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Overview
What is Clinisol?
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:
(pH adjusted with glacial acetic acid)
What does Clinisol look like?
What are the available doses of Clinisol?
Sorry No records found.
What should I talk to my health care provider before I take Clinisol?
Sorry No records found
How should I use Clinisol?
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.
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).
What interacts with Clinisol?
Hypersensitivity to one or more amino acids
Severe liver disease or hepatic coma
Anuria
Metabolic disorders involving impaired nitrogen utilization
What are the warnings of Clinisol?
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated.
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.
What are the precautions of Clinisol?
General
In order for parenterally administered amino acids to be retained by the body and utilized for protein synthesis adequate calories must be administered concurrently.
The administration of 15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package as part of total parenteral nutrition (TPN) with large volumes of hyperosmotic fluids requires periodic monitoring of the patient for signs of hyperosmolarity, hyperglycemia, glycosuria and hypertriglyceridemia.
During parenteral nutrition with concentrated dextrose and amino acid solutions, essential fatty acid deficiency syndrome may develop but may not be clinically apparent. Early demonstration of this condition can only be accomplished by analysis of plasma lipids. The syndrome may be prevented or corrected by appropriate treatment with intravenous fat emulsions.
For complete nutritional support, TPN regimens must also include multiple vitamins and trace elements. Potentially incompatible ions such as calcium and phosphate may be added to alternate infusate containers to avoid precipitation.
Initiation and termination of infusions of TPN fluids must be gradual to permit adjustment of endogenous insulin release.
Caution should be exercised against volume overload.
Do not administer unless solution is clear.
TPN delivered through a central or large peripheral vein is a special technique requiring a team effort by physician, nurse and pharmacist. The responsibility for administering this therapy should be confined to those trained in the procedures and alert to signs of complications. Complications known to occur from the placement of central venous catheters include sepsis and vein irritation due to hypertonicity of the infused solution. The risk of sepsis is present during intravenous therapy, especially when using central venous catheters for prolonged periods. It is imperative that the preparation of admixtures and the placement and care of the catheters be accomplished under controlled aseptic conditions.
Drug product contains no more than 25 μg/L of aluminum.
Laboratory Tests
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Long term animal studies with 15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package have not been performed to evaluate the carcinogenic potential, mutagenic potential or effects on fertility.
Pregnancy:
Teratogenic Effects
Pregnancy Category C.
Animal reproduction studies have not been conducted with 15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package. It is also not known whether 15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package should be given to a pregnant woman only if clearly needed.
Nursing Mothers:
Caution should be exercised when 15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package is administered to a nursing woman.
Pediatric Use:
Safety and effectiveness of 15% CLINISOL - sulfite-free (Amino Acid) Injection in pediatric patients have not been established by adequate and well-controlled studies. However, the use of amino acid injections in pediatric patients as an adjunct in the offsetting of nitrogen loss or in the treatment of negative nitrogen balance is referenced in the medical literature. See .
What are the side effects of Clinisol?
Local reactions consisting of a warm sensation, erythema, phlebitis and thrombosis at the infusion site have occurred with peripheral intravenous infusion of amino acids. In such cases the infusion site should be changed promptly to another vein. Generalized flushing, fever and nausea also have been reported during peripheral infusions of amino acid solutions.
The following metabolic complications have been reported with administration of TPN: metabolic acidosis and alkalosis, hypophosphatemia, hypocalcemia, osteoporosis, glycosuria, hyperglycemia, hyperosmolar nonketotic states and dehydration, rebound hypoglycemia, osmotic diuresis and dehydration, elevated liver enzymes, hypo- and hypervitaminosis, electrolyte imbalances, hyperammonemia, coma and death.
Sepsis has been reported following intravenous therapy, especially when using central venous catheters for prolonged periods.
Complications known to occur from the placement of central venous catheters are pneumothorax, hemothorax, hydrothorax, artery puncture and transection injury to the brachial plexus, malposition of the catheter, formation of arteriovenous fistula, phlebitis, thrombosis and air and catheter emboli.
What should I look out for while using Clinisol?
Hypersensitivity to one or more amino acids
Severe liver disease or hepatic coma
Anuria
Metabolic disorders involving impaired nitrogen utilization
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.
What might happen if I take too much Clinisol?
Sorry No Records found
How should I store and handle Clinisol?
15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package is available in VIAFLEX plastic containers as follows.Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended the product be stored at room temperature (25ºC/77ºF).Baxter Healthcare CorporationPrinted in USA07-19-72-998Rev. April 2014Baxter, Clinisol, Viaflex, and PL 146 are trademarks of Baxter International Inc.15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package is available in VIAFLEX plastic containers as follows.Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended the product be stored at room temperature (25ºC/77ºF).Baxter Healthcare CorporationPrinted in USA07-19-72-998Rev. April 2014Baxter, Clinisol, Viaflex, and PL 146 are trademarks of Baxter International Inc.15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package is available in VIAFLEX plastic containers as follows.Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended the product be stored at room temperature (25ºC/77ºF).Baxter Healthcare CorporationPrinted in USA07-19-72-998Rev. April 2014Baxter, Clinisol, Viaflex, and PL 146 are trademarks of Baxter International Inc.15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package is available in VIAFLEX plastic containers as follows.Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended the product be stored at room temperature (25ºC/77ºF).Baxter Healthcare CorporationPrinted in USA07-19-72-998Rev. April 2014Baxter, Clinisol, Viaflex, and PL 146 are trademarks of Baxter International Inc.15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package is available in VIAFLEX plastic containers as follows.Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended the product be stored at room temperature (25ºC/77ºF).Baxter Healthcare CorporationPrinted in USA07-19-72-998Rev. April 2014Baxter, Clinisol, Viaflex, and PL 146 are trademarks of Baxter International Inc.15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package is available in VIAFLEX plastic containers as follows.Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended the product be stored at room temperature (25ºC/77ºF).Baxter Healthcare CorporationPrinted in USA07-19-72-998Rev. April 2014Baxter, Clinisol, Viaflex, and PL 146 are trademarks of Baxter International Inc.15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package is available in VIAFLEX plastic containers as follows.Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended the product be stored at room temperature (25ºC/77ºF).Baxter Healthcare CorporationPrinted in USA07-19-72-998Rev. April 2014Baxter, Clinisol, Viaflex, and PL 146 are trademarks of Baxter International Inc.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package is intended for use in a pharmacy admixture program and as such is restricted to the preparation of admixtures for intravenous use. 15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package given by central venous infusion in combination with energy sources, vitamins, trace elements and electrolytes, will meet the requirements for weight maintenance or weight gain. The energy component may be derived solely from dextrose or may be provided by a combination of dextrose and intravenous fat emulsion.
Non-Clinical Toxicology
Hypersensitivity to one or more amino acidsSevere liver disease or hepatic coma
Anuria
Metabolic disorders involving impaired nitrogen utilization
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.
Patients who are receiving a beta-adrenergic blocking agent orally and Betaxolol Hydrochloride Ophthalmic Solution should be observed for a potential additive effect either on the intraocular pressure or on the known systemic effects of beta blockade.
Close observation of the patient is recommended when a beta blocker is administered to patients receiving catecholamine-depleting drugs such as reserpine, because of possible additive effects and the production of hypotension and/or bradycardia.
Betaxolol is an adrenergic blocking agent; therefore, caution should be exercised in patients using concomitant adrenergic psychotropic drugs.
In order for parenterally administered amino acids to be retained by the body and utilized for protein synthesis adequate calories must be administered concurrently.
The administration of 15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package as part of total parenteral nutrition (TPN) with large volumes of hyperosmotic fluids requires periodic monitoring of the patient for signs of hyperosmolarity, hyperglycemia, glycosuria and hypertriglyceridemia.
During parenteral nutrition with concentrated dextrose and amino acid solutions, essential fatty acid deficiency syndrome may develop but may not be clinically apparent. Early demonstration of this condition can only be accomplished by analysis of plasma lipids. The syndrome may be prevented or corrected by appropriate treatment with intravenous fat emulsions.
For complete nutritional support, TPN regimens must also include multiple vitamins and trace elements. Potentially incompatible ions such as calcium and phosphate may be added to alternate infusate containers to avoid precipitation.
Initiation and termination of infusions of TPN fluids must be gradual to permit adjustment of endogenous insulin release.
Caution should be exercised against volume overload.
Do not administer unless solution is clear.
TPN delivered through a central or large peripheral vein is a special technique requiring a team effort by physician, nurse and pharmacist. The responsibility for administering this therapy should be confined to those trained in the procedures and alert to signs of complications. Complications known to occur from the placement of central venous catheters include sepsis and vein irritation due to hypertonicity of the infused solution. The risk of sepsis is present during intravenous therapy, especially when using central venous catheters for prolonged periods. It is imperative that the preparation of admixtures and the placement and care of the catheters be accomplished under controlled aseptic conditions.
Drug product contains no more than 25 μg/L of aluminum.
Local reactions consisting of a warm sensation, erythema, phlebitis and thrombosis at the infusion site have occurred with peripheral intravenous infusion of amino acids. In such cases the infusion site should be changed promptly to another vein. Generalized flushing, fever and nausea also have been reported during peripheral infusions of amino acid solutions.
The following metabolic complications have been reported with administration of TPN: metabolic acidosis and alkalosis, hypophosphatemia, hypocalcemia, osteoporosis, glycosuria, hyperglycemia, hyperosmolar nonketotic states and dehydration, rebound hypoglycemia, osmotic diuresis and dehydration, elevated liver enzymes, hypo- and hypervitaminosis, electrolyte imbalances, hyperammonemia, coma and death.
Sepsis has been reported following intravenous therapy, especially when using central venous catheters for prolonged periods.
Complications known to occur from the placement of central venous catheters are pneumothorax, hemothorax, hydrothorax, artery puncture and transection injury to the brachial plexus, malposition of the catheter, formation of arteriovenous fistula, phlebitis, thrombosis and air and catheter emboli.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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