Midazolam Hydrochloride Solution for injection

What is this medicine?

MIDAZOLAM (MID ay zoe lam) is a benzodiazepine. It is used to cause relaxation or sleep before surgery and to block memory of the procedure.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• an alcohol or drug abuse problem
• bipolar disorder, depression, psychosis, or other mental health condition
• glaucoma
• heart disease
• kidney disease
• liver disease
• lung or breathing disease
• seizures or a history of seizures
• suicidal thoughts
• an unusual or allergic reaction to midazolam, other benzodiazepines, benzyl alcohol, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

This medicine is for injection into a muscle or vein. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. While this medicine may be prescribed for children for selected conditions, precautions do apply.

What if I miss a dose?

This does not apply.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• delavirdine
• efavirenz
• grapefruit juice
• itraconazole
• ketoconazole
• protease inhibitors for HIV infection or AIDS

This medicine may also interact with the following medications:

• cimetidine
• diltiazem
• droperidol
• general anesthetics
• prescription pain medicines
• rifampin, rifapentine, or rifabutin
• secobarbital
• some antibiotics like clarithromycin, erythromycin, and troleandomycin
• some medicines for seizures like carbamazepine, phenobarbital, phenytoin, and primidone
• thiopental
• verapamil

What should I watch for while using this medicine?

Your condition will be monitored carefully while you are receiving this medicine.

The effects of this medicine can last for several hours after use. It can affect your ability to drive or do anything that needs mental alertness. Do not attempt to drive yourself home if you have received this medicine for minor outpatient surgery. You may feel dizzy and lightheaded. To reduce the risk of dizzy or fainting spells, do not sit up or stand up quickly, especially if you are an older patient. Alcohol can make you more drowsy or dizzy. Avoid alcoholic drinks for at least 24 hours after you receive this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• difficulty breathing, wheezing
• disorientation, or hallucinations during recovery
• dizziness or lightheadedness
• fast or irregular heartbeat
• numbness or tingling in the hands or feet
• pain, redness, or swelling at the injection site
• seizures
• skin rash or itching

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• coughing, hiccups
• difficulty sleeping, nightmares
• drowsiness
• headache
• involuntary eye and muscle movements
• loss of memory of events just before, during, and after use
• nausea, vomiting
• speech difficulty

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.