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MIDAZOLAM HCL
MIDAZOLAM - INJECTION

Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

MIDAZOLAM - INJECTION

(mid-AZE-oh-lam)

COMMON BRAND NAME(S): Versed

WARNING: Rapid intravenous (IV) use of midazolam can cause severe breathing problems which could cause brain damage or be fatal if left untreated. Therefore, when using this medication IV it must be used only under close medical supervision. Children, infants, elderly or weak patients are more sensitive to the effects of midazolam. Thus, lower doses should be used for these patients or when other sedating drugs are used with midazolam. Newborns must not be given midazolam by rapid IV injection.

Uses

Midazolam is used before operations or procedures to relax you, make you sleepy and to decrease your memory of the event.

OTHER

Uses

This drug may also be used to treat seizures.

How To Use

This drug is given slowly by vein (IV) or into a large muscle (IM). The dosage is adjusted for your medical history, age and type of medical procedure or condition being treated. Drowsiness (sedative) effects usually are obvious within 15 minutes. The length of time before drug effects wear off varies considerably. Flumazenil is a medication that may be used to reverse the sedative effect of this drug.

Side Effects

Dizziness, headache and pain or redness at the injection site might occur. If these persist or worsen, notify your doctor. Report promptly: unusually slow or shallow breathing. Very unlikely but report promptly: unusually fast/slow/ irregular heartbeat, fainting, confusion, mental/mood changes, trouble breathing, muscle twitching, uncontrolled movements. Seek immediate medical attention if an allergic reaction occurs, however unlikely. Symptoms include: throat discomfort, difficulty breathing, skin rash, hives, itching. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

Tell your doctor your medical history, especially of: allergies (especially drug allergies), heart problems, kidney problems, liver problems, lung diseases, narrow-angle glaucoma. Avoid alcohol while using this drug. Side effects may be aggravated. Do not drive or use hazardous machinery until the effects of the drug have disappeared (e.g., drowsiness). A preservative (benzyl alcohol) which may be found in this product or in the liquid used to mix this product (diluent) can infrequently cause serious problems (sometimes death) if given by injection to an infant during the first months of life (neonatal period). The risk is greater with lower birth weight infants and is greater with increased amounts of benzyl alcohol. Symptoms include sudden gasping, low blood pressure, or a very slow heartbeat. Report these symptoms to the doctor immediately should they occur. If possible, a preservative-free product should be used when treating neonates. This drug is not recommended for use during pregnancy. Consult your doctor before using this drug. This drug is excreted into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast- feeding. Caution is advised when this drug is used in the elderly as elderly patients are usually more sensitive to its effects.

Drug Interactions

Tell your doctor of all nonprescription and prescription medication you use, especially of: H2 blockers (e.g., cimetidine), fluconazole, theophylline, aminophylline, erythromycin. Also report use of drugs that make you drowsy, such as: narcotic pain relievers (e.g., morphine, codeine), psychiatric medicines, other anti-anxiety drugs, anti-seizure drugs, certain antihistamines (e.g., diphenhydramine), other muscle relaxants, sleeping pills, sedatives. Do not start or stop any medicine without doctor or pharmacist approval.

Overdose

If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include confusion, slow reflexes, clumsiness, deep sleep, and loss of consciousness.

Notes

Tests such as breathing rate and blood pressure are done periodically during treatment.

Missed Dose

If you miss a dose, contact your doctor to establish a new dosing schedule. Do not "double-up" the doses.

Storage

Store at room temperature between 59 and 86 degrees F (15-30 degrees C) away from light and moisture.