Pronunciation:

MID-ay-zoe-lam

Brand Names:

• Nayzilam

Dosage Forms:

• Spray

Warnings:

Warning: Risks from concomitant use with opioids; abuse, misuse, and addiction; dependence and withdrawal reactionsConcomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for 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.The use of benzodiazepines, including midazolam, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing midazolam and throughout treatment, assess each patient's risk for abuse, misuse, and addiction.The continued use of benzodiazepines may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Although midazolam is indicated only for intermittent use, if used more frequently than recommended abrupt discontinuation or rapid dosage reduction of midazolam may precipitate acute withdrawal reactions, which can be life-threatening. For patients using midazolam more frequently than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue midazolam .

Classifications:

Therapeutic—

Anticonvulsant

Pharmacologic—

Benzodiazepine, Short or Intermediate Acting

Uses of This Medicine:

Midazolam nasal is used as short-term treatment for seizure clusters (also known as “acute repetitive seizures”) in patients 12 years of age and older.

Midazolam is a benzodiazepine. Benzodiazepines belong to the group of medicines called central nervous system (CNS) depressants, which are medicines that slow down the nervous system.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of midazolam nasal in children younger than 12 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of midazolam nasal in the elderly. However, elderly patients are more likely to have age-related liver or kidney problems, which may require caution in the dose for patients receiving this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amprenavir
• Atazanavir
• Boceprevir
• Cobicistat
• Darunavir
• Delavirdine
• Flumazenil
• Fosamprenavir
• Indinavir
• Itraconazole
• Levoketoconazole
• Lopinavir
• Nelfinavir
• Saquinavir
• Telaprevir
• Tipranavir

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adagrasib
• Alfentanil
• Alprazolam
• Amobarbital
• Anileridine
• Aprobarbital
• Aripiprazole
• Baclofen
• Belzutifan
• Benzhydrocodone
• Bromazepam
• Bromopride
• Buprenorphine
• Buspirone
• Butabarbital
• Butalbital
• Butorphanol
• Calcifediol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbinoxamine
• Carisoprodol
• Ceritinib
• Cetirizine
• Chloral Hydrate
• Chlordiazepoxide
• Chlorpromazine
• Chlorzoxazone
• Ciprofloxacin
• Clarithromycin
• Clobazam
• Clonazepam
• Clorazepate
• Codeine
• Conivaptan
• Cyclobenzaprine
• Dabrafenib
• Dantrolene
• Daridorexant
• Dexmedetomidine
• Dezocine
• Diacetylmorphine
• Diazepam
• Difenoxin
• Dihydrocodeine
• Diphenhydramine
• Diphenoxylate
• Doxylamine
• Dronedarone
• Duvelisib
• Esketamine
• Estazolam
• Eszopiclone
• Ethchlorvynol
• Ethylmorphine
• Fedratinib
• Fentanyl
• Fexinidazole
• Flibanserin
• Fluconazole
• Flunitrazepam
• Flurazepam
• Fosnetupitant
• Fospropofol
• Gabapentin
• Gabapentin Enacarbil
• Halazepam
• Hydrocodone
• Hydromorphone
• Hydroxyzine
• Idelalisib
• Imatinib
• Isavuconazonium Sulfate
• Ivacaftor
• Ivosidenib
• Ketamine
• Ketazolam
• Ketobemidone
• Lacosamide
• Larotrectinib
• Lefamulin
• Lemborexant
• Lenacapavir
• Letermovir
• Levocetirizine
• Levorphanol
• Lofexidine
• Lorazepam
• Lorlatinib
• Loxapine
• Lumacaftor
• Magnesium Oxybate
• Mavacamten
• Meclizine
• Meperidine
• Mephenesin
• Mephobarbital
• Meprobamate
• Meptazinol
• Metaxalone
• Methadone
• Methocarbamol
• Methohexital
• Methotrimeprazine
• Metoclopramide
• Mirtazapine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Nefazodone
• Netupitant
• Nicomorphine
• Nilotinib
• Nitrazepam
• Olutasidenib
• Omaveloxolone
• Opium
• Opium Alkaloids
• Orlistat
• Orphenadrine
• Oxazepam
• Oxycodone
• Oxymorphone
• Pacritinib
• Papaveretum
• Paregoric
• Pentazocine
• Pentobarbital
• Perampanel
• Periciazine
• Phenobarbital
• Piritramide
• Pirtobrutinib
• Posaconazole
• Potassium Oxybate
• Prazepam
• Pregabalin
• Primidone
• Promethazine
• Propofol
• Quazepam
• Ramelteon
• Remifentanil
• Remimazolam
• Ribociclib
• Ritlecitinib
• Ropeginterferon Alfa-2b-njft
• Scopolamine
• Secobarbital
• Sodium Oxybate
• Sufentanil
• Tapentadol
• Temazepam
• Thiopental
• Thioridazine
• Tilidine
• Tizanidine
• Tocilizumab
• Topiramate
• Tramadol
• Trazodone
• Triazolam
• Trofinetide
• Zaleplon
• Zolpidem
• Zopiclone
• Zuranolone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aprepitant
• Armodafinil
• Carbamazepine
• Cimetidine
• Crizotinib
• Cyclosporine
• Dalfopristin
• Diltiazem
• Echinacea
• Erythromycin
• Fluvoxamine
• Fosaprepitant
• Fosphenytoin
• Ginkgo Biloba
• Goldenseal
• Halothane
• Laropiprant
• Mitotane
• Phenytoin
• Quinupristin
• Rifapentine
• Roxithromycin
• St John's Wort
• Telithromycin
• Theophylline
• Verapamil
• Voriconazole

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol or drug abuse, history of or
• Depression or
• Eye or vision problems (eg, open-angle glaucoma) or
• Hemodynamic instability (unstable blood pressure) or
• Lung or breathing problems (eg, chronic obstructive pulmonary disease)—Use with caution. May make these conditions worse.

• Congestive heart failure or
• Kidney disease, moderate to severe—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.

• Glaucoma, acute narrow-angle—Should not be used in patients with this condition.

Proper Use of This Medicine:

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. If too much of this medicine is used for a long time, it may become habit-forming (causing mental or physical dependence) or cause an overdose.

This medicine comes with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

A second dose may be needed if the patient's seizure cluster has not stopped 10 minutes after the first dose. Do not use a second dose of this medicine if the patient has difficulty with breathing or excessive sleepiness during a seizure cluster episode.

Do not use this medicine for more than one episode every 3 days and more than 5 episodes per month.

To use the nasal spray:

• This medicine is for use only in the nose. Do not get any of it into your eyes or on your skin. If it does get on these areas, rinse it off right away.
• Do not open the blister packaging until you are ready to use it. Do not test or prime the spray before use.
• Hold the nasal spray with your thumb on the plunger and your middle and pointer fingers on each side of the nozzle.
• Place the tip of the nozzle into 1 nostril until your fingers on either side of the nozzle touches the bottom of your nose.
• Press the plunger firmly using 1 motion to get your dose. You do not need to breathe in deeply.
• Use each nasal spray unit only one time.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For nasal dosage form (spray):
  • For seizure clusters:
    • Adults and children 12 years of age and older—5 milligrams (mg) or 1 spray into one nostril. A second spray may be taken 10 minutes after the first dose if needed. Do not use a second dose if you have trouble breathing or excessive sleepiness during a seizure cluster episode. Do not use more than 2 doses to treat a single episode.
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress while you are using this medicine to make sure that this medicine is working properly and to check for unwanted effects.

Tell your doctor if you are pregnant or planning to become pregnant. Using this medicine during the later pregnancy may cause problems in your newborn baby (eg, sedation or withdrawal symptoms). Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, feeding problems, a high-pitched cry, irritability, low muscle tone, restlessness, shakiness or tremors, sluggishness, trouble breathing, weight loss, vomiting, or fails to gain weight. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Do not change your dose or suddenly stop using this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent a possible worsening of your seizures and reduce the possibility of withdrawal symptoms including changes in behavior, discouragement, feeling sad or empty, irritability, lack of appetite, loss of interest or pleasure, trouble concentrating, seeing or hearing things that others do not see or hear, thoughts of killing oneself, trouble sleeping, unusual movements, responses, or expressions.

Symptoms of an overdose include: changes in patterns and rhythms of speech, confusion, drowsiness, hallucinations, lack of coordination, loss of consciousness, loss of strength or energy, muscle pain or weakness, nightmares, relaxed and calm feeling, sleepiness or unusual drowsiness, shakiness and unsteady walk, slurred speech, trouble in speaking, trouble sleeping, unsteadiness, trembling, or other problems with muscle control or coordination, unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness, unusual excitement, nervousness, restlessness, or irritability, or unusual weak feeling. Call your doctor right away if you notice these symptoms.

This medicine may cause respiratory depression (serious breathing problem that can be life-threatening), especially when used with narcotic pain medicines. Tell your doctor if you are using any narcotic medicine, such as codeine, fentanyl, hydrocodone, morphine, or oxymorphone.

This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, barbiturates or seizure medicine, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you stop using this medicine. Check with your doctor before taking any of the other medicines listed above while you are using this medicine.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Also tell your doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these side effects, tell your doctor right away.

This medicine may cause drowsiness, trouble with thinking, trouble with controlling movements, or trouble with seeing clearly. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. Get up slowly or lie down for a while to relieve dizziness or lightheadedness.

Check with your doctor right away if blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).

Call your doctor right away:

• If your seizures still continue after using this medicine.
• If your seizures are different from your previous episodes.
• If you are alarmed by the number or severity of your seizure episodes.
• If you are alarmed by the color or breathing of the patient.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

Agitation

blindness

blurred vision

combativeness

decreased vision

difficult or trouble breathing

difficulty sleeping

discouragement

dizziness

eye pain

feeling sad or empty

headache

irregular, fast or slow, or shallow breathing

irritability

jerking or shaking

lack of appetite

lightheadedness

loss of interest or pleasure

mood or other mental changes

muscle tremor

nausea

pale or blue lips, fingernails, or skin

restlessness

seeing, hearing, or feeling things that are not there

tearing

thoughts or attempts at killing oneself

trouble concentrating

trouble sitting still

trouble sleeping

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Agitation

changes in patterns and rhythms of speech

confusion

drowsiness

lack of coordination

loss of consciousness

loss of strength or energy

nightmares

relaxed and calm feeling

shakiness and unsteady walk

sleepiness

slurred speech

talkativeness

trouble speaking

unsteadiness, trembling, or other problems with muscle control or coordination

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

unusual excitement, nervousness, restlessness, or irritability

unusual weak feeling

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Nasal discomfort

Less common

Abnormal product taste

changes in patterns and rhythms of speech

headache

runny nose

slurred speech

throat irritation

trouble in speaking

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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