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Soybean Oil
Overview
What is NutriLipid I.V. Fat Emulsion?
Nutrilipid® 20% is a sterile, nonpyrogenic fat emulsion prepared for intravenous administration.
Each 100 mL of Nutrilipid® 20% contains: Soybean Oil 20 g; Egg Yolk Phospholipid 1.2 g; Glycerin USP (glycerol) 2.5 g; Sodium Oleate 0.03 g; Water for Injection USP qs.
pH adjusted with Sodium Hydroxide NF.
pH: 6.8 (6.0-8.9); Osmolality: 390 mOsmolKg (actual). Contains emulsified fat particles averaging approximately 0.26 micron in diameter, similar to naturally occurring chylomicrons. The total caloric value, including fat, phospholipid, and glycerol is 2.0 Kcal per mL.
Soybean oil is a refined natural product consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure:
Egg yolk phospholipids are a mixture of naturally occurring phospholipids isolated from egg yolk.
Glycerol is chemically designated CH0 and is a clear colorless, hygroscopic syrupy liquid. It is added to adjust tonicity.
Not made with natural rubber latex, PVC or DEHP.
Drug product contains no more than 25 mcg/L of aluminum.
What does NutriLipid I.V. Fat Emulsion look like?
What are the available doses of NutriLipid I.V. Fat Emulsion?
Nutrilipid® 20% is a lipid injectable emulsion:
What should I talk to my health care provider before I take NutriLipid I.V. Fat Emulsion?
Hepatic Impairment: Use with caution; monitor liver function parameters ()
How should I use NutriLipid I.V. Fat Emulsion?
Nutrilipid® 20% is indicated as a source of calories and essential fatty acids for parenteral nutrition and as a source of essential fatty acids when a deficiency occurs when oral or enteral nutrition is not possible, insufficient, or contraindicated.
Nutrilipid® 20% Pharmacy Bulk Package is not intended for direct intravenous administration ()
For intravenous infusion only through a peripheral or central line ()
Recommended dosage depends on age, energy expenditure, clinical status, body weight, tolerance, ability to metabolize and consideration of additional energy given to the patient ()
What interacts with NutriLipid I.V. Fat Emulsion?
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What are the warnings of NutriLipid I.V. Fat Emulsion?
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What are the precautions of NutriLipid I.V. Fat Emulsion?
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What are the side effects of NutriLipid I.V. Fat Emulsion?
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What should I look out for while using NutriLipid I.V. Fat Emulsion?
Nutrilipid® 20% is contraindicated in patients who have:
What might happen if I take too much NutriLipid I.V. Fat Emulsion?
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 NutriLipid I.V. Fat Emulsion?
Before reconstitutionDo not store lyophilized powder above 25°C (77°F).Reconstituted and infusion solutionsThe reconstituted solution, immediately diluted in 0.9% Sodium Chloride Injection may be stored at room temperature (25°C) and used within 6 hours or stored for 24 hours under refrigeration (5°C) and used within 4 hours after removal from refrigeration. Solutions of INVANZ should not be frozen.Before reconstitutionDo not store lyophilized powder above 25°C (77°F).Reconstituted and infusion solutionsThe reconstituted solution, immediately diluted in 0.9% Sodium Chloride Injection may be stored at room temperature (25°C) and used within 6 hours or stored for 24 hours under refrigeration (5°C) and used within 4 hours after removal from refrigeration. Solutions of INVANZ should not be frozen.Before reconstitutionDo not store lyophilized powder above 25°C (77°F).Reconstituted and infusion solutionsThe reconstituted solution, immediately diluted in 0.9% Sodium Chloride Injection may be stored at room temperature (25°C) and used within 6 hours or stored for 24 hours under refrigeration (5°C) and used within 4 hours after removal from refrigeration. Solutions of INVANZ should not be frozen.Before reconstitutionDo not store lyophilized powder above 25°C (77°F).Reconstituted and infusion solutionsThe reconstituted solution, immediately diluted in 0.9% Sodium Chloride Injection may be stored at room temperature (25°C) and used within 6 hours or stored for 24 hours under refrigeration (5°C) and used within 4 hours after removal from refrigeration. Solutions of INVANZ should not be frozen.Nutrilipid® 20% is supplied as a sterile emulsion in the following fill sizes:Do not freeze. If accidentally frozen, discard the container. Store below 25°C (77°F).Use of the Pharmacy Bulk Package for admixing should be limited to up to four hours after opening. Admixtures should be used promptly with storage under refrigeration (2-8°C) not to exceed 24 hours and must be completely used within 24 hours after removal from refrigeration.Nutrilipid® 20% is supplied as a sterile emulsion in the following fill sizes:Do not freeze. If accidentally frozen, discard the container. Store below 25°C (77°F).Use of the Pharmacy Bulk Package for admixing should be limited to up to four hours after opening. Admixtures should be used promptly with storage under refrigeration (2-8°C) not to exceed 24 hours and must be completely used within 24 hours after removal from refrigeration.Nutrilipid® 20% is supplied as a sterile emulsion in the following fill sizes:Do not freeze. If accidentally frozen, discard the container. Store below 25°C (77°F).Use of the Pharmacy Bulk Package for admixing should be limited to up to four hours after opening. Admixtures should be used promptly with storage under refrigeration (2-8°C) not to exceed 24 hours and must be completely used within 24 hours after removal from refrigeration.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Nutrilipid® 20% administered intravenously provides biologically utilizable source of calories and essential fatty acids.
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.
Nutrilipid® 20% causes an increase in heat production, decrease in respiratory quotient, and increase in oxygen consumption following its administration.
Non-Clinical Toxicology
Nutrilipid® 20% is contraindicated in patients who have:In one survey, 2.3% of patients taking labetalol hydrochloride in combination with tricyclic antidepressants experienced tremor, as compared to 0.7% reported to occur with labetalol hydrochloride alone. The contribution of each of the treatments to this adverse reaction is unknown, but the possibility of a drug interaction cannot be excluded.
Drugs possessing beta-blocking properties can blunt the bronchodilator effect of beta-receptor agonist drugs in patients with bronchospasm; therefore, doses greater than the normal anti-asthmatic dose of beta-agonist bronchodilator drugs may be required.
Cimetidine has been shown to increase the bioavailability of labetalol hydrochloride. Since this could be explained either by enhanced absorption or by an alteration of hepatic metabolism of labetalol hydrochloride, special care should be used in establishing the dose required for blood pressure control in such patients.
Synergism has been shown between halothane anesthesia and intravenously administered labetalol hydrochloride. During controlled hypotensive anesthesia using labetalol hydrochloride in association with halothane, high concentrations (3% or above) of halothane should not be used because the degree of hypotension will be increased and because of the possibility of a large reduction in cardiac output and an increase in central venous pressure. The anesthesiologist should be informed when a patient is receiving labetalol hydrochloride.
Labetalol hydrochloride blunts the reflex tachycardia produced by nitroglycerin without preventing its hypotensive effect. If labetalol hydrochloride is used with nitroglycerin in patients with angina pectoris, additional antihypertensive effects may occur.
Care should be taken if labetalol is used concomitantly with calcium antagonists of the verapamil type.
Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.
Deaths in preterm infants after infusion of intravenous lipid emulsions have been reported. Autopsy findings included intravascular lipid accumulation in the lungs.
Base the decision to treat preterm and small for gestational age infants with intravenous lipid emulsion upon careful benefit-risk assessment. Strictly adhere to the recommended total daily dose; hourly infusion rate should be as slow as possible and should not exceed 0.75 mL/kg/hour [see ].
Preterm and small for gestational age infants have poor clearance of intravenous lipid emulsion and increased free fatty acid plasma levels following fat emulsion infusion; therefore, seriously consider administration of less than the maximum recommended doses in these patients in order to decrease the likelihood of intravenous fat overload.
Carefully monitor the infant’s ability to eliminate the infused lipids from the circulation (such as serum triglycerides and/or plasma free fatty acid levels) [see ].
Because of the risk of thrombocytopenia, monitor platelet counts frequently in neonatal patients receiving parenteral nutrition with Nutrilipid® 20%.
Adverse Reactions described elsewhere in labeling:
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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