Clinisol

Clinisol

Clinisol Recall

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Questions & Answers

Side Effects & Adverse Reactions

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.

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

Once container closure has been penetrated, withdrawal of contents should be completed within 4 hours. After initial entry, maintain contents at room temperature (25ºC/77ºF).

Any admixture storage should be under refrigeration and limited to a brief period of time, preferably less than 24 hours.

Administration of amino acid solutions at excessive rates or to patients with hepatic insufficiency may result in plasma amino acid imbalances, hyperammonemia, prerenal azotemia, stupor and coma. Conservative doses of amino acids should be given to these patients, dictated by the nutritional status of the patient. Should symptoms of hyperammonemia develop, amino acid administration should be discontinued and the patient's clinical status reevaluated.

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.

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

15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package 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.

History

There is currently no drug history available for this drug.

Other Information

15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package is a sterile, clear, nonpyrogenic, hypertonic solution of essential and nonessential amino acids. 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). Exposure to temperatures above 25ºC/77ºF 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. 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 test for plastic containers as well as by tissue culture toxicity studies.

Each 100 mL of 15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package contains:

Amino Acids

15.0 g

Total Nitrogen

2.37 g

pH

6.0 (5.0 to 7.0)

(pH adjusted with glacial acetic acid)

Essential Amino Acids

Lysine - (from Lysine Acetate) C6H14N2O2

1.18 g

Leucine - C6H13NO2

1.04 g

Phenylalanine – C9H11NO2

1.04 g

Valine - C5H11NO2

960 mg

Histidine - C6H9N3O2

894 mg

Isoleucine - C6H13NO2

749 mg

Methionine - C5H11NO2S

749 mg

Threonine - C4H9NO3

749 mg

Tryptophan - C11H12N2O2

250 mg

Nonessential Amino Acids

Alanine - C3H7NO2

2.17 g

Arginine - C6H14N4O2

1.47 g

Glycine - C2H5NO2

1.04 g

Proline - C5H9NO2

894 mg

Glutamic Acid - C5H9NO4

749 mg

Serine - C3H7NO3

592 mg

Aspartic Acid - C4H7NO4

434 mg

Tyrosine - C9H11NO3

39 mg

Anion profiles per liter*

Acetate from Lysine Acetate and glacial acetic acid

127 mEq

*Balanced by ions from amino acids.

Osmolarity (Calc.)

1357 mOsmol/L

Clinisol Manufacturers


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

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