Diastat AcuDial

INSTRUCTIONS FOR CAREGIVERS UPON RECEIPT FROM PHARMACY

  • Remove the syringe from the case.

  • Confirm the dose prescribed by your doctor is visible, and if known, is correct.

FOR EACH SYRINGE:
  • Confirm that the prescribed dose is visible in the dose display window.

  • Confirm that the green “READY” band is visible.

  • Return the syringe to the case.

SEE PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT THESE INSTRUCTIONS.

The instructions are also available on the bottom of each drug product package.

CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.

ADMINISTRATION INSTRUCTIONS
IMPORTANT

Read first before using

To the caregiver using Diastat :
Please do not give Diastat  until:

1. You have thoroughly read these instructions

2. Reviewed administration steps with the doctor

3. Understand the directions

To the caregiver using Diastat AcuDial :
Please do not give Diastat AcuDial  until:

1. You have confirmed:

  • Prescribed dose is visible and if known, is correct

  • Green “ready” band is visible

Confirm the dose and green ready band are visible.

2. You have thoroughly read these instructions

3. Reviewed administration steps with the doctor

4. Understand the directions

Please do not administer Diastat  until you feel comfortable with how to use Diastat. The doctor will tell you exactly when to use Diastat. When you use Diastat  correctly and safely you can help bring seizures under control. Be sure to discuss every aspect of your role with the doctor. If you are not comfortable, then discuss your role with the doctor again.

Where can I find more information and support?

For information on Diastat  and Diastat AcuDial :
Call 1-877-261-2719

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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.