Usual Adult Dose for Light Sedation

Induction of Procedural Sedation: 5 mg IV (over 1 minute)

• For American Society of Anesthesiologists Physical Status Classification System (ASA) III and IV patients: 2.5 to 5 mg IV (over 1 minute) based on the general condition of the patient

Maintenance of Procedural Sedation (as needed): 2.5 mg IV (over 15 seconds)

• For ASA III and IV patients: 1.25 to 2.5 mg IV (over 15 seconds)

Comments:

• Peak sedation occurs about 3 to 3.5 minutes after an initial 5 mg IV injection (administered over 1 minute).
• At least 2 minutes must elapse before administration of any supplemental dose.
• Dosing of this drug should be individualized and titrated to desired clinical response.
• Subsequent doses should be titrated based on clinical judgment and assessment of the depth of sedation; if maintenance of procedural sedation is inadequate, alternative agents should be considered.
• In clinical trials, fentanyl 25 to 75 mcg was administered for analgesia before the first dose of this drug; supplemental doses of fentanyl were administered as needed for analgesia.

Use: For the induction and maintenance of procedural sedation in patients undergoing procedures lasting 30 minutes or less

Usual Adult Dose for Sedation

Induction of Procedural Sedation: 5 mg IV (over 1 minute)

• For American Society of Anesthesiologists Physical Status Classification System (ASA) III and IV patients: 2.5 to 5 mg IV (over 1 minute) based on the general condition of the patient

Maintenance of Procedural Sedation (as needed): 2.5 mg IV (over 15 seconds)

• For ASA III and IV patients: 1.25 to 2.5 mg IV (over 15 seconds)

Comments:

• Peak sedation occurs about 3 to 3.5 minutes after an initial 5 mg IV injection (administered over 1 minute).
• At least 2 minutes must elapse before administration of any supplemental dose.
• Dosing of this drug should be individualized and titrated to desired clinical response.
• Subsequent doses should be titrated based on clinical judgment and assessment of the depth of sedation; if maintenance of procedural sedation is inadequate, alternative agents should be considered.
• In clinical trials, fentanyl 25 to 75 mcg was administered for analgesia before the first dose of this drug; supplemental doses of fentanyl were administered as needed for analgesia.

Use: For the induction and maintenance of procedural sedation in patients undergoing procedures lasting 30 minutes or less

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Severe liver dysfunction: The dose should be carefully titrated to effect; depending on overall patient status, lower frequency of supplemental doses may be needed to achieve the level of sedation required for the procedure.

Comments:

• All patients should be monitored for sedation-related cardiorespiratory complications.

Precautions

US BOXED WARNINGS:

• PERSONNEL AND EQUIPMENT FOR MONITORING AND RESUSCITATION: Only personnel trained in the administration of procedural sedation, and not involved in the conduct of the diagnostic or therapeutic procedure, should administer this drug; 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. This drug has been associated with bradycardia, hypotension, and hypoxia; vital signs should be continuously monitored 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 this drug.
• RISKS FROM CONCOMITANT USE WITH OPIOID ANALGESICS AND OTHER SEDATIVE-HYPNOTICS: Concomitant use of benzodiazepines (including this drug) and opioid analgesics may result in profound sedation, respiratory depression, coma, and death; the sedative effect of this IV drug can be accentuated by concomitantly administered CNS depressant medications, including other benzodiazepines and propofol. Patients should be continuously monitored for respiratory depression and depth of sedation.

CONTRAINDICATIONS:

• History of severe hypersensitivity reaction to dextran 40 or products containing dextran 40

Safety and efficacy have not been established in patients younger than 18 years; this drug is not recommended for use in these patients.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule IV

Dialysis

Data not available

Other Comments

Administration advice:

• Since this drug can depress respiration, continuously monitor patients for early signs of hypoventilation, airway obstruction, and apnea using capnography, pulse oximetry, and clinical assessment.
• Only personnel trained in the administration of procedural sedation (and not involved in the conduct of the diagnostic or therapeutic procedure) should administer this drug; 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.
• Supplemental oxygen, resuscitative drugs, and age- and size-appropriate equipment for bag/valve/mask assisted ventilation must be immediately available during administration of this drug; a benzodiazepine reversal agent should be immediately available.
• Continuously monitor vital signs during sedation and through recovery.
• Prepared IV solutions should be administered immediately.

Storage requirements:

• Before reconstitution: Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).
• Once removed from packaging, the vials should be protected from light.
• Reconstituted solution: If not used immediately, may store in the vial for up to 8 hours at 20C to 25C (68F to 77F); after 8 hours, any unused solution must be discarded.

Reconstitution/preparation techniques:

• The product must be prepared immediately before use.
• The manufacturer product information should be consulted.

IV compatibility:

• Compatible: 0.9% Sodium Chloride Injection, USP; 5% Dextrose Injection, USP; 20% Dextrose Injection, USP; 5% Dextrose and 0.45% Sodium Chloride Injection, USP; Ringer's Solution (contains Sodium Chloride, Potassium Chloride, and Calcium Chloride Dihydrate)
• Incompatible: Lactated Ringer's Solution (also known as Ringer's Lactate Solution, Compound Sodium Lactate Solution, Hartmann's Solution; contains Sodium Chloride, Sodium Lactate, Potassium Chloride, and Calcium Chloride Dihydrate); Acetated Ringer's Solution (contains Sodium Chloride, Sodium Acetate, Potassium Chloride, and Calcium Chloride Dihydrate)
• Compatibility with other agents has not been adequately evaluated; this drug should not be mixed with other drugs or fluids before administration.

Monitoring:

• General: Vital signs (continuously during sedation and through recovery)
• Respiratory: For early signs of hypoventilation, airway obstruction, and apnea (continuously)

Patient advice:

• Notify health care provider about alcohol or medication use.
• If exposed to this drug during pregnancy, monitor your neonate for signs of sedation, respiratory depression, and feeding problems.
• Inform health care provider if you are pregnant during treatment with this drug.
• If nursing, consider reducing infant exposure by pumping and discarding breast milk for 5 hours after receiving this drug during procedural sedation.