Generic name: SOYBEAN OIL 6g in 100mL, MEDIUM-CHAIN TRIGLYCERIDES 6g in 100mL, OLIVE OIL 5g in 100mL, FISH OIL 3g in 100mL
Dosage form: injection, emulsion
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
- Smoflipid is for central or peripheral intravenous infusion. When administered with dextrose and amino acids, the choice of a central or peripheral venous route should depend on the osmolarity of the final infusate. Solutions with osmolarity of ≥ 900 mOsm/L must be infused through a central vein.
- Use a 1.2 micron in-line filter.
- Use a dedicated line for parenteral nutrition (PN). Smoflipid can be infused concurrently into the same vein as dextrose-amino acid solutions (as part of PN) by a Y-connector located near the infusion site; flow rates of each solution should be controlled separately by infusion pumps.
- To prevent air embolism, use a non-vented infusion set or close the vent on a vented set, avoid multiple connections, do not connect flexible bags in series, fully evacuate residual gas in the bag prior to administration, do not pressurize the flexible bag to increase flow rates, and if administration is controlled by a pumping device, turn off pump before the bag runs dry.
- Do not use administration sets and lines that contain di-2-ethylhexyl phthalate (DEHP). Administration sets that contain polyvinyl chloride (PVC) components have DEHP as a plasticizer.
Instructions for Use
- After removing the overpouch, Smoflipid should be used immediately. If not used immediately, the product should not be stored longer than 24 hours at 2° to 8°C (36° to 46°F). After removal from storage, the emulsion should be infused within 24 hours.
- Prepare the admixture in PN containers using strict aseptic techniques to avoid microbial contamination.
- Do not add Smoflipid to the PN container first; destabilization of the lipid may occur.
- Smoflipid may be mixed with amino acid and dextrose injections to produce “all-in-one” PN admixtures. The following proper mixing sequence must be followed to minimize pH-related problems by ensuring that typically acidic dextrose injections are not mixed with lipid emulsions alone:
- Transfer dextrose injection to the PN container.
- Transfer amino acid injection.
- Transfer Smoflipid.
Simultaneous transfer of amino acid injection, dextrose injection, and Smoflipid to the PN container is also permitted. Use gentle agitation during admixing to minimize localized concentration effects; shake bags gently after each addition.
- Do not inject additives directly into Smoflipid.
- Additions to the PN admixtures should be evaluated by a pharmacist for compatibility. Questions about compatibility may be directed to Fresenius Kabi USA, LLC. If it is deemed advisable to introduce additives, use strict aseptic techniques to avoid microbial contamination.
- The prime destabilizers of emulsions are excessive acidity (such as a pH < 5) and inappropriate electrolyte content. Amino acid solutions exert buffering effects that protect the emulsion from destabilization. Give careful consideration to the addition of divalent cations (Ca++ and Mg++), which have been shown to cause emulsion instability.
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Inspect the admixture to ensure that:
- precipitates have not formed during preparation of the admixture, and
- the emulsion has not separated. Separation of the emulsion can be visibly identified by a yellowish streaking or the accumulation of yellowish droplets in the admixed emulsion.
Discard the admixture if any of these are observed.
- The remaining contents of a partly used bag must be discarded.
- Infuse admixtures containing Smoflipid immediately. Admixtures should be used promptly with storage under refrigeration at 2° to 8°C (36° to 46°F) not to exceed 24 hours and must be infused completely within 24 hours after removal from refrigeration.
Adult Dosing Information
- The dosing of Smoflipid depends on the patient’s individual energy requirements influenced by age, body weight, tolerance, clinical status, and the ability to eliminate and metabolize lipids.
- When determining dose, energy supplied by dextrose and amino acids from PN, as well as energy from oral or enteral nutrition, has to be taken into account. Energy and lipid provided from lipid-based medications should also be taken into account (e.g., propofol).
- Prior to administration of Smoflipid, correct severe fluid and electrolyte disorders.
- Smoflipid contains 0.163 to 0.225 mg/mL of all-rac-α-tocopherol. The daily US recommended dietary allowance (RDA) in adults for α-tocopherol (Vitamin E) is 15 mg. Take into account the amount of α-tocopherol in Smoflipid when determining the need for additional supplementation.
Recommended Adult Dosing
- The recommended dosage of Smoflipid for adult patients is 1 to 2 grams/kg per day and should not exceed 2.5 grams/kg per day.1 The initial rate of infusion should be 0.5 mL/min for the first 15 to 30 minutes of infusion. If tolerated, gradually increase until reaching the required rate after 30 minutes. Maximum infusion rate should not exceed 0.5 mL/kg/hour. The daily dose should also not exceed a maximum of 60% of total energy requirements [see Overdosage (10)].
- The recommended duration of infusion for Smoflipid is between 12 and 24 hours, depending on the clinical situation. The administration flow rate is determined by dividing the volume of lipid by the duration of the infusion.
- Before starting the infusion, determine serum triglyceride levels to establish the baseline value. In patients with elevated triglyceride levels, initiate Smoflipid at a lower dosage and advance in smaller increments, monitoring the triglyceride levels with each adjustment [see Warnings and Precautions (5.8, 5.9)].