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CLINOLIPID lipid injectable emulsion, USP is a sterile, non-pyrogenic, homogenous, white, milky lipid emulsion for intravenous infusion. The lipid content of CLINOLIPID is 0.2 g/mL and comprises a mixture of refined olive oil and refined soybean oil in an approximate ratio of 4:1 (olive:soy). The mean concentration of linoleic acid (an omega-6 essential fatty acid) is 35.8 mg/mL (range 27.6 to 44.0 mg/mL) and a-linolenic acid (an omega-3 essential fatty acid) is 4.7 mg/mL (range 1.0 to 8.4 mg/mL). The phospholipids provide 470 milligrams or 15 mmol of phosphorus per liter.
The total energy content, including fat, phospholipids and glycerin is 2000 kcal/L.
Each 100 mL of CLINOLIPID 20% contains approximately 16 g of Olive Oil NF and 4 g of Soybean Oil USP, 1.2 g Egg Phospholipids NF, 2.25 g Glycerin USP, 0.03 g Sodium Oleate, and Water for Injection USP. Sodium Hydroxide NF for pH adjustment, pH: 6.0 to 9.0.
The olive and soybean oils are refined natural products consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure:
 |
Where 
and 
are the saturated and unsaturated fatty residues.
The major component fatty acids are linoleic (13.8 to 22.0%), oleic (44.3 to 79.5%), palmitic (7.6 to 19.3%), linolenic (0.5 to 4.2%), palmitoleic (0.0 to 3.2%) and stearic (0.7 to 5.0%). These fatty acids have the following chemical and structural formulas:
 |
CLINOLIPID has an osmolality of approximately 340 mOsmol/kg water (which represents an osmolarity of 260 mOsmol/liter of emulsion).
CLINOLIPID contains no more than 25 mcg/L of aluminum.
CLINOLIPID is indicated in adults and pediatric patients, including term and preterm neonates, as a source of calories and essential fatty acids for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated.
Fragments of the administration port membrane could be dislodged into the bag after spiking. Use a 1.2 micron in-line filter during administration of CLINOLIPID (alone or as part of an admixture) to remove particulate matter or micro-precipitate contamination during administration of a lipid injection (alone or as part of an admixture). Particulate matter greater than 5 microns has the capability of obstructing blood flow through capillaries, which could lead to embolism and vascular occlusion. Do not use filters of less than 1.2 micron pore size with lipid emulsions.
Before opening the overwrap, check the color of the oxygen indicator. Compare the color of the indicator to the reference color printed next to the OK symbol depicted in the printed area of the indicator label. Do not use the product if the color of the oxygen absorber/indicator does not correspond to the reference color printed next to the OK symbol.
After opening the bag, use the contents immediately and discard unused portion.
Visually inspect that the emulsion is a homogeneous liquid with a milky appearance. Inspect for particulate matter and discoloration prior to administration, whenever solution and container permit.
Do not exceed the recommended maximum infusion rate (0.75 mL/kg/hour for pediatric patients and 0.5 mL/kg/hour for adults) [see Dosage and Administration (2.4) and Warnings and Precautions (5.1)].
Do not connect flexible bags in series to avoid air embolism due to possible residual gas contained in the primary bag.
Air embolism can result if residual gas in the bag is not fully evacuated prior to administration if the flexible bag is pressurized to increase flow rates.
Do not use vented administration sets with the vent in the open position. This can result in air embolism.
If CLINOLIPID is mixed with dextrose and/or amino acid solutions, check the compatibility before administration by inspecting the mixture closely for the presence of precipitates. Formation of precipitates could result in vascular occlusion.
CLINOLIPID can be administered via central or peripheral vein. 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.
Do not use administration sets and lines that contain di-2-ethylhexyl phthalate (DEHP).
Use only a 1.2 micron pore size in-line filter to administer CLINOLIPID. DO NOT use any size less than 1.2 micron pore size in-line filter [see Dosage and Administration (2.1)].
When Admixing CLINOLIPID in the Pharmacy:
Prepare the admixture using strict aseptic techniques to avoid microbial contamination.
Do not add additives directly to CLINOLIPID. Do not add CLINOLIPID to the total parenteral nutrition container first; destabilization of the lipid may occur from such an admixture.
Do not use the EXACTAMIX Inlet REF 173 (H938173) with an EXACTAMIX compounder to transfer CLINOLIPID. This inlet spike has been associated with dislodgement of the administration port membrane into the CLINOLIPID bag. Use of EXACTAMIX Inlet REF 174 (H938174) is recommended.
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:
Amino Acid Injection, Dextrose Injection and Lipid Emulsions may be simultaneously transferred to the admixture container. Use gentle agitation during admixing to minimize localized concentration effects; shake bags gently after each addition.
The prime destabilizers of emulsions are excessive acidity (such as a pH below 5) and inappropriate electrolyte content. Give careful consideration to additions of divalent cations (Ca++ and Mg++), which have been shown to cause emulsion instability. Amino acid solutions exert buffering effects that protect the emulsion.
Inspect the admixture closely for separation of the emulsion. This 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. Discard the admixture if any of the above is observed.
Protect the admixed parenteral nutrition solution from light.
The recommended nutritional requirements of lipid and recommended dosages of CLINOLIPID to be administered to meet those requirements for pediatric and adult patients are provided in Table 1, along with recommendations for the initial and maximum infusion rates. For complete parenteral nutrition, concomitant supplementation with amino acids, carbohydrates, electrolytes, vitamins, and trace elements is necessary.
Prior to administration of CLINOLIPID, correct severe water and electrolyte disorders, severe fluid overload states, and severe metabolic disorders. Before starting the infusion, obtain serum triglyceride levels to establish the baseline value. In patients with elevated triglyceride levels, initiate CLINOLIPID injection at a lower dose, and advance in smaller increments, checking the triglyceride levels prior to each adjustment.
Adjust the infusion rate by taking into account the dose being administered, the daily volume intake, and the duration of the infusion. Do not exceed the maximum infusion rates in Table 1 [Warnings and Precautions (5.1) and see Overdosage (10)].
The recommended duration of infusion for a parenteral nutrition bag is between 12 and 24 hours, depending on the clinical situation. For preterm and term neonates, the recommended duration of infusion is 20 to 24 hours. Treatment with parenteral nutrition may be continued for as long as required by the patient’s condition.
The maximum daily dosage of CLINOLIPID should be based on individual total nutritional requirements and patient tolerance (Table 1).
Table 1: Recommended Pediatric and Adult Dosage and Infusion Rate
| Age | Nutritional Requirements | Direct Infusion Rate* | ||
| Recommended Initial Dosage and Maximum Dosage | Initial | Maximum | ||
| Birth to 2 years of age (including preterm and term neonates **) [see Warnings and Precautions (5.1)] |
Initial 0.5 to 1 g/kg/day not to exceed 3 g/kg/day*** |
0.1 to 0.2 mL/kg/hour for the first 15 to 30 minutes; gradually increase the required rate after 30 minutes |
0.75 mL/kg/hour | |
| Pediatric patients 2 to less than 12 years of age |
Initial 1 to 2 g/kg/day not to exceed 3 g/kg/day*** |
0.2 to 0.4 mL/kg/hour for the first 15 to 30 minutes; gradually increase the required rate after 30 minutes |
0.75 mL/kg/hour | |
| Pediatric patients 12 to 17 years of age |
Initial 1 g/kg/day not to exceed 3 g/kg/day*** |
0.2 to 0.4 mL/kg/hour for the first 15 to 30 minutes; gradually increase the required rate after 30 minutes |
0.75 mL/kg/hour | |
| Adults | 1 to 1.5 g/kg/day not to exceed 2.5 g/kg/day*** |
0.2 mL/kg/hour for the first 15 to 30 minutes; if tolerated, gradually increase the required rate after 30 minutes |
0.5 mL/kg/hour | |
|
* CLINOLIPID Pharmacy Bulk Package is not intended for direct intravenous administration. **The neonatal period is defined as including term, post-term, and preterm newborn infants. The neonatal period for term and post-term infants is the day of birth plus 27 days. For preterm infants, the neonatal period is defined as the day of birth through the expected age of delivery plus 27 days (i.e., 44 weeks post-menstrual age). *** Daily dosage should also not exceed a maximum of 60% of total energy requirements [see Overdosage (10)]. |
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CLINOLIPID is a sterile, homogenous, white, milky, lipid injectable emulsion supplied as:
CLINOLIPID is a sterile, white, milky homogenous lipid injectable emulsion supplied in CLARITY polyolefin Flexible Containers as follows:
| Strengths | Container Size | Product Code | NDC Number (1 Bag) |
NDC Number (Shelf Pack) |
| 20% (20 g/100 mL) (0.2 g/mL) | 100 mL | EADB9520 | 0338-9540-01 (single-dose Flexible Container) |
0338-9540-05 (15 pack) |
| 20% (50 g/250 mL) (0.2 g/mL) | 250 mL | EADB9521 | 0338-9540-02 (single-dose Flexible Container) |
0338-9540-06 (10 pack) |
| 20% (100 g/500 mL) (0.2 g/mL) | 500 mL | EADB9523 | 0338-9540-03 (single-dose Flexible Container) |
0338-9540-07 (12 pack) |
| 20% (200 g/1,000 mL) (0.2 g/mL) | 1,000 mL | EADB9524 | 0338-9540-04 (Pharmacy Bulk Package bag) |
0338-9540-08 (6 pack) |
The CLARITY Container is a lipid-compatible plastic container (PL 2401-1). The bag is packaged in an oxygen barrier overpouch, which contains an oxygen absorber / oxygen indicator sachet.
CLINOLIPID should be stored at 20°C to 25°C (68°F to 77°F). Excursion permitted between 15°C to 30 °C (59°F to 86°F). See USP Controlled Room Temperature. Protect from freezing. Avoid excessive heat. Store in overpouch until ready to use.
After removing the overpouch, infuse immediately. If not used immediately, the product should be stored for no longer than 24 hours at not more than 25°C (77°F) [See Dosage and Administration (2.2)].
Use the pharmacy bulk package immediately for admixing after removal from overpouch. If not used immediately, the product should be stored for no longer than 24 hours at not more than 25°C (77°F) [see Dosage and Administration (2.2)].
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Baxter, Clarity, Clinolipid and Exactamix are trademarks of Baxter International Inc.
Included as part of the PRECAUTIONS section.
In the postmarketing setting, serious adverse reactions including acute respiratory distress, metabolic acidosis, and death have been reported in neonates and infants after rapid infusion of intravenous lipid emulsions. Hypertriglyceridemia was commonly reported.
Strictly adhere to the recommended total daily dosage; the hourly infusion rate should not exceed 0.75 mL/kg/hour [see Dosage and Administration (2.4)].
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 risk due to poor lipid clearance should be considered when administering intravenous lipid emulsions.
Carefully monitor the infant’s ability to eliminate the infused lipids from the circulation (e.g., measure serum triglycerides and/or plasma free fatty acid levels). If signs of poor clearance of lipids from the circulation occur, stop the infusion and initiate a medical evaluation [see Warnings and Precautions (5.5, 5.7) and Overdosage (10)].
Parenteral nutrition-associated liver disease (PNALD), also referred to as intestinal failure-associated liver disease (IFALD), can present as cholestasis or hepatic steatosis, and may progress to steatohepatitis with fibrosis and cirrhosis (possibly leading to chronic hepatic failure). The etiology of PNALD is multifactorial; however, intravenously administered phytosterols (plant sterols) contained in plant-derived lipid emulsions, including CLINOLIPID, have been associated with development of PNALD.
Monitor liver tests in patients treated with CLINOLIPID and consider discontinuation or dosage reduction if abnormalities occur.
Hepatobiliary disorders including cholecystitis and cholelithiasis have developed in some PN-treated patients without preexisting liver disease.
Monitor liver tests when administering CLINOLIPID. Patients developing signs of hepatobiliary disorders should be assessed early to determine whether these conditions are related to CLINOLIPID use.
CLINOLIPID contains soybean oil and egg phospholipids, which may cause hypersensitivity reactions. Cross reactions have been observed between soybean and peanut. In postmarketing experience, anaphylaxis has been reported following CLINOLIPID administration [see Adverse Reactions (6.2)].
CLINOLIPID is contraindicated in patients with known hypersensitivity to egg, soybean, peanut, or any of the active or inactive ingredients in CLINOLIPID [see Contraindications (4)]. If a hypersensitivity reaction occurs, stop infusion of CLINOLIPID immediately and initiate appropriate treatment and supportive measures.
Lipid emulsions, such as CLINOLIPID, can support microbial growth and are an independent risk factor for the development of catheter-related bloodstream infections. To decrease the risk of infectious complications, ensure aseptic techniques are used for catheter placement, catheter maintenance, and preparation and administration of CLINOLIPID.
Monitor for signs and symptoms of infection including fever and chills, as well as laboratory test results that might indicate infection (including leukocytosis and hyperglycemia). Perform frequent checks of the intravenous catheter insertion site for edema, redness, and discharge.
Fat overload syndrome is a rare condition that has been reported with intravenous lipid formulations and is characterized by a sudden deterioration in the patient's condition (e.g., fever, anemia, leukopenia, thrombocytopenia, coagulation disorders, hyperlipidemia, hepatomegaly, deteriorating liver function, and central nervous system manifestations such as coma). A reduced or limited ability to metabolize lipids, accompanied by prolonged plasma clearance (resulting in higher lipid levels), may result in this syndrome. Although fat overload syndrome has been most frequently observed when the recommended lipid dose or infusion rate was exceeded, cases have also been described when the lipid formulation was administered according to instructions.
If signs or symptoms of fat overload syndrome occur, stop CLINOLIPID. The syndrome is usually reversible when the infusion of the lipid emulsion is stopped.
Administering PN to severely undernourished patients may result in the refeeding syndrome, which is characterized by intracellular shift of potassium, phosphorus, and magnesium as the patients become anabolic. Thiamine deficiency and fluid retention may also develop. To prevent these complications, closely monitor severely malnourished patients and slowly increase their nutrient intake.
The use of CLINOLIPID is contraindicated in patients with hypertriglyceridemia with serum triglyceride concentrations >1,000 mg/dL.
Patients with conditions such as inherited lipid disorders, obesity, diabetes mellitus, or metabolic syndromes have a higher risk of developing hypertriglyceridemia with the use of CLINOLIPID. In addition, patients with hypertriglyceridemia may have worsening of their hypertriglyceridemia with administration of CLINOLIPID. Excessive dextrose administration may further increase such risk.
Evaluate patients’ capacity to metabolize and eliminate the infused lipid emulsion by measuring serum triglycerides before the start of infusion (baseline value) and regularly throughout treatment. If triglyceride levels are above 400 mg/dL in adults, stop the CLINOLIPID infusion and monitor serum triglyceride levels to avoid clinical consequences of hypertriglyceridemia such as pancreatitis.
To minimize the risk of new or worsening of hypertriglyceridemia, assess high-risk patients for their overall energy intake including other sources of lipids and dextrose, as well as concomitant drugs that may affect lipid and dextrose metabolism.
CLINOLIPID contains no more than 25 mcg/L of aluminum.
The aluminum contained in CLINOLIPID may reach toxic levels with prolonged administration in patients with impaired kidney function. Preterm infants are at greater risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions that contain aluminum. Patients with impaired kidney function, including preterm infants, 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 of total parenteral nutrition products.
In pediatric trials, EFAD was defined by calculating the Holman index (the triene [Mead acid] to tetraene [arachidonic acid] ratio; T:T ratio > 0.4). One patient treated with CLINOLIPID became at risk for EFAD (T:T ratio >0.2) after 14 days of treatment. No cases of biochemical EFAD and no cases of clinical EFAD were observed; however, the median treatment duration in three of the four pediatric trials was 15 days or less. There are insufficient data to determine whether CLINOLIPID can supply adequate amounts of essential fatty acids in patients who may need treatment for more than 15 days.
Monitor patients for laboratory evidence (e.g., abnormal fatty acid levels) and clinical symptoms of EFAD (e.g., skin manifestations, poor growth). Laboratory testing using the triene to tetraene ratio may not be adequate to diagnose EFAD, and assessment of individual fatty acid levels may be needed. Ensure patients are receiving recommended dosages of CLINOLIPID to prevent EFAD [see Dosage and Administration (2.4) and Description (11)].
Monitor fluid status closely in patients with pulmonary edema or heart failure.
Throughout treatment, monitor serum triglycerides [see Warnings and Precautions (5.7)], fluid and electrolyte status, serum osmolarity, blood glucose, liver and kidney function, blood count (including platelets), and coagulation parameters.
The lipids contained in CLINOLIPID may interfere with the results of some laboratory tests (e.g., hemoglobin, lactate dehydrogenase, bilirubin, oxygen saturation) if the blood is sampled before the lipids have cleared from the bloodstream. Conduct these tests at least 6 hours after stopping the infusion.
CLINOLIPID 20% contains Vitamin K that may counteract anticoagulant activity [see Drug Interactions (7)].
Studies with CLINOLIPID have not been performed to evaluate the carcinogenic potential, mutagenic potential, or effects on fertility.
CLINOLIPID was evaluated in toxicity studies conducted in rats and dogs for up to 3 months. The principal signs of toxicity noted in the 3-month studies were:
At doses of 3 g/kg/day, slight lipid and pigmentary overload of the liver and vacuolization of Kupffer cells were observed in rats and dogs. At a dose of 12 g/kg/day in rats, hepatocellular vacuolation, granulomatous inflammation of the liver, hepatocellular necrosis and hemosiderosis of the liver and lipid deposits and splenic hemosiderosis, were observed. In dogs, at a dose of 6 g/kg/day, brownish-yellow pigmentation in the Kupffer cells of liver and spleen, hyperplasia of vacuolated Kupffer cells, hepatocyte vacuolization, a slight increase in the number of lipid storage cells (Ito cells) in the liver and macrophage vacuolization of the spleen were observed.
In the event of overdose, serious adverse reactions may result [see Warnings and Precautions (5.1, 5.5)]. 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.
The use of CLINOLIPID is contraindicated in patients with the following:
CLINOLIPID 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.
Infused essential fatty acids are synthesized into higher derivative fatty acids. Olive oil contains significant amounts of alpha-tocopherol that contributes to Vitamin E status.
The fatty acids, phospholipids, and glycerol found in lipid emulsions are metabolized by cells to carbon dioxide and water. The metabolism of these substances results in the generation of energy in the form of adenosine triphosphate (ATP). Some fatty acids are stored in the body in fat tissue, cell membranes, or as intracellular triglycerides. There is constant turn-over of these tissues, with the result that the lipid components are eventually metabolized to carbon dioxide and water. Carbon dioxide is expired through the lungs. Water is excreted through the kidneys or lost through evaporation/expiration through the skin, lungs, and other tissue surfaces. Some lipids (i.e., phospholipids, cholesterol, and bile acids) are excreted through the biliary system.
When initiating CLINOLIPID administration, discuss the following information with the patient or caregiver:
Inform patients and caregivers that use of parenteral nutrition may result in parenteral nutrition-associated liver disease and/or other hepatobiliary disorders [see Warnings and Precautions (5.2)].
Inform patients and caregivers that CLINOLIPID may cause hypersensitivity reactions, including anaphylaxis. If CLINOLIPID is infused at home, instruct patients or caregivers to stop the infusion of CLINOLIPID immediately and seek medical attention if they experience signs or symptoms of a hypersensitivity reaction, such as rapid or weak heartbeat, feeling faint, difficulty in breathing or swallowing, vomiting, nausea, headache, sweating, dizziness, hives, rash, itching, flushing dizziness, fever, or chills [see Warnings and Precautions (5.3)].
Inform patients and caregivers that patients who receive CLINOLIPID are at risk of infection. If CLINOLIPID is infused at home, instruct patients or caregivers to ensure aseptic techniques are used for the preparation and administration of CLINOLIPID and to monitor for signs and symptoms of infection [see Warnings and Precautions (5.4)].
Inform patients and caregivers that fat overload syndrome has been reported with the use of intravenous lipid emulsions. If CLINOLIPID is infused at home, instruct patients or caregivers to stop CLINOLIPID if signs or symptoms of fat overload syndrome occur [see Warnings and Precautions (5.5)].
If the patient is severely malnourished, inform patients and caregivers that administering parenteral nutrition including CLINOLIPID may result in refeeding syndrome [see Warnings and Precautions (5.6)].
Inform patients and caregivers about the risks of hypertriglyceridemia with CLINOLIPID use [seeWarnings and Precautions (5.7)].
Inform patients and caregivers that prolonged PN administration in patients with renal impairment, including preterm neonates, may result in aluminum reaching toxic levels associated with central nervous system and bone toxicity [see Warnings and Precautions (5.8)].
If it is acceptable for a patient or caregiver to administer CLINOLIPID at home, then provide recommendations on how to prepare, add compatible additives (when appropriate), administer, and store CLINOLIPID [see Dosage and Administration (2.1, 2.2)].
