Active Ingredient: Remimazolam
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: Intravenous, 5 milligrams remimazolam, over the duration of 3 minutes. Afterwards, intravenous, 2.5 milligrams remimazolam,.
Regimen B: Intravenous, 7 milligrams remimazolam, over the duration of 3 minutes. Afterwards, intravenous, 2.5 milligrams remimazolam,.
Regimen C: In case that patient weight is ≤ 50 kg, intravenous, between 2.5 milligrams remimazolam and 5 milligrams remimazolam, over the duration of 3 minutes. Afterwards, in case that patient weight is ≤ 50 kg, intravenous, between 1.25 milligrams remimazolam and 2.5 milligrams remimazolam,.
Remimazolam dosing should be individually titrated to an effective dose which provides the desired level of sedation and minimises adverse reactions (see table). Additional doses can be administered as needed to induce or maintain the desired level of sedation. At least 2 minutes should elapse prior to administration of any supplemental dose in order to fully assess the sedative effect. If 5 doses of remimazolam within 15 minutes do not result in the desired level of sedation then an additional or another sedative should be considered. Remimazolam is associated with fast onset and offset of sedation. In clinical trials, peak sedation occurred 3-3.5 minutes after the initial bolus and patients became fully alert 12-14 minutes from last dose of remimazolam.
Opioid co-administered medicinal products are known to increase the sedative effect of remimazolam and to depress the ventilatory response to carbon dioxide stimulation.
Dosing guidelines for adults:
| Adults <65 years of age | ASA-PS# III-IV and/or body weight <50 kg | |
|---|---|---|
| Procedural sedation with opioid* | Induction Administer opioid Wait 1-2 min Initial dose: Injection: 5 mg (2 mL) over 1 min Wait 2 min Maintenance / titration Injection: 2.5 mg (1 mL) over 15 sec Maximal total dose administrated in the clinical trials was 33 mg. | Induction Administer opioid Wait 1-2 min Initial dose: Injection: 2.5-5 mg (1-2 mL) over 1 min Wait 2 min Maintenance / titration Injection: 1.25-2.5 mg (0.5-1 mL) over 15 sec Maximal total dose administrated in the clinical trials was 17.5 mg. |
| Procedural sedation without opioid | Induction Injection: 7 mg (2.8 mL) over 1 min Wait 2 min Maintenance / titration Injection: 2.5 mg (1 mL) over 15 sec Maximal total dose administrated in the clinical trials was 33 mg. | Induction Injection: 2.5-5 mg (1-2 mL) over 1 min Wait 2 min Maintenance / titration Injection: 1.25-2.5 mg (0.5-1 mL) over 15 sec Maximal total dose administrated in the clinical trials was 17.5 mg. |
* e.g. 50 micrograms fentanyl or a suitably reduced dose for debilitated patients.
# American Society of Anesthesiologists Physical Status
Patients with ASA-PS III-IV may be more sensitive to the effects of sedatives. Before administration of remimazolam a careful assessment of the overall condition of patients with ASA-PS III-IV, especially with low body weight (<50 kg), is therefore of particular relevance when deciding upon individualised dosage adjustments for these patients.
Remimazolam is for intravenous use. Remimazolam must be reconstituted before use with sodium chloride (0.9%) solution for injection.
For:
Intravenous, between 2.5 milligrams remimazolam and 5 milligrams remimazolam, over the duration of 3 minutes. Afterwards, intravenous, between 1.25 milligrams remimazolam and 2.5 milligrams remimazolam,.
Remimazolam dosing should be individually titrated to an effective dose which provides the desired level of sedation and minimises adverse reactions (see table). Additional doses can be administered as needed to induce or maintain the desired level of sedation. At least 2 minutes should elapse prior to administration of any supplemental dose in order to fully assess the sedative effect. If 5 doses of remimazolam within 15 minutes do not result in the desired level of sedation then an additional or another sedative should be considered. Remimazolam is associated with fast onset and offset of sedation. In clinical trials, peak sedation occurred 3-3.5 minutes after the initial bolus and patients became fully alert 12-14 minutes from last dose of remimazolam.
Opioid co-administered medicinal products are known to increase the sedative effect of remimazolam and to depress the ventilatory response to carbon dioxide stimulation.
Dosing guidelines:
| Elderly ≥65 years of age and/or with ASA-PS# III-IV and/or body weight <50 kg | |
|---|---|
| Procedural sedation with opioid* | Induction Administer opioid Wait 1-2 min Initial dose: Injection: 2.5-5 mg (1-2 mL) over 1 min Wait 2 min Maintenance / titration Injection: 1.25-2.5 mg (0.5-1 mL) over 15 sec Maximal total dose administrated in the clinical trials was 17.5 mg. |
| Procedural sedation without opioid | Induction Injection: 2.5-5 mg (1-2 mL) over 1 min Wait 2 min Maintenance / titration Injection: 1.25-2.5 mg (0.5-1 mL) over 15 sec Maximal total dose administrated in the clinical trials was 17.5 mg. |
* e.g. 50 micrograms fentanyl or a suitably reduced dose for elderly or debilitated patients.
# American Society of Anesthesiologists Physical Status
Elderly patients and patients with ASA-PS III-IV may be more sensitive to the effects of sedatives. Before administration of remimazolam a careful assessment of the overall condition of patients ≥65 years of age and/or with ASA-PS III-IV, especially with low body weight (<50 kg), is therefore of particular relevance when deciding upon individualised dosage adjustments for these patients.
Remimazolam is for intravenous use. Remimazolam must be reconstituted before use with sodium chloride (0.9%) solution for injection.
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