Drugs Details

Drugs Info of Intralipid 20%
Drugs Details
  • Drugs Type  : FDA
  • Date : 18th Feb 2015 04:25 am
  • Brand Name : Intralipid 20%
  • Generic Name : 20% I.V. Fat Emulsion) In Excel® Container
Descriptions

INTRALIPID® 20% (20% i.v. fat emulsion) (A 20% INTRAVENOUS FAT EMULSION) IS A STERILE, NON-PYROGENIC FAT EMULSION PREPARED FOR INTRAVENOUS ADMINISTRATION AS A SOURCE OF CALORIES AND ESSENTIAL FATTY ACIDS. IT IS MADE UP OF 20% SOYBEAN OIL, 1.2% EGG YOLK PHOSPHOLIPIDS, 2.25% GLYCERIN, AND WATER FOR INJECTION. IN ADDITION, SODIUM HYDROXIDE HAS BEEN ADDED TO ADJUST THE PH SO THAT THE FINAL PRODUCT PH IS 8. PH RANGE IS 6 TO 8.9.

The soybean oil is a refined natural product consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure:

soybean oil structural formula illustration

- ARE SATURATED AND UNSATURATED FATTY ACID RESIDUES.

The major component fatty acids are linoleic (44-62%), oleic (19-30%), palmitic (7-14%), linolenic (4-11%) and stearic (1.4-5.5%)1. These fatty acids have the following chemical and structural formulas:

Fatty acids - structural formula illustration

PURIFIED EGG PHOSPHATIDES ARE A MIXTURE OF NATURALLY OCCURRING PHOSPHOLIPIDS WHICH ARE ISOLATED FROM THE EGG YOLK. THESE PHOSPHOLIPIDS HAVE THE FOLLOWING GENERAL STRUCTURE:

Purified egg phosphatides structural formula illustration

R1C- AND R2C- CONTAIN SATURATED AND UNSATURATED FATTY ACIDS THAT ABOUND IN NEUTRAL FATS. R3 IS PRIMARILY EITHER THE CHOLINE OR ETHANOLAMINE ESTER OF PHOSPHORIC ACID.

Choline and Ethanolamine  structural formula illustration

GLYCERIN IS CHEMICALLY DESIGNATED C3H8O3 AND IS A CLEAR COLORLESS, HYGROSCOPIC SYRUPY LIQUID. IT HAS THE FOLLOWING STRUCTURAL FORMULA:

Glycerin  structural formula illustration

INTRALIPID® 20% (20% i.v. fat emulsion) (A 20% INTRAVENOUSA FAT EMULSION) HAS AN OSMOLALITY OF APPROXIMATELY 350 MOSMOL/KG WATER (WHICH REPRESENTS 260 MOSMOL/LITER OF EMULSION) AND CONTAINS EMULSIFIED FAT PARTICLES OF APPROXIMATELY 0.5 MICRON SIZE.

THE TOTAL CALORIC VALUE, INCLUDING FAT, PHOSPHOLIPID AND GLYCERIN, IS 2.0 KCAL PER ML OF INTRALIPID® 20% (20% i.v. fat emulsion) . THE PHOSPHOLIPIDS PRESENT CONTRIBUTE 47 MILLIGRAMS OR APPROXIMATELY 1.5 MMOL OF PHOSPHORUS PER 100 ML OF THE EMULSION.

THE PRIMARY CONTAINER IS MANUFACTURED FROM EXCEL® FILM, A POLYPROPYLENE BASED MATERIAL COMPRISED OF THREE CO-EXTRUDED LAYERS.

THE PLASTIC CONTAINER IS MADE FROM MULTILAYERED FILM SPECIFICALLY DESIGNED FOR PARENTERAL DRUGS. IT CONTAINS NO PLASTICIZERS AND EXHIBITS VIRTUALLY NO LEACHABLES. THE SOLUTION CONTACT LAYER IS A RUBBERIZED COPOLYMER OF ETHYLENE AND PROPYLENE. THE CONTAINER IS NONTOXIC AND BIOLOGICALLY INERT. THE CONTAINER-SOLUTION UNIT IS A CLOSED SYSTEM AND IS NOT DEPENDENT UPON ENTRY OF EXTERNAL AIR DURING ADMINISTRATION. THE CONTAINER IS OVERWRAPPED TO PROVIDE PROTECTION FROM THE PHYSICAL ENVIRONMENT AND TO PROVIDE AN ADDITIONAL MOISTURE BARRIER WHEN NECESSARY.

What are the precautions when taking 20% i.v. fat emulsion (Intralipid 20%)?

See also Warning section.

Before receiving the fat emulsion, tell your doctor or pharmacist if you are allergic to it; or to eggs, safflower oil, or soy/peanut found in some brands; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This product should not be used if you have certain medical conditions. Before using this product, consult your doctor or pharmacist if you have: high fat (lipid) levels in the blood.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: severe liver disease, kidney disease, lung disease, anemia, blood clotting disorder.

Kidney function declines as you grow...

Read All Potential Precautions of Intralipid 20% »

1. PADLEY FB: "MAJOR VEGETABLE FATS," THE LIPID HANDBOOK (GUNSTONE FD, HARWOOD JL, PADLEY FB, EDS.), CHAPMAN AND HALL LTD., CAMBRIDGE, UK (1986), PP. 88-9.

What are the precautions when taking 20% i.v. fat emulsion (Intralipid 20%)?

See also Warning section.

Before receiving the fat emulsion, tell your doctor or pharmacist if you are allergic to it; or to eggs, safflower oil, or soy/peanut found in some brands; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This product should not be used if you have certain medical conditions. Before using this product, consult your doctor or pharmacist if you have: high fat (lipid) levels in the blood.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: severe liver disease, kidney disease, lung disease, anemia, blood clotting disorder.

Kidney function declines as you grow...

Read All Potential Precautions of Intralipid 20% »


This monograph has been modified to include the generic and brand name in many instances.

Indications

INTRALIPID® 20% (20% i.v. fat emulsion) IS INDICATED AS A SOURCE OF CALORIES AND ESSENTIAL FATTY ACIDS FOR PATIENTS REQUIRING PARENTERAL NUTRITION FOR EXTENDED PERIODS OF TIME (USUALLY FOR MORE THAN 5 DAYS) AND AS A SOURCE OF ESSENTIAL FATTY ACIDS FOR PREVENTION OF EFAD.

Dosage Administration

INTRALIPID® 20% (20% i.v. fat emulsion) SHOULD BE ADMINISTERED AS A PART OF INTRAVENOUS NUTRITION VIA PERPHERAL VEIN OR BY CENTRAL VENOUS INFUSION.

Adult Patients

THE INITIAL RATE OF INFUSION IN ADULTS SHOULD BE 0.5 ML/MINUTE FOR THE FIRST 15 TO 30 MINUTES OF INFUSION. IF NO UNTOWARD REACTIONS OCCUR (SEE ADVERSE REACTIONS SECTION), THE INFUSION RATE CAN BE INCREASED TO 1 ML/MINUTE. NOT MORE THAN 500 ML OF INTRALIPID® 20% (20% i.v. fat emulsion) SHOULD BE INFUSED INTO ADULTS ON THE FIRST DAY OF THERAPY. IF THE PATIENT HAS NO UNTOWARD REACTIONS, THE DOSE CAN BE INCREASED ON THE FOLLOWING DAY. THE DAILY DOSAGE SHOULD NOT EXCEED 2.5 G OF FAT/KG OF BODY WEIGHT (12.5 ML OF INTRALIPID® 20% PER KG). INTRALIPID® 20% (A 20% I.V. FAT EMULSION) SHOULD MAKE UP NO MORE THAN 60% OF THE TOTAL CALORIC INPUT TO THE PATIENT. CARBOHYDRATE AND A SOURCE OF AMINO ACIDS SHOULD COMPRISE THE REMAINING CALORIC INPUT.

Pediatric Patients

THE DOSAGE FOR PREMATURE INFANTS STARTS AT 0.5 G FAT/KG BODY WEIGHT/24 HOURS (2.5 ML INTRALIPID® 20% (20% i.v. fat emulsion) ) AND MAY BE INCREASED IN RELATION TO THE INFANT'S ABILITY TO ELIMINATE FAT. THE MAXIMUM DOSAGE RECOMMENDED BY THE AMERICAN ACADEMY OF PEDIATRICS IS 3 G FAT/KG/24 HOURS3 THE INITIAL RATE OF INFUSION IN OLDER PEDIATRIC PATIENTS SHOULD BE NO MORE THAN 0.05 ML/MINUTE FOR THE FIRST 10 TO 15 MINUTES. IF NO UNTOWARD REACTIONS OCCUR, THE RATE CAN BE CHANGED TO PERMIT INFUSION OF 0.5 ML OF INTRALIPID® 20% (20% i.v. fat emulsion) /KG/HOUR. THE DAILY DOSAGE SHOULD NOT EXCEED 3 G OF FAT/KG OF BODY WEIGHT3 INTRALIPID® 20% (20% i.v. fat emulsion) SHOULD MAKE UP NO MORE THAN 60% OF THE TOTAL CALORIC INPUT TO THE PATIENT. CARBOHYDRATE AND A SOURCE OF AMINO ACIDS SHOULD COMPRISE THE REMAINING CALORIC INPUT.

Essential Fatty Acid Deficiency

WHEN INTRALIPID® 20% (20% i.v. fat emulsion) IS ADMINISTERED TO CORRECT ESSENTIAL FATTY ACID DEFICIENCY, EIGHT TO TEN PERCENT OF THE CALORIC INPUT SHOULD BE SUPPLIED BY INTRALIPID® 20% IN ORDER TO PROVIDE ADEQUATE AMOUNTS OF LINOLEIC AND LINOLENIC ACIDS. WHEN EFAD OCCURS TOGETHER WITH STRESS, THE AMOUNT OF INTRALIPID® 20% (20% i.v. fat emulsion) NEEDED TO CORRECT THE DEFICIENCY MAY BE INCREASED.

Administration

SEE MIXING GUIDELINES AND LIMITATIONS SECTION FOR INFORMATION REGARDING MIXING THIS FAT EMULSION WITH OTHER PARENTERAL FLUIDS.

INTRALIPID® 20% (20% i.v. fat emulsion) CAN BE INFUSED INTO THE SAME CENTRAL OR PERIPHERAL VEIN AS CARBOHYDRATE/AMINO ACIDS SOLUTIONS BY MEANS OF A Y-CONNECTOR NEAR THE INFUSION SITE. THIS ALLOWS FOR MIXING OF THE EMULSION IMMEDIATELY BEFORE ENTERING THE VEIN OR FOR ALTERNATION OF EACH PARENTERAL FLUID. IF INFUSION PUMPS ARE USED, FLOW RATES OF EACH PARENTERAL FLUID SHOULD BE CONTROLLED WITH A SEPARATE PUMP. FAT EMULSION MAY ALSO BE INFUSED THROUGH A SEPARATE PERIPHERAL SITE. FILTERS OF LESS THAN 1.2 MICRON PORE SIZE MUST NOT BE USED WITH INTRALIPID® 20% (20% i.v. fat emulsion) .

CONVENTIONAL ADMINISTRATION SETS AND TPN POOLING BAGS CONTAIN POLYVINYL CHLORIDE (PVC) COMPONENTS THAT HAVE DEHP (DIETHYL HEXYL PHTHALATE) AS A PLASTICIZER. FAT-CONTAINING FLUIDS SUCH AS INTRALIPID® 20% (20% i.v. fat emulsion) EXTRACT DEHP FROM THESE PVC COMPONENTS AND IT MAY BE ADVISABLE TO CONSIDER INFUSION OF INTRALIPID® 20% (20% i.v. fat emulsion) THROUGH A NON-DEHP ADMINISTRATION SET.

DO NOT USE ANY BAG IN WHICH THERE APPEARS TO BE AN OILING OUT ON THE SURFACE OF THE EMULSION. PARENTERAL DRUG PRODUCTS SHOULD BE INSPECTED VISUALLY FOR PARTICULATE MATTER AND DISCOLORATION PRIOR TO ADMINISTRATION. WHENEVER SOLUTION AND CONTAINER PERMIT.

MIXING GUIDELINES AND LIMITATIONS

INVESTIGATIONS HAVE BEEN CONDUCTED WHICH DEMONSTRATE THE COMPATIBILITY OF INTRALIPID® 20% (A 20% I.V. FAT EMULSION) WHEN PROPERLY MIXED WITH EITHER NOVAMINE® OR 8.5% TRAVASOL®OR 10% TRAVASOL® AMINO ACID INJECTIONS WITHOUT ELECTROLYTES FOR USE IN TPN THERAPY. 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:

  1. TRANSFER DEXTROSE INJECTION TO THE TPN ADMIXTURE CONTAINER
  2. TRANSFER AMINO ACID INJECTION
  3. TRANSFER INTRALIPID® 20% (20% i.v. fat emulsion) (A 20% INTRAVENOUS FAT EMULSION)

NOTE: AMINO ACID INJECTION, DEXTROSE INJECTION AND INTRALIPID® 20% (20% i.v. fat emulsion) MAY BE SIMULTANEOUSLY TRANSFERRED TO THE ADMIXTURE CONTAINER. ADMIXING SHOULD BE ACCOMPANIED BY GENTLE AGITATION TO AVOID LOCALIZED CONCENTRATION EFFECTS.

THESE 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. IT IS ESSENTIAL THAT THE ADMIXTURE BE PREPARED USING STRICT ASEPTIC TECHNIQUES AS THIS NUTRIENT MIXTURE IS A GOOD GROWTH MEDIUM FOR MICROORGANISMS.

ADDITIVES OTHER THAN THOSE NAMED ABOVE MAY BE INCOMPATIBLE. COMPLETE INFORMATION IS NOT AVAILABLE. THOSE ADDITIVES KNOWN TO BE INCOMPATIBLE SHOULD NOT BE USED. CONSULT WITH PHARMACIST, IF AVAILABLE. IF, IN THE INFORMED JUDGMENT OF THE PHYSICIAN, IT IS DEEMED ADVISABLE TO INTRODUCE ADDITIVES, USE ASEPTIC TECHNIQUE. MIX THOROUGHLY WHEN ADDITIVES HAVE BEEN INTRODUCED. DO NOT STORE SOLUTIONS CONTAINING ADDITIVES (E.G., VITAMINS AND MINERALS). ADDITIVES MUST NOT BE ADDED DIRECTLY TO INTRALIPID® 20% AND IN NO CASE SHOULD INTRALIPID® 20% (20% i.v. fat emulsion) BE ADDED TO THE TPN CONTAINER FIRST. BAGS SHOULD BE SHAKEN GENTLY AFTER EACH ADDITION TO MINIMIZE LOCALIZED CONCENTRATION.

SUPPLEMENTAL ELECTROLYTES, TRACE METALS OR MULTIVITAMINS MAY BE REQUIRED IN ACCORDANCE WITH THE PRESCRIPTION OF THE ATTENDING PHYSICIAN.

THE PRIME DESTABILIZERS OF EMULSIONS ARE EXCESSIVE ACIDITY (LOW PH) AND INAPPROPRIATE ELECTROLYTE CONTENT. CAREFUL CONSIDERATION SHOULD BE GIVEN TO ADDITIONS OF DIVALENT CATIONS (CA++ AND MG++) WHICH HAVE BEEN SHOWN TO CAUSE EMULSION INSTABILITY. AMINO ACID SOLUTIONS EXERT A BUFFERING EFFECT PROTECTING THE EMULSION.

THE ADMIXTURE SHOULD BE INSPECTED CAREFULLY FOR "BREAKING OR OILING OUT" OF THE EMULSION. "BREAKING OR OILING OUT" IS DESCRIBED AS THE SEPARATION OF THE EMULSION AND CAN BE VISIBLY IDENTIFIED BY A YELLOWISH STREAKING OR THE ACCUMULATION OF YELLOWISH DROPLETS IN THE ADMIXED EMULSION. THE ADMIXTURE SHOULD ALSO BE EXAMINED FOR PARTICULATES. THE ADMIXTURE MUST BE DISCARDED IF ANY OF THE ABOVE IS OBSERVED.

Instructions for Use - Intralipid® 20% (20% i.v. fat emulsion) Container

1. The integrity indicator (Oxalert™) A should be inspected before removing the overpouch.
If the indicator is black the overpouch is damaged and the product should be discarded.
Instructions for Use - illustration 1
2. Remove the overwrap by tearing at the notch and pulling down along the container. The Oxalert™ sachet A and the oxygen absorber B should be disposed. Instructions for Use - illustration 2
3. Remove set port cover lifting ring with thumb and forefinger and pulling upwards. Instructions for Use - illustration 3
4. Use a non-vented infusion set or close the air vent on a vented set. Follow the instructions for use for the infusion set. Use a spike conforming to ISO 8536-4, diameter 5.6 ± 0.1 mm. Instructions for Use - illustration 4
5. The bag should be port side up when the infusion set is attached. Insertthe spike straight into the set port. Twist and push the spike through thediaphragm.
Do not spike bag while the bag is hanging on the IV pole.
Instructions for Use - illustration 5
6. The step of the spike (shown by the arrow) should not be inserted into Instructions for Use - illustration 6
7. To hang the bag, invert and place hanger through container notch. Instructions for Use - illustration 7

 

How Supplied

INTRALIPID® 20% (20% i.v. fat emulsion) IS SUPPLIED AS A STERILE EMULSION IN THE FOLLOWING FILL SIZES: 100 ML, 250 ML, 500 ML AND 1000 ML.

100 ML:   0338-0519-48
250 ML:   0338-0519-02
500 ML:   0338 0519-03
1000 ML: 0338-0519-04

Storage

INTRALIPID® 20% (20% i.v. fat emulsion) SHOULD NOT BE STORED ABOVE 25°C (77°F). DO NOT FREEZE INTRALIPID® 20% (20% i.v. fat emulsion) . IF ACCIDENTALLY FROZEN, DISCARD THE BAG.

3. AMERICAN ACADEMY OF PEDIATRICS: USE OF INTRAVENOUS FAT EMULSION IN PEDIATRIC PATIENTS. PEDIATRICS 1981; 68:5(NOV) 738-43.

(Rev June 2006) Manufactured for Baxter Healthcare Corporation Clintec Nutrition Division Deerfield, IL 60015 USA Manufactured by Fresenius Kabi, Uppsala, Sweden
Intralipid® is a registered trademark of Fresenius Kabi AB., Novamine® is a registered trademark of Fresenius Kabi AB., Travasol® is a registered trademark of Baxter Healthcare Corporation. FDA Rev date: 4/24/2007


This monograph has been modified to include the generic and brand name in many instances.

Side Effects

THE ADVERSE REACTIONS OBSERVED CAN BE SEPARATED INTO TWO CLASSES:

  1. THOSE MORE FREQUENTLY ENCOUNTERED ARE DUE: EITHER TO CONTAMINATION OF THE INTRAVENOUS CATHETER AND RESULT IN SEPSIS, OR TO VEIN IRRITATION BY CONCURRENTLY INFUSED HYPERTONIC SOLUTIONS AND MAY RESULT IN THROMBOPHLEBITIS. THESE ADVERSE REACTIONS ARE INSEPARABLE FROM THE HYPERALIMENTATION PROCEDURE WITH OR WITHOUT INTRALIPID® 20% (A 20% I.V. FAT EMULSION).
  2. LESS FREQUENT REACTIONS MORE DIRECTLY RELATED TO INTRALIPID® 20% (20% i.v. fat emulsion) ARE: A) IMMEDIATE OR EARLY ADVERSE REACTIONS, EACH OF WHICH HAS BEEN REPORTED TO OCCUR IN CLINICAL TRIALS, IN AN INCIDENCE OF LESS THAN 1%; DYSPNEA, CYANOSIS, ALLERGIC REACTIONS, HYPERLIPEMIA, HYPERCOAGULABILITY, NAUSEA, VOMITING, HEADACHE, FLUSHING, INCREASE IN TEMPERATURE, SWEATING, SLEEPINESS, PAIN IN THE CHEST AND BACK, SLIGHT PRESSURE OVER THE EYES, DIZZINESS, AND IRRITATION AT THE SITE OF INFUSION, AND, RARELY, THROMBOCYTOPENIA IN NEONATES; B) DELAYED ADVERSE REACTIONS SUCH AS HEPATOMEGALY, JAUNDICE DUE TO CENTRAL LOBULAR CHOLESTASIS, SPLENOMEGALY, THROMBOCYTOPENIA, LEUKOPENIA, TRANSIENT INCREASES IN LIVER FUNCTION TESTS, AND OVERLOADING SYNDROME (FOCAL SEIZURES, FEVER, LEUKOCYTOSIS, HEPATOMEGALY. SPLENOMEGALY AND SHOCK).

THE DEPOSITION OF A BROWN PIGMENTATION IN THE RETICULOEN-DOTHELIAL SYSTEM, THE SO CALLED "INTRAVENOUS FAT PIGMENT," HAS BEEN REPORTED IN PATIENTS INFUSED WITH INTRALIPID® 20% (20% i.v. fat emulsion) . THE CAUSES AND SIGNIFICANCE OF THIS PHENOMENON ARE UNKNOWN.

Read the Intralipid 20% (20% i.v. fat emulsion) Side Effects Center for a complete guide to possible side effects

Interactions

No information provided


This monograph has been modified to include the generic and brand name in many instances.

Warnings

DEATHS IN PRETERM INFANTS AFTER INFUSION OF INTRAVENOUS FAT EMULSION HAVE BEEN REPORTED IN THE MEDICAL LITERATURE.2 AUTOPSY FINDINGS INCLUDED INTRAVASCULAR FAT ACCUMULATION IN THE LUNGS. TREATMENT OF PREMATURE AND LOW BIRTH WEIGHT INFANTS WITH INTRAVENOUS FAT EMULSION MUST BE BASED UPON CAREFUL BENEFIT-RISK ASSESSMENT. STRICT ADHERENCE TO THE RECOMMENDED TOTAL DAILY DOSE IS MANDATORY; HOURLY INFUSION RATE SHOULD BE AS SLOW AS POSSIBLE IN EACH CASE AND SHOULD NOT IN ANY CASE EXCEED 1 G FAT/KG IN FOUR HOURS. PREMATURE AND SMALL FOR GESTATIONAL AGE INFANTS HAVE POOR CLEARANCE OF INTRAVENOUS FAT EMULSION AND INCREASED FREE FATTY ACID PLASMA LEVELS FOLLOWING FAT EMULSION INFUSION; THEREFORE, SERIOUS CONSIDERATION MUST BE GIVEN TO ADMINISTRATION OF LESS THAN THE MAXIMUM RECOMMENDED DOSES IN THESE PATIENTS IN ORDER TO DECREASE THE LIKELIHOOD OF INTRAVENOUS FAT OVERLOAD. THE INFANT'S ABILITY TO ELIMINATE THE INFUSED FAT FROM THE CIRCULATION MUST BE CAREFULLY MONITORED (SUCH AS SERUM TRIGLYCERIDES AND/OR PLASMA FREE FATTY ACID LEVELS). THE LIPEMIA MUST CLEAR BETWEEN DAILY INFUSIONS.

CAUTION SHOULD BE EXERCISED IN ADMINISTERING OF INTRALIPID® 20% (20% i.v. fat emulsion) (A 20% INTRAVENOUS FAT EMULSION) TO PATIENTS WITH SEVERE LIVER DAMAGE, PULMONARY DISEASE, ANEMIA OR BLOOD COAGULATION DISORDERS, OR WHEN THERE IS DANGER OF FAT EMBOLISM.

WARNING: THIS PRODUCT CONTAINS ALUMINUM THAT MAY BE TOXIC. ALUMINUM MAY REACH TOXIC LEVELS WITH PROLONGED PARENTERAL ADMINISTRATION IF KIDNEY FUNCTION IS IMPAIRED. PREMATURE NEONATES ARE PARTICULARLY AT RISK BECAUSE THEIR KIDNEYS ARE IMMATURE, AND THEY REQUIRE LARGE AMOUNTS OF CALCIUM AND PHOSPHATE SOLUTIONS, WHICH CONTAIN ALUMINUM.

RESEARCH INDICATES THAT PATIENTS WITH IMPAIRED KIDNEY FUNCTION, INCLUDING PREMATURE NEONATES, WHO RECEIVE PARENTERAL LEVELS OF ALUMINUM AT GREATER THAN 4 TO 5 MCG/KG/DAY ACCUMULATE ALUMINUM AT LEVELS ASSOCIATED WITH CENTRAL NERVOUS SYSTEM AND BONE TOXICITY. TISSUE LOADING MAY OCCUR AT EVEN LOWER RATES OF ADMINISTRATION.

Precautions

WHEN INTRALIPID® 20% (20% i.v. fat emulsion) IS ADMINISTERED, THE PATIENTS CAPACITY TO ELIMINATE THE INFUSED FAT FROM THE CIRCULATION MUST BE MONITORED BY USE OF AN APPROPRIATE LABORATORY DETERMINATION OF SERUM TRIGLYCERIDES. OVERDOSAGE MUST BE AVOIDED.

DURING LONG TERM INTRAVENOUS NUTRITION WITH INTRALIPID® 20% (20% i.v. fat emulsion) , LIVER FUNCTION TESTS SHOULD BE PERFORMED. IF THESE TESTS INDICATE THAT LIVER FUNCTION IS IMPAIRED, THE THERAPY SHOULD BE WITHDRAWN.

FREQUENT (SOME ADVISE DAILY) PLATELET COUNTS SHOULD BE DONE IN NEONATAL PATIENTS RECEIVING PARENTERAL NUTRITION WITH INTRALIPID® 20% (20% i.v. fat emulsion) .

DRUG PRODUCT CONTAINS NO MORE THAN 25 MCG/L OF ALUMINUM.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies with Intralipid® have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

Pregnancy Category C: Animal reproduction studies have not been conducted with Intralipid® It is also not known whether Intralipid® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Intralipid® should be given to a pregnant woman only if clearly needed.

Nursing Mothers: Caution should be exercised when Intralipid® is administered to a nursing woman.

Pediatric Use: See DOSAGE AND ADMINISTRATION.

AVOID OVERDOSAGE ABSOLUTELY.

2. LEVENE MI, WIGGLESWORTH JS, DESAI R: PULMONARY FAT ACCUMULATION AFTER INTRALIPID® INFUSION IN THE PRETERM INFANT. LANCET 1980; 2(8199):815-8.


This monograph has been modified to include the generic and brand name in many instances.

OverDose

IN THE EVENT OF FAT OVERLOAD DURING THERAPY, STOP THE INFUSION OF INTRALIPID® 20% UNTIL VISUAL INSPECTION OF THE PLASMA, DETERMINATION OF TRIGLYCERIDE CONCENTRATIONS, OR MEASUREMENT OF PLASMA LIGHT-SCATTERING ACTIVITY BY NEPHELOMETRY INDICATES THE LIPID HAS CLEARED. RE-EVALUATE THE PATIENT AND INSTITUTE APPROPRIATE CORRECTIVE MEASURES. SEE WARNINGS AND PRECAUTIONS.

ContrainDications

THE ADMINISTRATION OF INTRALIPID® 20% (20% i.v. fat emulsion) IS CONTRAINDICATED IN PATIENTS WITH DISTURBANCES OF NORMAL FAT METABOLISM SUCH AS PATHOLOGIC HYPERLIPEMIA, LIPOID NEPHROSIS OR ACUTE PANCREATITIS IF ACCOMPANIED BY HYPERLIPIDEMIA.


This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

INTRALIPID®20% IS METABOLIZED AND UTILIZED AS A SOURCE OF ENERGY CAUSING AN INCREASE IN HEAT PRODUCTION, DECREASE IN RESPIRATORY QUOTIENT AND INCREASE IN OXYGEN CONSUMPTION. THE INFUSED FAT PARTICLES ARE CLEARED FROM THE BLOOD STREAM IN A MANNER THOUGHT TO BE COMPARABLE TO THE CLEARING OF CHYLOMICRONS.

INTRALIPID® 20% (20% i.v. fat emulsion) WILL PREVENT THE BIOCHEMICAL LESIONS OF ESSENTIAL FATTY ACID DEFICIENCY (EFAD), AND CORRECT THE CLINICAL MANI-FESTATIONS OF THE EFAD SYNDROME.


This monograph has been modified to include the generic and brand name in many instances.

Patient Information

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.


This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

FAT EMULSION - INJECTION

 

COMMON BRAND NAME(S): Intralipid, Liposyn

 

WARNING: This product must be used cautiously in premature or low-birth-weight infants since it has caused very serious (possibly fatal) lung problems in these patients. The infant must be monitored closely while receiving this product. If this product is to be given to a premature or low-birth-weight infant, talk with the doctor about the risks and benefits of using this product.

 

USES: This product is used to provide calories to patients who are getting their nutrition through an injection into the vein. Calories are needed to provide the body with energy so that the body can work properly. This product is also used to provide a certain nutrient (essential fatty acids) to people who do not have enough of it. This product helps to prevent or reverse the signs of this deficiency (e.g., scaly skin, poor growth, poor wound healing).

 

HOW TO USE: This product is given by injection into a vein as directed by your doctor. Before using, check this product visually for particles, oil, or discoloration. If any of these are present, do not use the liquid. Learn all preparation and usage instructions in the product package. If any of the information is unclear, consult your doctor or pharmacist.

Except for heparin, do not add any medication/minerals to the product container.

Dosage is based on your medical condition, weight, and response to treatment.

Consumer Overview Side Effect

SIDE EFFECTS: Headache, dizziness, flushing, drowsiness, nausea, vomiting, or sweating may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: signs of infection (e.g., fever, persistent sore throat), pain/swelling/redness at injection site, pain/swelling/redness of arms/legs, bluish skin, sudden weight gain, shortness of breath, back/chest pain.

Tell your doctor immediately if any of these rare but very serious side effects occur: mental/mood changes, bone pain, muscle weakness, yellowing skin/eyes, dark urine, easy bruising/bleeding, severe stomach/abdominal pain, trouble breathing.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Intralipid 20% (20% i.v. fat emulsion) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: See also Warning section.

Before receiving the fat emulsion, tell your doctor or pharmacist if you are allergic to it; or to eggs, safflower oil, or soy/peanut found in some brands; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This product should not be used if you have certain medical conditions. Before using this product, consult your doctor or pharmacist if you have: high fat (lipid) levels in the blood.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: severe liver disease, kidney disease, lung disease, anemia, blood clotting disorder.

Kidney function declines as you grow older. This medication contains aluminum, which is removed by the kidneys. Therefore, elderly people may be at greater risk for bone pain and mental/mood changes while using this drug.

Kidney function is not fully developed in newborns and infants. This medication contains aluminum, which is removed by the kidneys. Therefore, newborns and infants may be at greater risk for bone pain and mental/mood changes while using this drug.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: Laboratory and/or medical tests (e.g., platelet count, liver function, lipid panel) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

 

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store the unopened container at room temperature between 68-77 degrees F (20-25 degrees C) away from light. The mixed product may be stored in the refrigerator between 36-46 degrees F (2-8 degrees C) for up to 24 hours. Finish giving the mixed product within 24 hours after removal from the refrigerator. Protect this product from freezing. Discard partially used containers. Do not save for later use. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

Information last revised February 2014. Copyright(c) 2014 First Databank, Inc.

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