Usual Adult Dose for Sedation

Standard Dosing Regimen for Sedation (in patients aged 18 to less than 65 years who are healthy or have mild systemic disease as categorized by the American Society of Anesthesiologists [ASA P1 or P2]):
RECOMMENDED DOSE: IV bolus of 6.5 mg/kg followed by supplemental doses of 1.6 mg/kg IV (25% of initial dosage) as needed to achieve the desired level of sedation (the dosage should be individualized and titrated to the level of sedation required for the procedure)

Comments:

• The dosage of this drug should be individually titrated to the level of sedation required for the procedure.
• Supplemental doses should be given based on the level of sedation of the patient and the level of sedation required for the procedure. Supplemental doses should only be given when patients can demonstrate purposeful movement in response to verbal or light tactile stimulation and no more frequently than every 4 minutes. The minimum dosage required to facilitate the procedure should be used.
• Consideration should be given to the potential for worsened cardiorespiratory depression prior to using this drug concomitantly with other drugs that have the same potential (e.g., sedative hypnotics or narcotic analgesics).
• In clinical studies, an opioid premedication (fentanyl citrate 50 mcg IV) was administered 5 minutes prior to the initial dose of this drug.

Usual Geriatric Dose for Sedation

Modified Dosing Regimen for sedation (in patients 65 years of age or older or those with severe systemic disease as categorized by the American Society of Anesthesiologists [ASA P3 or P4]):
RECOMMENDED DOSE: 75% of the standard and supplemental dosing regimen

Comments:

• The dosage of this drug should be individually titrated to the level of sedation required for the procedure.
• Supplemental doses of this drug should be given based on the level of sedation of the patient and the level of sedation required for the procedure. Supplemental doses should only be given when patients can demonstrate purposeful movement in response to verbal or light tactile stimulation and no more frequently than every 4 minutes. The minimum dosage required to facilitate the procedure should be used.
• Consideration should be given to the potential for worsened cardiorespiratory depression prior to using this drug concomitantly with other drugs that have the same potential (e.g., sedative hypnotics or narcotic analgesics).
• In clinical studies, an opioid premedication (fentanyl citrate 50 mcg IV) was administered 5 minutes prior to the initial dose of this drug.

Renal Dose Adjustments

CrCl 30 mL/min or greater: No adjustment recommended

CrCl less than 30 mL/min: Limited safety and efficacy data are available. The manufacturer recommends caution.

Liver Dose Adjustments

The manufacturer recommends caution when initiating therapy in patients with hepatic impairment.

Dose Adjustments

• Patients with severe systemic disease (ASA P3 or P4) should receive the same modified dosing regimen as patients greater than or equal to 65 years old.
• The dosage is limited by lower and upper weight limits of 60 kg and 90 kg. Adults who weigh greater than 90 kg should be dosed as if they weigh 90 kg. Adults who weigh less than 60 kg should be dosed as if they weigh 60 kg. Dosages lower than those specified for the lower weight limit may be used to achieve lesser levels of sedation.

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule IV

Dialysis

Data not available

Other Comments

General:

• This drug should be administered only by persons trained in the administration of general anesthesia and not involved in the diagnostic or therapeutic procedure.
• Facilities for maintenance of a patent airway, providing artificial ventilation, administering supplemental oxygen, and instituting cardiovascular resuscitation should be immediately available.
• The safety of this drug has not been established when used for continuous infusion.

• Patients should be monitored for their ability to demonstrate purposeful response while sedated.
• Patients should be monitored during sedation and through the recovery process for early signs of hypotension, apnea, airway obstruction, and/or oxygen desaturation.