Pronunciation:

MID-ay-zoe-lam

Brand Names:

• Versed
• Midazolam

Dosage Forms:

• Solution

Warnings:

Midazolam has been associated with respiratory depression and respiratory arrest, especially when used for sedation in noncritical care settings. Use only in settings that can provide for continuous monitoring of respiratory and cardiac function. The initial dose and all subsequent doses should always be titrated slowly. Midazolam injection should not be administered by rapid injection in the neonatal population as severe hypotension and seizures have been reported .

Classifications:

Therapeutic—

Anesthetic Adjunct

Pharmacologic—

Benzodiazepine, Short or Intermediate Acting

Uses of This Medicine:

Midazolam injection is used to produce sleepiness or drowsiness and relieve anxiety before surgery or certain procedures. When midazolam is used before surgery, the patient will not remember some of the details about the procedure. Midazolam injection is also used as an anesthesia to produce loss of consciousness before and during surgery.

Midazolam injection is also used to treat status epilepticus, a severe type of seizure where there is more than one seizure within 5 minutes.

Midazolam is a benzodiazepine. Benzodiazepines belong to the group of medicines called central nervous system (CNS) depressants, which are medicines that slow down the nervous system.

This medicine is given only by or under the direct supervision of your doctor.

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of midazolam injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of midazolam injection in the elderly. However, elderly patients are more likely to have age-related liver, kidney, heart, or lung problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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 this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amprenavir
• Atazanavir
• Boceprevir
• Cobicistat
• Darunavir
• Delavirdine
• Flumazenil
• Fosamprenavir
• Indinavir
• Itraconazole
• Levoketoconazole
• Lopinavir
• Nelfinavir
• Saquinavir
• Telaprevir
• Tipranavir

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adagrasib
• Alfentanil
• Alprazolam
• Amobarbital
• Anileridine
• Aprobarbital
• Aripiprazole
• Baclofen
• Benzhydrocodone
• Bromazepam
• Bromopride
• Buprenorphine
• Buspirone
• Butabarbital
• Butalbital
• Butorphanol
• Calcifediol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbamazepine
• Carbinoxamine
• Carisoprodol
• Ceritinib
• Cetirizine
• Chloral Hydrate
• Chlordiazepoxide
• Chlorpromazine
• Chlorzoxazone
• Ciprofloxacin
• Clarithromycin
• Clobazam
• Clonazepam
• Clorazepate
• Codeine
• Conivaptan
• Cyclobenzaprine
• Dabrafenib
• Dantrolene
• Daridorexant
• Dexmedetomidine
• Dezocine
• Diacetylmorphine
• Diazepam
• Difenoxin
• Dihydrocodeine
• Diphenhydramine
• Diphenoxylate
• Doxylamine
• Dronedarone
• Duvelisib
• Esketamine
• Estazolam
• Eszopiclone
• Ethchlorvynol
• Ethylmorphine
• Fedratinib
• Fentanyl
• Fexinidazole
• Flibanserin
• Fluconazole
• Flunitrazepam
• Flurazepam
• Fosnetupitant
• Fospropofol
• Gabapentin
• Gabapentin Enacarbil
• Halazepam
• Hydrocodone
• Hydromorphone
• Hydroxyzine
• Idelalisib
• Imatinib
• Isavuconazonium Sulfate
• Ivacaftor
• Ivosidenib
• Ketamine
• Ketazolam
• Ketobemidone
• Lacosamide
• Larotrectinib
• Lefamulin
• Lemborexant
• Lenacapavir
• Letermovir
• Levocetirizine
• Levorphanol
• Lofexidine
• Lorazepam
• Lorlatinib
• Loxapine
• Lumacaftor
• Magnesium Oxybate
• Mavacamten
• Meclizine
• Meperidine
• Mephenesin
• Mephobarbital
• Meprobamate
• Meptazinol
• Metaxalone
• Methadone
• Methocarbamol
• Methohexital
• Methotrimeprazine
• Metoclopramide
• Mirtazapine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Nefazodone
• Netupitant
• Nicomorphine
• Nilotinib
• Nitrazepam
• Oliceridine
• Olutasidenib
• Omaveloxolone
• Opium
• Opium Alkaloids
• Orlistat
• Orphenadrine
• Oxazepam
• Oxycodone
• Oxymorphone
• Pacritinib
• Papaveretum
• Paregoric
• Pentazocine
• Pentobarbital
• Perampanel
• Periciazine
• Phenobarbital
• Piritramide
• Pirtobrutinib
• Posaconazole
• Potassium Oxybate
• Prazepam
• Pregabalin
• Primidone
• Promethazine
• Propofol
• Quazepam
• Ramelteon
• Remifentanil
• Remimazolam
• Ritlecitinib
• Ropeginterferon Alfa-2b-njft
• Scopolamine
• Secobarbital
• Sodium Oxybate
• Sufentanil
• Tapentadol
• Temazepam
• Thiopental
• Thioridazine
• Tilidine
• Tizanidine
• Topiramate
• Tramadol
• Trazodone
• Triazolam
• Trofinetide
• Zaleplon
• Zolpidem
• Zopiclone
• Zuranolone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aprepitant
• Armodafinil
• Cimetidine
• Crizotinib
• Cyclosporine
• Dalfopristin
• Diltiazem
• Echinacea
• Erythromycin
• Fluvoxamine
• Fosaprepitant
• Fosphenytoin
• Ginkgo Biloba
• Goldenseal
• Halothane
• Hydrastis
• Laropiprant
• Mitotane
• Phenytoin
• Quinupristin
• Rifapentine
• Roxithromycin
• St John's Wort
• Telithromycin
• Theophylline
• Verapamil
• Voriconazole

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other medical problems—

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

• Alcohol or abuse, or history of or
• Drug abuse or dependence, or history of or
• Lung or breathing problems or
• Muscle or nerve problem (eg, myasthenia gravis)—Midazolam may make these conditions worse.

• Glaucoma, narrow-angle—Use is not recommended in patients with this condition.

• Heart failure or
• Kidney disease or
• Liver disease or
• Obesity (overweight)—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.

• Hypotension (low blood pressure) or
• Lung or breathing problems (eg, COPD) , severe or
• Patients in shock or with loss of consciousness (coma) or
• Sleep apnea (temporary stopping of breathing during sleep)—Use with caution. May increase risk for severe and serious breathing problems (eg, respiratory depression).

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. It is given as a shot into one of your muscles.

After you receive a shot of this medicine, your doctor will watch you closely to make sure it is working properly and to check for unwanted effects.

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely after you receive this medicine to make sure it is working properly and to check for any unwanted effects.

Tell your doctor if you are pregnant or planning to become pregnant. Using this medicine during the later pregnancy may cause problems in your newborn baby (eg, sedation or withdrawal symptoms). Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, feeding problems, a high-pitched cry, irritability, low muscle tone, restlessness, shakiness or tremors, sluggishness, trouble breathing, weight loss, vomiting, or fails to gain weight. If you think you have become pregnant while using the medicine, tell your doctor right away.

Symptoms of an overdose include: change or loss of consciousness, confusion, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, irregular, fast or slow, or shallow breathing, lack of coordination, loss of strength or energy, muscle pain or weakness, pale or blue lips, fingernails, or skin, shakiness and unsteady walk, unsteadiness, trembling, or other problems with muscle control or coordination, sweating, trouble breathing, unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness, or unusual weak feeling. Call your doctor right away if you notice these symptoms.

This medicine may cause respiratory depression (serious breathing problem that can be life-threatening), especially when used with narcotic pain medicines. Tell your doctor if you are using any narcotic medicine, such as droperidol, fentanyl, meperidine, morphine, or secobarbital.

This medicine contains benzyl alcohol which may cause serious reactions to newborn, premature, or low-birthweight infants. Talk this with your doctor if you are concerned.

This medicine may cause drowsiness, trouble with thinking, trouble with controlling movements, or trouble with seeing clearly. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Check with your doctor right away if blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).

This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, barbiturates (used for seizures), muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you stop taking this medicine. Check with your doctor before using any of the above while you are receiving this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Less common

Aggressiveness

agitation

anxiety

choking

confusion

decreased awareness or responsiveness

decreased urine output

difficulty walking, speaking, or writing

discouragement

dizziness

feeling sad or empty

fever

headache

irritability

lack of appetite

loss of bladder or bowel control

loss of consciousness

loss of interest or pleasure

memory loss

muscle twitching

nausea

nightmares or unusually vivid dreams

rapid weight gain

seizures

severe sleepiness

strong urge to urinate

swelling of the face, ankles, or hands

thirst

trouble concentrating

trouble sleeping

trouble breathing

unable to speak

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Agitation

changes in patterns and rhythms of speech

confusion

excitement

irritability

lack of coordination

loss of strength or energy

muscle pain or weakness

relaxed and calm feeling

restlessness

shakiness and unsteady walk

slurred speech

talkativeness

trouble in speaking

unsteadiness, trembling, or other problems with muscle control or coordination

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

unusual weak feeling

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

Rare

Muscle stiffness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.