POTASSIUM CHLORIDE IN SODIUM .9 g/100mL; .15 g/100mL Solution — NDC 0264-7865-00 (Billing 00264-7865-00)

WARNINGS The administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentration. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration.

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 is sodium retention with edema. Infusion of isotonic (0.9%) sodium chloride during or immediately after surgery may result in excessive sodium retention. Use the patient's circulatory system status as a guide.

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

ADVERSE REACTIONS Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation, and hypervolemia. Too rapid infusion of hypertonic solutions may cause local pain and venous irritation. Rate of administration should be adjusted according to tolerance.

Use of the largest peripheral vein and a small bore needle is recommended. (See DOSAGE AND ADMINISTRATION .) Symptoms may result from an excess or deficit of one or more of the ions present in the solution; therefore, frequent monitoring of electrolyte levels is essential. Hypernatremia may be associated with edema and exacerbation of congestive heart failure due to the retention of water, resulting in an expanded extracellular fluid volume.

Reactions reported with the use of potassium-containing solutions include nausea, vomiting, abdominal pain and diarrhea. The signs and symptoms of potassium intoxication include paresthesias of the extremities, areflexia, muscular or respiratory paralysis, mental confusion, weakness, hypotension, cardiac arrhythmias, heart block, electrocardiographic abnormalities and cardiac arrest. Potassium deficits result in disruption of neuromuscular function, and intestinal ileus and dilatation.

If infused in large amounts, chloride ions may cause a loss of bicarbonate ions, resulting in an acidifying effect. The physician should also be alert to the possibility of adverse reactions to drug additives. Prescribing information for drug additives to be administered in this manner should be consulted.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

PRECAUTIONS General This solution should be used with care in patients with hypervolemia, renal insufficiency, urinary tract obstruction, or impending or frank cardiac decompensation. Extraordinary electrolyte losses that may occur during protracted nasogastric suction, vomiting, diarrhea or gastrointestinal fistula drainage may necessitate additional electrolyte supplementation. Additional essential electrolytes, minerals, and vitamins should be supplied as needed.

Sodium-containing solutions should be administered with caution to patients receiving corticosteroids or corticotropin, or to other salt-retaining patients. Infusion of more than one liter of isotonic (0.9%) sodium chloride may supply more sodium and chloride than normally found in serum, and can exceed normal tolerance, resulting in hypernatremia; this may also cause a loss of bicarbonate ions, resulting in an acidifying effect. Potassium therapy should be guided primarily by serial electrocardiograms, especially in patients receiving digitalis.

Serum potassium levels are not necessarily indicative of tissue potassium levels. Solutions containing potassium should be used with caution in the presence of cardiac disease, particularly when accompanied by renal disease. Care should be exercised in administering solutions containing sodium or potassium to patients with renal or cardiovascular insufficiency, with or without congestive heart failure, particularly if they are postoperative or elderly.

To minimize the risk of possible incompatibilities arising from mixing this solution with other additives that may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration, and periodically during administration. Do not use plastic containers in series connection. If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result.

If administration is not controlled by a pumping device, refrain from applying excessive pressure (>300mmHg) causing distortion to the container such as wringing or twisting. Such handling could result in breakage of the container. This solution is intended for intravenous administration using sterile equipment.

It is recommended that intravenous administration apparatus be replaced at least once every 24 hours. Use only if solution is clear and container is undamaged. Laboratory Tests Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.

Significant deviations from normal concentrations may require tailoring of the electrolyte pattern, in this or alternative solutions. Carcinogenesis, Mutagenesis, Impairment of Fertility Studies with Potassium Chloride in 0.9% Sodium Chloride Injection have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility. Pregnancy: Teratogenic Effects Animal reproduction studies have not been conducted with Potassium Chloride in 0.9% Sodium Chloride Injection.

It is also not known whether Potassium Chloride in 0.9% Sodium Chloride Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Potassium Chloride in 0.9% Sodium Chloride Injection should be given to a pregnant woman only if clearly needed. Labor and Delivery The effects of Potassium Chloride in 0.9% Sodium Chloride Injection on the duration of labor or delivery, on the possibility that forceps delivery or other intervention or resuscitation of the newborn will be necessary, and on the later growth, development, and functional maturation of the child are unknown.

As reported in the literature, potassium containing solutions have been administered during labor and delivery. Caution should be exercised,… [Excerpted — this section continues on DailyMed.]