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Olive Oil and Soybean Oil
Overview
What is Clinolipid?
CLINOLIPID lipid injectable emulsion, USP is a sterile, non-pyrogenic lipid emulsion for intravenous infusion. CLINOLIPID is a lipid emulsion containing a mixture of refined olive oil and refined soybean oil in an approximate ratio of 4:1 (olive:soy). The lipid content is 0.2 g/mL. In CLINOLIPID, the mean composition of linoleic acid (an omega-6 essential fatty acid) is 35.8 mg/mL (range 27.6 to 44.0 mg/mL) and α-linolenic acid (an omega-3 essential fatty acid) is 4.7 mg/mL (range 1.0 to 8.4 mg/mL). The phospholipids provide 470 milligrams or 15 mmol of phosphorus per liter.
The total energy content, including fat, phospholipids and glycerin is 2000 kcal/L.
Each 100 mL of CLINOLIPID 20% contains approximately 16 g of Olive Oil NF and 4 g of Soybean Oil USP, 1.2 g Egg Phospholipids NF, 2.25 g Glycerin USP, 0.03 g Sodium Oleate, and Water for Injection USP. Sodium Hydroxide NF for pH adjustment, pH: 6.0 to 9.0.
The olive and soybean oils are refined natural products consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure:
The major component fatty acids are linoleic (13.8 to 22.0%), oleic (44.3 to 79.5%), palmitic (7.6 to 19.3%), linolenic (0.5 to 4.2%), palmitoleic (0.0 to 3.2%) and stearic (0.7 to 5.0%). These fatty acids have the following chemical and structural formulas:
CLINOLIPID has an osmolality of approximately 340 mOsmol/kg water (which represents an osmolarity of 260 mOsmol/liter of emulsion)
CLINOLIPID contains no more than 25 mcg/L of aluminum.
What does Clinolipid look like?
What are the available doses of Clinolipid?
CLINOLIPID 20% is a lipid injectable emulsion. The lipid content is 0.2 grams/mL in 100 mL, 250 mL, 500 mL, and 1000 mL. ()
What should I talk to my health care provider before I take Clinolipid?
Hepatic Impaired: Use with caution in patients with preexisting liver disease or liver insufficiency. ()
How should I use Clinolipid?
CLINOLIPID is indicated in adults for providing a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.
Limitations of Use
CLINOLIPID is not indicated for use in pediatric patients because there is insufficient data to demonstrate that CLINOLIPID provides sufficient amounts of essential fatty acids in this population. [See ]
The omega-3: omega-6 fatty acid ratio in CLINOLIPID has not been shown to improve clinical outcomes compared to other intravenous lipid emulsions. [See ]
Fragments of the administration port membrane could be dislodged into the bag after spiking. Use a 1.2 micron in-line filter during administration of CLINOLIPID (alone or as part of an admixture) to remove particulate matter or micro-precipitate contamination during administration of a lipid injection (alone or as part of an admixture). Particulate matter greater than 5 microns has the capability of obstructing blood flow through capillaries, which could lead to embolism and vascular occlusion. Do not use filters of less than 1.2 micron pore size with lipid emulsions.
What interacts with Clinolipid?
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What are the warnings of Clinolipid?
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What are the precautions of Clinolipid?
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What are the side effects of Clinolipid?
Sorry No records found
What should I look out for while using Clinolipid?
The use of CLINOLIPID is contraindicated in patients with the following:
What might happen if I take too much Clinolipid?
In the event of overdose, fat overload syndrome may result [see ]. Stop the infusion to allow lipids to clear from serum. The effects are usually reversible after the lipid infusion is stopped. If medically appropriate, further intervention may be indicated. The lipid administered and fatty acids produced are not dialyzable.
How should I store and handle Clinolipid?
Store at FOR YOUR PROTECTION:Store at FOR YOUR PROTECTION:CLINOLIPID lipid injectable emulsion, USP is supplied in single-dose CLARITY polyolefin bags as follows:The CLARITY Container is a lipid-compatible plastic container (PL 2401-1). The bag is packaged in an oxygen barrier overpouch, which contains an oxygen absorber / oxygen indicator sachet.CLINOLIPID should be stored at 20 to 25 °C (68 to 77 °F). Excursion permitted between 15 to 30 °C (59 to 86 °F). See USP Controlled Room Temperature. Protect from freezing. Avoid excessive heat. Store in overpouch until ready to use. CLINOLIPID lipid injectable emulsion, USP is supplied in single-dose CLARITY polyolefin bags as follows:The CLARITY Container is a lipid-compatible plastic container (PL 2401-1). The bag is packaged in an oxygen barrier overpouch, which contains an oxygen absorber / oxygen indicator sachet.CLINOLIPID should be stored at 20 to 25 °C (68 to 77 °F). Excursion permitted between 15 to 30 °C (59 to 86 °F). See USP Controlled Room Temperature. Protect from freezing. Avoid excessive heat. Store in overpouch until ready to use. CLINOLIPID lipid injectable emulsion, USP is supplied in single-dose CLARITY polyolefin bags as follows:The CLARITY Container is a lipid-compatible plastic container (PL 2401-1). The bag is packaged in an oxygen barrier overpouch, which contains an oxygen absorber / oxygen indicator sachet.CLINOLIPID should be stored at 20 to 25 °C (68 to 77 °F). Excursion permitted between 15 to 30 °C (59 to 86 °F). See USP Controlled Room Temperature. Protect from freezing. Avoid excessive heat. Store in overpouch until ready to use.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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 important for membrane structure and function, precursors for bioactive molecules (such as prostaglandins), and as regulators of gene expression.
Non-Clinical Toxicology
The use of CLINOLIPID is contraindicated in patients with the following:Concomitant use of isosorbide mononitrate with phosphodiesterase inhibitors in any form is contraindicated (see ).
Concomitant use of isosorbide mononitrate with riociguat, a soluble guanylate cyclase stimulator, is contraindicated (see ).
The vasodilating effects of isosorbide mononitrate may be additive with those of other vasodilators. Alcohol, in particular, has been found to exhibit additive effects of this variety.
Marked symptomatic orthostatic hypotension has been reported when calcium channel blockers and organic nitrates were used in combination. Dose adjustments of either class of agents may be necessary.
Deaths in preterm infants after infusion of intravenous lipid emulsions have been reported. Autopsy findings included intravascular lipid accumulation in the lungs.
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.
The safe and effective use of CLINOLIPID in pediatric patients, including preterm infants, has not been established. CLINOLIPID is not indicated for and not recommended for use in pediatric patients.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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