Nephramine
Loading...Nephramine Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
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.
This product contains sodium bisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
Safe and effective use of central venous nutrition requires a knowledge of nutrition as well as clinical expertise in recognition and treatment of the complications which can occur. Frequent clinical evaluation and laboratory determinations are necessary for proper monitoring of central venous nutrition. Laboratory tests should include measurement of blood sugar, electrolyte, and serum protein concentrations; kidney and liver function tests; and evaluation of acid-base balance and fluid balance. Other laboratory tests may be suggested by the patient's condition.
NephrAmine® does not replace dialysis and conventional supportive therapy in patients with renal failure.
Administration of NephrAmine® to pediatric patients, especially in high dose ranges, may result in hyperammonemia. Administration of NephrAmine® to infants, particularly neonates and low birth weight infants, may result in elevated plasma amino acid levels (e.g., hypermethionemia) and hyperammonemia. In these very young age groups, amino acid formulations developed specifically for nutritional support of infants and pediatric patients, should be considered.
Clinically significant hypokalemia, hypophosphatemia, or hypomagnesemia may occur as a result of therapy with NephrAmine® and hypertonic dextrose and replacement therapy may become necessary.
Administration of nitrogen in any form to patients with marked hepatic insufficiency or hepatic coma may result in plasma amino acid imbalances, hyperammonemia, or central nervous system deterioration. NephrAmine® should, therefore, be used with caution in such patients.
The intravenous administration of these solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the solute concentration of the solution infused. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the concentration of the solution.
Conservative doses of amino acids should be given, dictated by the nutritional status of the patient.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
5.4% NephrAmine® (Essential Amino Acid Injection) is indicated for adult and pediatric use, in conjunction with other measures, to provide nutritional support for uremic patients, particularly when oral nutrition is infeasible or impractical. See WARNINGS, PRECAUTIONS, Pediatric Use, Special Precautions in Pediatric Patients, and DOSAGE AND ADMINISTRATION.
History
There is currently no drug history available for this drug.
Other Information
5.4% NephrAmine® (Essential Amino Acid Injection) is a sterile, nonpyrogenic solution containing crystalline essential amino acids plus histidine. Each 250 mL unit provides Rose's recommended daily intake of essential amino acids1 plus 625 mg of histidine, considered essential for uremics. The total nitrogen content of a 250 mL unit is approximately 1.6 grams (10 g of protein equivalent) in 14 grams of amino acids. All amino acids designated USP are the "L" isomer.
Each 100 mL contains:
Histidine USP2..............................................0.25 g
Isoleucine USP..............................................0.56 g
Leucine USP.................................................0.88 g
Lysine...........................................................0.64 g
(added as Lysine Acetate USP....................0.90 g)
Methionine USP............................................0.88 g
Phenylalanine USP.........................................0.88 g
Threonine USP..............................................0.40 g
Tryptophan USP...........................................0.20 g
Valine USP....................................................0.64 g
Cysteine....................................................<0.014 g
(as Cysteine HCl•H2O USP....................<0.020 g)
Sodium Bisulfite (as an antioxidant)..............<0.05 g
Water for Injection USP......................................qs
pH adjusted with Sodium Hydroxide NF as required.
pH: 6.5 (6.0–7.0); Calculated Osmolarity: 435 mOsmol/liter
Total Nitrogen: Approx. 0.65 g/100 mL
Concentration of Electrolytes (mEq/liter): Sodium 5
Chloride <3; Acetate Approx. 44
- 1
- Rose WC: The sequence of events leading to the establishment of the amino acid needs of man. Am J Public Health; 1968: 58 (11):2020–2027.
- 2
- Histidine is considered an essential amino acid in uremic patients.
Sources
Nephramine Manufacturers
-
B. Braun Medical Inc.
![Nephramine (Histidine, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Cysteine, And Sodium Bisulfite) Injection, Solution [B. Braun Medical Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Nephramine | B. Braun Medical Inc.
The objective of nutritional management of renal decompensation is the provision of sufficient amino acid and caloric support for protein synthesis without greatly exceeding the renal capacity to excrete metabolic wastes.
Three grams of nitrogen per day provided as essential amino acids with adequate calories produce nitrogen equilibrium in many stable patients with chronic uremia. Although nitrogen requirements may be higher in stressed or acutely uremic patients, or those on dialysis, provision of additional nitrogen may not be possible due to fluid intake limits or glucose intolerance.
The usual methods of determining individual patient requirements for amino acids such as nitrogen balance or daily body weight are difficult to perform or interpret in the uremic patient. Therefore, dosage is guided by the patient's fluid intake limits and glucose and nitrogen tolerances, as well as metabolic and clinical response. Rate of rise of blood urea nitrogen generally diminishes with infusion of essential amino acids. However, excessive intake of dietary protein or increased protein catabolism may alter this response.
Adult UseGenerally, 250 to 500 mL of 5.4% NephrAmine® (Essential Amino Acid Injection), containing approximately 1.6 to 3.2 grams of nitrogen (in 13.4 to 26.8 grams of essential amino acids), are given daily. Adequate calories should be provided simultaneously. Each 250 mL of NephrAmine® is typically mixed aseptically with 500 mL of 70% dextrose to yield a solution of 1.8% NephrAmine® in 47% dextrose. This mixture provides a calorie-to-nitrogen ratio of 744:1.
Solution administrated by peripheral vein should not exceed twice normal serum osmolarity (718 mOsmol/L).
Pediatric UseInitial total daily dose should be low and increased slowly. As the dose is increased, frequent laboratory and clinical monitoring is strongly recommended, especially in very young patients, to avoid clinically significant elevations of serum ammonia and plasma amino acid levels. Dosage of NephrAmine® above one gram of essential amino acids per kg of body weight per day is not recommended. In pediatric patients, the final solution should not exceed twice normal serum osmolarity (718 mOsmol/L).
Use of 5.4% NephrAmine® in pediatric patients is governed by the same considerations that affect the use of any amino acid solution in pediatrics. The amount administered is dosed on the basis of grams of amino acids/kg of body weight/day.
See INDICATIONS AND USAGE, WARNINGS, PRECAUTIONS, Pediatric Use, and Special Precautions in Pediatric Patients.
Fat emulsion coadministration should be considered when prolonged (more than 5 days) parenteral nutrition is required in order to prevent essential fatty acid deficiency (E.F.A.D.). Serum lipids should be monitored for evidence of E.F.A.D. in patients maintained on fat free TPN.
Electrolyte supplementation may be required. Undiluted NephrAmine® (Essential Amino Acid Injection) contains 5 mEq/liter of sodium. Elevated serum potassium, phosphorus, and magnesium levels generally decrease during treatment with NephrAmine®. Although these effects are beneficial, especially in acute renal failure, in some instances the reduction may be so great that supplementation of these electrolytes is required, especially in the presence of cardiac arrhythmias or digitalis toxicity. During periods of anuria or oliguria, electrolyte supplementation should be done with caution, even if serum levels are in the low normal range.
Compatibility of electrolyte additives to the 5.4% NephrAmine®/hypertonic dextrose mixture must be considered, and potentially incompatible ions such as calcium and phosphate may be added to alternate infusion bottles to avoid precipitation. In patients with hyperchloremic or other metabolic acidosis, sodium and potassium may be added as acetate or lactate salts to provide bicarbonate precursor. The electrolyte content of NephrAmine® must be considered when calculating daily electrolyte intake. Serum electrolytes, including magnesium and phosphorus, should be monitored frequently.
If a patient's nutritional intake is primarily parenteral, vitamins, especially the water soluble vitamins, should also be provided.
Hypertonic mixtures of essential amino acids and dextrose may be safely administered by continuous infusion through a central venous catheter with the tip located in the superior vena cava. Initial infusion rates should be slow, generally 20–30 mL/hour. Increases by increments of 10 mL/hour each 24 hours are recommended to a maximum of 60–100 mL/hour. If administration rate should fall behind schedule, no attempt to "catch up" to planned intake should be made.
Administration rate is governed by the patient's nitrogen, fluid, and glucose tolerance. Uremic patients are frequently glucose intolerant, especially in association with peritoneal dialysis, and may require the administration of exogenous insulin to prevent hyperglycemia. Blood glucose levels must be determined frequently. To prevent rebound hypoglycemia, a solution containing 5% dextrose should be administered when hypertonic dextrose infusions are abruptly discontinued.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Care must be taken to avoid incompatible admixtures. Consult with pharmacist.
Login To Your Free Account