Answers to Frequently Asked Questions.

What is Diastat AcuDial ?

Diastat AcuDial  (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.

When should Diastat AcuDial  be given?

To control increased seizure activity, give Diastat AcuDial  during acute repetitive seizure episodes or as directed by your physician.
A repetitive seizure is a seizure that follows soon after another seizure ends.

The doctor will tell you and your caregiver exactly when to use Diastat AcuDial . By using Diastat AcuDial  correctly, you can help bring breakthrough 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.

To help the person with seizures:
  • You must be able to tell the difference between cluster and
    ordinary seizures
  • You must be comfortable and satisfied that you are able to give Diastat AcuDial 
  • You need to agree with the doctor on the exact conditions when to treat with Diastat AcuDial 
  • You must know how and for how long you should check the person after giving Diastat AcuDial 
To know what responses to expect:
  • You need to know how soon seizures should stop or decrease in frequency after giving Diastat AcuDial 
  • You need to know what you should do if the seizures do not stop or there is a change in the person’s breathing, behavior, or condition that alarms you

If you have any questions or feel unsure about using the treatment, CALL THE DOCTOR before using Diastat AcuDial .

How soon should the seizure(s) stop after giving Diastat AcuDial ?

If seizure(s) continue 15 minutes after giving Diastat AcuDial, or per the doctor's instructions, your caregiver should call for medical help.

Do I still need to take my other seizure medications after Diastat AcuDial  stops my seizures?

Diastat AcuDial  does not replace other medications. Do not stop taking any other medications as prescribed and directed by your healthcare provider.

What does my caregiver need to know about Diastat AcuDial ?

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

Before administering Diastat AcuDial  for the first time, your caregiver must read and completely understand the dosing instructions. Your healthcare provider should provide this information to you and your caregiver. After administering Diastat AcuDial, your caregiver must stay with you for 4 hours and make notes if any of the following occur: changes in resting breathing rate, changes in color, and possible side effects from treatment.

What side effects could occur?

Diastat AcuDial  has been used in children 2 years of age or older and adults. The most frequent side effect in the clinical studies was 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 or your caregiver should tell your doctor about any side effects that you experience.

Why is it important not to use Diastat  or Diastat AcuDial while taking opioids?

Potentially fatal effects (trouble breathing and sedation) may occur if Diastat  or Diastat AcuDial  is used with opioids. Do not use Diastat  or Diastat AcuDial  while you are taking opioids unless you are instructed to do so and are supervised by a health care provider.

When should my caregiver call for emergency help?

There are certain situations that require medical help. Your doctor or nurse should explain when your caregiver should seek medical help. Here are some examples:

  • Seizure(s) continues 15 minutes after giving Diastat AcuDial  or per the doctor's instructions
  • Seizure behavior is different from other episodes
  • The frequency or severity of the seizure(s) is alarming
  • The color or breathing of the person is alarming
  • Any other unusual or serious problems

Before You Leave
the Pharmacy

Make sure the Diastat AcuDial  is
properly dialed and locked before use. »LEARN MORE
Fpo
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 effects (trouble breathing and sedation) may occur if DIASTAT or DIASTAT AcuDial 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.
  • 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 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 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 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 Companies Inc. Customer Service at 1-800-556-1937.

Please click here for full Prescribing Information 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 effects (trouble breathing and sedation) may occur if DIASTAT or DIASTAT AcuDial 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.
  • 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 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 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 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 Companies Inc. Customer Service at 1-800-556-1937.

Please click here for full Prescribing Information 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 effects (trouble breathing and sedation) may occur if DIASTAT or DIASTAT AcuDial 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.
  • 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 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 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 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 Companies Inc. Customer Service at 1-800-556-1937.

Please click here for full Prescribing Information 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 effects (trouble breathing and sedation) may occur if DIASTAT or DIASTAT AcuDial 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.
  • 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 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 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 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 Companies Inc. Customer Service at 1-800-556-1937.

Please click here for full Prescribing Information including Boxed Warning regarding potentially fatal interactions with opioids.