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.

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.

For the caregiver giving Diastat AcuDial

• Read the Instructions for Use that come with Diastat AcuDial before using it.
• Use Diastat AcuDial exactly as your healthcare provider tells you to.
• Step-by-step instructions
  • Lie the person down and put them on their side where they can't fall.
  • Get the Diastat AcuDial.
  • Get the syringe, check the dose and green "ready" band is visible.
  • To remove the cap from the syringe push up with your thumb and pull the cap with your. other hand. Make sure the Seal Pin is removed with the cap.
  • Lubricate the rectal tip with lubricating jelly.
  • Turn the person on their side facing you. Pull there pants down below their bottom.
  • Bend their upper leg forward to expose their rectum.
  • Separate the buttock to expose their rectum.
  • Gently insert the Diastat AcuDial syringe into the rectum so that the rim of the syringe fits snuggly against the rectal opening.
  • Slowly count to 3 while gently pushing the plunger in until it stops.
  • Slowly count to 3 before removing the syringe from the rectum.
  • Slowly count to 3 while holding the buttocks together to prevent the gel from leaking out.
  • Keep the person on their side facing you and note the time Diastat AcuDial was administered while continuing to watch them.
  • Watch the person for 4 hours and take note of any changes in the resting breathing rate or color. Also watch for possible side effects.
  • Based on the doctor's directions or prescription a second dose of Diastat AcuDial may be required. If a second dose is needed, give it 4 to 12 hours after the first dose.

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

• Seizure(s) continues 15 minutes after giving Diastat AcuDial or as per doctor's instructions.
• Seizure behavior is different from other episodes.
• You are alarmed by the frequency or severity of the seizure(s).
• You are alarmed by the color or breathing of the person.
• The person is having unusual or serious problems.

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

• 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

Do not use Diastat AcuDial if:

• you are allergic to diazepam or any of the ingredients in Diastat AcuDial. See below for a complete list of ingredients in Diastat AcuDial
• you have an eye condition known as acute narrow angle glaucoma
• you are taking opioids unless you are instructed to do so and are supervised by a health care provider.
• prolonged sleepiness has been observed in infants treated with diazepam. Therefore, diazepam rectal gel is not recommended for use in children under six months of age.

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:

• have asthma
• have pneumonia
• kidney disease
• liver disease
• have a history of drug abuse, misuse or addiction
• have an eye condition known as acute narrow angle glaucoma

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.

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

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.

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.

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.