Product Information
Registration Status: ActiveSIN12439P
CLINOLEIC EMULSION FOR INFUSION 20% is approved to be sold in Singapore with effective from 2003-08-10. It is marketed by BAXTER HEALTHCARE (ASIA) PTE LTD, with the registration number of SIN12439P.
This product contains Olive Oil 20g/100ml, and Soybean Oil in the form of EMULSION. It is approved for INTRAVENOUS use.
This product is manufactured by BAXTER SA in BELGIUM.
It is an Over-the-counter Medicine that can be freely obtained from any retailer
Product Reference
Important Note: For generic product, the SPC/PIL provided may not be brand specific.
{{/items}} {{^items}}Description
Oil extracted from olives [L857]. Consists primarily of the glycerides of the fatty acids linoleic, oleic and palmitic. Used as a source of fatty acids in total parenteral nutrition and as an additive in some cosmetic products [FDA Label].
Indication
For use in adults as a source of calories and fatty acids in total parenteral nutrition [FDA Label]. Sometimes used as an additive in cosmetic products.
Mechanism of Action
Fatty acids act as a substrate in energy production through beta-oxidation as well as important components of cell membrane structures and prescursors for bioactive molecules like prostaglandins [FDA Label].
Toxicity
Fat overload sydrome is the primary form of toxicity characterized by a sudden deterioration in the patient's condition accompanied by fever, anemia, leukopenia, thrombocytopenia, coagulation disorders, hyperlipidemia, liver fatty infiltration, deteriorating liver function, and central nervous system manifestations such as coma [FDA Label]. The precise cause of this is unclear. While it is most likely to occur during overdosage of lipids some occurences have been reported when lipids are administered appropriately. Intraperitoneal LD50 in mice of >50g/kg and intravenous LD50 in rats of 1320mg/kg [L857].
Active Ingredient/Synonyms
Olive oil | Olive oil |
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.
Description
Derived from soybeans, soybean oil is a common vegetable oil and a source of polyunsaturated and saturated fatty acids. It is a complex mixture of triglycerides where per 100 g, soybean oil has 16 g of saturated fat, 23 g of monounsaturated fat, and 58 g of polyunsaturated fat. The major component fatty acids are linoleic (48% - 58%), oleic (17% - 30%), palmitic (9% -13%), linolenic (4% - 11%), and stearic (2.5% - 5.0%). It is used as a cooking oil and lipid emulsion for parenteral nutrition in clinical settings. Soybean oil-based lipid emulsion is the only FDA-approved lipid formulation for clinical use.
Indication
Indicated for parenteral nutrition as a source of calories and essential fatty acids when oral or enteral nutrition is not possible, insufficient, or contraindicated.
Mechanism of Action
Fatty acids serve as an important substrate for energy production. The most common mechanism of action for energy production derived from fatty acid metabolism is beta oxidation. Fatty acids are also important for membrane structure and function, precursors for bioactive molecules (such as prostaglandins), and as regulators of gene expression. Soybean oil-based lipid emulsion may also cause an increase in heat production, decrease in respiratory quotient, and increase in oxygen consumption following its administration [L855]. Soybean oil contents prevent abnormally high triacylglycerol synthesis and its accumulation as lipid droplets in the liver by regulating hepatic lipogenesis and lipolysis. In vitro, soybean oil is shown to prevent downregulation of CYP2C2, CYP2C11 and CYP3A2 mRNA thus maintaining hepatic drug oxidation capabilities. Soybean oil is broken down into free fatty acids that activate PPAR-alpha, which regulate hepatic CYP4A1 that hydroxylate saturated and unsaturated fatty acids. Soybean oil is also shown to prevent up/downregulation of efflux transporters and maintain mRNA levels of hepatic antioxidant enzymes in vitro rat studies [A19591].
Pharmacokinetics
- Absorption
- Following infusion, there is a transient increase in plasma triglycerides.
- Distribution
- After triglycerides are hydrolyzed, fatty acids can enter the tissues where they may be oxidized or resynthesized into triglcerides and stored.
- Metabolism
- The infused lipid particles are removed from the bloodstream in a manner generally thought to be similar to the enzymatic clearance of naturally produced chylomicrons formed after enteral fat intake. The triglycerides are hydrolyzed to free fatty acids and glycerol by the enzyme lipoprotein lipase. In the liver, circulating free fatty acids are oxidized or converted to very low density lipoproteins by hepatic lipase that re-enter the bloodstream.
- Elimination
Clearance
The elimination rate of lipid emulsions depends on particle size, fatty acid composition, apolipoprotein content of the lipid globules, lipoprotein lipase activity, and hepatic lipase activity [L854].
Toxicity
The most frequent adverse effects were nausea, vomiting and muscle spasm. Soybean oil-based lipid emulsions can cause hypersensitivity reactions and risks of catheter-related infections. Fat overload syndrome is a rare condition that has been reported with intravenous lipid emulsions, due to a reduced or limited ability to metabolize lipids accompanied by prolonged plasma clearance. Worsensing conditions of the patients can be seen including hematological effects, declined hepatic function and central nervous system manifestations. Hypertriglyceridema may occur. Preterm and small-for-gestational-age infants have poor clearance of intravenous lipid emulsion and increased free fatty acid plasma levels following lipid emulsion infusion, leading to accumulation in lungs. It is advised not to exceed 0.75 mL/kg/hour.
Active Ingredient/Synonyms
Soybean oil | Soybean oil |
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.