Data from FDA - Curated by EPG Health - Last updated 05 July 2018

Indication(s)

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.

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Advisory information

contraindications
CONTRAINDICATIONS Hypersensitivity to one or more amino acids Severe liver disease or hepatic coma Anuria Metabolic disorders involving impaired nitrogen utilization
Special warnings and precautions
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 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 Dosage and 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.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION 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 Infusion In 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 Infusion In 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).
Pregnancy and lactation
Nursing Mothers: Caution should be exercised when 15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package is administered to a nursing woman.

More information

Category Value
Authorisation number ANDA020512
Agency product number OF5P57N2ZX
Orphan designation No
Product NDC 0338-0502
Date Last Revised 01-06-2018
Type HUMAN PRESCRIPTION DRUG
RXCUI 800588
Marketing authorisation holder Baxter Healthcare Corporation