Drug: Aminosyn RF 5.2% Sulfite Free

Aminosyn®-RF 5.2%, Sulfite-Free, (an amino acid injection — renal formula) is a sterile, nonpyrogenic solution for intravenous infusion. Aminosyn-RF 5.2% is oxygen sensitive. The solution contains the following crystalline amino acids:   mg/100 mL Min. Daily
Need (mg**) Essential Amino Acids   Isoleucine 462 700   Leucine 726 1100   Lysine Acetate* 535 800   Methionine 726 1100   Phenylalanine 726 1100   Threonine 330 500   Tryptophan 165 250   Valine 528 800 Nonessential Amino Acids   Arginine 600 __   Histidine*** 429 __ * Amount cited is for Lysine alone and does not include the acetate salt.
** The minimum daily quantities needed to maintain nitrogen balance in the healthy adult. (Rose, W.C., The Sequence of Events Leading to the Establishment of the Amino Acid Needs of Man, Am J. Public Health, 58:2020, 1968.)
*** Histidine is considered essential for patients in renal failure. Electrolytes and Product Characteristics
Acetate (C2H3O2_)a (mEq/Liter) 113 Protein Equivalent (approx. grams/liter) 52.27 Total Nitrogen (grams/liter) 7.93 Osmolarity (mOsmol/liter) 427 pH (Range) 5.2 (4.5 to 6.0b) a Includes acetate from acetic acid used in processing and from Lysine acetate.
b Adjusted with acetic acid. Each 500 mL represents three Rose Units of essential amino acids plus arginine and histidine. The formulas for the individual amino acids present in Aminosyn-RF 5.2% are as follows: Essential Amino Acids   Isoleucine, USP (C6H13NO2)   Leucine, USP (C6H13NO2)   Lysine Acetate, USP (C6H14N2O2•CH3COOH)   Methionine, USP (C5H11NO2S)   Phenylalanine, USP (C9H11NO2)   Threonine, USP (C4H9NO3)   Tryptophan, USP (C11H12N2O2)   Valine, USP (C5H11NO2) Nonessential Amino Acids   Arginine, USP (C6H14N4O2)   Histidine, USP (C6H9N3O2) The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Last reviewed on RxList: 1/13/2009
This monograph has been modified to include the generic and brand name in many instances.

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Adverse effects include metabolic, fluid, electrolyte and acid-base imbalances unless appropriate monitoring and corrective management are accomplished during Aminosyn-RF 5.2%, Sulfite-Free, (an amino acid injection — renal formula) therapy. Read the Aminosyn RF 5.2% Sulfite Free (amino acid injection 5.2% renal formula) Side Effects Center for a complete guide to possible side effectsLearn More »

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Dosage Fat emulsion coadministration should be considered when prolonged (more than 5 days) parenteral nutrition is required in order to prevent essential fatty acid deficiency (EFAD). Serum lipids should be monitored for evidence of EFAD in patients maintained on fat-free TPN. Adults: The objective of nutritional management of renal decompensation is to provide sufficient amino acid and caloric support for protein synthesis without exceeding the renal capacity to excrete metabolic wastes. A dosage of 2.4 to 4.7 grams of nitrogen per day (from essential amino acids) with adequate calories will maintain nitrogen equilibrium in patients with uremia. If more nitrogen and calories are required in severely stressed patients in acute renal failure who cannot eat, higher dosages may be administered provided great care is taken to avoid exceeding limits of fluid intake or glucose tolerance. In general, dosage should be guided by fluid, glucose and nitrogen tolerances, as well as the metabolic and clinical response. The rate of rise in BUN generally diminishes with infusion of essential amino acids. However, excessive intake of protein or increased protein catabolism may alter this response. The usual daily dose ranges from 300 to 600 mL of Aminosyn-RF 5.2%, Sulfite-Free, (an amino acid injection — renal formula) equivalent to 2.4 to 4.7 grams of nitrogen in 15.7 to 31 grams of essential amino acids. Adequate calories should be administered simultaneously. Each 500 mL of Aminosyn-RF 5.2% mixed under sterile conditions with 832 mL of Dextrose 70% will provide a solution of 1.95% of Aminosyn-RF 5.2% in 44% dextrose. This mixture provides a calorie-to-nitrogen ratio of 504:1. Electrolyte supplementation may be required. Elevated phosphorus, potassium and magnesium levels generally decrease during treatment with Aminosyn-RF 5.2%. Particular care should be taken in the presence of cardiac arrhythmias or digitalis toxicity to assure that sufficient quantities of these electrolytes are provided when necessary. Compatibility of electrolyte additives to the mixtures of Aminosyn-RF 5.2% and hypertonic dextrose must be considered and potentially incompatible ions (calcium, phosphate) may be added to alternate infusion bottles to avoid precipitation. Children: Pediatric requirements for Aminosyn-RF 5.2% vary greatly depending upon growth, nutritional state and degree of renal insufficiency. A dosage of 0.5 to 1 gram of essential amino acids per kilogram of body weight per day will meet the requirements of the majority of pediatric patients. Initial daily dosage of Aminosyn-RF 5.2% should be low and increased slowly; more than one gram of essential amino acids per kilogram of body weight per day is not recommended. The total volume of nutritional solution and the rate at which it is administered will vary with the child's age, nutritional and growth state, as well as the degree of renal failure. See Special Precautions in Pediatric Patients for additional information. Administration Aminosyn-RF 5.2% admixed with sufficient dextrose to provide caloric energy requirements may be safely administered via a central venous catheter with the tip located in the vena cava. Initial infusion rates should be slow, generally 20 to 30 mL/hour for the first 6 to 8 hours. Increments of 10 mL/hour for each hour are suggested up to a maximum rate of 60 to 100 mL/hour. If administration rates fall behind the scheduled 24 hour dosage, no attempt should be made to catch up to the planned intake. The patient's fluid, nitrogen and glucose tolerance should be the governing factor of the rate of administration. Uremic patients are frequently glucose intolerant especially in association with peritoneal dialysis; insulin may be required to prevent hyperglycemia. When hypertonic dextrose infusion is abruptly discontinued, rebound hypoglycemia may be prevented by administering 5% dextrose. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. WARNING: Do not use flexible container in series connections.

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No information provided. Last reviewed on RxList: 1/13/2009
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Aminosyn-RF 5.2%, Sulfite-Free, (an amino acid injection — renal formula) is indicated only as an adjunct to management of patients with potentially reversible acute renal failure who are unable to eat. When infused with hypertonic dextrose as a source of calories and with added appropriate electrolytes and vitamins, Aminosyn-RF 5.2% is suitable as an intravenous source of protein in a parenteral nutritional regimen for such patients.

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  1. Severe uncorrected electrolyte or acid-base imbalance.
  2. Hyperammonemia.
  3. Decreased circulating blood volume.
Last reviewed on RxList: 1/13/2009
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. See WARNINGS and PRECAUTIONS.

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Aminosyn-RF 5.2%, Sulfite-Free, (an amino acid injection — renal formula) is supplied in 500 mL single-dose containers (List No. 4166). Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Avoid exposure to light. Revised: November, 2004. Hospira, Inc., Lake Forest, IL 60045 USA. FDA Rev date: 6/18/2003 Last reviewed on RxList: 1/13/2009
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

CLINICAL EVALUATIONS AND LABORATORY DETERMINATIONS, AT THE DISCRETION OF THE ATTENDING PHYSICIAN, ARE NECESSARY FOR PROPER MONITORING DURING ADMINISTRATION. Blood studies should include glucose, urea nitrogen, serum electrolytes, acid-base balance, blood ammonia levels, serum proteins, kidney and liver function tests, serum osmolality and hemogram. Circulating blood volume should be determined if indicated. If sepsis is suspected, blood cultures should be taken. Clinically significant hypocalcemia, hypophosphatemia or hypomagnesemia may occur as a result of therapy with Aminosyn-RF 5.2%, Sulfite-Free, (an amino acid injection — renal formula) and hypertonic dextrose; electrolyte replacement may become necessary. 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 restrict the intake of nonessential nitrogen. Hypertonic dextrose solutions are a convenient and metabolically effective source of concentrated calories. Special care must be taken when giving hypertonic glucose to provide calories in diabetic or prediabetic patients. Hypertonic solutions should be administered through an indwelling catheter with the tip located in the superior vena cava. When abrupt cessation of hypertonic dextrose is required, monitoring for rebound hypoglycemia should be instituted. Essential fatty acid deficiency (EFAD) is becoming increasingly recognized in patients on long term TPN (more than 5 days). The use of fat emulsion to provide 4–10% of total caloric intake as linoleic acid may prevent EFAD. Fluid balance should be carefully monitored in patients with renal failure to avoid excessive fluid overload, especially in relation to cardiac insufficiency. SPECIAL PRECAUTIONS FOR CENTRAL INFUSIONS ADMINISTRATION BY CENTRAL VENOUS CATHETER SHOULD BE USED ONLY BY THOSE FAMILIAR WITH THIS TECHNIQUE AND ITS COMPLICATIONS.

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