This form of midazolam is used by children with epilepsy to treat serious seizures that don't stop (lasting more than 5 minutes). Midazolam belongs to a class of medications known as benzodiazepines. It works by calming the brain and nerves.

See also Warning section.

Read the Patient Information Leaflet and Instructions for Use if available from the pharmacist before your child starts midazolam and each time you get a refill. Be sure to keep this medication handy in case it is needed. Learn ahead of time how to properly use this medication. Caregivers should learn when this medication should be used and what to watch for after using this medication. If there are any questions, ask the doctor or pharmacist.

This medication is given in the mouth as directed by the doctor. The solution in the syringe should be given slowly into the space between the cheek and the lower gum. The dosage is based on your child's age. Only one dose should be given to treat the seizure.

Do not use this product to treat episodes more often than once every 5 days, or more than 5 times in a month. Doing so may make this medication stop working well. Your child's seizures may get worse or happen more often. Talk with the doctor if this medication stops working well.

Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if your child has a substance use disorder (such as overuse of or addiction to drugs/alcohol). Use this medication exactly as prescribed to lower the risk of addiction. Ask the doctor or pharmacist for more details.

Get emergency help right away if seizures last (more than 10 minutes after giving the medication) or get worse after using the medication as directed, or if there is a change in your child's breathing, coloring, behavior, or condition that alarms you.

See also Warning section.

Nausea, vomiting, dizziness, or drowsiness may occur. If any of these effects last or get worse, tell the doctor or pharmacist promptly.

Remember that this medication has been prescribed because the doctor has judged that the benefit to your child is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell the doctor right away if your child has any serious side effects, including:

• slow/fast heartbeat

A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell the doctor right away if there are any unusual/sudden changes in your child's mood, thoughts, or behavior such as signs of depression, suicidal thoughts/attempts, thoughts about harming themselves.

Get medical help right away if your child has any very serious side effects, including:

• fainting
• rapid/slow/shallow breathing

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact the doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before giving midazolam, tell the doctor or pharmacist if your child is allergic to it; or to other benzodiazepines (such as diazepam); or if your child has any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to the pharmacist for more details.

Before using this medication, tell the doctor or pharmacist your child's medical history, especially of:

• kidney disease
• liver disease
• breathing problems (such as chronic obstructive pulmonary disease-COPD, sleep apnea)
• heart disease (such as heart failure)
• glaucoma
• personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol)

This drug may make your child dizzy or drowsy. Alcohol or marijuana (cannabis) can make your child more dizzy or drowsy. Do not let your child drive, use machinery, or do anything that needs alertness until your child can do it safely. Avoid alcoholic beverages. Talk to the doctor if your child is using marijuana (cannabis).

Before having surgery, tell the doctor or dentist about all the products your child uses (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Newborn babies of mothers who use this medication late in pregnancy may have symptoms such as slow/shallow breathing, nonstop crying, shaking, or trouble feeding. However, since untreated seizures are a serious condition that can harm both a pregnant woman and her unborn baby, do not stop using this medication unless directed by the doctor. Discuss the risks and benefits with the doctor.

This medication passes into breast milk. Consult the doctor before breastfeeding.

See also Warning section.

Drug interactions may change how your child's medications work or increase their risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products your child uses (including prescription/nonprescription drugs and herbal products) and share it with the doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without the doctor's approval.

A product that may interact with this drug is:

• sodium oxybate

Other medications can affect the removal of midazolam from your child's body, which may affect how midazolam works. Examples include HIV protease inhibitors (such as atazanavir), lonafarnib, ritonavir, rifamycins (such as rifabutin, rifampin), among others.

The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is used with other products that may also cause drowsiness or breathing problems. Tell the doctor or pharmacist if your child is taking other products such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your child's medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask the pharmacist about using those products safely.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: severe drowsiness, slow/shallow breathing, confusion, loss of coordination.

Do not share this medication with others. Sharing it is against the law.

Not applicable.

Store at room temperature. Do not refrigerate or freeze. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Your child's condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).