Diastat

Generic name: Diazepam
Dosage form: rectal gel
Drug class: Benzodiazepine anticonvulsants

Usage of Diastat

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.

Diastat side effects

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:

anxiety

difficulty thinking

mental changes

depression

insomnia

abnormal skin sensations

muscle weakness

tremors

twitching

ringing in your ears

burning or prickling feeling in your hands, arms, or feet

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.

Before taking Diastat

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.

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How to use Diastat

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

2-5 years of age: 0.5 mg/kg

6-11 years of age: 0.3 mg/kg

12 years of age and older: 0.2 mg/kg

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

See the full prescribing information for additional information about dosing

Some people may need to round their dose of Diastat AcuDial up or down. Check with your doctor about what is right for you

Diastat AcuDial 10 mg syringe comes with a 4.4 cm tip

Diastat AcuDial 20 mg syringe comes with a 6.0 cm tip

Diastat 2.5 mg comes with a 4.4 cm tip

Warnings

Diastat AcuDial may cause serious side effects including:

Potentially fatal effects (trouble breathing and sedation) may occur if Diastat AcuDial is used with opioids. 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.

If you are a caregiver administering Diastat AcuDial, ensure that you have read and understand the Administration and Disposal Instructions section of the Diastat AcuDial full Prescribing Information. Ensure that: (1) you can identify the difference between cluster of seizures (and/or the events that precipitate the onset of seizures) from ordinary seizure activity (2) a doctor confirms that you are able to use the product as instructed (3) you understand which seizures may or may not be treated with diazepam rectal gel (4) you monitor the effect of diazepam rectal gel and know when to seek professional medical help.

There is a risk of abuse, misuse, and addiction with Diastat AcuDial, which can lead to overdose and death, especially when used in combination with other medications (e.g., opioid analgesics), alcohol, and/or illicit substances and even at recommended doses. If you experience the signs and symptoms of benzodiazepine abuse, misuse, and/or addiction, including but not limited to delirium, paranoia, suicidal thoughts, seizures, and difficulty breathing, seek medical help. Dispose of unused drug properly, according to the directions from your healthcare provider.

Use with caution if you have breathing difficulties (such as asthma or pneumonia), kidney or liver disease, or are elderly. Talk to your doctor if any of these conditions apply to you, or if you are not sure if any of these conditions apply to you.

Diazepam rectal gel can cause drug addiction. Using Diastat AcuDial more frequently than recommended may lead to physical dependence. 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, including but not limited to anxiety, difficulty thinking, mental changes, depression, insomnia, abnormal skin sensations, muscle weakness, tremors, or twitching, ringing in your ears, and a burning or prickling feeling in your hands, arms, or feet, lasting weeks to more than 12 months.

What other drugs will affect Diastat

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.

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