Generic name: midazolam (nasal) (my DAZ oh lam)
Brand name: Nayzilam
Drug class: Benzodiazepines
Nayzilam nasal spray contains midazolam, a benzodiazepine (ben-zoe-dye-AZE-eh-peen).
Nayzilam nasal spray is a prescription medicine used short term to treat seizure clusters (also called "acute repetitive seizures") in adults and children at least 12 years old.
Nayzilam is a federal controlled substance (C-IV) because it can be abused or lead to dependence. Keep in a safe place to prevent misuse and abuse. Selling or giving away this medicine may harm others and is against the law. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription drugs, or street drugs.
It is not known if Nayzilam is safe and effective in children under 12 years of age.
Warnings
You should not use Nayzilam if you have narrow-angle glaucoma.
MISUSE OF NAYZILAM CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.
Nayzilam can slow or stop your breathing, especially if you have recently used an opioid medication, alcohol, or other drugs that can slow your breathing. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, if you are hard to wake up, or if you stop breathing.
Do not stop using Nayzilam suddenly, or you could have dangerous withdrawal symptoms that could last for several weeks to months.
Some people have thoughts about suicide while using Nayzilam. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.
Before taking this medicine
You should not use Nayzilam nasal spray if you are allergic to midazolam, or if you have:
- narrow-angle glaucoma.
To make sure Nayzilam is safe for you, tell your doctor if you have ever had:
- open-angle glaucoma;
- depression, or a mood disorder;
- suicidal thoughts or actions;
- liver or kidney disease;
- asthma, emphysema, bronchitis, chronic obstructive pulmonary disorder (COPD), or other breathing problems;
- congestive heart failure;
- drug or alcohol addiction; or
- if you use opioid medicine.
Some people have thoughts about suicide while using seizure medicine. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.
Tell your doctor if you are pregnant or plan to become pregnant. Your name may be listed on a pregnancy registry to track the effects of midazolam on the baby.
- If you use Nayzilam while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks.
- Using Nayzilam nasal spray right before childbirth may cause breathing problems, feeding problems, or dangerously low body temperature in the newborn baby.
It may not be safe to breastfeed while using Nayzilam. Ask your doctor about any risk.
How should I use Nayzilam nasal spray?
Use Nayzilam exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.
Midazolam may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.
Do not take by mouth. This medicine is for use only in the nose.
Before using Nayzilam nasal spray, be sure you know how to recognize what is and is not a seizure cluster and when it is best to use this medicine. Ask your doctor or pharmacist if you have questions.
Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.
Nayzilam nasal spray is usually given as a single spray into one nostril. If you still have seizures 10 minutes after using 1 spray, use a second spray in the opposite nostril.
Get emergency medical help if you have still have seizures after using Nayzilam.
You should not use a second spray if you have very slow breathing after using the first spray.
Do not use more than 2 sprays of Nayzilam nasal spray to treat a seizure cluster. Do not use this medicine to treat more than 1 seizure cluster every 3 days, or more than 5 seizure clusters in one month (30 days).
Do not stop using this medicine suddenly, or you could have dangerous withdrawal symptoms. Follow your doctor's instructions about tapering your dose.
Store at room temperature away from moisture and heat. Keep the spray bottle in the blister pack until you are ready to use the medicine.
Dosing information
Usual Adult Dose for Seizures:
Nasal:
-Initial dose: 5 mg (1 spray) intranasally in 1 nostril ONCE
-Subsequent dose: 5 mg (1 spray) intranasally in the opposite nostril after 10 minutes if the patient has not responded to the initial dose
-Maximum dose: 10 mg/day.
Usual Pediatric Dose for Seizures:
Nasal:
12 years and older:
-Initial dose: 5 mg (1 spray) intranasally in 1 nostril ONCE
-Subsequent dose: 5 mg (1 spray) intranasally in the opposite nostril after 10 minutes if the patient has not responded to the initial dose
-Maximum dose: 10 mg/day
Comments:
-This drug should not be used to treat more than 1 episode every 3 days, and no more than 5 episodes/month.
-The subsequent dose should not be administered if the patient has difficulty breathing OR if the patient has sedation that is not typically observed during a seizure cluster episode.
Use: Acute treatment of intermittent, stereotypic episodes of frequent seizure activity (e.g., acute repetitive seizures, seizure clusters) that are distinct from a patient's usual seizure pattern
What happens if I miss a dose?
Since Nayzilam is used when needed, it does not have a daily dosing schedule. Call your doctor if your symptoms do not improve after using this medicine.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of midazolam can be fatal.
Overdose symptoms may include severe drowsiness, confusion, muscle weakness, loss of coordination, or coma.
What should I avoid while using Nayzilam nasal spray?
Do not drink alcohol. Dangerous side effects or death could occur.
Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.
Nayzilam side effects
Get emergency medical help if you have signs of an allergic reaction to Nayzilam: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Midazolam can slow or stop your breathing, especially if you have recently used an opioid medication, alcohol, or other drugs that can slow your breathing. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, if you are hard to wake up, or if you stop breathing.
Call your doctor right away or seek emergency medical help if you have the following symptoms while using Nayzilam or after you stop using it:
- extreme drowsiness;
- unusual muscle movements, or a seizure;
- sudden mood or behavior changes, hallucinations;
- agitation, anxiety, panic, trouble sleeping, feeling irritable; or
- depression, thoughts about suicide or hurting yourself.
Some people who stopped using this medicine suddenly had withdrawal symptoms lasting up to a year or longer, including: anxiety, problems with thinking or memory, depression, ringing in your ears, trouble sleeping, muscle twitching, or a burning, prickling, or crawling sensation. Ask your doctor how to safely stop using this medicine.
Common Nayzilam side effects may include:
- drowsiness;
- headache;
- runny nose, discomfort in your nose; or
- throat irritation.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Nayzilam?
Using Nayzilam nasal spray with other drugs that slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
Many drugs can interact with midazolam. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.