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Lusedra

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Lusedra

Indications
Dosage
How Supplied

INDICATIONS

LUSEDRA™ (fospropofol disodium) injection is an intravenous sedative-hypnotic agent indicated for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures.

DOSAGE AND ADMINISTRATION

Dosing Guidelines

  • Administer LUSEDRA (fospropofol disodium injection) intravenously as a bolus injection.
  • Use supplemental oxygen for all patients undergoing sedation with LUSEDRA (fospropofol disodium injection) .
  • Individualize the dosage of LUSEDRA (fospropofol disodium injection) and titrate to the level of sedation required for the procedure.
  • In adults aged 18 to < 65 years who are healthy or have mild systemic disease as categorized by the American Society of Anesthesiologists (ASA P1 or P2), the standard dosing regimen of LUSEDRA (fospropofol disodium injection) should be followed [see Standard Dosing Regimen for Sedation].
  • In adults who are ≥ 65 years of age or who have severe systemic disease (ASA P3 or P4), the modified dosing regimen should be followed [see Modified Dosing Regimen for Sedation in Patients ≥ 65 years or Those with Severe Systemic Disease].
  • Administer supplemental doses of LUSEDRA (fospropofol disodium injection) based on the patient's level of sedation and the level of sedation required for the procedure. Give 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. Use only the minimum dosage required to facilitate the procedure.
  • Consider the potential for worsened cardiorespiratory depression prior to using LUSEDRA (fospropofol disodium injection) concomitantly with other drugs that have the same potential (e.g., sedative-hypnotics or narcotic analgesics) [see WARNINGS AND PRECAUTIONS].
  • In clinical studies, an opioid premedication (fentanyl citrate 50 mcg intravenously) was administered fve minutes prior to the initial dose of LUSEDRA (fospropofol disodium injection) .

Standard Dosing Regimen for Sedation

In adults aged 18 to < 65 years who are healthy or have mild systemic disease (ASA P1 or P2)1, the standard dosing regimen of LUSEDRA (fospropofol disodium injection) is an initial intravenous bolus of 6.5 mg/kg followed by supplemental doses of 1.6 mg/kg intravenously (25% of initial dosage) as needed to achieve the desired level of sedation as shown in Table 1.

The dosage of LUSEDRA (fospropofol disodium injection) is limited by lower and upper weight bounds of 60 kg and 90 kg. Adults who weigh > 90 kg should be dosed as if they weigh 90 kg. No initial dose should exceed 16.5 mL; no supplemental dose should exceed 4 mL. Adults who weigh < 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. In clinical studies, an opioid premedication (fentanyl citrate 50 mcg IV) was administered five minutes prior to the initial dose of LUSEDRA (fospropofol disodium injection) .

Table 1. Standard Dosing Regimen, Adults 18 to < 65 Years of Age Who are Healthy or Have Mild Systemic Disease (ASA P1 or P2)

  Initial Dose Supplemental Dose
No more frequently than every 4 min.
Weight (kg) mg mL mg mL
≤ 60 385 11 105 3
61 to 63 402.5 11.5 105 3
64 to 65 420 12 105 3
66 to 68 437.5 12.5 105 3
69 to 71 455 13 105 3
72 to 74 472.5 13.5 122.5 3.5
75 to 76 490 14 122.5 3.5
77 to 79 507.5 14.5 122.5 3.5
80 to 82 525 15 140 4
83 to 84 542.5 15.5 140 4
85 to 87 560 16 140 4
88 to 89 577.5 16.5 140 4
≥ 90 577.5 16.5 140 4
Note: Doses in this table are rounded to the nearest half-milliliter volume to facilitate practical measurement; hence, they may differ slightly from the dose recommended on the basis of mg/kg.

Modified Dosing Regimen for Sedation in Patients ≥ 65 years or Those with Severe Systemic Disease (ASA P3 or P4)

Adults ≥ 65 years of age orthose with severe systemic disease (ASA P3 or P4)1 should receive initial and supplemental intravenous dosages of 75% of the standard dosing regimen, as presented in Table 2. LUSEDRA (fospropofol disodium injection) is administered intravenously as a bolus injection. In clinical studies, an opioid premedication (fentanyl citrate 50 mcg IV) was administered five minutes prior to the initial dose of LUSEDRA (fospropofol disodium injection) .

Table 2. Modified Dosing Regimen, Ages ≥ 65 Years Or Those with Severe Systemic Disease

  Initia Dose Supplemental Dose
No more frequently than every 4 min.
Weight (kg) mg mL mg mL
≤ 60 297.5 8.5 70 2
61 to 62 297.5 8.5 70 2
63 to 64 315 9 87.5 2.5
65 to 66 315 9 87.5 2.5
67 to 69 332.5 9.5 87.5 2.5
70 to 73 350 10 87.5 2.5
74 to 77 367.5 10.5 87.5 2.5
78 to 80 385 11 105 3
81 to 84 402.5 11.5 105 3
85 to 87 420 12 105 3
88 to 89 437.5 12.5 105 3
≥ 90 437.5 12.5 105 3
Note: Doses in this table are rounded to the nearest half-milliliter volume to facilitate practical measurement; hence, they may differ slightly from the dose recommended on the basis of mg/kg.

Preparation

LUSEDRA (fospropofol disodium injection) is provided as a ready to use formulation intended for single-patient use only. Prepare LUSEDRA (fospropofol disodium injection) following strict aseptic techniques. Draw LUSEDRA (fospropofol disodium injection) into sterile syringes immediately after vials are opened. Discard any unused portion at the end of the procedure.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use if there is evidence of particulate matter or discoloration.

LUSEDRA (fospropofol disodium injection) has been shown to be compatible with the following fluids:

  • 5% Dextrose Injection, USP
  • 5% Dextrose and 0.2% Sodium Chloride, USP
  • 5% Dextrose and 0.45% Sodium Chloride Injection, USP
  • 0.9% Sodium Chloride Injection, USP
  • Lactated Ringer's Injection, USP
  • Lactated Ringer's and 5% Dextrose Injection, USP
  • 0.45% Sodium Chloride Injection, USP
  • 5% Dextrose, 0.45% NaCl and 20 mEq KCl, USP

Do not mix LUSEDRA (fospropofol disodium injection) with other drugs or fluids prior to administration. LUSEDRA (fospropofol disodium injection) is not physically compatible with midazolam HCl or meperidine HCl, and compatibility with other agents has not been adequately evaluated.

Administer LUSEDRA (fospropofol disodium injection) through a secure, freely flowing, peripheral intravenous line using commonly available intravenous administration sets. Flush the infusion line with normal saline before and after administration of LUSEDRA (fospropofol disodium injection) .

LUSEDRA (fospropofol disodium injection) is not light sensitive. LUSEDRA (fospropofol disodium injection) does not need to be filtered before use.

HOW SUPPLIED

Dosage Forms And Strengths

Single-use vial contents: Solution for intravenous administration containing 35 mg of fospropofol disodium per mL (1,050 mg of fospropofol disodium in 30 mL).

LUSEDRA, 35 mg/mL (total of 1,050 mg/30 mL) fospropofol disodium, is supplied as a single-use, aqueous, sterile, nonpyrogenic, clear, colorless solution in glass vials ready for intravenous injection. Each vial is filled with 32.1 mL intended to deliver a minimum of 30 mL of fospropofol disodium solution. Store at controlled room temperature 25°C (77°F). Excursions permitted between 15° and 30°C (59° and 86°F).

NDC 62856-350-08

REFERENCES

1. Kost, M. Moderate Sedation/Analgesia: Core Competencies for Practice. Elsevier Health Sciences, 2004: 62-63.

Eisai Inc. 100 Tice Boulevard, Woodcliff Lake, NJ 07677. USA. Revised 10/2009

Last reviewed on RxList: 2/10/2010
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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