

Each Twin Pack contains two diazepam rectal gel delivery systems, two packets of lubricating jelly, and administration and disposal Instructions available on the bottom of the package. Diastat^® AcuDial™ is also packed with Instructions for Caregivers upon receipt from pharmacy.

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).

Diastat ^® AcuDial™

INSTRUCTIONS FOR CAREGIVERS UPON RECEIPT FROM PHARMACY

• Remove the syringe from the case.

• Confirm the dose prescribed by your doctor is visible and if known, is correct.

FOR EACH SYRINGE:

• Confirm that the prescribed dose is visible in the dose display window.

• Confirm that the green “READY” band is visible.

• Return the syringe to the case.

SEE PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT THESE INSTRUCTIONS.

The instructions are also available on the bottom of each drug product package.

CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.

Valium^® is a registered trademark of Roche Pharmaceuticals.

Distributed by:
Valeant Pharmaceuticals International
One Enterprise
Aliso Viejo, CA 92656 USA

Manufactured by:
DPT Laboratories, LTD.
San Antonio, Texas 78215

128486
Rev. 11/06