Versed

Midazolam comes as a syrup to take by mouth. It is usually given as a single dose by a doctor or nurse before a medical procedure or surgery.

Do not let your child eat grapefruit or drink grapefruit juice while taking this medication.

Versed is one of several brand names of the drug midazolam, which is given before and during surgeries and some medical procedures to induce drowsiness, relieve anxiety, and prevent remembering the event.

The drug is also used to cause a loss of consciousness during surgery or when a seriously ill person's breathing is assisted by a ventilator.

Midazolam may also be used to treat insomnia and seizures in children.

Midazolam belongs to a group of drugs known as benzodiazepines, or central nervous system depressants.

The Food and Drug Administration (FDA) approved midazolam in 1985. It's only given by or under the supervision of a doctor who's trained to use it.

Midazolam comes as a tablet, syrup, or injectable solution. Children having surgery typically take the oral syrup.

Midazolam Warnings

Midazolam may cause serious breathing problems that could lead to permanent brain injury or death. You should only receive this medicine if your doctor has equipment to monitor your heart and lungs and provide life-saving medical treatment immediately if your breathing stops.

You should tell your physician if you have a severe infection or if you have or have ever had:

• Lung, airway, or breathing problems
• Heart disease
• Kidney disease
• Liver disease

Also, tell your doctor if you are taking any of the following medicines before receiving midazolam:

• Antidepressants
• Barbiturates such as secobarbital (Seconal)
• Droperidol (Inapsine)
• Medications for anxiety, mental illness, or seizures
• Narcotic medications for pain such as fentanyl (Actiq, Duragesic, Sublimaze), meperidine (Demerol), and morphine (Avinza, Kadian, MS Contin, and others)
• Sedatives
• Sleeping pills
• Tranquilizers

You should also alert your physician if you have ever used street drugs or abused prescription medications.

Tell your physician if you have recently stopped drinking large amounts of alcohol before taking this medicine.

You shouldn't receive midazolam if you have glaucoma (eye conditions, including increased pressure within the eye, that cause damage to the optic nerve and possibly vision loss).

Older adults should receive lower doses of midazolam, as higher doses are more likely to cause serious side effects in people age 65 or older.

If you receive repeated midazolam injections in the intensive care unit (ICU) for a long period of time, you may become dependent on it. Your doctor will probably gradually reduce the drug dosage until it is discontinued entirely to prevent withdrawal symptoms.

Pregnancy and Midazolam

Midazolam is a Pregnancy Category D drug, which means it could harm an unborn baby. You shouldn't be given this medicine while you are pregnant.

The drug can also pass into breast milk and may harm a breastfeeding baby. Tell your physician if you are breastfeeding before receiving Versed.

Common Side Effects of Midazolam

You should call your doctor if any of the following side effects become severe or don't go away:

• Headache
• Nausea
• Drowsiness
• Vomiting
• Hiccups
• Coughing
• Pain, redness, or hardening of your skin at the injection site if the drug is given intravenously

Serious Side Effects of Midazolam

You should call your doctor immediately if you experience any of the side effects listed in the Warnings section, or any of the following:

• Agitation or aggression
• Confusion or unusual thoughts or behaviors
• Restlessness
• Vision changes
• Uncontrollable shaking of a part of your body
• Stiffening and jerking of your arms and legs
• Seizures
• Uncontrollable rapid eye movements
• Hives, rash, or itching
• Slow or irregular heartbeat
• Difficulty breathing or swallowing

Midazolam and Memory Loss

Midazolam normally causes a loss of memory during the time the drug is given and for a period of time afterward.

However, some patients report worsening memory after taking midazolam, and this possible effect needs more study.

Dosage Forms & Strengths

oral syrup: Schedule IV

• 2mg/mL

injectable solution: Schedule IV

• 1mg/mL
• 5mg/mL

Preoperative Sedation/Anxiolysis With Anterograde Amnesia

IM

• 70-80 mcg/kg (dose range ~5 mg) 30-60 minutes before surgery (reduce 50% for chronically ill or geriatric patients) 

IV

• Initial: Usually 0.5-1 mg given over 2 minutes (not to exceed 2.5 mg/dose); wait 2-3 minutes to evaluate sedative effect after each dose adjustment; total dose >5 mg usually not necessary to reach desired sedation; use 30% less midazolam if patient premedicated with narcotics or other CNS depressants
• Debilitated or chronically ill patients: 1.5 mg IV initially; may repeat with 1 mg/dose IV q2-3 min PRN; not to exceed cumulative dose of 3.5 mg; peak effect may be delayed in elderly, so increments should be smaller and rate of injection slower
• Maintenance: 25% of initial effective dose PRN by slow titration; reduce 30% if premedicated with opiate (50% in elderly/chronically ill)

Anesthesia

Induction

• <55 years without premedication: 300-350 mcg/kg IV injection over 20-30 seconds; wait 2-3 minutes to evaluate sedative effect after each dose adjustment; may use increments of 25% of initial dose PRN to complete induction; may use up to 0.6 mg/kg total dose in resistant cases, but such dosing may prolong recovery 
• >55 years without premedication and with no systemic disease, in a patient who is not weak: 300 mcg/kg over 20-30 seconds initially; wait 2-3 minutes to evaluate sedative effect after each dose adjustment
• >55 years without premedication but presence of systemic disease or weak patient: 200-250 mcg/kg over 20-30 seconds usually enough; 0.15 mg/kg enough in some cases; wait 2-3 minutes to evaluate sedative effect after each dose adjustment
• >55 years with premedication: 150-350 mcg/kg IV injection over 20-30 seconds; wait 2-3 minutes to evaluate sedative effect after each dose adjustment; a dose of 250 mcg/kg usually enough to achieve desired effect

Maintenance

• May administer increments of 25% of induction dose PRN when there are signs that anesthetic effects are lightening

Sedation of Intubated/Ventilated Patients

Load: 10-50 mcg/kg (dose range 0.5-4 mg) slow IV injection or infusion over several minutes; repeat q5-15min PRN 

Maintenance: Initial, 20-100 mcg/kg/hr infusion; titrate up or down 25-50% PRN

Dosing Considerations

Because it is water soluble, takes approximately 3 times longer than diazepam to peak EEG effects; thus, clinician must wait 2-3 minutes to fully evaluate sedative effects before initiating procedure or repeating dose

Has twice the affinity for benzodiazepine receptors that diazepam has

May be administered IM if unable to obtain vascular access

Anesthesia: Typical adult induction and maintenance doses may need to be decreased in some elderly patients by 20-50%, because the elderly overall are more susceptible to CNS depressants than is the general population

Status Epilepticus (Off-label)

Administer when convulsion >5 min or if convusions occur after having intermittent seizures without regaining consciousness for >5 mi

Administer 10 mg IM once or 0.2 mg/kg IM once; not to exceed 10 mg IM

Refractory Status Epilepticus (Off-label)

Alternatively, 0.2 mg/kg bolus followed by continuous infusion of 0.05-2 mg/kg/hr; titrate to cessation of electrographic seizures or burst of suppression; if breakthrough of status epilepticus occurs while on continuous infusion, administer bolus of 0.1-0.2 mg/kg and increase infusion rate by 0.05-0.1 mg/kg/hr (0.83-1.66 mcg/kg/min q3-4hr; may withdraw infusion after at least 24-48 hr of electrographic control; withdraw gradually to prevent recurrent status epilepticus

Status Epilepticus (Orphan)

Orphan designation for treatment of status epilepticus

Sponsor

• Meridian Medical Technologies, Inc., A Pfizer Company; 6350 Stevens Forest Road; Columbia, Maryland 21046

Organophophorous Poisoning (Orphan)

Orphan designation for treatment of seizures induced by organophosphorous insecticide poisoning

Sponsor

• Meridian Medical Technologies, Inc., A Pfizer Company; 6350 Stevens Forest Road; Columbia, Maryland 21046

Seizure Clusters (Orphan)

Rescue treatment of seizures in patients on stable AED regimens who require control of intermittent bouts of increased seizure activity (eg, acute repetitive seizures, seizure clusters)

Administered by intranasal route

Orphan indication sponsors

• Upsher-Smith Laboratories, Inc. 6701 Evenstad Drive Maple Grove, MN 55369-6026
• Schwarz Biosciences, Inc. 8010 Arco Corporate Drive Raleigh, NC 27617

Geriatric Dosing

Preoperative sedation/anxiolysis with anterograde amnesia

• IM: 2-3 mg (~20-50 mcg/kg) 30-60 minutes before surgery; some elderly patients may respond to as little as 1 mg; onset is 15 minutes (peaking at 30-60 min)
• IV (>60 years): 1-1.5 mg initially; not to exceed >1.5 mg in 2 min period; may repeat with 1 mg/dose q2-3min PRN; not to exceed cumulative dose of 3.5 mg; peak effect may be delayed in elderly, so increments should be smaller and rate of injection slower
• IV maintenance: 25% of initial effective dose PRN by slow titration

Dosing considerations

• Anesthesia: Typical adult induction and maintenance doses may need to be decreased in some elderly patients by 20-50%, because the elderly overall are more susceptible to CNS depressants than is the general population

Dosage Forms & Strengths

syrup: Schedule IV

• 2mg/mL

injectable solution: Schedule IV

• 1mg/mL
• 5mg/mL

Sedation

500-750 mcg/kg PO once diluted by juice 20-30 minutes prior to procedure; not to exceed 20 mg 

100-150 mcg/kg IM; up to 500 mcg/kg used; not to exceed 10 mg

IV

• <6 months: Initial, 50 mcg/kg IV over 2-3 minutes; titrate with small increments to clinical effect; monitor closely
• 6 months-6 years: Initial, 50-100 mcg/kg IV over 2-3 minutes; repeat q2-3min PRN; may require up to 600 mcg/kg total dose; not to exceed 6 mg total dose
• 6-12 years: Initial, 25-50 mcg/kg IV over 2-3 minutes; repeat q2-3min PRN; may require up to 400 mcg/kg; not to exceed 10 mg total dose

Anesthesia (Non-neonatal)

Loading dose: 50-150 mcg/kg IV over 2-3 minutes PRN to achieve desired effect 

Continuous infusion: 1-2 mcg/kg/min IV infusion

Anesthesia (Neonatal)

IV loading dose should not be used in neonates

Continuous infusion: 0.5 mcg/kg/min IV infusion 

Common side effects of Versed include:

Injectable:

• Drowsiness
• Amnesia
• Hiccups
• Nausea
• Vomiting
• Injection site irritation
• Pain at injection site

Syrup:

• Drowsiness
• Amnesia
• Hiccups
• Nausea
• Vomiting
• Rash

Versed can cause serious side effects (see "Versed Precautions").

These are not all the possible side effects of Versed. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Midazolam is a benzodiazepine (ben-zoe-dye-AZE-eh-peen) sedative.

Midazolam is used to sedate a person who is having a minor surgery, dental work, or other medical procedure.

Midazolam may also be used for purposes not listed in this medication guide.

Midazolam can slow or stop your breathing, especially if you have recently used a narcotic (opioid) medication. Midazolam should be used only in a hospital, dentist office, or other clinic setting where any serious side effects can be quickly treated.

Midazolam is usually given as a single dose just before your surgery or procedure.

After you take midazolam, you will be watched closely to make sure the medicine is working and does not cause harmful side effects.

Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely while you are in surgery.

Midazolam can make you very drowsy, dizzy, or light-headed. These effects may last longer in older adults. Use caution to avoid falling or accidental injury after you have received midazolam injection. You may need help getting out of bed for at least the first 8 hours.

Midazolam is used to produce sleepiness or drowsiness and to relieve anxiety before surgery or certain procedures. Midazolam is also given to produce amnesia (loss of memory) so that the patient will not remember any discomfort or undesirable effects that may occur after a surgery or procedure.

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 immediate supervision of a doctor trained to use 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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of midazolam in children below 6 months of age. Safety and efficacy have not been established.

Geriatric

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

Pregnancy

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.

Interactions with 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
• Ketoconazole
• Lopinavir
• Nelfinavir
• Ritonavir
• 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.

• Alfentanil
• Amobarbital
• Aprobarbital
• Bromazepam
• Bromopride
• Buprenorphine
• Butabarbital
• Butalbital
• Butorphanol
• Calcifediol
• Carbinoxamine
• Carisoprodol
• Ceritinib
• Chloral Hydrate
• Chlorzoxazone
• Clarithromycin
• Codeine
• Conivaptan
• Dantrolene
• Dihydrocodeine
• Doxylamine
• Ethchlorvynol
• Fentanyl
• Flibanserin
• Fospropofol
• Hydrocodone
• Hydromorphone
• Idelalisib
• Isavuconazonium Sulfate
• Levorphanol
• Lumacaftor
• Meclizine
• Meperidine
• Mephenesin
• Mephobarbital
• Meprobamate
• Metaxalone
• Methadone
• Methocarbamol
• Methohexital
• Mirtazapine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Nilotinib
• Orlistat
• Oxycodone
• Oxymorphone
• Pentazocine
• Pentobarbital
• Periciazine
• Phenobarbital
• Posaconazole
• Primidone
• Propofol
• Ribociclib
• Secobarbital
• Simeprevir
• Sodium Oxybate
• Sufentanil
• Tapentadol
• Thiopental
• Tramadol
• Zolpidem

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

Interactions with Food/Tobacco/Alcohol

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:

• Apnea (temporary stopping of breathing) or
• Heart disease or
• Hypoventilation (slow breathing) or
• Infections or
• Lung disease, severe or
• Lung or airway blockage—Use with caution. May increase risks for more serious side effects.

• Congestive heart failure or
• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Glaucoma, acute narrow-angle—Should not be used in patients with this condition.