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Diastat AcuDial

Generic name: diazepam
Brand names: Diastat, Diastat AcuDial
Dosage form: rectal gel
Drug class: Benzodiazepine anticonvulsants

Medically reviewed by Philip Thornton, DipPharm. Last updated on Apr 4, 2023.

What is Diastat AcuDial?

Diastat AcuDial is a rectal gel used to treat seizures in people with epilepsy. Diastat AcuDial contains the medication diazepam, which belongs to a class of drugs called benzodiazepine anticonvulsant medications.

Diastat AcuDial works by reducing the excitability of nerve cells or neurons in the brain. It does this by helping a neurotransmitter called gamma-aminobutyric acid (GABA) work. GABA is a chemical messenger that blocks impulses between nerve cells.

Diastat AcuDial is given via a rectal delivery system. The rectal delivery system combines a pre-filled syringe with a plastic applicator with a flexible, molded tip which is used to deliver the medication into the rectum. The syringe has a window on it that displays the dose and a green band that confirms when the dose is ready to be given.

Diastat AcuDial contains the same gel formulation of diazepam as Diastat, which uses an older rectal delivery system that doesn't have a window displaying the dose of the medication.

Diastat was approved by the US Food and Drug Administration (FDA) in 1997. When the new delivery system - Diastat AcuDial - was approved in 2005, only the lowest strength pre-filled syringe of Diastat (containing diazepam 2.5mg/0.5ml) remained on the market. The higher strength versions of Diastat were discontinued at that time.

What is Diastat AcuDial used for?

Diastat AcuDial is used to treat occasional episodes of increased seizures that are different from a patient’s usual seizure pattern in patients with epilepsy 2 years of age and older.

It is not know whether Diastat AcuDial is safe and effective in children under 2 years of age.

Federal law prohibits the transfer of this medication to any person other than the person for whom it was prescribed.

Important information

Diastat AcuDial may cause serious side effects including:

Who should not use Diastat AcuDial?

Do not use Diastat AcuDial if:

What should I tell my doctor before using Diastat AcuDial?

Before using Diastat AcuDial tell you healthcare provider about all of your medical conditions, including if you:

Before using Diastat AcuDial, discus with the healthcare provider any additional steps you may need to take if there is leakage of Diastat AcuDial or a bowel movement.

How should I use Diastat AcuDial?

For the caregiver giving Diastat AcuDial

Call for help if any of the following occur when using Diastat AcuDial

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using Diastat?

Do not operate machinery, drive a motor vehicle, or ride a bike until you no longer feel the effects of Diastat AcuDial.

Do not use Diastat AcuDial with alcohol or in combination with other Central Nervous System (CNS) medications or products that cause respiratory (breathing) or CNS depressant effects. Talk to your doctor if you have any questions about medications or products that you should not use in combination with Diastat.

Dosing information

The recommended dose of Diastat AcuDial depends on the age of the person:

The following tables provide acceptable weight ranges for each dose and age category

2-5 years
0.5 mg/kg
Weight (kg) Dose (mg)
6 to 10 5
11 to 15 7.5
16 to 20 10
21 to 25 12.5
26 to 30 15
31 to 35 17.5
36 to 44 20
6-11 years
0.3 mg/kg
Weight (kg) Dose (mg)
10 to 16 5
17 to 25 7.5
26 to 33 10
34 to 41 12.5
42 to 50 15
51 to 58 17.5
59 to 74 20
12+ years
0.2 mg/kg
Weight (kg) Dose (mg)
14 to 25 5
26 to 37 7.5
38 to 50 10
51 to 62 12.5
63 to 75 15
76 to 87 17.5
88 to 111 20

What are the side effects of Diastat?

Suddenly stopping or reducing the dose of Diastat AcuDial very quickly may precipitate acute withdrawal reactions, which can be life-threatening. In some cases, patients have developed withdrawal symptoms lasting weeks to more than 12 months, including but not limited to:

The most frequent side effect reported for Diastat AcuDial in clinical studies was somnolence (sleepiness or drowsiness).

Other side effects included dizziness, headache, pain, abdominal pain, nervousness, vasodilation (increase in diameter of blood vessel), diarrhea, ataxia/incoordination (lack of coordination), euphoria (feeling of great happiness or well-being), asthma, rhinitis (irritation of the nose similar to an allergy or a cold), and rash.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

You may also contact Bausch Health Customer Service at 1-800-321-4576.

Interactions

Potentially fatal effects (trouble breathing and sedation) may occur if Diastat AcuDial is used with opioids or other benzodiazepines. Do not use Diastat AcuDial while you are taking opioids unless you are instructed to do so and are supervised by a health care provider.

Do not use Diastat AcuDial with alcohol or in combination with other Central Nervous System (CNS) medications or products that cause respiratory (breathing) or CNS depressant effects.

Pregnancy and breastfeeding

No clinical studies have been conducted with diazepam rectal gel in pregnant women. There are concerns about the use of diazepam during pregnancy. Talk to your doctor before using Diastat AcuDial if you are nursing, pregnant, or of childbearing potential.

Storage

Keep out of reach of children.

What are the ingredients in Diastat AcuDial?

Active ingredients: diazepam

Inactive ingredients: propylene glycol, alcohol, unspecified hypromellose, sodium benzoate, benzyl alcohol, benzoic acid, water

Diastat and Diastat AcuDial contain the same diazepam rectal gel. An authorized generic versions of diazepam rectal gel is also available.

Diastat AcuDial is manufactured for Bausch Health US, LLC Bridgewater, NJ 08807 USA by DPT Laboratories, Ltd San Antonio, TX 78215 USA.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.