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:

Electrolytes and Product Characteristics

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:

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.

Intravenous infusion of amino acids may induce a rise in blood urea nitrogen (BUN), especially in patients with impaired hepatic or renal function. Appropriate laboratory tests should be performed periodically and infusion discontinued or nitrogen content reduced if BUN levels continue to rise inappropriately.

Administration of nitrogen in any form to patients with marked hepatic insufficiency may result in serum amino acid imbalances or CNS complications. Aminosyn-RF 5.2%, Sulfite-Free, (an amino acid injection — renal formula), therefore, should be used with caution in such patients.

Solutions containing acetate ion should be used with great care in patients with metabolic or respiratory alkalosis.

Hyperammonemia is of special significance in infants, as it can result in mental retardation. Therefore, it is essential that blood ammonia levels be measured frequently in infants.

Aminosyn-RF 5.2% does not replace dialysis and conventional supportive therapy in patients with renal failure.

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.

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

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 entire FDA prescribing information for Aminosyn RF 5.2 (Amino Acid Injection 5.2% Renal Formula)