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Aminosyn RF 5.2

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Aminosyn RF 5.2% Sulfite Free

INDICATIONS

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.

DOSAGE AND ADMINISTRATION

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.

HOW SUPPLIED

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.

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