Versed (Injection)

Midazolam injection is used to make you feel sleepy or drowsy and to help with anxiety before surgery or certain procedures. When midazolam is used before surgery, you will not remember some details about the procedure. Midazolam injection is also used as anesthesia to cause loss of consciousness before and during surgery.

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

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

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

It is very important that your doctor checks your progress closely after you receive this medicine to ensure 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 later pregnancy may cause problems in your newborn baby (e.g., sedation or withdrawal symptoms). Tell your doctor right away if your baby has an unusual 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 an unusual weak feeling. Call your doctor right away if you notice these symptoms.

This medicine may cause respiratory depression (a 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 in newborn, premature, or low-birthweight infants. Discuss this with your doctor if you are concerned.

This medicine may cause drowsiness, trouble thinking, trouble controlling movements, or trouble 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 reading, or any other change in vision occurs during or after treatment. Your doctor may want your eyes to be checked by an ophthalmologist (eye doctor).

This medicine will increase 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 medicines for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicines, prescription pain medicines 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.

In deciding to use a drug, the risks of using the medicine must be weighed against the beneficial it will do. This is a decision you and your clinician will make. For this drug, the following should be considered:

Allergies

Inform your physician if you have ever had any unusual or allergic reaction to this medicine or any other medicines. As well inform 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.

Pediatric

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.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific issues 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 issues, 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 chance when using this drug during breastfeeding. Weigh the potential benefits against the potential chances before using this drug while breastfeeding.

Interactions with Medicines

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

Using this medication with any of the following drugs is not advised. Your clinician may decide not to treat you with this medication or change some of the other drugs you take.

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

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

• Adagrasib
• Alfentanil
• Alprazolam
• Amobarbital
• Anileridine
• Aprobarbital
• Aripiprazole
• Baclofen
• Belzutifan
• Benzhydrocodone
• Bromazepam
• Bromopride
• Buprenorphine
• Buspirone
• Butabarbital
• Butalbital
• Butorphanol
• Calcifediol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• 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
• 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
• Ribociclib
• Ritlecitinib
• Ropeginterferon Alfa-2b-njft
• Scopolamine
• Secobarbital
• Sodium Oxybate
• Sufentanil
• Tapentadol
• Temazepam
• Thiopental
• Thioridazine
• Tilidine
• Tizanidine
• Tocilizumab
• Topiramate
• Tramadol
• Trazodone
• Triazolam
• Trofinetide
• Zaleplon
• Zolpidem
• Zopiclone
• Zuranolone

Using this drug with any of the following drugs may cause an increased risk of certain adverse effects, but using both drugs may be the best therapy for you. If both drugs are prescribed together, your clinician may change the dose or how frequently you use one or both of the medicines.

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

Interactions with Food/Tobacco/Alcohol

Certain drugs 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 drugs 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 normally not advised, but may be unavoidable in some cases. If used together, your doctor may change the dose or how frequently you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Using this drug with any of the following may cause an increased chance of certain side effects but may be unavoidable in some cases. If used together, your clinician may change the dose or how frequently 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 issues may affect the use of this drug. Make sure you inform your clinician if you have any other medical issues, especially:

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

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

• Heart failure or
• Kidney disease or
• Liver disease or
• Obesity (overweight)—Use with caution. The effects may be increased since of the slower removal of the medication 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 discontinuing of breathing during sleep)—Use with caution. May raise risk for serious and severe breathing issues (eg, respiratory depression).

Along with its necessary effects, a medicine can cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor or nurse right away 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 happen 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, 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.

In the U.S.

• Versed

In Canada

• Midazolam

Available Dosage Forms:

• Solution

Therapeutic Class: Anesthetic Adjunct

Pharmacologic Class: Benzodiazepine, Short or Intermediate Acting

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.

• What is the correct way to use Nayzilam Nasal Spray?