Overview
11 DESCRIPTION CLINOLIPID lipid injectable emulsion, USP is a sterile, non-pyrogenic, homogenous, white, milky lipid emulsion for intravenous infusion. The lipid content of CLINOLIPID is 0.2 g/mL and comprises a mixture of refined olive oil and refined soybean oil in an approximate ratio of 4:1 (olive:soy). The mean concentration of linoleic acid (an omega-6 essential fatty acid) is 35.
Mechanism of Action
12 CLINICAL PHARMACOLOGY CLINOLIPID administered intravenously provides biologically utilizable source of calories and essential fatty acids. 12.1 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 important for membrane structure and function, precursors for bioactive molecules (such as prostaglandins), and as regulators of gene expression. 12.2 Pharmacodynamics Infused essential fatty acids are synthesized into higher derivative fatty acids. Olive oil contains significant amounts of alpha-tocopherol that contributes to Vitamin E status. 12.
Indications
- 1 INDICATIONS AND USAGE CLINOLIPID is indicated in adults and pediatric patients, including term and preterm neonates, as a source of calories and essential fatty acids for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINOLIPID is indicated in adults and pediatric patients, including term and preterm neonates, as a source of calories and essential fatty acids for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated. ( 1 )
Common Doses
- 1 g
- 3 g
- 2 g
- 1.5 g
Dosage
2 DOSAGE AND ADMINISTRATION • Use a 1.2 micron in-line filter when administering to a patient. ( 2.1 ) • For infusion into a central or peripheral vein. ( 2.2 ) • See full prescribing information for administration and admixing instructions. ( 2.2 , 2.3 ) • CLINOLIPID Pharmacy Bulk Package is only indicated for use in pharmacy admixture programs for the preparation of three-in-one or total nutrition admixtures. ( 2.2 ) • Protect the admixed parenteral solution from light. ( 2.
Contraindications
- 4 CONTRAINDICATIONS The use of CLINOLIPID is contraindicated in patients with the following: • Known hypersensitivity to egg, soybean, peanut or to any of the active or inactive ingredients in CLINOLIPID [see Warnings and Precautions (5.3) ] . • Severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride >1,000 mg/dL) [see Warnings and Precautions (5.7) ] . • Known hypersensitivity to egg, soybean, peanut, or any of the active or inactive ingredients.
Side Effects
- 6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants [see Warnings and Precautions (5.1) ] • Parenteral Nutrition-Associated Liver Disease and Other Hepatobiliary Disorders [see Warnings and Precautions (5.2)] • Hypersensitivity reactions [see Warnings and Precautions (5.3) ] • Infections [see Warnings and Precautions (5.4) ] • Fat overload syndrome [see Warnings and Precautions (5.
Interactions
- 7 DRUG INTERACTIONS No drug interaction studies have been performed with CLINOLIPID. Olive and soybean oils have a natural content of Vitamin K 1 that may counteract the anticoagulant activity of coumadin derivatives, including warfarin. The anticoagulant activity of coumarin derivatives, including warfarin, may be counteracted. ( 7 )