Diazepam Rectal

Diastat (dye-ah-stat) is the brand name used in the United States and Canada for the seizure medicine with the generic name diazepam in the form of a gel that is inserted into the patient's rectum to stop a cluster of repeated seizures. Similar products are available in the UK and elsewhere.

Diazepam was first used in the United States in 1968. The pill form (best known by the brand name Valium, but also available in many generic forms) is too slowly absorbed when taken by mouth to be used to stop a seizure, and is only moderately effective against epilepsy. If diazepam pills are used daily, they become less effective as tolerance develops, and dependence also becomes a problem. Emergency personnel sometimes give diazepam by injection to stop prolonged or repeated seizures. Diastat, the first at-home alternative, was approved by the United States Food and Drug Administration (FDA) in 1997.

Diastat

Diastat (DYE-ah-stat) is the brand name used in the United States and Canada for the seizure medicine with the generic name diazepam (dye-az-eh-pam). It is available in a gel form that is inserted into the patient’s rectum to stop a cluster of repeated seizures. Similar products are available in the UK and other countries. It was approved by the United States Food and Drug Administration (FDA) in 1997 as the first at-home alternative to treat clusters of seizures.

Liquid Injection
Diastat Rectal Delivery System

"Quick-Dose" rectal delivery system (resembling a syringe with a flexible, molded tip):

  • Pediatric: 2.5 mg, 5 mg
  • "Universal": 10 mg
  • Adult: 15 mg, 20 mg

Indications

Diastat is a gel formulation of diazepam intended for rectal administration in the management of selected patients with refractory epilepsy, on stable regimens of antiepileptic drugs, who require intermittent use of diazepam to control bouts of increased seizure activity.

Bouts of increased seizure activity are often called seizure clusters.

Forms

Diastat is distributed in the United States by Valeant. The name or appearance may differ in other places. The dose will usually be the same. These descriptions apply to the U.S. versions:

Efficacy of Diazepam Rectal

Two randomized, double-blind studies compared Diastat to placebo. The first study enrolled 91 patients (47 children, 44 adults), who received the first dose of Diastat at the onset of an identified seizure episode. Children were given a second dose four hours later whereas adults were dosed four and 12 hours after the first dose. The median seizure frequency for the Diastat treated group was zero seizures per hour, compared to a median seizure frequency of 0.3 seizures per hour for the placebo group (p < 0.0001). In addition, 62% of patients treated with Diastat were seizure-free during the observation period (12 hours for children, 24 hours for adults) compared to 20% of placebo patients.

The second study enrolled 114 patients (53 children, 61 adults). The dose was given at the onset of the identified episode. The median seizure frequency for the Diastat-treated group was zero seizures per 12 hours, compared to 2.0 seizures per 12 hours for the placebo group (p < 0.03). Patients treated with Diastat also had prolonged time-to-next-seizure compared to placebo (p = 0.0072).

Common side effects of Diazepam Rectal

In clinical trials, the most frequent adverse event reported was somnolence (23%). Less frequent adverse events reported were dizziness, headache, pain, abdominal pain, nervousness, vasodilation, diarrhea, ataxia, euphoria, incoordination, asthma, rhinitis, and rash (2% - 5%).

Impact of Diazepam Rectal on bone health

Please see package insert. 

Other Uses of Diazepam Rectal

Some physicians have recommended the use of Diastat in children with a history of febrile seizures in the event they develop a high fever in order to prophylax against febrile seizures.

Diazepam Rectal Contraindications

Diastat is contraindicated in patients with a known hypersensitivity to diazepam and in patients with acute narrow angle glaucoma.

Diazepam Rectal Interactions with other medications

See package insert.

Diazepam Rectal effects on Children

Read package insert.

Diazepam Rectal and Pregnancy

Read package insert.

Diazepam Rectal effects on Seniors

Read package insert.

Diazepam Rectal Dosing and titration

The following information is adapted from the package insert for Diastat.

Calculating Prescribed Dose

The Diastat dose should be individualized for maximum beneficial effect. The recommended dose of Diastat is 0.2-0.5 mg/kg depending on age.

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 Diastat is provided in fixed, unit-doses of 5, 10, 15 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.

The rectal delivery system includes a plastic applicator with a flexible, molded tip available in two lengths, designated for convenience as “Pediatric”, “Universal” and “Adult”. The 2.5 and 5 mg dosages are available with a 4.4 cm Pediatric tip, the 10 mg dosage is available with a 4.4 cm Universal tip and the 15 and 20 mg dosages are available with a 6.0 cm Adult tip. It is important to note that if a 15 mg dose is to be administered to a pediatric patient utilizing the plastic applicator with a pediatric tip, prescriptions must be written for 2 different twin packs, one for the 5 mg dosage and one for the 10 mg dosage.

The prescribed dose of Diastat should be adjusted by the physician periodically to reflect changes in the patient’s age or weight. It is recommended that dosage be reviewed at six month intervals.

A 2.5 mg dose is available for use as a supplemental dose. This dose may be prescribed at the discretion of the physician for patients who require more precise dose titration than is achieved using one of the four standard doses provided. The 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 Diastat. A second dose, when required, may be given 4-12 hours after the first dose.

Treatment Frequency

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

Diazepam Rectal Package insert

In the United States, companies that manufacture medicines are required to publish certain kinds of information about each product. This document is commonly known as a “package insert” because it is usually included with each package of the medicine.

You can also read these documents (also called "prescribing information") online. The U.S. package insert for Diastat (diazepam) is found at:

Some of the information may differ in other countries.

To learn how to read and understand a package insert, see "How to read a package insert."

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