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17 June, 2019 00:00 00 AM / LAST MODIFIED: 16 June, 2019 11:34:01 PM

FDA approves Nayzilam (midazolam) nasal spray to treat seizure clusters

drugs.com
FDA approves Nayzilam (midazolam) nasal spray to treat seizure clusters

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.

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 (C-IV) because it can be abused or lead to dependence. Keep this medicine in a safe place to prevent misuse and abuse. Selling or giving it away 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 this medicine 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.

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.

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.

Use Nayzilam in the nose only.

Use this medicine exactly as your healthcare provider tells you to use it and follow the Instructions for Use that comes with your prescription.

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 may be used if you have been told to do so by your healthcare provider.

If a second dose is used, give the second dose in the other nostril.

Do not give more than 2 doses 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 three 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 or overdose, call your healthcare provider or go to the nearest emergency room right away.

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.

Nayzilam side effects

Nayzilam may cause serious side effects, including:

See Important information 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.

The most common side effects include:

sleepiness

headache

runny nose

nasal discomfort

throat irritation

These are not all the possible side effects. Call your doctor for medical advice about side effects

 

 

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Editor : M. Shamsur Rahman

Published by the Editor on behalf of Independent Publications Limited at Media Printers, 446/H, Tejgaon I/A, Dhaka-1215.
Editorial, News & Commercial Offices : Beximco Media Complex, 149-150 Tejgaon I/A, Dhaka-1208, Bangladesh. GPO Box No. 934, Dhaka-1000.

Editor : M. Shamsur Rahman
Published by the Editor on behalf of Independent Publications Limited at Media Printers, 446/H, Tejgaon I/A, Dhaka-1215.
Editorial, News & Commercial Offices : Beximco Media Complex, 149-150 Tejgaon I/A, Dhaka-1208, Bangladesh. GPO Box No. 934, Dhaka-1000.

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