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Smoflipid

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Overview

What is Smoflipid?

Smoflipid is a sterile, nonpyrogenic, white, homogenous lipid emulsion for intravenous infusion. The lipid content of Smoflipid is 0.20 g/mL, and comprises a mixture of soybean oil, medium-chain triglycerides (MCTs), olive oil, and fish oil. The mean essential fatty acid content of Smoflipid is 35 mg/mL (range of 28 to 50 mg/mL) linoleic acid (omega-6) and 4.5 mg/mL (range of 3 to 7 mg/mL) α-linolenic acid (omega-3). The phosphate content is 15 mmol/L.

The total energy content, including fat, phospholipids, and glycerol is 2,000 kcal/L.

Each 100 mL of Smoflipid contains approximately 6 g soybean oil, 6 g MCT, 5 g olive oil, 3 g fish oil, 1.2 g egg phospholipids, 2.5 g glycerin, 16.3 to 22.5 mg all--α-tocopherol, 0.3 g sodium oleate, water for injection, and sodium hydroxide for pH adjustment (pH 6 to 9).

Smoflipid has an osmolality of approximately 380 mOsm/kg water (which represents an osmolarity of 270 mOsm/L).

The oils included in Smoflipid consist of a mixture of triglycerides of predominantly unsaturated fatty acids with the following structure:

where , , and   are saturated and unsaturated fatty acid residues.  The major components of the fatty acids in Smoflipid are oleic acid (23% to 35%), linoleic acid (14% to 25%), caprylic acid (13% to 24%), palmitic acid (7% to 12%), capric acid (5% to 15%), stearic acid (1.5% to 4%),  α-linolenic acid (1.5% to 3.5%), eicosapentaenoic acid (EPA; 1% to 3.5%), and docosahexaenoic acid (DHA; 1% to 3.5%).



What does Smoflipid look like?



What are the available doses of Smoflipid?

Smoflipid is a lipid injectable emulsion with a lipid content of 0.2 grams/mL in 100 mL, 250 mL, and 500 mL. ()

What should I talk to my health care provider before I take Smoflipid?

How should I use Smoflipid?

Smoflipid is indicated in adults as 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

The omega-6: omega-3 fatty acid ratio and Medium Chain Triglycerides in Smoflipid have not been shown to improve clinical outcomes compared to other intravenous lipid emulsions

For intravenous infusion only into a peripheral or central vein. ()

Recommended dosage depends on age, energy expenditure, clinical status, body weight, tolerance, ability to metabolize, and consideration of additional energy given to the patient. ()

The usual daily dosage in adults is 1 to 2 grams/kg per day and should not exceed 2.5 grams/kg per day ()


What interacts with Smoflipid?

Sorry No Records found


What are the warnings of Smoflipid?

Sorry No Records found


What are the precautions of Smoflipid?

Sorry No Records found


What are the side effects of Smoflipid?

Sorry No records found


What should I look out for while using Smoflipid?

Use of Smoflipid is contraindicated in patients with:


What might happen if I take too much Smoflipid?

In the event of an overdose, fat overload syndrome may occur. Stop the Smoflipid infusion until triglyceride levels have normalized. The effects are usually reversible by stopping the lipid infusion. If medically appropriate, further intervention may be indicated. Lipids are not dialyzable from serum.


How should I store and handle Smoflipid?

Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Smoflipid is a sterile lipid injectable emulsion with a lipid content of 0.2 gram/mL available in the following sizes:Smoflipid should be stored at 20° to 25°C (68° to 77°F).  See USP Controlled Room Temperature. Avoid excessive heat. Do not freeze.  If accidentally frozen, discard bag.  Store in overpouch until ready for use. After removing the overpouch, Smoflipid should be infused immediately. Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C. If not used immediately, storage should not be longer than 24 hours at 2° to 8°C (36° to 46°F). After removal from storage, theproduct should be infused within 24 hours.Admixtures containing Smoflipid should be infused 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. Smoflipid is a sterile lipid injectable emulsion with a lipid content of 0.2 gram/mL available in the following sizes:Smoflipid should be stored at 20° to 25°C (68° to 77°F).  See USP Controlled Room Temperature. Avoid excessive heat. Do not freeze.  If accidentally frozen, discard bag.  Store in overpouch until ready for use. After removing the overpouch, Smoflipid should be infused immediately. Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C. If not used immediately, storage should not be longer than 24 hours at 2° to 8°C (36° to 46°F). After removal from storage, theproduct should be infused within 24 hours.Admixtures containing Smoflipid should be infused 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. Smoflipid is a sterile lipid injectable emulsion with a lipid content of 0.2 gram/mL available in the following sizes:Smoflipid should be stored at 20° to 25°C (68° to 77°F).  See USP Controlled Room Temperature. Avoid excessive heat. Do not freeze.  If accidentally frozen, discard bag.  Store in overpouch until ready for use. After removing the overpouch, Smoflipid should be infused immediately. Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C. If not used immediately, storage should not be longer than 24 hours at 2° to 8°C (36° to 46°F). After removal from storage, theproduct should be infused within 24 hours.Admixtures containing Smoflipid should be infused 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. Smoflipid is a sterile lipid injectable emulsion with a lipid content of 0.2 gram/mL available in the following sizes:Smoflipid should be stored at 20° to 25°C (68° to 77°F).  See USP Controlled Room Temperature. Avoid excessive heat. Do not freeze.  If accidentally frozen, discard bag.  Store in overpouch until ready for use. After removing the overpouch, Smoflipid should be infused immediately. Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C. If not used immediately, storage should not be longer than 24 hours at 2° to 8°C (36° to 46°F). After removal from storage, theproduct should be infused within 24 hours.Admixtures containing Smoflipid should be infused 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.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Non-Clinical Toxicology
Use of Smoflipid is contraindicated in patients with:

Antipsychotic drugs such as phenothiazines or haloperidol; tricyclic antidepressants (see ).

Deaths after infusion of soybean-based intravenous lipid emulsions have been reported in preterm infants.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 Smoflipid in pediatric patients, including preterm infants, has not been established.

Adverse reactions described elsewhere in labeling:

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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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Professional

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Tips

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Interactions

Interactions

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