Clinisol Lysine, Leucine, Phenylalanine, Valine, Histidine, Isoleucine, Methionine, Threonine, Tryptophan, Alanine, Arginine, Glycine, Proline, Glutamic Acid, Serine, Aspartic Acid, Tyrosine 1.18 g/100mL; 1.04 g/100mL; 1.04 g/100mL; 960 mg/100mL; 894 mg/100mL; 749 mg/100mL; 749 mg/100mL; 749 mg/100mL; 250 mg/100mL; 2.17 g/100mL; 1 Injection, Solution, 500 mL — NDC 0338-0502-03 (Billing 00338-0502-03)

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.

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.

PRECAUTIONS 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.

It is essential that a carefully prepared protocol, based on current medical practices be followed. Drug product contains no more than 25 μg/L of aluminum. Laboratory Tests Frequent clinical evaluations and laboratory determinations are necessary for proper monitoring during administration.

Laboratory tests should include blood glucose, serum electrolytes, liver and renal function, serum osmolarity, blood ammonia, serum protein, pH, hematocrit, and WBC. When 15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package is combined with electrolytes, care should be used in administering this solution to patients with congestive heart failure, renal failure, edema, adrenal hyperactivity, acid base imbalance and those receiving diuretics or antihypertensive therapy. Serum electrolytes should be monitored daily.

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 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… [Excerpted — this section continues on DailyMed.]