Rectal Rescue Medicines
The FDA announced that there is an ongoing shortage of both brand and generic forms of diazepam rectal gel. This medication is used for rescue therapy in people with epilepsy, including children. We strongly encourage you to speak with your healthcare provider about your/your child’s options for rescue therapy, since new FDA-approved rescue therapy products have entered the market.
Diazepam rectal gel is commercially available under the brand name of Diastat® AcuDial™. The names Diastat and Diastat AcuDial refer to the same medicine. The AcuDial system is a specific way of delivering the correct amount of the medicine.
Who can use diazepam rectal gel?
Diastat has been approved by the U.S. Food and Drug Administration (FDA) for use by family members and non-medical caregivers. Prescribed by a health care provider, it can help people with refractory epilepsy (2 years of age and older) who regularly use other seizure medicines, yet also require “as needed” diazepam to control bouts of increased seizures.
- Most commonly, Diastat is used in children or people who are not able to take medicines by mouth or who find this way of giving medicine more helpful.
- This medication is given rectally, which can be difficult in a public setting. For individuals who are school-age or older, there are other formulations of rescue medications that are given nasally (into the nose) or buccally (into the cheek). These options may be more socially acceptable to the person with epilepsy.
Diastat should be used with caution by
- People with breathing problems, elderly people, or females who are pregnant, nursing, or planning to get pregnant.
- People who also take opioids. Use of these two drugs in combination can lead to severe sedation, breathing problems and death.
Use and Dose
- Ask your doctor or nurse for specific instructions on when to use it and whether a second dose of medicine can be used.
- The dose of Diastat is prescribed according to body weight.
- The AcuDial delivery system allows the pharmacist to set the applicators to deliver the prescribed dose.
- When picking up your medicine from the pharmacy, it is important to check the dose of Diastat with your pharmacist.
- Make sure your health care provider knows about weight changes as your child grows so they can adjust the dose appropriately.
- Do not reuse syringes for any reason or save partial amounts of medicine for later use.
Packaging and Storage
- The medicine comes prepackaged in special applicators or syringes that are used to give the medicine rectally.
- Two syringes or applicators come in each package with lubricant and instructions on how to use it.
- Diastat does not need to be refrigerated, but it is important to store it in a safe place, away from children.
- Each twin pack will last up to 4 years.
- After the Diastat has been given, follow disposal instructions that come with the medicine.
How do you know if the proper dose has been set?
- When the prescription is picked up from the pharmacy, check to see if the prescribed dose is written in the display window on the applicator.
- There should also be a green band that says READY.
- If you don't see the dose or green band, it is not ready to use. Take it back to the pharmacist to set the dose.
- Also check to make sure that the syringe tip is the size that was ordered by the doctor.
- Take the Diastat back to the pharmacist if you are not sure if it's ready to use.
How is it given?
While some people may be able to give it to themselves, it is easiest to have someone else do it. Usually a parent, caregiver, or designated adult will give this to a child.
Anyone who will be giving Diastat should be taught how to use it properly by a doctor or nurse.
The following steps outline how to give Diastat® AcuDial™. Make sure to review these instructions with the prescribing health care professional and follow the package insert guidelines that come in the Diastat package.
- Turn the person on their side so they are facing you (or the person who will be giving it).
- Get the medicine out of the package and check the dose of the medicine with the doctor’s order.
- Remove the cap from the syringe and make sure that the “seal pin” is removed with the cap.
- Put lubricating jelly on the tip of the syringe.
- Fix the person’s clothes and bend the upper leg forward so the rectum can be seen.
- Spread the cheeks of the buttocks and gently insert the tip of the syringe into the rectum.
- Push the plunger on the syringe in and slowly count to 3. Count to 3 again before removing the syringe.
- Then squeeze the buttocks together and count to 3 to prevent leaking of the medicine.
- Fix the person’s clothes back to normal.
- Follow the doctor’s recommendations for observing the person afterwards.
For More Information
How long does it take to work?
Diastat is absorbed quickly from the rectum. Seizures may stop within 15 minutes of giving the medicine, but it will continue to work for much longer. The Diastat reaches a peak level in the bloodstream in about 1.5 hours but can last almost 2 days.
- Follow instructions from your doctor carefully on how often Diastat can be given.
- Since it can last a long time in the body, a second dose should be given only if and when it's prescribed for continued seizures.
- Also make sure you know how often you can use this for cluster seizures. For example, how many days between clusters can it be given and how many times a month can it be used?
- Diastat is generally recommended to be used only once every 5 days or no more than 5 times a month. If you have clusters more often than this, talk to your health care professional about what to do.
- Ask your health care provider when a second dose should be given.
- Ask your health care provider how often to use it.
- Enter the information on your Seizure Action Plan.
- Diastat should not be used instead of your child's regular medicine.
What are common side effects of Diastat?
Diastat is generally well-tolerated.
- The most common side effect reported during research studies was sleepiness. Since it is given after a seizure, it may be hard to tell if sleepiness is due to the seizure or the medicine.
- Other, less frequent side effects include dizziness, headache, pain, stomach pain, nervousness, dilated blood vessels, diarrhea, unsteady walking, clumsiness, euphoria or elevated mood, asthma or wheezing, stuffy nose, and skin rash.
- If any of these side effects occur, talk to your doctor and nurse about what to do.
- If your child develops a serious problem or has trouble tolerating it, you may be told not to give it to your child again.
- If other minor side effects occur after using it, write down what happens and how your child feels in a seizure diary to share with the doctor.
- Write down how your child feels after using Diastat.
- Call your doctor or get emergency medical attention for your child if any serious problems occur after using Diastat.
Is any special monitoring needed?
After a person has a cluster of seizures and is given Diastat, give the person a place to rest if possible and watch how they are doing for a period of time.
- Diastat’s instructions recommend someone stay with the person for 4 hours after Diastat is given. Make sure the person is not having any changes in their breathing, skin color, or side effects.
- If the child is sleepy, let them rest for a while. When they are feeling back to normal, let them return to their usual activity.
- Watch the child to make sure that seizures have stopped. How long this may take will depend on their seizure frequency before Diastat was given and their usual seizure pattern.
- No special monitoring equipment is needed.
- Call for emergency medical help (usually 911) if
- Seizure activity continues for 15 minutes after the Diastat is given.
- If a convulsive seizure lasts longer than 5 minutes, even if Diastat has already been given.
- Seizures look different than before.
- Seizures occur one right after the other.
- Changes in breathing or color are seen.
- Unusual or serious problems occur.
- You are worried or bothered by how the person is doing.
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