Clinisol
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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
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Manufacturer Warnings
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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 |
Sources
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]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Clinisol | Baxter Healthcare Corporation
Doses which achieve nitrogen equilibrium or positive balance are the most desirable. The dosage on the first day should be approximately half the anticipated optimal dosage and should be increased gradually to minimize glycosuria; similarly, withdrawal should be accomplished gradually to avoid rebound hypoglycemia.
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).
Pediatric Use:Use of 15% CLINISOL - sulfite-free (Amino Acid) Injection in pediatric patients is governed by the same considerations that affect the use of any amino acid solution in pediatrics. The amount administered is dosed on the basis of grams of amino acids/kg of body weight/day. Two to three g/kg of body weight for infants with adequate calories are generally sufficient to satisfy protein needs and promote positive nitrogen balance. Solutions administered by peripheral vein should not exceed twice normal serum osmolarity (718 mOsmol/L).
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
A slight yellow color does not alter the quality and efficacy of this product.
Additives may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. When compounding admixtures, use aseptic technique. Mix thoroughly. Do not store any unused portion of 15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package.
Central Vein InfusionIn unstressed adult patients with no unusual nitrogen losses, a minimum dosage of 0.1 gram nitrogen (4.2 mL of 15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package) plus 4.4 grams (15 calories) of dextrose/fat emulsion per kilogram of body weight per day is required to achieve nitrogen balance and weight stability. For patients stressed by surgery, trauma or sepsis, and those with unusual nitrogen losses, the dosage required for maintenance may be as high as 0.3 to 0.4 grams of nitrogen (13 to 17 mL 15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package) per kilogram of body weight per day, with proportionate increases in non-protein calories. Periodic assessment of nitrogen balance of the individual patient is the best indicator of proper dosage. Use of an infusion pump is advisable to maintain a steady infusion rate during central venous infusion.
Peripheral InfusionIn patients for whom central vein catheterization is not advisable, admixtures with 15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package can be administered by peripheral vein. Dilution of 250 mL 15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package in 750 mL of 10% dextrose will reduce the osmolarity to a level (718 mOsmol/L) which is more favorable to the maintenance of the integrity of the walls of the veins. If infused simultaneously, fat emulsion will provide a dilution effect upon the osmolarity, as well. In pediatric patients, the final solution should not exceed twice normal serum osmolarity (718 mOsmol/L).
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