Sodium Chloride, Calcium Chloride, Potassium Chloride, Magnesium Chloride, And Sodium Acetate Anhydrous
FDA Drug Information • Also known as: Tpn Electrolytes
- Brand Names
- Tpn Electrolytes
- Route
- INTRAVENOUS
- Dosage Form
- INJECTION, SOLUTION, CONCENTRATE
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
DESCRIPTION TPN Electrolytes (multiple electrolyte additive) is a sterile, nonpyrogenic, concentrated solution of intra- and extracellular ions for intravenous infusion after dilution as a maintenance electrolyte replenisher only. It contains no phosphate and no bacteriostat, antimicrobial agent or added buffer. The pH is 6.6 (6.0 to 7.5). May contain hydrochloric acid for pH adjustment. The osmolar concentration is 6.2 mOsmol/mL (calc.). __________________________ *Total Parenteral Nutrition Ingredients and ion constituents of the solution are as follows: Ingredient or Ion mg/20 mL mEq/20 mL Sodium Chloride 321 Calcium Chloride (dihydrate) 331 Potassium Chloride 1491 Magnesium Chloride (hexahydrate) 508 Sodium Acetate (anhydrous) 2420 Sodium (Na + ) 35 Potassium (K + ) 20 Calcium (Ca ++ ) 4.5 Magnesium (Mg ++ ) 5 Chloride (Cl − ) 35 Acetate (CH 3 COO − ) 29.5 Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluble in water. Calcium Chloride, USP dihydrate is chemically designated CaCl 2
What Is Sodium Chloride, Calcium Chloride, Potassium Chloride, Magnesium Chloride, And Sodium Acetate Anhydrous Used For?
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.
Dosage 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.
Side Effects (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.
Warnings and Precautions
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.
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.
Pregnancy and Breastfeeding
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.
Overdosage
OVERDOSAGE In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. See WARNINGS and PRECAUTIONS .
How Supplied
HOW SUPPLIED TPN Electrolytes (multiple electrolyte additive) is supplied in the following single-dose delivery system: Unit of Sale Concentration Each NDC 0409-5779-01 25 in a carton 20 mL NDC 0409-5779-11 20 mL Vial Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1091-1.0 Revised: 9/2017 Logo
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.