AVAILABLE: It's the exact same medication — the authorized generic version of DIASTAT® ACUDIAL™
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DIASTAT ACUDIAL Can Help Control a Prolonged Breakthrough Seizure

  • DIASTAT ACUDIAL  is an at-home medication for patients 2 years of age and older on stable antiepileptic drugs (AEDs) who require occasional use of diazepam to control bouts of increased seizure activity or prolonged breakthrough seizures (increased seizure activity; also called serial or cluster seizures)
  • A prolonged breakthrough seizure can occur anytime, anywhere—even if you or your loved one is taking AEDs
  • DIASTAT ACUDIAL  can control a seizure after it starts—possibly avoiding a visit to the emergency room (individual results may vary)
  • DIASTAT ACUDIAL  is ready wherever you need it—home, school, work, vacations, etc
  • It is recommended that DIASTAT ACUDIAL  gel be used to treat no more than five episodes per month and no more than one episode every
    five days

Administration Instructions provide patients, family, and caregivers easy-to-understand instructions on how to treat the seizure immediately—anytime or anywhere, with DIASTAT ACUDIAL 

» Administration Instructions

The Seizure Treatment Preparedness Plan can be used to create personalized step-by-step instructions for family and caregivers to follow, to help assure that the patient’s prolonged breakthrough seizure is treated properly and his or her medical needs are met. Work with your physician to complete the Preparedness Plan.

» Adult Seizure Treatment Preparedness Plan
» Child Seizure Treatment Preparedness Plan
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DIASTAT device

Before You Leave
the Pharmacy

Make sure the DIASTAT ACUDIAL  is
properly dialed and locked before use. »LEARN MORE

INDICATIONS AND USAGE

DIASTAT® (diazepam rectal gel) 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.

IMPORTANT SAFETY INFORMATION

  • Potentially fatal effects (trouble breathing and sedation) may occur if DIASTAT is used with opioids. Do not use DIASTAT while you are taking opioids unless you are instructed to do so and are supervised by a health care provider.
  • Do not use DIASTAT if you are allergic to diazepam.
  • Do not use DIASTAT if you have an eye condition known as acute narrow angle glaucoma.
  • If you are a caregiver administering DIASTAT, ensure that you have read and understand the Administration and Disposal Instructions section of the DIASTAT 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, and (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, 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.
  • Do not operate machinery, drive a motor vehicle, or ride a bike until you no longer feel the effects of DIASTAT.
  • Do not use DIASTAT 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.
  • 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.
  • The controlled studies demonstrating the effectiveness of diazepam rectal gel included children two years of age and older. The efficacy and safety of diazepam rectal gel in children under two years of age has not been established.
  • 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 if you are nursing, pregnant, or of childbearing potential.
  • 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 more frequently than recommended may lead to physical dependence. Suddenly stopping or reducing the dose of DIASTAT 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.
  • The most frequent side effect reported for DIASTAT 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.

Please click here for full Prescribing Information including Boxed Warning for risks from concomitant use with opioids; abuse, misuse, and addiction; and dependence and withdrawal reactions.

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INDICATION

DIASTAT® (diazepam rectal gel) 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.

IMPORTANT SAFETY INFORMATION

  • Potentially fatal effects (trouble breathing and sedation) may occur if DIASTAT is used with opioids. Do not use DIASTAT while you are taking opioids unless you are instructed to do so and are supervised by a health care provider.
  • Do not use DIASTAT if you are allergic to diazepam.
  • Do not use DIASTAT if you have an eye condition known as acute narrow angle glaucoma.
  • If you are a caregiver administering DIASTAT, ensure that you have read and understand the Administration and Disposal Instructions section of the DIASTAT 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, and (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, 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.
  • Do not operate machinery, drive a motor vehicle, or ride a bike until you no longer feel the effects of DIASTAT.
  • Do not use DIASTAT 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.
  • 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.
  • The controlled studies demonstrating the effectiveness of diazepam rectal gel included children two years of age and older. The efficacy and safety of diazepam rectal gel in children under two years of age has not been established.
  • 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 if you are nursing, pregnant, or of childbearing potential.
  • 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 more frequently than recommended may lead to physical dependence. Suddenly stopping or reducing the dose of DIASTAT 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.
  • The most frequent side effect reported for DIASTAT 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.

Please click here for full Prescribing Information including Boxed Warning for risks from concomitant use with opioids; abuse, misuse, and addiction; and dependence and withdrawal reactions.