Midazolam Nasal Spray

Midazolam nasal spray is used for emergency situations to stop cluster seizures (episodes of increased seizure activity) in adults and children 12 years of age and older who are taking other medications to treat epilepsy (seizures). Midazolam is in a class of medications called benzodiazepines. It works by calming abnormal overactivity in the brain.

Midazolam comes as a spray to inhale through the nose. It is used when needed, according to your doctor's directions. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use midazolam nasal spray exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

If your seizure does not respond to a dose of midazolam nasal spray, your doctor may tell you to inhale a second dose. Your doctor will give you instructions on how and when you may take a second dose. Follow your doctor's directions for inhaling a second dose.

Before midazolam nasal spray is prescribed, the doctor will talk to you and your caregiver about how to recognize signs of the type of seizure activity that should be treated with this medication. Your caregiver will also be taught how to administer the nasal spray.

Keep midazolam nasal spray with you or available at all times so that you will be able to use it to control your seizures when they occur.

If used regularly, midazolam may be habit forming. Do not use a larger dose than your doctor tells you to. Midazolam nasal spray is not meant to be used on a daily basis. Midazolam nasal spray should not be used more than 5 times a month or more often than every 3 days. If you or your caregiver think that you need midazolam nasal spray more often than this, talk to your doctor.

Directions for the caregiver to administer the nasal spray:

1. Read all of the manufacturer's instructions for using the nasal spray before you use your first dose.

2. Remove the device from the blister pack.

3. Hold the sprayer between your fingers and thumb, but be careful not to press the plunger.

4. Put the tip of the sprayer into one nostril until your fingers are against the bottom of the person's nose.

5. Press the plunger firmly with your thumb.

6. Remove the tip from the nose.

7. The sprayer contains only one dose of medication. After you have used it, dispose of it safely, so that is out of the reach of children and pets.

After administering the nasal spray, the caregiver should watch the person with seizures carefully. If any of the following occur, call 911 immediately:

• the seizures seem different or worse than usual.

• you are worried about how often seizures are happening or how long seizures are lasting.

• you are worried about a change in skin color or breathing of the person with seizures.

• the person is having unusual or serious problems.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking midazolam nasal spray,

• tell your doctor and pharmacist if you are allergic to midazolam (Nayzilam, Seizalam), any other medications, or any of the ingredients in midazolam nasal spray. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: clarithromycin; diltiazem (Cardizem, Cartia, Taztia, Tiazac); erythromycin (E.E.S., Eryc, Eryped, Ery-tab, others); itraconazole (Sporanox, Tolsura); ketoconazole, verapamil (Calan, Verelan, in Tarka); medications for anxiety, colds or allergies, or mental illness; phenobarbital; muscle relaxants; sedatives; and tranquilizers. Many other medications may also interact with midazolam nasal spray, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• tell your doctor if you have glaucoma (increased pressure in the eyes that may cause gradual loss of vision). Your doctor may tell you not to use midazolam nasal spray.

• tell your doctor if you have or have ever had lung problems such as asthma, chronic obstructive pulmonary disease (COPD), emphysema, or bronchitis; congestive heart failure; or liver or kidney disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using midazolam nasal spray, call your doctor.

• if you are having surgery, including dental surgery, tell the doctor or dentist that you are using midazolam nasal spray.

• you should know that midazolam may make you very drowsy and may affect your memory, thinking, and movements. Do not drive a car or operate machinery until you know how this medication affects you.

• you should know that alcohol can make the side effects from midazolam nasal spray worse.

• you should know that your mental health may change in unexpected ways and you may become suicidal (thinking about harming or killing yourself or planning or trying to do so) while you are using midazolam nasal spray for the treatment of epilepsy. A small number of adults and children 5 years of age and older (about 1 in 500 people) who took anticonvulsants such as midazolam to treat various conditions during clinical studies became suicidal during their treatment. Some of these people developed suicidal thoughts and behavior as early as one week after they started taking the medication. There is a risk that you may experience changes in your mental health if you take an anticonvulsant medication such as midazolam, but there may also be a risk that you will experience changes in your mental health if your condition is not treated. You and your doctor will decide whether the risks of taking an anticonvulsant medication are greater than the risks of not taking the medication. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: panic attacks; agitation or restlessness; new or worsening irritability, anxiety, or depression; acting on dangerous impulses; difficulty falling or staying asleep; aggressive, angry, or violent behavior; mania (frenzied, abnormally excited mood); talking or thinking about wanting to hurt yourself or end your life; withdrawing from friends and family; preoccupation with death and dying; giving away prized possessions; or any other unusual changes in behavior or mood. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

Talk to your doctor about eating grapefruit and drinking grapefruit juice while using this medicine.

• Midazolam nasal spray may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • drowsiness

  • sore or irritated nose

  • sore or irritated throat

  • runny nose

  • headache

  • unusual taste in the mouth

  • difficulty speaking

  • watery or runny eyes

• Some side effects can be serious. If you experience any symptoms listed in the IMPORTANT WARNING section or the SPECIAL PRECAUTIONS section, stop using midazolam nasal spray and call your doctor immediately or get emergency medical treatment.

• Midazolam nasal spray may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

• If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• drowsiness

• confusion

• loss of coordination

• slow reflexes

• coma (loss of consciousness for a period of time)

Keep all appointments with your doctor.

If you have symptoms that are different from your usual seizures, you or your caregiver should call your doctor immediately.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.