Midazolam (MID-ay-zoe-lam)

Treats seizure clusters.

Brand Name(s):

Nayzilam

When This Medicine Should Not Be Used:

How to Use This Medicine:

Spray

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• 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:
  • This medicine is for use only in the nose. Do not get any of it in 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.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how midazolam works. Tell your doctor if you are using clarithromycin, diltiazem, erythromycin, itraconazole, ketoconazole, or verapamil.
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol. Tell your doctor if you are also using codeine, fentanyl, hydrocodone, morphine, or oxymorphone.
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or planning to become pregnant. Using this medicine during the later part of a pregnancy may cause problems in your newborn baby (including sedation or withdrawal symptoms). Tell your doctor right away if you think you have become pregnant.
• Tell your doctor if you are breastfeeding or planning to breastfeed. This medicine passes into your breast milk and may cause problems in your baby. Talk to your doctor about the best way to feed your baby.
• Tell your doctor if you have kidney or liver disease, heart failure, low blood pressure, lung or breathing problems (including COPD), eye or vision problems, depression, or a history of alcohol or drug abuse.
• This medicine may cause the following problems:
  • Increased risk of overdose, which can be life-threatening
  • Respiratory depression (serious breathing problem that can be life-threatening), especially when used with narcotic pain medicines
  • Low blood pressure
  • Increased risk of suicidal thoughts or behavior
  • Eye or vision problems, including increased pressure in the eye
• This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely. Your seizures may return or occur more often if you stop using this medicine suddenly.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Agitation, tremor, restlessness, jerky muscle movement you cannot control (often in your face, tongue, or jaw)
• Blue lips, fingernails, or skin, trouble breathing, chest pain
• Blurred vision, change or loss of consciousness, dizziness, faintness, lightheadedness, problems with coordination or walking, unusual drowsiness
• Confusion
• Changes in mood or behavior, thoughts or attempts of hurting yourself
• Extreme tiredness or weakness, slow heartbeat

If you notice these less serious side effects, talk with your doctor:

• Nasal discomfort

If you notice other side effects that you think are caused by this medicine, tell your doctor

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