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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use CLINOLIPID safely and effectively. See full prescribing information for CLINOLIPID.
CLINOLIPID (lipid injectable emulsion), for intravenous use
Initial U.S. Approval: 1975
WARNING: DEATH IN PRETERM INFANTS
See full prescribing information for complete boxed warning
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•Deaths in preterm infants have been reported in literature. ( 5.1 , 8.4 )
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•Autopsy findings included intravascular fat accumulation in the lungs. ( 5.1 , 8.4 )
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•Preterm and low birth weight infants have poor clearance of intravenous lipid emulsion and increased free fatty acid plasma levels following lipid emulsion infusion. ( 5.1 , 8.4 )
RECENT MAJOR CHANGES
Dosage and Administration, (2.1, 2.2, 2.3) 07/2016
INDICATIONS AND USAGE
CLINOLIPID is indicated in adults for parenteral nutrition providing a source of calories and essential fatty acids when oral or enteral nutrition is not possible, insufficient, or contraindicated. (1)
Limitations of Use:
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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 ( 1, 8.4)
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The omega-3: omega-6 fatty acid ratio in CLINOLIPID has not been shown to improve clinical outcomes compared to other intravenous lipid emulsions ( 1)
DOSAGE AND ADMINISTRATION
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Use a 1.2 micron in-line filter when administering to a patient ( 2.1)
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See full prescribing information for administration and admixing instructions ( 2.2, 2.3)
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CLINOLIPID is intended for intravenous infusion. ( 2.4)
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The recommended dose depends on energy expenditure, clinical status, body weight, tolerance, ability to metabolize and consideration of additional energy given to the patient. The usual daily lipid dosage in adults is 1 to 1.5 g/kg/day and should not exceed 2.5 g/kg/day. ( 2.4)
DOSAGE FORMS AND STRENGTHS
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. (3)
CONTRAINDICATIONS
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Known hypersensitivity to egg and soybean proteins, the lipid emulsion and/or excipients. ( 4)
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Severe hyperlipidemia or severe disorders of lipid metabolism. ( 4)
WARNINGS AND PRECAUTIONS
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Preterm infants have poor clearance of intravenous lipid emulsion. ( 5.1)
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Monitor for signs or symptoms of hypersensitivity reactions. ( 5.2)
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Monitor for signs and symptoms of infection, fat overload, and refeeding complications. ( 5.3, 5.4, 5.5)
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Frequent clinical and laboratory determinations are necessary. ( 5.6)
ADVERSE REACTIONS
The most common (5%) adverse drug reactions from clinical trials were nausea and vomiting, hyperlipidemia, hyperglycemia, hypoproteinemia and abnormal liver function tests. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
DRUG INTERACTIONS
The anticoagulant activity of coumarin derivatives, including warfarin, may be counteracted. (7)
USE IN SPECIFIC POPULATIONS
Hepatic Impaired: Use with caution in patients with preexisting liver disease or liver insufficiency. (8.5)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 7/2016
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
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