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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Save up to $60* off your
next prescription of
Diastat AcuDial 

*Eligible patients to pay first $10 of their copay or retail cost of the prescription before the $60 benefit is applied.
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Eligibility/Terms and Conditions
By using the DIASTAT Savings Card, you confirm that you understand and agree to comply with the following terms and conditions of this offer. This offer is only valid for patients with commercial insurance. This offer is not valid for any person eligible for reimbursement of prescriptions, in whole or in part, by any federal, state, or other governmental programs, including, but not limited to, Medicare (including Medicare Advantage and Part A, B, and D plans), Medicaid, TRICARE, Veterans Administration or Department of Defense health coverage, CHAMPUS, the Puerto Rico Government Health Insurance Plan or any other federal or state health care programs. You agree not to seek reimbursement for all or any part of the benefit received through this offer and are responsible for making any required reports of your use of this offer to any insurer or other third party who pays any part of the prescription filled. This offer is good only in the United States of America (including the District of Columbia, Puerto Rico and the U.S. Virgin Islands) at participating retail pharmacies. You must be 18 years of age or older to redeem this offer for yourself or a minor. You must present the coupon along with your prescription to participate in this program. The coupon is good for use only with the products identified herein. No other purchase is necessary. This offer cannot be redeemed at government-subsidized clinics. The coupon is good for a maximum of 1 prescription fill and has a maximum value. You are responsible for paying any remaining amount over the maximum value. The coupon and offer are not health insurance. The selling, purchasing, trading, or counterfeiting of the coupon is prohibited by law. Void if reproduced. This offer is not valid with other offers. The coupon has no cash value. No cash back. Valeant Pharmaceuticals reserves the right to rescind, revoke, terminate, or amend this offer at any time, without notice. You understand and agree to comply with the terms and conditions of this offer as set forth above. This offer and coupon expire on 12/31/17. For questions, please call 1-844-492-9894.

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.