Diastat AcuDial  Can 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 Diazepam rectal 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 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 Preparedness Plan
» Child Preparedness Plan

Before You Leave
the Pharmacy

Make sure the Diastat AcuDial  is
properly dialed and locked before use.
»LEARN MORE
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INDICATION

DIASTAT® (diazepam rectal gel) is a gel formulation of diazepam intended for rectal administration for certain patients with epilepsy who are already taking antiepileptic medications, and who require occasional use of diazepam to control bouts of increased seizure activity.

IMPORTANT SAFETY INFORMATION
  • Potentially fatal additive effects (respiratory depression and sedation) may occur if Diastat or Diastat AcuDial is used with opioids. Do not to use such drugs together unless 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 accompanying Administration and Disposal Instructions. 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.
  • 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 effects. Talk to your doctor if you have any questions about medications or products that you should not use in combination with DIASTAT.
  • Prolonged CNS depression has been observed in neonates treated with diazepam. Therefore, diazepam rectal gel is not recommended for use in children under six months of age.
  • The controlled trials demonstrating the effectiveness of Diazepam rectal gel included children two years of age and older. Clinical studies have not been conducted to establish the efficacy and safety of Diazepam rectal gel in children under two years of age.
  • Pregnancy Category D - No clinical studies have been conducted with diazepam rectal gel in pregnant women. Data from several sources raise 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. Use no more than every five days and no more than five times per month.
  • The most frequent side effect reported for DIASTAT in clinical trials was somnolence (sleepiness or drowsiness). Other side effects include 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 Valeant Customer Service at 1-800-556-1937.

» Click here for full Prescribing Information for Diastat including Boxed Warning regarding potentially fatal interactions with opioids.

INDICATIONS AND USAGE

DIASTAT® (diazepam rectal gel) is a gel formulation of diazepam intended for rectal administration for certain patients with epilepsy who are already taking antiepileptic medications, and who require occasional use of diazepam to control bouts of increased seizure activity.

IMPORTANT SAFETY INFORMATION
  • Potentially fatal additive effects (respiratory depression and sedation) may occur if Diastat or Diastat AcuDial is used with opioids. Do not to use such drugs together unless 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 accompanying Administration and Disposal Instructions. 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.
  • 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 effects. Talk to your doctor if you have any questions about medications or products that you should not use in combination with DIASTAT.
  • Prolonged CNS depression has been observed in neonates treated with diazepam. Therefore, diazepam rectal gel is not recommended for use in children under six months of age.
  • The controlled trials demonstrating the effectiveness of Diazepam rectal gel included children two years of age and older. Clinical studies have not been conducted to establish the efficacy and safety of Diazepam rectal gel in children under two years of age.
  • Pregnancy Category D - No clinical studies have been conducted with diazepam rectal gel in pregnant women. Data from several sources raise 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. Use no more than every five days and no more than five times per month.
  • The most frequent side effect reported for DIASTAT in clinical trials was somnolence (sleepiness or drowsiness). Other side effects include 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 Valeant Customer Service at 1-800-556-1937.

» Click here for full Prescribing Information for Diastat including Boxed Warning regarding potentially fatal interactions with opioids.

INDICATION

DIASTAT® (diazepam rectal gel) is a gel formulation of diazepam intended for rectal administration for certain patients with epilepsy who are already taking antiepileptic medications, and who require occasional use of diazepam to control bouts of increased seizure activity.

IMPORTANT SAFETY INFORMATION
  • Potentially fatal additive effects (respiratory depression and sedation) may occur if Diastat or Diastat AcuDial is used with opioids. Do not to use such drugs together unless 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 accompanying Administration and Disposal Instructions. 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.
  • 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 effects. Talk to your doctor if you have any questions about medications or products that you should not use in combination with DIASTAT.
  • Prolonged CNS depression has been observed in neonates treated with diazepam. Therefore, diazepam rectal gel is not recommended for use in children under six months of age.
  • The controlled trials demonstrating the effectiveness of Diazepam rectal gel included children two years of age and older. Clinical studies have not been conducted to establish the efficacy and safety of Diazepam rectal gel in children under two years of age.
  • Pregnancy Category D - No clinical studies have been conducted with diazepam rectal gel in pregnant women. Data from several sources raise 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. Use no more than every five days and no more than five times per month.
  • The most frequent side effect reported for DIASTAT in clinical trials was somnolence (sleepiness or drowsiness). Other side effects include 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 Valeant Customer Service at 1-800-556-1937.

» Click here for full Prescribing Information for DIastat including Boxed Warning regarding potentially fatal interactions with opioids.







 
INDICATION

DIASTAT® (diazepam rectal gel) is a gel formulation of diazepam intended for rectal administration for certain patients with epilepsy who are already taking antiepileptic medications, and who require occasional use of diazepam to control bouts of increased seizure activity.

IMPORTANT SAFETY INFORMATION
  • Potentially fatal additive effects (respiratory depression and sedation) may occur if Diastat or Diastat AcuDial is used with opioids. Do not to use such drugs together unless 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 accompanying Administration and Disposal Instructions. 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.
  • 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 effects. Talk to your doctor if you have any questions about medications or products that you should not use in combination with DIASTAT.
  • Prolonged CNS depression has been observed in neonates treated with diazepam. Therefore, diazepam rectal gel is not recommended for use in children under six months of age.
  • The controlled trials demonstrating the effectiveness of Diazepam rectal gel included children two years of age and older. Clinical studies have not been conducted to establish the efficacy and safety of Diazepam rectal gel in children under two years of age.
  • Pregnancy Category D - No clinical studies have been conducted with diazepam rectal gel in pregnant women. Data from several sources raise 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. Use no more than every five days and no more than five times per month.
  • The most frequent side effect reported for DIASTAT in clinical trials was somnolence (sleepiness or drowsiness). Other side effects include 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 Valeant Customer Service at 1-800-556-1937.

» Click here for full Prescribing Information for Diastat including Boxed Warning regarding potentially fatal interactions with opioids.