Midazolam Nasal Spray

IMPORTANT WARNING:

Midazolam may increase the risk of serious or life-threatening breathing problems, sedation, or coma if used along with certain medications. Tell your doctor if you are taking or plan to take certain opiate medications for cough such as codeine (in Triacin-C, in Tuxarin ER, in Tuzistra XR) or hydrocodone (in Tussicaps) or for pain such as codeine (in Fioricet, in Fiorinal, in Trezix), fentanyl (Actiq, Duragesic, Subsys, others), hydrocodone (Hysingla ER, Zohydro ER, in Anexsia, in Apadaz, in Hycodan), hydromorphone (Dilaudid), meperidine (Demerol), methadone (Methadose), morphine (Duramorph PF, Kadian, Kynmobi, MS Contin, others), oxycodone (Xtmpza ER, in Oxycet, in Percocet, in Roxicet, others), oxymorphone, and tramadol (Conzip, Qdolo, Ultram, in Ultracet). Your doctor may need to change the dosages of your medications and will monitor you carefully. If you use midazolam nasal spray with any of these medications and you develop any of the following symptoms, call your doctor immediately or seek emergency medical care immediately: unusual dizziness, lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. Be sure that your caregiver or family members know which symptoms may be serious so they can call the doctor or emergency medical care if you are unable to seek treatment on your own.

Midazolam may be habit forming. Do not use a larger dose, use it more often, or for a longer time than your doctor tells you to. Tell your doctor if you have ever drunk large amounts of alcohol, if you use or have ever used street drugs, or have overused prescription medications. Do not drink alcohol or use street drugs during your treatment. Drinking alcohol or using street drugs during your treatment with midazolam nasal spray also increases the risk that you will experience these serious, life-threatening side effects. Also tell your doctor if you have or have ever had depression or another mental illness.

Midazolam may cause a physical dependence (a condition in which unpleasant physical symptoms occur if a medication is suddenly stopped or taken in smaller doses), especially if you use it more frequently than recommended. Do not stop using this medication or use fewer doses without talking to your doctor. Stopping midazolam suddenly can worsen your condition and cause withdrawal symptoms that may last for several weeks to more than 12 months. Your doctor probably will decrease your midazolam dose gradually. Call your doctor or get emergency medical treatment if you experience any of the following symptoms: unusual movements; ringing in your ears; anxiety; memory problems; difficulty concentrating; confusion; sleep problems; seizures; shaking; muscle twitching; changes in mental health; depression; burning or prickling feeling in your hands, arms, legs or feet; seeing or hearing things that others do not see or hear; thoughts of harming or killing yourself or others; overexcitement; or losing touch with reality.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with midazolam nasal spray and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm).

WHY is this medicine prescribed?

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.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

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.

What SPECIAL PRECAUTIONS should I follow?

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 while taking midazolam nasal spray. Your doctor may need to change the doses of your medications or carefully monitor you for side effects.

• 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.

• 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.

What SPECIAL DIETARY instructions should I follow?

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

What SIDE EFFECTS can this medicine cause?

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).

What should I know about STORAGE and DISPOSAL of this medication?

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.

What should I do in case of OVERDOSE?

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)

What OTHER INFORMATION should I know?

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.