CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients. CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.
CLINIMIX E may be used to treat negative nitrogen balance in patients. ( 1 )
Contraindications
The use of CLINIMIX E is contraindicated in: 1. Neonates (28 days of age or younger) receiving concomitant treatment with ceftriaxone, even if separate infusion lines are used, due to the risk of fatal ceftriaxone calcium salt precipitation in the neonate’s bloodstream [see Warnings and Precautions (5.2) , Use in Specific Populations (8.4) ] . 2. Patients with known hypersensitivity to one or more amino acids or dextrose [see Warnings and Precautions (5.3) ] . 3.
Patients with inborn errors of amino acid metabolism due to risk of severe metabolic and neurologic complications. 4. Patients with pulmonary edema or acidosis due to low cardiac output.
Concomitant treatment with ceftriaxone in neonates (28 days of age or younger). ( 4 )
Known hypersensitivity to one or more amino acids or dextrose. ( 4 )
Inborn errors of amino acid metabolism. ( 4 )
Patients with pulmonary edema or acidosis due to low cardiac output. ( 4 )
Warnings and precautions
Pulmonary Embolism due to Pulmonary Vascular Precipitates: if signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation. ( 5.1 )
Precipitation with Ceftriaxone: do not administer ceftriaxone simultaneously with CLINIMIX E via a Y-site. ( 4 , 5.2 , 8.4 )
Hypersensitivity Reactions: monitor for signs and symptoms and discontinue infusion if reactions occur. ( 5.3 )
Two medicines in one question?
Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.
Risk of Infections, Refeeding Complications, and Hyperglycemia or Hyperosmolar Hyperglycemic State: monitor for signs and symptoms; monitor laboratory parameters. ( 5.4 , 5.5 , 5.6 )
Vein Damage and Thrombosis: solutions with osmolarity of ≥ 900 mOsm/L must be infused through a central catheter. ( 2.2 , 5.7 )
Hepatobiliary Disorders: monitor liver function parameters and ammonia levels. ( 5.8 )
Aluminum Toxicity: increased risk in patients with impaired kidney function, including preterm infants. ( 5.9 , 8.4 )
Parenteral Nutrition Associated Liver Disease: increased risk in patients who receive parenteral nutrition for extended periods of time, especially preterm infants; monitor liver function tests, if abnormalities occur consider discontinuation or dosage reduction. ( 5.10 , 8.4 )
Electrolyte Imbalance and Fluid Overload: patients with cardiac insufficiency or kidney disease may require adjustment of fluid, protein and electrolyte content. ( 5.11 , 8.4 )
5.1Pulmonary
Embolism due to Pulmonary Vascular Precipitates Pulmonary vascular precipitates causing pulmonary vascular emboli and pulmonary distress have been reported in patients receiving parenteral nutrition. In some cases, fatal outcomes due to pulmonary embolism have occurred. Patients, especially those with hypophosphatemia, may require the addition of phosphate. To prevent hypocalcemia, calcium supplementation should always accompany phosphate administration.
Excessive addition of calcium and phosphate increases the risk of the formation of calcium phosphate precipitates. Precipitates have been reported even in the absence of phosphate salt in the solution. Precipitation following passage through an in-line filter and suspected in vivo precipitate formation has also been reported. If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation. In addition to inspection of the solution [see Dosage and Administration (2.1 , 2.2 , 2.3 , 2.4 )] , the infusion set and catheter should also periodically be checked for precipitates.
5.2Precipitation with Ceftriaxone Precipitation
of ceftriaxone-calcium can occur when ceftriaxone is mixed with calcium-containing parenteral nutrition solutions, such as CLINIMIX E, in the same intravenous administration line. Do not administer ceftriaxone simultaneously with CLINIMIX E via a Y-site. Deaths have occurred in neonates (less than 28 days of age) who received concomitant intravenous calcium-containing solutions with ceftriaxone resulting from calcium-ceftriaxone precipitates in the lungs and kidneys, even when separate infusion lines were used.
CLINIMIX E is contraindicated in neonates receiving ceftriaxone [see Contraindications (4) , Use in Specific Populations (8.4) ]. In patients older than 28 days (including adults), ceftriaxone and CLINIMIX E may be administered sequentially if the infusion lines are thoroughly flushed between infusions with a compatible fluid .
5.3Hypersensitivity Reactions
Hypersensitivity/infusion reactions including anaphylaxis have been reported with CLINIMIX E. Stop infusion immediately and treat patient accordingly if any signs or symptoms of a hypersensitivity reaction develop. Signs or symptoms may include: hypotension, hypertension, peripheral cyanosis, tachycardia, dyspnea, vomiting, nausea, urticaria, rash, pruritus, erythema, hyperhidrosis, pyrexia, and chills.
5.4Risk of Infections
Patients who require parenteral nutrition are at high risk of infections because the nutritional components of these solutions can support microbial growth. Infection and sepsis may also occur as a result of the use of intravenous catheters to administer parenteral nutrition. The risk of infection is increased in patients with malnutrition-associated immunosuppression, hyperglycemia exacerbated by dextrose infusion, long-term use and poor maintenance of intravenous catheters, or immunosuppressive effects of other concomitant conditions, drugs, or other components of the parenteral formulation (e.g., lipid emulsion).
To decrease the risk of infection, ensure aseptic technique in catheter placement and maintenance, as well as aseptic technique in the preparation and administration of the nutritional formula. Monitor for signs and symptoms (including fever and chills) of early infections, including laboratory test results (including leukocytosis and hyperglycemia) and frequent checks of the parenteral access device and insertion site for edema, redness and discharge.
5.5Refeeding Syndrome
Refeeding severely undernourished patients may result in refeeding syndrome, characterized by the intracellular shift of potassium, phosphorus, and magnesium as the patient becomes anabolic. Thiamine deficiency and fluid retention may also develop. To prevent these complications, monitor severely undernourished patients and slowly increase nutrient intakes.
5.6Hyperglycemia or Hyperosmolar Hyperglycemic State
When using CLINIMIX E in patients with diabetes mellitus, impaired glucose tolerance may worsen hyperglycemia. Administration of dextrose at a rate exceeding the patient’s utilization rate may lead to hyperglycemia, coma, and death. Patients with dehydration, resulting in a transient reduction in glomerular filtration rate and pre-renal azotemia, may be at greater risk of developing hyperosmolar hyperglycemic state. Monitor blood glucose levels and treat hyperglycemia to maintain optimum levels while administering CLINIMIX E.
Insulin may be administered or adjusted to maintain optimal blood glucose levels during CLINIMIX E administration.
5.7Vein Damage and Thrombosis Solutions
with osmolarity of 900 mOsm/L or greater must be infused through a central catheter. CLINIMIX E solutions containing more than 5% dextrose have an osmolarity greater than or equal to 900 mOsm/L. CLINIMIX E 4.25/10, 5/15, 5/20, 8/10 and 8/14 are indicated for administration into a central vein only, such as the superior vena cava [see Dosage and Administration (2.2) ] . The infusion of hypertonic nutrient injections into a peripheral vein may result in vein irritation, vein damage, and/or thrombosis.
CLINIMIX E 2.75/5 and 4.25/5 are indicated for peripheral administration, or may be infused into a central vein [see Dosage and Administration (2.2) ] . The primary complication of peripheral access is venous thrombophlebitis, which manifests as pain, erythema, tenderness or a palpable cord. Remove the catheter as soon as possible, if thrombophlebitis develops.
5.8Hepatobiliary Disorders
Hepatobiliary disorders are known to develop in some patients without preexisting liver disease who receive parenteral nutrition, including cholecystitis, cholelithiasis, cholestasis, hepatic steatosis, fibrosis and cirrhosis, possibly leading to hepatic failure. The etiology of these disorders is thought to be multifactorial and may differ between patients. Increase in blood ammonia levels and hyperammonemia may occur in patients receiving amino acid solutions.
In some patients this may indicate hepatic insufficiency or the presence of an inborn error of amino acid metabolism [see Contraindications (4) ] . Monitor liver function parameters and ammonia levels. Patients developing signs of hepatobiliary disorders should be assessed early by a clinician knowledgeable in liver diseases in order to identify possible causative and contributory factors, and possible therapeutic and prophylactic interventions.
5.9Aluminum Toxicity
CLINIMIX E contains no more than 25 mcg/L of aluminum. The aluminum contained in CLINIMIX E may reach toxic leve
Our copy of this section ends here. The full text is in the official label at the FDA. Open Drugs@FDA
Interactions
7.1 Drugs that Can Cause Hyperkalemia Because of its potassium content, CLINIMIX E should be administered with caution in patients treated with agents or products that can cause hyperkalemia or increase the risk of hyperkalemia, such as potassium sparing diuretics (amiloride, spironolactone, triamterene), with ACE inhibitors, angiotensin II receptor antagonists, or the immunosuppressants tacrolimus and cyclosporine.
Pregnancy and breastfeeding
8.1Pregnancy Risk Summary
There are no adequate or well-controlled studies in pregnant women with CLINIMIX E. Additionally, animal reproduction studies have not been conducted with amino acids and electrolytes and dextrose. It is not known whether CLINIMIX E can cause fetal harm when administered to a pregnant woman. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. However, the estimated background risk in the U.S. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies.
Clinical Considerations Disease-Associated Maternal and/or Embryo-Fetal Risk Based on clinical practice guidelines, parenteral nutrition should be considered in cases of severe maternal malnutrition where nutritional requirements cannot be fulfilled by the enteral route because of the risks to the fetus associated with severe malnutrition, such as preterm delivery, low birth weight, intrauterine growth restriction, congenital malformations and perinatal mortality.
Adverse reactions
The following serious adverse reactions are discussed in greater detail in other sections of the prescribing information.
Pulmonary embolism due to pulmonary vascular precipitates [see Warnings and Precautions (5.1) ]
Death in neonates due to calcium-ceftriaxone precipitates [see Warnings and Precautions (5.2) ]
Hypersensitivity reactions [see Warnings and Precautions (5.3) ]
Risk of Infections [see Warnings and Precautions (5.4) ]
Refeeding syndrome [see Warnings and Precautions (5.5) ]
Hyperglycemia or hyperosmolar hyperglycemic state [see Warnings and Precautions (5.6) ]
Vein damage and thrombosis [see Warnings and Precautions (5.7) ]
Hepatobiliary disorders [see Warnings and Precautions (5.8) ]
Electrolyte imbalance and fluid overload [see Warnings and Precautions (5.11) ] The following adverse reactions from voluntary reports or clinical studies have been reported with CLINIMIX E. Because many of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Diuresis
Extravasation
Glycosuria
Hyperglycemia
Hyperosmolar coma Adverse reactions include diuresis, extravasation, glycosuria, hyperglycemia, and hyperosmolar coma. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
Brand name
Clinimix E 5/35 Sulfite Free W/ Elect in Dextrose 35% W/ Calcium in Plastic Container
