Midazolam (injection)

Midazolam is used by itself or with other medicines to help lower anxiety, cause drowsiness, and prevent memory of events before and during surgery or a medical procedure.

Midazolam is also used to keep people sedated who are on a machine that helps them breathe (ventilator) in the intensive care unit (ICU).

Midazolam may also be used for other reasons not mentioned in this medication guide.

Midazolam can slow or stop your breathing, especially if you have recently used an opioid medication, alcohol, or other drugs that can slow your breathing.

Using this medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

You should not be treated with midazolam if you are allergic to it, or if you have:

• narrow-angle glaucoma.

Tell your doctor if you have or have ever had:

• an electrolyte imbalance (such as low blood levels of potassium or magnesium);
• open-angle glaucoma;
• recently used alcohol, sedatives, tranquilizers, or other opioid medications;
• chronic obstructive pulmonary disease (COPD);
• congestive heart failure; or
• liver or kidney disease.

Anesthesia may affect brain development in a young child or unborn baby (when used in the mother), which may lead to learning or behavior problems later in life. Long surgeries or repeated procedures pose the highest risks.

Anesthesia may still be necessary for a life-threatening condition, medical emergency, or surgery to correct a birth defect. Your doctor can inform you about all medicines given during a surgery or procedure.

Midazolam may contain an ingredient that can cause serious side effects or death in babies.

If you use midazolam during pregnancy, your baby could be born with life-threatening withdrawal symptoms, and may need medical treatment for several weeks.

Tell your doctor if you are breastfeeding. Do not breastfeed within 4 to 8 hours after receiving midazolam. If you are breastfeeding, tell your doctor if you notice excessive sedation, poor feeding, and poor weight gain in the nursing baby.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Midazolam can slow or stop your breathing, especially if you have recently used an opioid medication or alcohol. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue-colored lips, or if you are hard to wake up.

Midazolam can cause serious side effects, including:

• trouble breathing;
• confusion, agitation; or
• tremors, uncontrolled muscle movements.

Midazolam can cause problems with thinking or memory that may last several hours after the injection.

Common side effects of midazolam may include:

• amnesia, sleep apnea;
• irregular heartbeat and blood pressure;
• headache, drowsiness;
• cough, hiccups;
• slow breathing;
• nausea, vomiting; or
• pain, bruising, swelling, or irritation where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Midazolam is injected into a muscle or into a vein. A healthcare provider will give you this injection.

Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely.

Midazolam may be habit-forming. You may have withdrawal symptoms if you stop receiving midazolam suddenly.

In a medical setting, it is unlikely that you will miss a dose.

In a medical setting, an overdose would be treated quickly.

• Avoid drinking alcohol.

• Avoid driving or doing dangerous activities until the effects of midazolam have completely worn off. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Sometimes, it is not safe to use certain medicines together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or reduce how well the medicines work.

Using midazolam with other drugs that cause drowsiness or slow your breathing can make these effects worse. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your other medicines, especially:

• antibiotic or antifungal medicine;
• heart or blood pressure medicine; or
• HIV or AIDS medication.

This list is not complete, and many other drugs may affect midazolam. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.