Remimazolam (Intravenous Route) Description and Brand Names

Description and Brand Names

Drug information provided by: Merative, Micromedex®

US Brand Name

Byfavo

Descriptions

Remimazolam injection is used to start and maintain relaxation or sleep in patients undergoing medical procedures lasting 30 minutes or less. This medicine is an anesthetic and a sedative.

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

This product is available in the following dosage forms:

Powder for Solution

Before Using

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

Because of remimazolam's toxicity (eg, serious unwanted effects on early brain development), use in children is not recommended. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of remimazolam injection in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Breastfeeding

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.

Drug Interactions

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.

Flumazenil

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.

Acepromazine
Alfentanil
Alprazolam
Amobarbital
Anileridine
Aripiprazole
Aripiprazole Lauroxil
Asenapine
Baclofen
Benperidol
Benzhydrocodone
Bromazepam
Buprenorphine
Buspirone
Butabarbital
Butorphanol
Calcium Oxybate
Cannabidiol
Cannabis
Carbinoxamine
Carisoprodol
Carphenazine
Chloral Hydrate
Chlordiazepoxide
Chlorpromazine
Chlorzoxazone
Clobazam
Clonazepam
Clorazepate
Clozapine
Codeine
Cyclobenzaprine
Daridorexant
Dexmedetomidine
Diacetylmorphine
Diazepam
Dichloralphenazone
Difenoxin
Dihydrocodeine
Diphenhydramine
Diphenoxylate
Doxylamine
Droperidol
Enflurane
Esketamine
Estazolam
Eszopiclone
Ethchlorvynol
Ethopropazine
Ethylmorphine
Fentanyl
Flibanserin
Fluphenazine
Flurazepam
Fluspirilene
Fospropofol
Gabapentin
Gabapentin Enacarbil
Halazepam
Haloperidol
Halothane
Hexobarbital
Hydrocodone
Hydromorphone
Hydroxyzine
Isoflurane
Ivacaftor
Ketamine
Ketazolam
Ketobemidone
Lacosamide
Levocetirizine
Levorphanol
Lorazepam
Loxapine
Magnesium Oxybate
Meclizine
Melperone
Meperidine
Mephobarbital
Meprobamate
Meptazinol
Mesoridazine
Metaxalone
Methadone
Methdilazine
Methocarbamol
Methohexital
Methotrimeprazine
Methylene Blue
Midazolam
Mirtazapine
Molindone
Moricizine
Morphine
Morphine Sulfate Liposome
Nalbuphine
Nicomorphine
Nitrazepam
Nitrous Oxide
Olanzapine
Oliceridine
Opium
Opium Alkaloids
Orphenadrine
Oxazepam
Oxycodone
Oxymorphone
Papaveretum
Paregoric
Pentazocine
Pentobarbital
Perampanel
Perazine
Periciazine
Perphenazine
Phenobarbital
Pimozide
Piperacetazine
Pipotiazine
Piritramide
Potassium Oxybate
Prazepam
Pregabalin
Primidone
Prochlorperazine
Promazine
Promethazine
Propofol
Quazepam
Quetiapine
Ramelteon
Remifentanil
Remoxipride
Ropeginterferon Alfa-2b-njft
Secobarbital
Sertindole
Sodium Oxybate
Sufentanil
Sulpiride
Suvorexant
Tapentadol
Temazepam
Thiethylperazine
Thiopental
Thiopropazate
Thioridazine
Tilidine
Tizanidine
Tolonium Chloride
Topiramate
Tramadol
Triazolam
Trifluoperazine
Trifluperidol
Triflupromazine
Trimeprazine
Zaleplon
Zolpidem
Zopiclone
Zotepine
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.

Rifapentine
St John's Wort
Theophylline

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use

A nurse or other trained health professional will give you this medicine in a medical facility. This medicine is given through a needle placed into one of your veins.

Precautions

It is very important that your doctor check your progress closely while you are receiving this medicine to make sure this medicine is working properly and to check for 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.

Check with you doctor right away if you have bluish lips or skin, blurred vision, choking, confusion, dizziness, fainting, or lightheadedness when getting up suddenly from a lying or sitting position, drowsiness, pale skin, sweating, trouble breathing or speaking, or unusual tiredness or weakness after receiving this medicine. These could be symptoms of a serious heart or lung problem and may worsen when used with certain medicines (eg, benzodiazepine, opioid analgesic medicine).

This medicine may cause serious allergic reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a rash, itching, hoarseness, trouble breathing or swallowing, or any swelling of your hands, face, mouth, or throat after receiving this medicine.

Symptoms of an overdose include: change in consciousness, confusion, dizziness, faintness, or lightheadedness, hallucinations, loss of consciousness, loss of strength or energy, muscle pain or weakness, nightmares, shakiness and unsteady walk, slow or irregular heartbeat, sweating, trouble in speaking, unsteadiness, trembling, or other problems with muscle control or coordination, trouble sleeping, unusual excitement, nervousness, restlessness, or irritability, or unusual tiredness or weakness. Call your doctor right away if you notice these symptoms.

Check with your doctor before receiving this medicine with alcohol or other medicines that affect the central nervous system. The use of alcohol or other medicines that affect the CNS with remimazolam may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

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

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:

More common

Blurred vision
chest pain or discomfort
confusion
dizziness, fainting, or lightheadedness when getting up suddenly from a lying or sitting position
drowsiness
fast, slow, pounding, or irregular heartbeat or pulse
headache
nausea
nervousness
pounding in the ears
sweating
trouble breathing
unusual tiredness or weakness
vomiting

Less common

Body aches or pain
chills
cough
ear congestion
fever
loss of voice
runny or stuffy nose
sneezing
sore throat

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
difficulty sleeping
disorientation
drowsiness to profound loss of consciousness
irregular, fast or slow, or shallow breathing
loss of strength or energy
mood or other mental changes
nightmares
pale or blue lips, fingernails, or skin
seeing, hearing, or feeling things that are not there
shakiness and unsteady walk
slurred speech
talkativeness
unsteadiness, trembling, or other problems with muscle control or coordination
unusual drowsiness, dullness, or feeling of sluggishness
unusual weak feeling

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.

Portions of this document last updated: April 01, 2024

Original article: https://www.mayoclinic.org/drugs-supplements/remimazolam-intravenous-route/description/drg-20490791

Remimazolam (Intravenous Route)