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|Versed

MIDAZOLAM (Systemic)

Some commonly used brand names are:

In the U.S.—

• Versed

In Canada—

• Versed

Category

• Anesthetic, general, adjunct
• anesthetic, local, adjunct
• sedative-hypnotic
• anticonvulsant

Description

Midazolam (MID-ay-zoe-lam)is used to produce sleepiness or drowsiness and to relieve anxiety before surgery or certain procedures. It is also used to produce loss of consciousness before and during surgery. Midazolam is used sometimes in patients in intensive care units in hospitals to cause unconsciousness. This may allow the patients to withstand the stress of being in the intensive care unit and help the patients cooperate when a machine must be used to assist them with breathing.

Midazolam is given only by or under the immediate supervision of a doctor trained to use this medicine. If you will be receiving midazolam during surgery, your doctor or anesthesiologist will give you the medicine and closely follow your progress.

Midazolam is available in the following dosage forms:

• Oral
• Oral solution (U.S.)

• Parenteral
• Injection (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For midazolam, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to midazolam or other benzodiazepines (such as alprazolam [e.g., Xanax], bromazepam [e.g., Lectopam], chlordiazepoxide [e.g., Librium], clonazepam [e.g., Klonopin], clorazepate [e.g., Tranxene], diazepam [e.g., Valium], estazolam [e.g., ProSom], flurazepam [e.g., Dalmane], halazepam [e.g., Paxipam], ketazolam [e.g., Loftran], lorazepam [e.g., Ativan], nitrazepam [e.g., Mogadon], oxazepam [e.g., Serax], prazepam [e.g., Centrax], quazepam [e.g., Doral], temazepam [e.g., Restoril], triazolam [e.g., Halcion]). Also, tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Midazolam is not recommended for use during pregnancy because it may cause birth defects. Other benzodiazepines, such as chlordiazepoxide (e.g., Librium) and diazepam (e.g., Valium) that are related chemically and in action to midazolam, have been reported to increase the chance of birth defects when used during the first 3 months of pregnancy. Also, use of midazolam during pregnancy, especially during the last few days, may cause drowsiness, slow heartbeat, shortness of breath, or troubled breathing in the newborn infant. In addition, receiving midazolam just before or during labor may cause weakness in the newborn infant.

Breast-feeding—Midazolam passes into human breast milk. Because newborn babies may be especially sensitive to the effects of midazolam, you should discuss breast-feeding with your physician if you are going to receive midazolam. It may be advisable to stop breast-feeding for a short period of time after receiving midazolam.

Children—Newborn babies may be especially sensitive to the effects of midazolam. This may increase the chance of side effects during the use of this medicine. Also, time to complete recovery after midazolam is given may be longer in very ill newborn babies.

Older adults—Elderly people are especially sensitive to the effects of midazolam. This may increase the chance of side effects during the use of this medicine. Also, time to complete recovery after midazolam is given may be slower in the elderly than in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving midazolam, it is especially important that your health care professional know if you are taking any of the following:

• Central nervous system (CNS) depressants (medicines that cause drowsiness) or alcohol—The CNS depressant and other effects of alcohol, other medicines, or midazolam may be increased; also, the effects of midazolam may last longer
• Saquinavir (e.g., Fortovase, Invirase)—Saquinavir may interfere with the removal of midazolam from the body, which could lead to serious side effects

Other medical problems—The presence of other medical problems may affect the use of midazolam. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart disease or
• Kidney disease or
• Liver disease or
• Obesity (overweight)—The effects of midazolam may last longer

• Lung disease or
• Myasthenia gravis or other muscle and nerve disease—Midazolam may make the condition worse

Proper Use of This Medicine

Dosing—The dose of midazolam will be different for different patients. Your doctor will decide on the right amount for you. The dose will depend on:

• Your age;
• Your weight;
• Your general physical condition;
• The kind of surgery or other procedure you are having; and
• Other medicines you are taking or will receive before and during the procedure.

Precautions After Receiving This Medicine

For patients going home within 24 hours after receiving midazolam:

• Midazolam may cause some people to feel drowsy, tired, or weak for 1 or 2 days after it has been given. It may also cause problems with coordination and one"s ability to think. Therefore, do not drive, use machines, or do anything else that could be dangerous if you are not alert until the effects of the medicine have disappeared or until the day after you receive midazolam, whichever period of time is longer.
• Do not drink alcoholic beverages or take other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness) for about 24 hours after you have received midazolam, unless otherwise directed by your doctor . To do so may add to the effects of the medicine. Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; other sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; medicine for seizures; and muscle relaxants.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. While you are receiving midazolam your doctor will monitor you closely for the side effects of midazolam, for example, breathing problems and confusion.

Some side effects may occur that usually do not need medical attention. Most side effects will go away as the effects of midazolam wear off.

However, check with your doctor if any side effects continue or are bothersome.

Additional Information

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in the product labeling, midazolam is used in certain patients with the following medical condition:

• Epilepsy

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for this use.

Revised: 01/14/2002

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