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Nephramine

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Nephramine

WARNINGS

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 g/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 (essential amino acid injection) does not replace dialysis and conventional supportive therapy in patients with renal failure.

Administration of NephrAmine (essential amino acid injection) to pediatric patients, especially in high dose ranges, may result in hyperammonemia. Administration of NephrAmine (essential amino acid injection) 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 (essential amino acid injection) 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 (essential amino acid injection) 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.

PRECAUTIONS

General

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. Significant deviations from normal concentrations may require the use of additional electrolyte supplements.

In order to promote urea nitrogen reutilization in patients with renal failure, it is essential to provide adequate calories with minimal amounts of the essential amino acids, and to severely restrict the intake of nonessential nitrogen. Hypertonic dextrose solutions are a convenient and metabolically effective source of concentrated calories.

Fluid balance must be carefully monitored in patients with renal failure and care should be taken to avoid circulatory overload, particularly in association with cardiac insufficiency.

In patients with myocardial infarct, infusion of amino acids should always be accompanied by dextrose, since in anoxia, free fatty acids cannot be utilized by the myocardium, and energy must be produced anaerobically from glycogen or glucose.

Strongly hypertonic nutrient solutions should be administered through an indwelling intravenous catheter with the tip located in the superior vena cava.

Special care must be taken when giving hypertonic dextrose to glucose-intolerant patients such as diabetic or prediabetic and uremic patients, especially when the latter are receiving peritoneal dialysis. To prevent severe hyperglycemia in such patients, insulin may be required.

Administration of glucose at a rate exceeding the patient's utilization may lead to hyperglycemia, coma, and death.

Administration of amino acids without carbohydrates may result in the accumulation of ketone bodies in the blood. Correction of this ketonemia may be achieved by the administration of carbohydrates. Abrupt cessation of hypertonic dextrose infusion may result in rebound hypoglycemia.

When 5.4% NephrAmine® (Essential Amino Acid Injection) is subjected to changes in temperature, there is a chance that some transient crystallization of amino acids may occur. Thorough shaking of the bottle for about one minute should redissolve the amino acids. If the amino acids do not completely redissolve, the bottle must be rejected.

To minimize the risk of possible incompatibilities arising from mixing this solution with other additives that may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration, and periodically during administration.

Use only if solution is clear and vacuum is present.

Drug product contains no more than 25 g/L of aluminum.

Laboratory Tests

Frequent clinical evaluation and laboratory determinations are necessary for proper monitoring during administration.

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.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No in vitro or in vivo carcinogenesis, mutagenesis, or fertility studies have been conducted with 5.4% NephrAmine® (Essential Amino Acid Injection).

Pregnancy

Teratogenic Effects - Pregnancy Category C.

Animal reproduction studies have not been conducted with 5.4% NephrAmine (Essential Amino Acid Injection). It is also not known whether NephrAmine (essential amino acid injection) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. NephrAmine (essential amino acid injection) should be given to a pregnant woman only if clearly needed.

Labor and Delivery

Information is unknown.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when NephrAmine (essential amino acid injection) is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of amino acid injections in pediatric patients have not been established by adequate and well-controlled studies. However, the use of amino acid injections in pediatric patients as an adjunct in the offsetting of nitrogen loss or in the treatment of negative nitrogen balance is well established in the medical literature. In pediatric patients, the final solution should not exceed twice normal serum osmolarity (718 mOsmol/L).

See INDICATIONS, WARNINGS, and DOSAGE AND ADMINISTRATION.

Geriatric Use

NephrAmine (essential amino acid injection) has not been studied in geriatric patients. Elderly patients are known to be more prone to fluid overload and electrolyte imbalance than younger patients. This may be related to impairment of renal function which is more frequent in an elderly population. As a result the need for careful monitoring of fluid and electrolyte therapy is greater in the elderly. All patients, including the elderly, require an individual dose of all parenteral nutrition products to be determined by the physician on an individual case-by-case basis, which will be based on body weight, clinical condition and the results of laboratory monitoring tests. There is no specific geriatric dose.

See WARNINGS.

Special Precautions for Central Venous Nutrition

Administration by central venous catheter should be used only by those familiar with this technique and its complications.

Central venous nutrition may be associated with complications which can be prevented or minimized by careful attention to all aspects of the procedure including solution preparation, administration, and patient monitoring. It is essential that a carefully prepared protocol, based on current medical practices, be followed, preferably by an experienced team.

Although a detailed discussion of the complications of central venous nutrition is beyond the scope of this insert, the following summary lists those based on current literature:

Technical

The placement of a central venous catheter should be regarded as a surgical procedure. One should be fully acquainted with various techniques of catheter insertion as well as recognition and treatment of complications. For details of techniques and placement sites, consult the medical literature. X-ray is the best means of verifying catheter placement. Complications known to occur from the placement of central venous catheters are pneumothorax, hemothorax, hydrothorax, artery puncture and transection, injury to the brachial plexus, malposition of the catheter, formation of arterio-venous fistula, phlebitis, thrombosis, and air and catheter embolus.

Septic

The constant risk of sepsis is present during central venous nutrition. Since contaminated solutions and infusion catheters are potential sources of infection, it is imperative that the preparation of parenteral nutrition solutions and the placement and care of catheters be accomplished under controlled aseptic conditions.

Parenteral nutrition solutions should ideally be prepared in the hospital pharmacy under a laminar flow hood. The key factor in their preparation is careful aseptic technique to avoid inadvertent touch contamination during mixing of solutions and subsequent admixtures.

Parenteral nutrition solutions should be used promptly after mixing. Any storage should be under refrigeration for as brief a time as possible. Administration time for a single bottle and set should never exceed 24 hours.

Consult the medical literature for a discussion of the management of sepsis during central venous nutrition. In brief, typical management includes replacing the solution being administered with a fresh container and set, and the remaining contents are cultured for bacterial or fungal contamination. If sepsis persists and another source of infection is not identified, the catheter is removed, the proximal tip cultured, and a new catheter reinserted when the fever has subsided. Nonspecific, prophylactic antibiotic treatment is not recommended. Clinical experience indicates that the catheter is likely to be the prime source of infection as opposed to aseptically prepared and properly stored solutions.

Metabolic

The following metabolic complications have been reported: metabolic acidosis, hypophosphatemia, alkalosis, hyperglycemia and glycosuria, osmotic diuresis and dehydration, rebound hypoglycemia, elevated liver enzymes, hypo- and hypervitaminosis, electrolyte imbalances, and elevated plasma amino acid levels and hyperammonemia in infants and pediatric patients. Frequent clinical evaluation and laboratory determinations are necessary, especially during the first few days of central venous nutrition, to prevent or minimize these complications.

Special Precautions in Patients with Renal Insufficiency

Frequent laboratory studies are necessary in patients with renal insufficiency due to underlying metabolic abnormalities. Hyperglycemia, a frequent complication, may not be reflected by glycosuria in renal failure. Blood glucose, therefore, must be determined frequently, often every six hours to guide dosage of dextrose and insulin if required.

Serum concentrations of potassium, phosphorus, and magnesium may dramatically decline with successful treatment, individually or together; these substances should be supplemented as required. Special care must be taken to avoid hypokalemia in digitalized patients, or those with cardiac arrhythmias.

Special Precautions in Pediatric Patients

5.4% NephrAmine® (Essential Amino Acid Injection) should be used with special caution in pediatric patients, due to limited clinical experience.

Laboratory and clinical monitoring of pediatric patients, especially when nutritionally depleted, must be extensive and frequent. Initial total daily dose should be low, and increased slowly. Dosage of NephrAmine above one gram of essential amino acids per kilogram body weight per day is not recommended.

For infants, especially neonates and low birth weight infants, amino acid formulations developed specifically for nutritional support of infants and pediatric patients should be considered. If NephrAmine (essential amino acid injection) is administered to these very young patients, extra caution in frequent monitoring of plasma amino acid levels and serum ammonia is strongly recommended.

Frequent monitoring of blood glucose is required in neonates, low birth-weight, or septic infants as infusion of hypertonic dextrose carries a greater risk of hyperglycemia in such patients.

The absence of arginine in NephrAmine (essential amino acid injection) may accentuate the risk of hyperammonemia in infants.

In pediatric patients, the final solution should not exceed twice normal serum osmolarity (718 mOsmol/L).

Last reviewed on RxList: 1/28/2009
This monograph has been modified to include the generic and brand name in many instances.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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