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TPN ELECTROLYTES Warnings and Precautions (multitple electrolyte additive)

WARNINGS

CONCENTRATED, HYPERTONIC, ADDITIVE SOLUTION. Must be diluted in TPN solution prior to administration.

CONTAINS NO PHOSPHATE. Patients receiving TPN solutions containing concentrated dextrose require additive phosphate, in addition to TPN Electrolytes. Between 10 and 15 mM (310 to 465 mg) phosphorus are physically compatible with as much as 10 to 12 mEq calcium in the same admixture. The phosphate supplement should first be added to the amino acid or dextrose bottle and diluted well to avoid precipitation with calcium.

CONTAINS 20 mEq of POTASSIUM. The potassium content of other additives, such as potassium phosphate or potassium-containing antibiotics, must be considered in the context of total potassium delivered. TPN patients usually require 30 to 50 mEq of potassium per liter of TPN solution containing concentrated (20—25%) dextrose.

NOT INTENDED FOR PEDIATRIC USE.

Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention.

Solutions which contain potassium ions should be used with great care, if at all, in patients with hyperkalemia, severe renal failure and in conditions in which potassium retention is present.

In patients with diminished renal function, administration of solutions containing sodium or potassium ions may result in sodium or potassium retention.

Solutions containing acetate ions should be used with great care in patients with metabolic or respiratory alkalosis. Acetate should be administered with great care in those conditions in which there is an increased level or an impaired utilization of this ion, such as severe hepatic insufficiency.

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 mcg/kg/day accumulate aluminum levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.


PRECAUTIONS

Do not administer unless solution is clear and seal is intact. Discard unused portion.

Blood levels of sodium, potassium, calcium, magnesium, phosphorus and chloride should be monitored frequently during TPN (total parenteral nutrition). Significant deviations from normal may justify further supplementation or substitution of individual electrolyte additives (in place of TPN Electrolytes) to tailor the electrolyte supplement to meet individual patient requirements.

In patients with renal dysfunction or cardiovascular insufficiency, especially in elderly or postsurgical patients, consider the potential effects of sodium (35 mEq) and potassium (20 mEq) present in TPN Electrolytes.

Extraordinary electrolyte losses are not necessarily corrected by TPN Electrolytes. In protracted vomiting or diarrhea or in patients with fistula drainage or nasogastric suction, separate replacement therapy may be necessary, based upon analysis of losses sustained.

Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions, to patients receiving corticosteroids or corticotropin.

Solutions containing acetate ions should be used with caution as excess administration may result in metabolic alkalosis.

Pregnancy

Animal reproduction studies have not been conducted with TPN Electrolytes. It is also not known whether TPN Electrolytes can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. TPN Electrolytes should be given to a pregnant woman only if clearly needed.

GERIATRIC USE

An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Sodium ions and phosphorus are known to be substantially secreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

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