Product Information
Registration Status: ActiveFRESOFOL MCT/LCT EMULSION FOR INJECTION OR INFUSION IN PRE-FILLED SYRINGE 2% is approved to be sold in Singapore with effective from 2018-12-04. It is marketed by FRESENIUS KABI (SINGAPORE) PTE LTD, with the registration number of SIN15592P.
This product contains Propofol 20mg/ml in the form of INJECTION, EMULSION. It is approved for INTRAVENOUS use.
This product is manufactured by Fresenius Kabi Austria GmbH in AUSTRIA.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Description
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.
Mechanism of Action
The action of propofol involves a positive modulation of the inhibitory function of the neurotransmitter gama-aminobutyric acid (GABA) through GABA-A receptors.
Pharmacokinetics
- Absorption
- Rapid - time to onset of unconsciousness is 15-30 seconds, due to rapid distribution from plasma to the CNS. Distribution is so rapid that peak plasma concentrations cannot be readily measured. Duration of action is 5-10 minutes.
- Distribution
- * 60 L/kg [healthy adults]
- Metabolism
- Hepatically metabolized mainly by glucuronidation at the C1-hydroxyl. Hydroxylation of the benzene ring to 4-hydroxypropofol may also occur via CYP2B6 and 2C9 with subsequent conjugation to sulfuric and/or glucuronic acid. Hydroxypropofol has approximately 1/3 of hypnotic activity of propofol.
- Elimination
Clearance
* 23 - 50 mL/kg/min * 1.6 - 3.4 L/min [70 Kg adults]
Toxicity
Overdosage may increase pharmacologic and adverse effects or cause death.
IV LD50=53 mg/kg (mice), 42 mg/kg (rats). Oral LD50 (as a solution in soybean oil)=1230 mg/kg (mice), 600 mg/kg (rats)
Active Ingredient/Synonyms
2,6-Bis(1-methylethyl)phenol | 2,6-Diisopropylphenol | Disoprivan | Disoprofol | Propofol | Propofolum | Propofol |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.