Clinisol
Generic: LYSINE, LEUCINE, PHENYLALANINE, VALINE, HISTIDINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, TYROSINE
Basic Information
Manufacturer
Baxter Healthcare Corporation
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
65ffc962-7538-41ea-9afb-4af5fbce4c5b
Indications & Usage
INDICATIONS AND USAGE 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.
Warnings
WARNINGS 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.
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.
Adverse Reactions
ADVERSE REACTIONS 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.
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.