midazolam (PF) 1 mg/mL in 0.9 % sodium chloride intravenous solution

Generic name:
Midazolam - injection

Pronunciation
(mi-DAZ-oh-lam)

Brand name(s)
Versed

Giving midazolam by injection into a vein can sometimes cause severe breathing problems which could rarely lead to brain damage or be fatal. The risk of serious breathing problems is higher with high doses or if midazolam is given too quickly into a vein. Midazolam must be used only under close medical supervision.

Infants, children, older adults, or weak patients are more sensitive to the effects of midazolam. Lower doses should be used for these patients. Lower doses of midazolam should be used if a patient is also receiving other medications that cause drowsiness. Newborns must not be given midazolam by rapid injection because of the risk of very serious side effects.

Midazolam has a risk for abuse and addiction, which can lead to overdose and death. Using this medication with alcohol or other drugs that can cause drowsiness or breathing problems (especially opioid medications such as codeine, hydrocodone) may cause very serious side effects, including death. To lower your risk, your doctor should have you use the smallest dose of midazolam that works, and use it for the shortest possible time. Be sure you know how to use midazolam and what other drugs you should avoid taking with it. See also Drug Interactions section. Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up.

Suddenly stopping this medication may cause serious (possibly fatal) withdrawal, especially if you have used it for a long time or in high doses. To prevent withdrawal, your doctor may lower your dose slowly. Tell your doctor or pharmacist right away if you have any withdrawal symptoms such as headaches, trouble sleeping, restlessness, hallucinations/confusion, depression, nausea, or seizures. Withdrawal symptoms may sometimes last weeks to months.

Midazolam is used before surgery or a procedure. It helps to cause drowsiness, decrease anxiety, and to decrease your memory of the surgery or procedure. This medication may also be used to help with anesthesia or to sedate people who need a tube or machine to help with breathing. Midazolam works by calming the brain and nerves. It belongs to a class of drugs known as benzodiazepines.

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used for serious seizures that do not stop (status epilepticus).

See also Warning section.

This medication is given by slow injection into a vein or muscle as directed by your doctor. It is usually given by a health care professional. The dosage is based on your medical condition, type of procedure you are having, other medications you are receiving, age, weight, and response to treatment.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional. Giving this medication too fast into a vein can cause serious side effects. Before using, check this product for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.

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

See also Warning section.

Pain/redness at the injection site or dizziness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

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

Tell your doctor right away if you have any serious side effects, including:

• mental/mood changes (such as agitation, aggressive behavior)
• shaking
• uncontrolled movements
• low blood pressure

Get medical help right away if you have any very serious side effects, including:

• slow/shallow breathing
• seizures

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 your 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.

See also Warning section.

Before using midazolam, tell your doctor or pharmacist if you are allergic to it; or to other benzodiazepines (such as diazepam, lorazepam); or if you have any other allergies. This product may contain inactive ingredients which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

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

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely, or until 24 hours after anesthesia and surgery, whichever is longer. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

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

Infants and children younger than 3 years using anesthesia or drugs for sedation (including midazolam) for procedures/surgeries may be at risk for slower brain growth. Talk to the doctor about the risks and benefits of this medication.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using midazolam. Midazolam may harm an unborn baby. Newborn babies of mothers who receive this medication late in pregnancy may have symptoms such as slow/shallow breathing, nonstop crying, shaking, or trouble feeding. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

This drug passes into breast milk. Consult your doctor before breastfeeding.

See also Warning section.

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

Some products that may interact with this drug are:

• conivaptan
• HIV protease inhibitors (such as atazanavir)
• lonafarnib
• ritonavir
• sodium oxybate

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 your doctor or pharmacist if you are taking other products such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), other drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your 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: confusion, slow reflexes, clumsiness, slow/shallow breathing, deep sleep, coma.

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

Medical tests (such as breathing rate, blood pressure, oxygen saturation) should be done while you are using this medication. Consult your doctor for more details.

If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

Check the product package for instructions on how to store this medication, or ask your pharmacist. 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.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.