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Patients with severe systemic disease (ASA P3 or P4) should receive the modified dosing regimen.DOSAGE AND ADMINISTRATION: Use supplemental oxygen in all patients undergoing sedation with LUSEDRA.Alternative Doses: Recommended for patients over 65 years of age and awake fiberoptic intubation patients.Dosage Adjustment Due to possible pharmacodynamic interactions, a reduction in dosage of Precedex or other concomitant anesthetics, sedatives, hypnotics or opioids may be required when co-administered Dosage reductions may need to be considered for adult patients with hepatic impairment, and geriatric patients [see package insert] WARNINGS AND PRECAUTIONS: DOSAGE FORMS AND STRENGTHS: 1] Precedex Injection, 200 mcg/2 m L (100 mcg/m L) in a glass vial. 2] Precedex in 0.9% Sodium Chloride Injection 200 mcg/50 m L (4 mcg/m L) in a 50 m L glass bottle. 3] Precedex in 0.9% Sodium Chloride Injection 400 mcg/100 m L (4 mcg/m L) in a 100 m L glass bottle. Anesthesia: Initial: 0.2 to 0.6 mg/kg IV over 30-60 seconds for induction of anesthesia; maintenance: 5-20 mcg/kg/minute.INDICATIONS AND USAGE: LUSEDRA is a sedative-hypnotic agent indicated for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures.USE IN SPECIFIC POPULATIONS Patients 65 years of age should receive the modified dosing regimen.AAdminister supplemental doses only when patients can demonstrate purposeful movement in response to verbal or light tactile stimulation and no more frequently than every 4 minutes.

fospropofol disodium -LUSEDRA™ Injection CIV Mechanism of Action: Fospropofol disodium is a prodrug of propofol.

There are inadequate data to make dosage recommendations for induction of anesthesia in patients below the age of ten (10) years; therefore, such use is not recommended.

Geriatric patients may require reduced doses of etomidate.

(6) To report SUSPECTED ADVERSE REACTIONS, contact Eisai Inc.

at 1-888-422-4743 or FDA at 1-800-FDA-1088 or gov/medwatch.

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