Remimazolam

What is remimazolam?

Remimazolam (BYFAVO) for injection is a benzodiazepine indicated for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less.

What are the uses of this medicine?

• This medicine is indicated for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less.

How does this medicine work?

• BYFAVO is a benzodiazepine.
• BYFAVO binds to brain benzodiazepine sites (gamma amino butyric acid type A [GABAA] receptors), while its carboxylic acid metabolite (CNS7054) has a 300 times lower affinity for the receptor.
• BYFAVO, like other benzodiazepines, did not show clear selectivity between subtypes of the GABAA receptor.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• In patients with a history of severe hypersensitivity reaction to dextran 40 or products containing dextran 40.

What drug interactions can this medicine cause?

This medicine cannot be co administered with CNS depressant medications, including opioid analgesics, other benzodiazepines, and propofol. Continuously monitor vital signs during sedation and through the recovery period.

Is this medicine FDA approved?

• It was approved for use in the United States in 2020.

How should this medicine be used?

• Each single-patient-use vial contains 20 mg BYFAVO lyophilized powder for reconstitution.
• The product must be prepared immediately before use.
• To reconstitute, add 8.2 mL sterile 0.9% Sodium Chloride Injection, USP, to the vial, directing the stream of solution toward the wall of the vial.
• Gently swirl the vial (do not shake) until the contents are fully dissolved.
• The reconstituted product will deliver a final concentration of 2.5 mg/mL solution of BYFAVO.

Adult Patients:

• Administer an initial dose intravenously as a 5 mg push injection over a 1-minute time period.
• If necessary, administer supplemental doses of 2.5 mg intravenously over a 15-second time period.
• At least 2 minutes must elapse prior to the administration of any supplemental dose.

ASA III-IV Patients:

• Based on the general condition of the patient, administer 2.5 mg to 5 mg over 1-minute time period.
• If necessary, administer supplemental doses of 1.25 mg to 2.5 mg intravenously over a 15-second time period.
• At least 2 minutes must elapse prior to the administration of any supplemental dose.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As single-patient-use vial: Each glass, single-patient-use vial of BYFAVO (remimazolam) for injection contains 20 mg remimazolam.

This medicine is available in fallowing brand namesː

• BYFAVO

What side effects can this medication cause?

Common possible side effects of this medicine include:

• hypotension
• hypertension
• diastolic hypertension
• systolic hypertension
• hypoxia
• diastolic hypotension

What special precautions should I follow?

• Hypersensitivity reactions including anaphylaxis may occur.
• Benzodiazepine use during pregnancy can result in neonatal sedation.
• Observe newborns for signs of sedation and manage accordingly.
• Weigh benefits against potential risks when considering elective procedures in children under 3 years old.
• since this medicine may cause pediatric Neurotoxicity.

What to do in case of emergency/overdose?

Overdose of this medicine may lead to CNS depression, associated with drowsiness, confusion, and lethargy, with possible progression to ataxia, respiratory depression, and hypotension.

Management for overdosage:

• Flumazenil is indicated for the reversal of the sedative effects of benzodiazepines and may be used in situations when an overdose with BYFAVO is known or suspected.
• Flumazenil will only reverse benzodiazepine-induced effects and will not reverse the effects of other medications, such as opioid analgesics.
• Monitor patients treated with flumazenil for re-sedation, respiratory depression, and other residual benzodiazepine effects.
• Re-sedation by BYFAVO has not been observed after administration of flumazenil in clinical trials.

Can this medicine be used in pregnancy?

• Infants born to mothers using benzodiazepines during the later stages of pregnancy have been reported to experience symptoms of sedation.
• Benzodiazepines cross the placenta and may produce respiratory depression and sedation in neonates.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What should I know about storage and disposal of this medication?

• Store at controlled room temperature 20°C to 25°C (68°F to 77°F) excursions between 15° and 30°C (59° and 86°F) are allowed.
• Reconstituted BYFAVO can be stored in the vial for up to 8 hours under controlled room temperature at 20°C to 25°C (68°F to 77°F).
• Protect vials from light once they are removed from packaging.
• Discard unused portion.

Benzodiazipines

• Alprazolam
• Chlordiazepoxide
• Diazepam (Oral)
• Estazolam
• Flurazepam
• Lorazepam
• Midazolam
• Oxazepam
• Quazepam
• Temazepam
• Triazolam

Anticonvulsants Drugs

• Clobazam
• Clonazepam
• Clorazepate
• Diazepam (Intravenous)

Drug class for Remimazolam

Anticonvulsants, and Benzodiazepines]

• Dailymed label info on Remimazolam
• FDA Remimazolam

Remimazolam Resources
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