"The U.S. Food and Drug Administration today approved a device to help reduce the frequency of seizures in epilepsy patients who have not responded well to medications.
The RNS Stimulator consists of a small neurostimulator implanted within "...
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
DIAZEPAM - RECTAL
COMMON BRAND NAME(S): Diastat
USES: This medication is used to treat episodes of increased seizures (e.g., acute repetitive seizures, breakthrough seizures) in people who are already taking medications to control their seizures. This product is only recommended for short-term treatment of seizure attacks. It is not for ongoing daily use to prevent seizures. Uncontrolled seizures can turn into serious (possibly fatal) seizures that do not stop (status epilepticus).
Diazepam belongs to a class of medications called benzodiazepines which produce a calming effect on the brain and nerves (central nervous system). It is thought to work by increasing the effect of a certain natural chemical (GABA) in the brain.
HOW TO USE: Read the Patient/Caregiver Information Leaflet provided by your pharmacist before you use this product and each time you get a refill. If you have questions, consult your doctor or pharmacist.
This drug is given rectally by a caregiver trained to recognize the symptoms of your seizures and to correctly give the product. You and your caregivers must follow all instructions from your doctor and pharmacist exactly. Review all the instructions on how to give this medication in the product package. If you have any questions or feel unsure about using this medication, call the doctor or pharmacist before using this product. Get emergency help if the person is having a seizure and you do not feel comfortable using this product.
Before using, check the syringe for the correct dose. Your pharmacist should set the correct dose and lock the syringe in the "ready" position before giving you the product. Before leaving the pharmacy, look at each syringe. The dose should be in the display window on the side. You should see a green band with the word "ready" at the bottom of the syringe barrel. Look to make sure you have the correct syringe tip (e.g., smaller tip for a child) and that there are no cracks around the syringe tip. Return the product to the pharmacist if there is a problem or if you have any questions
Cracks can cause the medication to leak out and not provide the correct amount of medication. If you see a crack, use a different syringe. Cracks can appear over time, so keep checking your syringes to make sure you have good ones ready to use. Also check the expiration date on the package, and refill your prescription before the medication expires.
The dosage is based on age, weight, medical condition, and response to therapy. Be sure you understand when this medication should be used, how to use it, and how to check for side effects/seizure control. In some cases, a second dose may be prescribed and given 4 to 12 hours after the first dose. Usually, this medication should not be used to treat more than 5 episodes per month and no more than one episode every 5 days. If seizures continue after using this product as prescribed (e.g., no change 15 minutes after dose is given), or if there is a change in the person's breathing, behavior, or condition that alarms you, get emergency help right away.
This medication should not be used regularly. This medication may cause withdrawal reactions, especially if it has been used regularly for a long time (more than a few weeks) or in high doses. In such cases, withdrawal symptoms (such as increased seizures) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.
Though it is very unlikely to occur, this medication can also result in abnormal drug-seeking behavior (addiction/habit forming). Do not increase your dose, take it more frequently, or use it for a longer time than prescribed.
Dispose of this medication properly. Follow the directions in the Patient Information Leaflet. Do not reuse the syringe.
Do not stop taking your regular seizure control medications when you are given this drug.
Additional Diastat Information
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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