Pronunciation:

rem-i-MAZ-oh-lam

Brand Names:

• Byfavo

Dosage Forms:

• Powder for Solution

Warnings:

Warning: Personnel and Equipment for Monitoring and Resuscitation, and Risks from Concomitant Use with Opioid Analgesics and Other Sedative-HypnoticsOnly personnel trained in the administration of procedural sedation, and not involved in the conduct of the diagnostic or therapeutic procedure, should administer remimazolam.Administering personnel must be trained in the detection and management of airway obstruction, hypoventilation, and apnea, including the maintenance of a patent airway, supportive ventilation, and cardiovascular resuscitation.Remimazolam has been associated with hypoxia, bradycardia, and hypotension. Continuously monitor vital signs during sedation and through the recovery period.Resuscitative drugs, and age-and size-appropriate equipment for bag/valve/mask assisted ventilation must be immediately available during administration of remimazolam.Concomitant use of benzodiazepines with opioid analgesics may result in profound sedation, respiratory depression, coma, and death. The sedative effect of intravenous remimazolam can be accentuated by concomitantly administered CNS depressant medications, including other benzodiazepines and propofol. Continuously monitor patients for respiratory depression and depth of sedation .

Classifications:

Therapeutic—

Anesthetic Adjunct

Pharmacologic—

Benzodiazepine, Short or Intermediate Acting

Uses of This Medicine:

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.

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—

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.

Older adults—

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.

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.

• 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
• 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.

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:

• Allergy to dextran 40 or products containing dextran 40, history of—Should not be used in patients with this condition.

• Heart problems or
• Lung or breathing problems—Use with caution. May make these conditions worse.

• Liver disease, severe—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.

• Sleep apnea—Use with caution. May increase risk for more side effects.

Proper Use of This Medicine:

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 While Using This Medicine:

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 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:

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.