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 belongs to a group of drugs called benzodiazepines which help to slow down activity in the central nervous system.

This medication comes as a single-dose nasal spray liquid. It is given as one spray (5 mg dose) into one nostril. One additional spray into the opposite nostril may be administered if the seizure cluster is continuing 10 minutes after the first dose.

Common side effects include sleepiness, headache, runny nose, nasal discomfort and throat irritation. Do not drive, operate machinery, or do other activities that require mental alertness until you know how Nayzilam affects you.

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.

It is not known if Nayzilam is safe and effective in children under 12 years of age.

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

Serious side effects have been reported with Nayzilam. See the “Nayzilam Precautions” section.

The most common side effects include:

• sleepiness
• headache
• runny nose
• nasal discomfort
• throat irritation

These are not all of the possible side effects of Nayzilam.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

Especially tell your healthcare provider if you take any of the following medicines:

CYP3A4 inhibitors such as:

• erythromycin
• diltiazem
• verapamil
• ketoconazole
• itraconazole
• clarithromycin

Opioids such as:

• morphine
• hydrocodone
• oxymorphone
• codeine
• fentanyl

Other Central Nervous System (CNS) Depressants such as:

• benzodiazepines and sedatives/hypnotics
• anxiolytics
• tranquilizers
• muscle relaxants
• general anesthetics
• antipsychotics
• opioids
• alcohol

This is not a complete list of Nayzilam drug interactions. Ask your doctor or pharmacist for more information.

Nayzilam may cause serious side effects, including:

• Interaction with other central nervous system depressants 
• Serious breathing problems and excessive sleepiness
• Suicidal thoughts or actions
• Impaired mental alertness including memory problems. 
• Increase in eye pressure in people with acute narrow-angle glaucoma.

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
• an extreme increase in activity and talking (mania)
• new or worse anxiety
• new or worse irritability
• other unusual changes in behavior or mood

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.

Do not use Nayzilam if you:

• are allergic to midazolam.
• have an eye problem called acute narrow-angle glaucoma.

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. When taken with alcohol or medicines that can cause sleepiness or dizziness, Nayzilam may make your sleepiness or dizziness worse.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Nayzilam there are no specific foods that you must exclude from your diet when receiving this medication.

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. Midazolam passes into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you use Nayzilam.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Taking Nayzilam with certain other medicines can affect each other, causing side effects. Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist each time you get a new medicine. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.

Tell your healthcare provider if you are pregnant or plan to become pregnant.

Nayzilam may harm your unborn baby. Babies born to mothers receiving benzodiazepine medicines (including Nayzilam) late in pregnancy may be at risk of having breathing problems, feeding problems, dangerously low body temperature, and withdrawal symptoms. If you become pregnant while using Nayzilam, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. You can register by calling 1-888-233-2334. For more information about the registry, go to http://www.aedpregnancyregistry.org. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Midazolam passes into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you 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" that comes with this medication.
• 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.

Take Nayzilam exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended initial dose: Administer one spray (5 mg dose) into one nostril.

Second Dose: One additional spray (5 mg dose) into the opposite nostril may be administered after 10 minutes if the patient has not responded to the initial dose. 

Maximum Dosage and Treatment Frequency: Do not use more than 2 doses of Nayzilam to treat a seizure cluster. It is recommended that Nayzilam be used to treat no more than one episode every three days and treat no more than five episodes per month.

If you use too much Nayzilam, call your healthcare provider or go to the nearest emergency room right away.

Nayzilam is a federal controlled substance (C-IV) 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.

• Store Nayzilam at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep Nayzilam in the blister package until ready to use. 
• Keep Nayzilam and all medicines out of the reach of children.

WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.

• Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.

• Limit dosages and durations to the minimum required.

• Follow patients for signs and symptoms of respiratory depression and sedation.