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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.
DOSAGE AND ADMINISTRATION
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.
Generally, 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 (essential amino acid injection) is typically mixed aseptically with 500 mL of 70% dextrose to yield a solution of 1.8% NephrAmine (essential amino acid injection) 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).
Initial 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 (essential amino acid injection) 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.
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 (essential amino acid injection) . 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 (essential amino acid injection) /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 (essential amino acid injection) 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.
5.4% NephrAmine (Essential Amino Acid Injection) is supplied sterile and nonpyrogenic in glass containers with solid stoppers packaged 12 per case.
|5.4% NEPHRAMINE (ESSENTIAL AMINO ACID INJECTION) (Canada DIN 02029464)
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.
PROTECT FROM LIGHT UNTIL USE.
B. BRAUN MEDICAL INC. IRVINE CA USA 92614-5895. In Canada, distributed by: B. Braun Medical Inc. Scarborough, Ontario M1H 2W4. Revised: November 2005. FDA Rev date: 5/4/2006This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 1/28/2009
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