Midazolam Nasal Spray

Midazolam may cause serious or life-threatening breathing problems, drowsiness, or coma if used along with certain medications. Tell your doctor if you are taking or plan to take medications for cough or for pain. 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 do so.

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. Also tell your doctor if you have or have ever had depression or another mental illness.

Do not stop using this medication or use fewer doses without talking to your doctor. 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 Medication Guide. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm to obtain the Medication Guide.

Talk to your doctor about the risks of using midazolam nasal spray.

Midazolam nasal spray is used for emergency situations control certain types of 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. Use when needed, according to your doctor's directions.

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 stop, your doctor may tell you to inhale a second dose. Your doctor will give you instructions on how and when you may use a second dose. Follow these directions carefully.

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

Keep midazolam nasal spray with you or available at all times.

Do not use midazolam nasal spray more than 5 times a month or more often than every 3 days. Talk to your doctor if you think you need to use it more often.

1. Read all of the manufacturer's instructions 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.

• 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 or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• 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.
• this medication may not be recommended in people 65 years or older. Talk to your doctor about the risks and benefits of taking this medication.
• 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.
• talk to your doctor about the safe use of alcoholic beverages during your treatment with midazolam. 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. There is a chance that you may experience changes in your mental health if you take a 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. 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 do so.

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 or throat
• runny nose
• headache

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 (https://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).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

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, slowed 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. Midazolam nasal spray is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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