Fospropofol
Pronunciation: fos-PROE-poe-fol.
- Generic name
- fospropofol disodium
- Brand names
- Lusedra
- Drug class
- Prodrug of propofol; intravenous sedative-hypnotic
- Form
- Intravenous solution for bolus injection
- Route
- Intravenous injection
- Legal status
- Prescription-only intravenous medicine administered in a medical facility; brand discontinued in the United States
Availability and supply rules vary by country
Trade names by country:
Australia: · Full directory
What fospropofol disodium is and how it works
Fospropofol is an intravenous sedative-hypnotic prodrug that the body converts into propofol, the active agent. Its approved use was monitored anesthesia care (MAC) sedation for adults undergoing diagnostic or therapeutic procedures. (1) (2)
Fospropofol is administered only by trained anaesthesia or monitored-sedation personnel in a healthcare facility; it is not a medicine a patient takes at home. The Lusedra brand and its generics have been discontinued in the United States.
Mechanism of action: how fospropofol disodium works
Fospropofol is a water-soluble prodrug that, after intravenous injection, is converted by alkaline phosphatase into propofol, the active sedative-hypnotic agent. The detailed mechanism of action beyond this conversion step was not established in the sources reviewed for this page and is not stated here. (1)
What fospropofol disodium is used for
Monitored anesthesia care sedation
Fospropofol was indicated for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures. It was administered by trained anaesthesia or sedation personnel in a medical facility. (1)
Before taking fospropofol disodium
Do not take / not appropriate for
- Contraindications could not be confirmed from the primary FDA label text during this review and remain unresolved. ()
Tell your clinician about
- Tell the anaesthesia or sedation team about all medicines you take, especially any benzodiazepines or opioid (narcotic) pain medicines.
- Tell the team about any serious health conditions and your ASA physical status classification if you know it, since this affects the dosing regimen used.
- Tell the team if you are aged 65 or older.
- Confirm with the team whether you are pregnant, may be pregnant, or are breastfeeding before the procedure.
How to take fospropofol disodium
- Fospropofol is given only as an intravenous injection by trained anaesthesia or monitored-sedation personnel in a medical facility.
- Do not attempt to self-administer, adjust the dose, or use this medicine outside a healthcare setting.
- The dose is calculated by the clinician based on body weight, age, ASA physical status, and the observed level of sedation during the procedure.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3)
Missed dose
This medicine is given as a single procedural sedation course in a facility. A missed dose concept does not apply.
Overdose
This medicine is dosed and given by a trained anaesthesia or sedation team in a facility, not self-administered by the patient at home. The sources reviewed for this page do not establish specific overdose-management procedures beyond this facility-administration context; unresolved.
Side effects
Side effects are managed by the monitoring anaesthesia or sedation team during and after the procedure.
Paresthesia
What to notice: A tingling, burning, or stinging sensation, typically felt in the perineal or genital area. Reported incidence greater than 20%.
What to do: The sedation team monitors this during the procedure. (1)
Pruritus (itching)
What to notice: Generalised itching. Reported incidence greater than 20%.
What to do: The sedation team monitors this during the procedure. (1)
Respiratory depression or apnea
What to notice: Slowed or stopped breathing.
What to do: Detected and managed immediately by the facility sedation team. (1)
Hypoxemia
What to notice: Low blood oxygen, reported in about 4% of patients in trials.
What to do: Detected and managed immediately by the facility sedation team. (1)
Hypotension
What to notice: Low blood pressure, reported in about 4% of patients in trials.
What to do: Detected and managed immediately by the facility sedation team. (1)
Deeper-than-intended sedation
What to notice: Loss of purposeful responsiveness to verbal or tactile stimulation, reported in roughly 4–16% of patients depending on procedure type.
What to do: Detected and managed immediately by the facility sedation team. (1)
Serious warnings
Respiratory depression and apnea — emergency
Symptoms: Slowed or absent breathing.
Action: Managed immediately by the trained anaesthesia or sedation team in the facility administering the medicine. (1)
Unconfirmed boxed warning status —
Symptoms: The FDA label PDF could not be parsed directly during this review and a confirmed boxed warning was not established. Treat as unresolved.
Action: A clinician must consult the current FDA-approved prescribing information directly.
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Benzodiazepines | Additive cardiorespiratory depression — extra sedation and slowed breathing or circulation. | The anaesthesia or sedation team adjusts dosing and monitoring accordingly. (1) |
| Opioid (narcotic) analgesics | Additive cardiorespiratory depression — extra sedation and slowed breathing or circulation. | The anaesthesia or sedation team adjusts dosing and monitoring accordingly. (1) |
Pregnancy, breastfeeding, kidney/liver function, age
Patients aged 65 years and older
The standard adult dosing regimen is reduced to 75% of the standard dose for patients aged 65 years or older. The anaesthesia or sedation team calculates and administers this modified dose. (1)
Patients with severe systemic disease (ASA P3 or P4)
The standard adult dosing regimen is reduced to 75% of the standard dose for patients with severe systemic disease. The anaesthesia or sedation team calculates and administers this modified dose. (1)
Children and adolescents
No paediatric dosing was established from the sources reviewed. The approved indication was for adult patients only.
Pregnancy and breastfeeding
No specific pregnancy category or lactation guidance was established from the sources reviewed during this pass; unresolved.
Renal or hepatic impairment
No impairment-specific dosing adjustment beyond the general ASA P3/P4 modified dosing was found in the sources reviewed; unresolved.
Monitoring
Before starting
- Confirm the procedure, indication, and patient's age, weight, and ASA physical status classification.
- Review all concomitant medicines, especially benzodiazepines and opioids.
- Calculate the weight-based dose: standard regimen for adults 18 to <65 years and ASA P1/P2 is 6.5 mg/kg initial IV bolus (maximum 16.5 mL); modified regimen for patients ≥65 years or ASA P3/P4 is 75% of the standard dose.
- Apply weight-based dosing caps: patients weighing more than 90 kg are dosed as if they weigh 90 kg; patients weighing less than 60 kg are dosed as if they weigh 60 kg.
During treatment
- Give supplemental doses of 1.6 mg/kg IV (maximum 4 mL per supplemental dose) no more frequently than every 4 minutes, only when the patient demonstrates purposeful movement in response to the procedure or verbal command and based on observed sedation level.
- Respiratory depression, apnea, hypoxemia, hypotension, and deeper-than-intended sedation are recognised risks reported with this medicine; specific continuous-monitoring protocols and supportive-care procedures were not established in the sources reviewed for this page and are not detailed here — follow institutional monitored-anaesthesia-care protocols and the current FDA-approved label.
Storage
Fospropofol is stored and handled by the healthcare facility according to the manufacturer's instructions and institutional protocols. It is not a medicine a patient stores at home.
Professional information
Clinician-facing context only. Fospropofol was administered only by trained anaesthesia or monitored-sedation personnel in a medical facility. The brand is discontinued in the United States; use the current FDA-approved label if available.
United States (FDA label)
Indication: MAC sedation in adults undergoing diagnostic or therapeutic procedures
Dose summary: Standard (18 to <65 years, ASA P1/P2): initial IV bolus 6.5 mg/kg (max 16.5 mL); supplemental doses 1.6 mg/kg IV (max 4 mL) as needed, no more often than every 4 minutes. Modified (≥65 years or ASA P3/P4): 75% of the standard regimen. Weight caps: patients >90 kg dosed as 90 kg; patients <60 kg dosed as 60 kg. Supplemental doses only when the patient demonstrates purposeful movement in response to procedure/verbal command.
Renal context: No renal or hepatic impairment-specific dosing adjustment beyond the general ASA P3/P4 modified dosing was found in the sources reviewed; unresolved. (1)
Hepatic guidance
No hepatic-impairment-specific dosing was found in the sources reviewed.
Overdose note
Specific overdose-management procedures were not established in the sources reviewed for this page; unresolved. Follow institutional monitored-anaesthesia-care protocols and the current FDA-approved label. (1)
Frequently asked questions
Is fospropofol still available in the United States?
No. The Lusedra brand and its generics have been discontinued in the United States. (2)
Can I take fospropofol at home?
No. Fospropofol is administered only by trained anaesthesia or monitored-sedation personnel in a medical facility. It is not a self-administered outpatient medicine. (1)
Why does fospropofol cause tingling or itching?
Paresthesia (tingling, burning, or stinging, typically in the perineal or genital area) and pruritus (itching) were very common side effects reported in more than 20% of patients. The sedation team monitors these effects during the procedure. (1)
What is the mechanism of action of fospropofol disodium?
Fospropofol is a water-soluble prodrug that, after intravenous injection, is converted by alkaline phosphatase into propofol, the active sedative-hypnotic agent. The detailed mechanism of action beyond this conversion step was not established in the sources reviewed for this page and is not stated here. (1)
References
- Lusedra (fospropofol disodium) clinical monographDrugs.com (sourced from FDA-approved labeling) · United States · accessed 2026-08-05 · source 1
- Lusedra FDA Approval HistoryDrugs.com FDA approval history · United States · accessed 2026-08-05 · source 2
- LUSEDRA (fospropofol disodium) — prescribing informationU.S. Food and Drug Administration · United States · dated 2008 · accessed 2026-08-05 · source 3
Brand names by country
Single-ingredient fospropofol disodium names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.