Potassium chloride and Sodium chloride

Potassium Chloride in Sodium Chloride Injection, USP is indicated as a source of water and electrolytes.

Important Administration Instructions • Potassium Chloride in Sodium Chloride Injection, USP is intended for intravenous infusion using sterile equipment. • To avoid life threatening hyperkalemia, do not administer Potassium Chloride in Sodium Chloride Injection, USP as an intravenous push (i.e., intravenous injection manually with a syringe connected to the intravenous access) without a quantitative infusion device. • Do not connect flexible plastic containers in series in order to avoid air embolism due to possible residual air contained in the primary container. • Set the vent to the closed position on a vented intravenous administration set to prevent air embolism. • Use a dedicated line without any connections to avoid air embolism.

Potassium Chloride in Sodium Chloride Injection, USP is contraindicated in patients with: • Known hypersensitivity to potassium chloride and/or sodium chloride. • Clinically significant hyperkalemia.

Hypersensitivity Hypersensitivity and infusion reactions, including anaphylaxis and chills, have been reported with products containing potassium chloride and sodium chloride. Stop the infusion immediately if signs or symptoms of a hypersensitivity or infusion reaction develops. Appropriate therapeutic countermeasures must be instituted as clinically indicated. Electrolyte Imbalances Hyperkalemia Potassium-containing solutions, including Potassium Chloride in Sodium Chloride Injection, USP may increase the risk of hyperkalemia. Hyperkalemia can be asymptomatic and manifest only by increased serum potassium concentrations and/or characteristic electrocardiographic (ECG) changes. Cardiac conduction disorders (including complete heart block) and other cardiac arrhythmias, some fatal, can develop at any time during hyperkalemia.

The following adverse reactions associated with the use of Potassium Chloride in Sodium Chloride Injection, USP were identified in clinical trials or postmarketing reports. Because postmarketing reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure. General disorders and administration site condition s: Chills, and infusion site pain. Hypersensitivity reactions: generalized papules and erythema, rash, fever, vomiting, hypertension, tachycardia. Metabolism and nutrition disorders: Hyperkalemia, hyponatremia, hypernatremia, hyperchloremia acidosis, fluid overload. Cardiac disorders: Cardiac arrest as a manifestation of rapid intravenous administration and/or of hyperkalemia. Nervous System Disorders: Hyponatremic encephalopathy.

Lithium Renal sodium and lithium clearance may be increased during administration of Potassium Chloride in Sodium Chloride Injection, USP and result in decreased lithium concentrations. Monitor serum lithium concentrations during concomitant use. Other Products that Cause Hyperkalemia Administration of Potassium Chloride in Sodium Chloride Injection, USP in patients treated concurrently or recently with products that are associated with hyperkalemia increases the risk of severe and potentially fatal hyperkalemia, in particular in the presence of other risk factors for hyperkalemia. Avoid use of Potassium Chloride in Sodium Chloride Injection, USP in patients receiving such products (e.g., potassium sparing diuretics, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, or the immunosuppressants cyclosporine and tacrolimus).

It is recommended the product be stored between 20ºC to 25°C (68º F to 77°F)., brief exposure up to 40° C (104° F) does not adversely affect the product.