Data from FDA - Curated by Toby Galbraith - Last updated 28 July 2017

Indication(s)

INDICATIONS AND USAGE TPN Electrolytes (multiple electrolyte additive) is indicated for use as a supplement to nutritional solutions containing concentrated dextrose and amino acids delivered by central venous infusion, to help maintain electrolyte homeostasis in adult patients.

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Advisory information

contraindications
CONTRAINDICATIONS TPN Electrolytes (multiple electrolyte additive) is contraindicated in pathological conditions where additives of potassium, sodium, calcium, magnesium or chloride could be clinically deleterious, e.g., anuria, hyperkalemia, heart block or myocardial damage and severe edema due to cardiovascular, renal or hepatic failure.
Special warnings and precautions
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 Category C. 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.
Adverse reactions
ADVERSE REACTIONS Symptoms may result from an excess or deficit of one or more of the ions present in TPN Electrolytes. Therefore, frequent monitoring of electrolyte blood levels is recommended. Sodium excess can cause edema and exacerbation of congestive heart failure. Excess potassium can cause deviations from the normal ECG (electrocardiogram). Potassium deficits can impair neuromuscular function, causing muscle weakness or frank paralysis, intestinal dilatation and ileus. Calcium deficits can produce neuromuscular hyperexcitability, ranging from paresthesias, cramps and laryngospasm to tetany and grand mal seizures. Depressed calcium levels can accompany administration of parenteral phosphorous or large amounts of albumin. Magnesium deficiency can precipitate neuromuscular dysfunction, hyperirritability, psychotic behavior, tachycardia and hypertension. Magnesium excess can cause muscle weakness, ECG changes, sedation and mental confusion.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION One 20 mL volume of TPN Electrolytes (multiple electrolyte additive) is added to each liter of amino acid/dextrose solution. Alternatively, the TPN Electrolytes can be added to the bottle of amino acids or concentrated dextrose, to permit addition of the necessary phosphate additive to the remaining bottle. This latter technique helps avoid physical incompatibilities between calcium and phosphorus. A potassium phosphate additive is recommended for addition to nutritional solutions containing TPN Electrolytes. Between 10 and 30 mEq of potassium (as phosphate) should be added per liter of TPN solution, to augment the 20 mEq of potassium provided by TPN Electrolytes. Between two and three liters of TPN solution with added TPN Electrolytes are usually administered daily to adults. Solutions are given continuously over the entire 24-hour period at a constant rate, ranging from 83 to 125 mL/hour. TPN solutions containing TPN Electrolytes and concentrated dextrose are administered intravenously, through a central venous catheter. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

More information

Category Value
Authorisation number NDA018895
Agency product number M4I0D6VV5M
Orphan designation No
Product NDC 0409-5779
Date Last Revised 20-06-2017
Type HUMAN PRESCRIPTION DRUG
RXCUI 801451
Marketing authorisation holder Hospira, Inc.