Overview
Propofol is an intravenous anaesthetic agent used for induction and maintenance of general anaesthesia. IV administration of propfol is used to induce unconsciousness after which anaesthesia may be maintained using a combination of medications. Recovery from propofol-induced anaesthesia is generally rapid and associated with less frequent side effects (e.g. drowsiness, nausea, vomiting) than with thiopental, methohexital, and etomidate. Propofol may be used prior to diagnostic procedures requiring anaesthesia, in the management of refractory status epilepticus, and for induction and/or maintenance of anaesthesia prior to and during surgeries.
Indication
Used for induction and/or maintenance of anaesthesia and for management of refractory status epilepticus.
Associated Conditions
No associated conditions information available.
Research Report
Propofol (DB00818): A Comprehensive Clinical and Pharmacological Monograph
Introduction
Propofol, chemically identified as 2,6-diisopropylphenol, is a short-acting, intravenously administered hypnotic agent that has become a cornerstone of modern anesthetic practice.[1] Since its widespread introduction, it has fundamentally reshaped the landscape of anesthesia, primarily due to a highly favorable pharmacokinetic profile characterized by rapid and smooth induction of anesthesia, predictable dose-dependent effects, and a clear-headed, swift recovery.[3] These properties have been instrumental in facilitating the global expansion of ambulatory (day-case) surgery and have established propofol as the principal agent for total intravenous anesthesia (TIVA) techniques.[4] Its utility extends beyond the operating room to procedural sedation and the sedation of critically ill patients in the intensive care unit (ICU).[3]
This clinical versatility, however, is balanced by a significant and demanding risk profile. Propofol possesses a narrow therapeutic window, meaning the dose required for sedation is close to that which can cause profound, life-threatening cardiorespiratory depression, including hypotension, apnea, and loss of protective airway reflexes.[9] This inherent risk is compounded by the lack of a specific pharmacological reversal agent, mandating its administration by personnel expertly trained in general anesthesia and advanced airway management.[12] Furthermore, its lipid emulsion formulation creates a potential vector for microbial contamination if strict aseptic technique is not followed.[3] The drug also carries a potential for abuse, particularly among healthcare professionals, and is associated with the rare but often lethal complication of Propofol Infusion Syndrome (PRIS) when used at high doses or for prolonged periods.[12]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/08/12 | Not Applicable | Not yet recruiting | |||
2025/08/12 | Not Applicable | Not yet recruiting | Xijing Hospital | ||
2025/07/31 | Not Applicable | Not yet recruiting | |||
2025/07/29 | Not Applicable | Active, not recruiting | |||
2025/07/25 | Not Applicable | Not yet recruiting | Jinqiao Qian | ||
2025/07/24 | Not Applicable | Completed | Children's Hospital of Hebei Province | ||
2025/07/23 | Not Applicable | ENROLLING_BY_INVITATION | Tamas Vegh, MD | ||
2025/07/22 | Not Applicable | Not yet recruiting | |||
2025/07/22 | Not Applicable | Completed | |||
2025/07/14 | Not Applicable | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Dr. Reddy's Laboratories, Inc. | 43598-548 | INTRAVENOUS | 10 mg in 1 mL | 9/30/2022 | |
General Injectables & Vaccines, Inc | 52584-269 | INTRAVENOUS | 10 mg in 1 mL | 1/18/2017 | |
Sagent Pharmaceuticals | 25021-608 | INTRAVENOUS | 10 mg in 1 mL | 2/3/2023 | |
A-S Medication Solutions | 50090-4569 | INTRAVENOUS | 10 mg in 1 mL | 2/29/2020 | |
Fresenius Kabi USA, LLC | 63323-269 | INTRAVENOUS | 10 mg in 1 mL | 9/15/2023 | |
Hospira, Inc. | 0409-6010 | INTRAVENOUS | 10 mg in 1 mL | 2/14/2023 | |
Hospira, Inc. | 0409-4699 | INTRAVENOUS | 10 mg in 1 mL | 2/14/2023 | |
Amneal Pharmaceuticals Private Limited | 80830-2365 | INTRAVENOUS | 10 mg in 1 mL | 5/20/2025 | |
Hikma Pharmaceuticals USA Inc. | 0641-6196 | INTRAVENOUS | 10 mg in 1 mL | 11/18/2022 | |
Fresenius Kabi USA, LLC | 63323-269 | INTRAVENOUS | 10 mg in 1 mL | 3/24/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
Recofol N 10mg/ml Emulsion for injection or infusion | B.Braun Melsungen AG | SIN08801P | INJECTION | 10 mg/ml | 7/3/1996 |
Propofol-Lipuro 2% (20mg/ml) | SIN13622P | EMULSION | 20.0mg/ml | 3/23/2009 | |
FRESOFOL MCT/LCT (PROPOFOL) EMULSION FOR INJECTION OR INFUSION 2% | SIN12472P | EMULSION | 2% | 12/5/2003 | |
Recofol N 20mg/ml Emulsion for injection or infusion | B.Braun Melsungen AG | SIN11754P | INJECTION | 20 mg/ml | 1/3/2002 |
PROPOFOL-LIPURO INJECTION 1% w/v | SIN12266P | EMULSION | 10 mg/ml | 4/25/2003 | |
FRESOFOL MCT/LCT EMULSION FOR INJECTION OR INFUSION IN PRE-FILLED SYRINGE 2% | SIN15592P | INJECTION, EMULSION | 20mg/ml | 12/4/2018 | |
PROPOFOL 1% MCT/LCT FRESENIUS EMULSION FOR INJECTION OR INFUSION | SIN11577P | INJECTION | 1% | 7/4/2001 | |
BAXTER PROPOFOL MCT-LCT EMULSION FOR INJECTION OR INFUSION 1% W/V | SIN17047P | INJECTION, EMULSION | 10 mg/ml | 7/19/2024 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION 500MG/50ML | N/A | N/A | N/A | 7/3/2019 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
PROPOFOL-LIPURO 1% propofol 1000 mg/100 mL emulsion for injection bottle | 220081 | Medicine | A | 3/10/2015 | |
ANESIA propofol 1000mg/100mL emulsion for injection vial | 153585 | Medicine | A | 5/22/2009 | |
ANESIA propofol 200mg/20mL emulsion for injection vial | 153210 | Medicine | A | 5/22/2009 | |
DIPRIVAN propofol 200mg/20mL injection vial | 77251 | Medicine | A | 2/9/2001 | |
PROVIVE 1% propofol 1000mg/100mL emulsion for injection vial | 118940 | Medicine | A | 5/6/2005 | |
PROVIVE 1% propofol 500mg/50mL emulsion for injection vial | 118939 | Medicine | A | 5/6/2005 | |
PROPOFOL-LIPURO 2% propofol 1000 mg/50 mL emulsion for injection bottle | 220084 | Medicine | A | 3/10/2015 | |
Fresofol 1% MCT/LCT Propofol 500mg/50mL Emulsion for Intravenous Injection/Infusion vial | 193609 | Medicine | A | 11/23/2012 | |
PROPOFOL-LIPURO 1% propofol 200 mg/20 mL emulsion for injection vial | 220082 | Medicine | A | 3/10/2015 | |
PROPOFOL-LIPURO 1% propofol 500 mg/50 mL emulsion for injection bottle | 220083 | Medicine | A | 3/10/2015 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
DIPRIVAN 1% | 02018950 | Emulsion - Intravenous | 10 MG / ML | 12/31/1993 | |
TEVA-PROPOFOL | teva canada limited | 02437961 | Emulsion - Intravenous | 10 MG / ML | 11/20/2015 |
PROPOFOL | baxter corporation | 02468336 | Emulsion - Intravenous | 10 MG / ML | 4/24/2018 |
PROPOFOL INJECTION | fresenius kabi canada ltd | 02437643 | Emulsion - Intravenous | 10 MG / ML | 6/1/2015 |
PROPOFOL-II INJECTION | 02376865 | Emulsion - Intravenous | 10 MG / ML | 6/11/2013 | |
PROPOFOL INJECTION | baxter corporation | 02244379 | Emulsion - Intravenous | 10 MG / ML | 3/1/2002 |
PROPOFOL INJECTION | hospira healthcare ulc | 02242973 | Emulsion - Intravenous | 10 MG / ML | 4/2/2004 |
PROPOFOL INJECTION | marcan pharmaceuticals inc | 02525879 | Emulsion - Intravenous | 10 MG / ML | 4/18/2023 |
PROPOFOL INJECTION | 02236887 | Emulsion - Intravenous | 10 MG / ML | 2/5/1998 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
DIPRIVAN 10 mg/ml EMULSION INYECTABLE Y PARA PERFUSION | 58785 | EMULSIÓN INYECTABLE Y PARA PERFUSIÓN | Uso Hospitalario | Commercialized | |
PROPOFOL SANDOZ 20 MG/ML EMULSION INYECTABLE Y PARA PERFUSION EFG | Sandoz Farmaceutica S.A. | 76392 | EMULSIÓN INYECTABLE Y PARA PERFUSIÓN | Uso Hospitalario | Not Commercialized |
PROPOFOL SANDOZ 10 MG/ML EMULSION INYECTABLE Y PARA PERFUSION EFG | Sandoz Farmaceutica S.A. | 76391 | EMULSIÓN INYECTABLE Y PARA PERFUSIÓN | Uso Hospitalario | Not Commercialized |
DIPRIVAN 20 mg/ml EMULSION PARA PERFUSION | 60744 | EMULSIÓN INYECTABLE Y PARA PERFUSIÓN | Uso Hospitalario | Commercialized | |
PROPOFOL FRESENIUS 20 MG/ML EMULSION INYECTABLE Y PARA PERFUSION EFG | 64033 | EMULSIÓN INYECTABLE Y PARA PERFUSIÓN | Uso Hospitalario | Not Commercialized | |
PROPOFOL LIPOVEN FRESENIUS 20 mg/ml EMULSION INYECTABLE Y PARA PERFUSION | 67216 | EMULSIÓN INYECTABLE Y PARA PERFUSIÓN | Uso Hospitalario | Commercialized | |
PROPOFOL FARMAK 20 MG/ML EMULSION INYECTABLE Y PARA PERFUSION EFG | Farmak International Sp. Z O.O. | 89617 | EMULSIÓN INYECTABLE Y PARA PERFUSIÓN | Uso Hospitalario | Not Commercialized |
PROPOFOL LIPOVEN FRESENIUS 20 MG/ML EMULSION INYECTABLE Y PARA PERFUSION EN JERINGA PRECARGADA EFG | 77590 | EMULSIÓN INYECTABLE Y PARA PERFUSIÓN | Uso Hospitalario | Not Commercialized | |
PROPOFOL BIOQ 10 MG/ML EMULSION PARA PERFUSION EN SISTEMA DE ADMINISTRACION | Bioq Pharma B.V. | 83629 | EMULSIÓN PARA PERFUSIÓN EN SISTEMA DE ADMINISTRACIÓN | Uso Hospitalario | Not Commercialized |
PROPOFOL LIPURO 10 mg/ml EMULSIÓN INYECTABLE Y PARA PERFUSIÓN | 62953 | EMULSIÓN INYECTABLE Y PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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