Prosol

Prosol

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Questions & Answers

Side Effects & Adverse Reactions

This injection is for compounding only, not for direct infusion.

Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Because of the potential for life-threatening events, caution should be taken to ensure that precipitates have not formed in any parenteral nutrient admixture.

Caution should be exercised when admixing 20% PROSOL - sulfite-free (Amino Acid) Injection. This solution should be used promptly after admixing. Any storage should be under refrigeration and limited to a brief period of time, preferably less than 24 hours. Reference should be made to I.V. Fat Emulsion package insert and high concentration dextrose injection from Baxter Healthcare Corporation package insert for detailed information on each component.

Proper administration of this injection requires a knowledge of fluid and electrolyte balance and nutrition as well as clinical expertise in recognition and treatment of the complications which may occur.

Administration of amino acid solutions to a patient with hepatic insufficiency may result in serum amino acid imbalances, hyperammonemia, stupor and coma.

Hyperammonemia is of special significance in infants. This reaction appears to be related to a deficiency of the urea cycle amino acids of genetic or product origin. It is essential that blood ammonia be measured frequently in infants.

Conservative doses of this injection should be given to patients with known or suspected hepatic dysfunction. Should symptoms of hyperammonemia develop, administration should be discontinued and the patient's clinical status reevaluated.

Administration of amino acid solutions in the presence of impaired renal function presents special issues associated with retention of electrolytes.

This injection should not be administered simultaneously with blood through the same infusion set because of the possibility of pseudoagglutination.

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 μg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

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

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

20% PROSOL - sulfite-free (Amino Acid) Injection is indicated as an adjunct in the offsetting of nitrogen loss or in the treatment of negative nitrogen balance in patients where: (1) the alimentary tract cannot or should not be used, (2) gastrointestinal absorption of protein is impaired, or (3) metabolic requirements for protein are substantially increased, as with extensive burns. 20% PROSOL - sulfite-free (Amino Acid) Injection can be used to reduce fluid intake in patients who require both fluid restriction and total parenteral nutrition (TPN). 20% PROSOL - sulfite-free (Amino Acid) Injection is intended to be dosed on the basis of grams of amino acids/kg body weight/day. Therefore, this more concentrated amino acid solution provides the same nutritional value (grams of total amino acids) as in a more dilute form, but with the opportunity to limit fluid intake.

Central Vein Administration:

20% PROSOL - sulfite-free (Amino Acid) Injection is intended for use in a pharmacy admixture program and as such is restricted to the preparation of admixtures for intravenous use. Central vein infusion should be considered when amino acid solutions are to be admixed with hypertonic dextrose to promote protein synthesis such as for hypercatabolic or depleted patients or those requiring long term parenteral nutrition. 20% PROSOL - sulfite-free (Amino Acid) Injection should never be administered undiluted.

Peripheral Vein Administration:

For patients in whom the central vein route is not indicated, amino acid solutions diluted with low dextrose concentrations may be infused by peripheral vein with or without supplemented fat emulsion. In pediatric patients, the final solution should not exceed twice normal serum osmolarity (718 mOsmol/L). 20% PROSOL - sulfite-free (Amino Acid) Injection should never be administered by peripheral vein undiluted.

Protein-Sparing:

Dilute amino acid solutions for peripheral administration may be used in patients who exhibit no clinically significant protein malnutrition. The purpose of the solution is to replace protein losses which occur in relation to an intercurrent phenomenon which is known or suspected to be productive of a protein loss condition for a short or moderate period of time. Protein-sparing can be achieved by peripheral infusion of dilute amino acid solutions with or without dextrose. 20% PROSOL - sulfite-free (Amino Acid) Injection must be diluted below twice normal serum osmolarity (718 mOsmol/L).

History

There is currently no drug history available for this drug.

Other Information

20% PROSOL - sulfite-free (Amino Acid) Injection is a sterile, nonpyrogenic, hypertonic solution of essential and nonessential amino acids provided in a Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion.

The VIAFLEX Plastic Container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.

Each 100 mL of 20% PROSOL - sulfite-free (Amino Acid) Injection contains:

Amino Acids

20.0 g

Total Nitrogen

3.21 g

pH

6.0 (5.5 to 6.5)

(pH adjusted with glacial acetic acid.)

*
Balanced by ions from amino acids.

Essential Amino Acids

Valine - (CH3)2 CHCH (NH2) COOH

1.44 g

Lysine (added as Lysine Acetate) - H2N (CH2)4 CH (NH2) COOH

1.35 g

Histidine - (C3H3N2) CH2CH (NH2) COOH

1.18 g

Isoleucine - CH3CH2CH (CH3) CH (NH2) COOH

1.08 g

Leucine - (CH3)2 CHCH2CH (NH2) COOH

1.08 g

Phenylalanine - (C6H5) CH2 CH (NH2) COOH

1.00 g

Threonine - CH3CH (OH) CH (NH2) COOH

980 mg

Methionine - CH3S (CH2)2 CH (NH2) COOH

760 mg

Tryptophan - (C8H6N) CH2CH (NH2) COOH

320 mg

Nonessential Amino Acids

Alanine - CH3CH (NH2) COOH

2.76 g

Glycine - H2NCH2COOH

2.06 g

Arginine - H2NC (NH) NH (CH2)3 CH (NH2) COOH

1.96 g

Proline - [(CH2)3NHCH] COOH

1.34 g

Glutamic Acid - HOOC (CH2)2 CH (NH2) COOH

1.02 g

Serine - HOCH2 CH (NH2) COOH

1.02 g

Aspartic Acid - HOOC CH2 CH (NH2) COOH

600 mg

Tyrosine - [C6H4 (OH)] CH2CH (NH2) COOH

50 mg

Anion profiles per liter*

Acetate from Lysine Acetate and glacial acetic acid 140 mEq

140 mEq

Osmolarity (calc.)

1835 mOsmol/L

Prosol Manufacturers


  • Baxter Healthcare Corporation
    Prosol (Valine, Lysine, Histidine, Isoleucine, Leucine, Phenylalanine, Threonine, Methionine, Tryptophan, Alanine, Glycine, Arginine, Proline, Glutamic Acid, Serine, Aspartic Acid And Tyrosine) Injection, Solution [Baxter Healthcare Corporation]

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