Important Safety Information
Important Safety Information you should know about NAYZILAM® (midazolam) nasal spray, CIV
What is the most important information I should know about NAYZILAM?
NAYZILAM is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma, and death.
NAYZILAM may cause serious breathing problems and excessive sleepiness (sedation). Get emergency medical help right away if any of the following occur:
- unusually shallow or slowed breathing
- stop breathing, which may lead to your heart stopping
- unusually excessive sleepiness
Like other antiepileptic drugs, NAYZILAM may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
- thoughts about suicide or dying
- feeling agitated or restless
- acting aggressive, being angry, or violent
- attempts to commit suicide
- panic attacks
- acting on dangerous impulses
- new or worse depression
- trouble sleeping (insomnia)
- an extreme increase in activity and talking (mania)
- new or worse anxiety
- new or worse irritability
- other unusual changes in behavior or mood
How can I watch for early symptoms of suicidal thoughts or actions?
- Pay attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings.
- Keep all follow-up visits with your healthcare provider as scheduled.
Call your healthcare provider between visits as needed, especially if you are worried about symptoms. Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.
What is NAYZILAM?
- NAYZILAM is a prescription medicine used for the short-term treatment of seizure clusters (also known as “acute repetitive seizures”) in patients 12 years of age and older.
- NAYZILAM is a federal controlled substance (CIV) because it can be abused or lead to dependence. Keep NAYZILAM in a safe place to prevent misuse and abuse. Selling or giving away NAYZILAM 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.
Do not use NAYZILAM if you:
- are allergic to midazolam.
- have an eye problem called acute narrow-angle glaucoma.
Before you use NAYZILAM, tell your healthcare provider about all your medical conditions, including if you:
- have a history of depression, mood problems or suicidal thoughts or behavior.
- have asthma, emphysema, bronchitis, chronic obstructive pulmonary disease, or other breathing problems.
- have kidney or liver problems.
- have congestive heart failure.
- have a history of drug or alcohol abuse.
- are pregnant or plan to become pregnant. NAYZILAM may harm your unborn baby.
- are breastfeeding or plan to breastfeed.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
How should I use NAYZILAM?
- Use NAYZILAM in the nose only.
- Use NAYZILAM exactly as your healthcare provider tells you to use it and follow the Instructions for Use.
- Your healthcare provider has prescribed NAYZILAM to treat a type of seizure called a “seizure cluster”.
- If the seizure cluster is continuing 10 minutes after the first dose of NAYZILAM, a second dose of NAYZILAM may be used if you have been told to do so by your healthcare provider.
- If a second dose of NAYZILAM is used, give the second dose in the other nostril.
- Do not give more than 2 doses of NAYZILAM to treat a seizure cluster.
- If the seizures do not stop after NAYZILAM is used, get emergency medical help right away.
- Do not use NAYZILAM for more than one seizure cluster episode every 3 days. Do not use NAYZILAM for more than five seizure cluster episodes per month.
- If benzodiazepines are stopped after a person takes them daily, they can cause withdrawal symptoms. Stopping benzodiazepines suddenly can cause seizures that will not stop (status epilepticus), hearing or seeing things that are not there (hallucinations), shaking, nervousness, and stomach and muscle cramps. NAYZILAM is not intended to be taken daily.
- If you use too much NAYZILAM, call your healthcare provider or go to the nearest emergency room right away.
What should I avoid while using NAYZILAM?
- Do not drive, operate machinery, or do other activities that require mental alertness until you know how NAYZILAM affects you.
- Do not drink alcohol or take opioid medicines or other medicines that make you sleepy or dizzy while taking NAYZILAM until you talk to your healthcare provider.
What are the possible side effects of NAYZILAM?
NAYZILAM may cause serious side effects, including:
- See “What is the most important information I should know about NAYZILAM?” for information on serious side effects of:
- interaction with other central nervous system depressants
- serious breathing problems and excessive sleepiness
- suicidal thoughts or actions
- Impaired mental alertness including memory problems. See “What should I avoid while using NAYZILAM?”
- Increase in eye pressure in people with acute narrow-angle glaucoma. See “Do not take NAYZILAM if you:”
The most common side effects of NAYZILAM include:
- runny nose
- nasal discomfort
- throat irritation
These are not all the possible side effects of NAYZILAM. Call your doctor for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088, or you may contact ucbCARES® at 1-844-599-CARE.
Please see additional patient information in the Medication Guide. This information does not take the place of talking with your healthcare provider about your condition or your treatment. For more information, go to www.NAYZILAM.com or call 1-844-599-2273.
Please talk to your healthcare provider if you have any questions or concerns about NAYZILAM.