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Midazolam, marketed under the trade name Versed, among others, is a benzodiazepine medication used for anesthesia, procedural sedation, trouble sleeping, and severe agitation. It works by inducing sleepiness, decreasing anxiety, and causing a loss of ability to create new memories.


Description

Midazolam Uses

This medication is used in children before a procedure or anesthesia to cause drowsiness, decrease anxiety, and cause forgetfulness of the surgery or procedure. It should be used while the child is under the care of a health professional. It is not for home or long-term use.

Midazolam belongs to a class of medications called benzodiazepines, which produce a calming effect on the brain and nerves (central nervous system). It is thought to work by increasing the effect of a certain natural chemical (GABA) in the brain.

How to use Midazolam HCL

healthcare professional will prepare and measure your dose. Take this medication by mouth as directed by your doctor. It is usually given as a single dose before a procedure or anesthesia.

The dosage is based on your medical condition, response to therapy, weight, and other medications you may be taking.

If you suddenly stop using this medication, you may have withdrawal symptoms (such as shaking, sweatingvomiting, abdominal/muscle crampsseizures). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used midazolam regularly for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.

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). Do not increase your dose, take it more often, or use it for a longer time than prescribed. Talk with the doctor if this medication stops working well. Properly stop the medication when so directed.

Avoid eating grapefruit or drinking grapefruit juice while being treated with this medication unless the doctor instructs you otherwise. Grapefruit can increase the amount of certain medications in the bloodstream. Consult the doctor or pharmacist for more details.

Midazolam SIDE EFFECTSSee WARNINGS concerning serious cardiorespiratory events and possible paradoxical reactions. Fluctuations in vital signs were the most frequently seen findings following parenteral administration of midazolam in adults and included decreased tidal volume and/or respiratory rate decrease (23.3% of patients following IV and 10.8% of patients following IM administration) and apnea (15.4% of patients following IV administration), as well as variations in blood pressure and pulse rate. The majority of serious adverse effects, particularly those associated with oxygenation and ventilation, have been reported when midazolam is administered with other medications capable of depressing the central nervous system. The incidence of such events is higher in patients undergoing procedures involving the airway without the protective effect of an endotracheal tube (eg, upper endoscopy and dental procedures).

Administration of IM midazolam to elderly and/or higher risk surgical patients has been associated with rare reports of death under circumstances compatible with cardiorespiratory depression. In most of these cases, the patients also received other central nervous system depressants capable of depressing respiration, especially narcotics (see DOSAGE AND ADMINISTRATION).

The following additional adverse reactions were reported subsequent to intravenous administration as a single sedative/anxiolytic/amnestic agent in adult patients:

 

 

hiccoughs (3.9%) Local effects at the IV site
nausea (2.8%)
vomiting (2.6%)
coughing (1.3%)
“oversedation” (1.6%)
headache (1.5%)
drowsiness (1.2%)
tenderness (5.6%)
pain during injection (5.0%)
redness (2.6%)
induration (1.7%)
phlebitis (0.4%)

 

Pediatric Patients

The following adverse events related to the use of IV midazolam in pediatric patients were reported in the medical literature: desaturation 4.6%, apnea 2.8%, hypotension 2.7%, paradoxical reactions 2.0%, hiccough 1.2%, seizure-like activity 1.1% and nystagmus 1.1%. The majority of airway-related events occurred in patients receiving other CNS depressing medications and in patients where midazolam was not used as a single sedating agent.

Neonates

For information concerning hypotensive episodes and seizures following the administration of midazolam to neonates (see BOXED WARNINGCONTRAINDICATIONSWARNINGS and PRECAUTIONS).

Other adverse experiences, observed mainly following IV injection as a single sedative/anxiolytic/amnesia agent and occurring at an incidence of < 1.0% in adult and pediatric patients, are as follows:

Respiratory: Laryngospasm, bronchospasm, dyspnea, hyperventilation, wheezing, shallow respirations, airway obstruction, tachypnea.

Cardiovascular: Bigeminy, premature ventricular contractions, vasovagal episode, bradycardiatachycardia, nodal rhythm.

Gastrointestinal: Acid taste, excessive salivation, retching.

CNS/NeuromuscularRetrograde amnesia, euphoria, hallucination, confusion, argumentativeness, nervousness, anxiety, grogginess, restlessness, emergence delirium or agitation, prolonged emergence from anesthesia, dreaming during emergence, sleep disturbance, insomnia, nightmares, athetoid movements, seizure-like activity, ataxia, dizziness, dysphoria, slurred speech, dysphoniaparesthesia.

Special Senses: Blurred vision, diplopia, nystagmus, pinpoint pupils, cyclic movements of eyelids, visual disturbance, difficulty focusing eyes, ears blocked, loss of balance, light-headedness.

Integumentary: Hive-like elevation at injection site, swelling or feeling of burning, warmth or coldness at injection site.

Hypersensitivity: Allergic reactions including anaphylactoid reactions, hives, rash, pruritus.

Miscellaneous: Yawning, lethargy, chills, weakness, toothache, faint feeling, hematoma.

Drug Abuse And Dependence

Midazolam is subject to Schedule IV control under the Controlled Substances Act of 1970.

Midazolam was actively self-administered in primate models used to assess the positive reinforcing effects of psychoactive drugs.

Midazolam produced physical dependence of a mild to moderate intensity in cynomolgus monkeys after 5 to 10 weeks of administration. Available data concerning the drug abuse and dependence potential of midazolam suggest that its abuse potential is at least equivalent to that of diazepam.

Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, hallucinations, tremor, abdominal and muscle cramps, vomiting and sweating), have occurred following abrupt discontinuation of benzodiazepines, including midazolam. Abdominal distention, nausea, vomiting, and tachycardia are prominent symptoms of withdrawal in infants. The more severe withdrawal symptoms have usually been limited to those patients who had received excessive doses over an extended period of time. Generally milder withdrawal symptoms (eg, dysphoria and insomnia) have been reported following abrupt discontinuance of benzodiazepines taken continuously at therapeutic levels for several months. Consequently, after extended therapy, abrupt discontinuation should generally be avoided and a gradual dosage tapering schedule followed. There is no consensus in the medical literature regarding tapering schedules; therefore, practitioners are advised to individualize therapy to meet patient’s needs. In some case reports, patients who have had severe withdrawal reactions due to abrupt discontinuation of high-dose long-term midazolam, have been successfully weaned off of midazolam over a period of several days.

Precautions

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

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: glaucoma (narrow-angle).

Before using this medication, tell the doctor or pharmacist your medical history, especially of: kidney diseaseliver diseasebreathing problems (e.g., chronic obstructive pulmonary diseaseCOPDsleep apnea), heart disease (e.g., congestive heart failure), glaucoma (open-angle), 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. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell the doctor or dentist that you are using this medication.

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.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Infants born to mothers who used similar medications for an extended time have had withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, or diarrhea. Consult your doctor for more details.

This medication passes into breast milk. Consult your doctor before breast-feeding.

Interactions

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 include: delavirdineHIV protease inhibitors (e.g., ritonavirsaquinaviratazanavir), sodium oxybate.

Other medications can affect the removal of midazolam from your body, which may affect how midazolam works. Examples include azole antifungals (such as itraconazoleketoconazole), macrolide antibiotics (such as erythromycin), cimetidine, rifamycins (such as rifabutinrifampin), St. John’s wort, certain anti-seizure medicines (such as carbamazepine, phenytoin), calcium channel blockers (such as diltiazemverapamil), certain SSRIs (such as fluoxetinefluvoxamine), nefazodone, conivaptan, among others.

The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken 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), drugs for sleep or anxiety (such as alprazolamlorazepam, zolpidem), muscle relaxants (such as carisoprodolcyclobenzaprine), or antihistamines (such as cetirizinediphenhydramine).

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.

Overdose

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 their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: drowsiness, confusion, loss of coordination.

Notes

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

This medication has been prescribed for your current procedure only. Do not use it later for another condition or procedure unless told to do so by the doctor. A different medication may be necessary in that case.

Laboratory and/or medical tests (e.g., breathing, blood pressure, heartbeat) should be performed periodically to monitor your progress or check for side effects. Consult the doctor for more details.

Missed Dose

Not applicable.

Storage

Not applicable. This medication is given in a hospital, clinic, or doctor’s office and will not be stored at home.Information last revised May 2019.

DRUG INTERACTIONS

The sedative effect of intravenous midazolam is accentuated by any concomitantly administered medication, which depresses the central nervous system, particularly narcotics (eg, morphine, meperidine and fentanyl) and also secobarbital and droperidol. Consequently, the dosage of midazolam should be adjusted according to the type and amount of concomitant medications administered and the desired clinical response (see DOSAGE AND ADMINISTRATION.)

Caution is advised when midazolam is administered concomitantly with drugs that are known to inhibit the P450 3A4 enzyme system such as cimetidine (not ranitidine), erythromycin, diltiazem, verapamil, ketoconazole and itraconazole. These drug interactions may result in prolonged sedation due to a decrease in plasma clearance of midazolam.

The effect of single oral doses of 800 mg cimetidine and 300 mg ranitidine on steady-state concentrations of midazolam was examined in a randomized crossover study (n=8). Cimetidine increased the mean midazolam steady-state concentration from 57 to 71 ng/mL. Ranitidine increased the mean steady-state concentration to 62 ng/mL. No change in choice reaction time or sedation index was detected after dosing with the H2 receptor antagonists.

In a placebo-controlled study, erythromycin administered as a 500 mg dose, tid, for 1 week (n=6), reduced the clearance of midazolam following a single 0.5 mg/kg IV dose. The half-life was approximately doubled.

The effects of diltiazem (60 mg tid) and verapamil (80 mg tid) on the pharmacokinetics and pharmacodynamics of midazolam were investigated in a three-way cross-over study (n=9). The half-life of midazolam increased from 5 to 7 hours when midazolam was taken in conjunction with verapamil or diltiazem. No interaction was observed in healthy subjects between midazolam and nifedipine.

A moderate reduction in induction dosage requirements of thiopental (about 15%) has been noted following use of intramuscular midazolam for premedication in adults.

The intravenous administration of midazolam decreases the minimum alveolar concentration (MAC) of halothane required for general anesthesia. This decrease correlates with the dose of midazolam administered; no similar studies have been carried out in pediatric patients but there is no scientific reason to expect that pediatric patients would respond differently than adults.

Although the possibility of minor interactive effects has not been fully studied, midazolam and pancuronium have been used together in patients without noting clinically significant changes in dosage, onset or duration in adults. Midazolam does not protect against the characteristic circulatory changes noted after administration of succinylcholine or pancuronium and does not protect against the increased intracranial pressure noted following administration of succinylcholine. Midazolam does not cause a clinically significant change in dosage, onset or duration of a single intubating dose of succinylcholine; no similar studies have been carried out in pediatric patients but there is no scientific reason to expect that pediatric patients would respond differently than adults.

No significant adverse interactions with commonly used premedications or drugs used during anesthesia and surgery (including atropinescopolamine, glycopyrrolate, diazepam, hydroxyzine, d-tubocurarine, succinylcholine and other nondepolarizing muscle relaxants) or topical local anesthetics (including lidocaine, dyclonine HCl and benzocaine) have been observed in adults or pediatric patients. In neonates, however, severe hypotension has been reported with concomitant administration of fentanyl. This effect has been observed in neonates on an infusion of midazolam who received a rapid injection of fentanyl and in patients on an infusion of fentanyl who have received a rapid injection of midazolam.

Caution is advised when midazolam is administered to patients receiving erythromycin since this may result in a decrease in the plasma clearance of midazolam.

Drug/Laboratory Test Interactions

Midazolam has not been shown to interfere with results obtained in clinical laboratory tests.

Midazolam

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