Midazolam Injection

Midazolam injection may cause serious or life-threatening breathing problems. Tell your doctor and pharmacist if you are taking medications for pain or cough.

Midazolam injection is used before medical procedures and surgery and during surgery to cause drowsiness, relieve anxiety, and avoid any memory of the event. Midazolam injection is also used in seriously ill people in intensive care units (ICU) who are breathing with the help of a machine. Midazolam injection is in a class of medications called benzodiazepines. It works by slowing activity in the brain to allow relaxation and decreased consciousness.

Midazolam injection comes as a solution (liquid) to be given intramuscularly (into the muscle) or intravenously (into the vein) by a doctor or nurse in a hospital or clinic. It is given as needed or as frequently as your doctor determines you need it.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving midazolam injection,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• some medications should not be taken with midazolam injection. Other medications may cause dosing changes or extra monitoring when taken with midazolam injection. Make sure you have discussed any medications you are currently taking or plan to take before starting midazolam injection with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking midazolam injection, please get the advice of your doctor or pharmacist.
• the following nonprescription or herbal products may interact with midazolam injection: cimetidine. Be sure to let your doctor and pharmacist know that you are taking this medication before you start receiving midazolam injection.
• tell your doctor if you have glaucoma (increased pressure in the eyes that may cause gradual loss of vision). Your doctor may decide not to give you midazolam injection.
• tell your doctor if you drink large amounts of alcohol or if you have or have ever had kidney or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding.
• you should know that midazolam may make you very drowsy and may affect your memory, thinking, and movements. Do not drive a car or do other activities that require you to be fully alert for the period of time described by your doctor. If your child received midazolam injection, watch him or her carefully to be sure that he or she does not fall while walking during this time.
• talk to your doctor about the safe use of alcoholic beverages after your treatment with midazolam. Alcohol can make the side effects from midazolam injection worse.
• you should know that repeated or lengthy use (>3 hours) of general anesthetic or sedation drugs in infants and children <3 years of age or in women in the last few months of their pregnancy may affect the child's brain development. Other studies in infants and toddlers show that a single, short exposure to anesthetic and sedation drugs is unlikely to have negative effects on behavior or learning. However, further research is needed. Parents and caregivers of children <3 years of age and pregnant women should talk to their doctors about the risks of anesthesia on brain development.

Unless your doctor tells you otherwise, continue your normal diet.

Midazolam injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• drowsiness
• nausea, vomiting
• coughing
• pain, redness, or hardening of the skin at the injection site

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• agitation, restlessness, uncontrollable shaking of a part of the body, stiffening and jerking of the arms and leg, aggression
• seizures
• hives, rash, itching, difficulty breathing or swallowing

Midazolam injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• drowsiness, confusion, slowed reflexes,
• slowed breathing and heartbeat
• coma (loss of consciousness for a period of time)

Keep all appointments with your doctor.

Ask your doctor or pharmacist if you have any questions about midazolam injection.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

• Versed^® Injection