AVAILABLE: It's the exact same medication — the authorized generic version of DIASTAT® ACUDIAL
LEARN MORE

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.

AcusStat AcuDial Device

2. You have thoroughly read these instructions

3. Reviewed administration steps with the doctor

4. Understand the directions

Please do not administer DIASTAT ACUDIAL  until you feel comfortable with how to use DIASTAT ACUDIAL . The doctor will tell you exactly when to use DIASTAT ACUDIAL . When you use DIASTAT ACUDIAL  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

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.

toggle sticky footer menu

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.







 

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.