Potassium Chloride

POTASSIUM CHLORIDE- potassium chloride injection, solution
ICU Medical Inc.

For Use Only With A Calibrated Infusion Device

Highly Concentrated

Flexible Plastic Container

Ready To Use

Rx only

DESCRIPTION

This Potassium Chloride Injection is a sterile, nonpyrogenic, highly concentrated, ready-to-use solution of Potassium Chloride, USP in Water for Injection, USP for electrolyte replenishment in a single dose container for intravenous administration. It contains no antimicrobial agents.

Potassium

Chloride

Injection

mEq Potassium/

Container

Composition

(g/L)

Potassium

Chloride, USP

(KCl)

Osmolarity*

(mOsmol/L)

(calc)

pH

Ionic Concentration

(mEq/L)

Potassium

Chloride

10 mEq/100 mL

7.45

200

5.8

(4.0 to 8.0)

100

100

10 mEq/50 mL

20 mEq/100 mL

14.9

400

5.8

(4.0 to 8.0)

200

200

20 mEq/50 mL

40 mEq/100 mL

29.8

799

5.8

(4.0 to 8.0)

400

400

*Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions (≥600 mOsmol/L) may cause vein damage.

This flexible plastic container is fabricated from a specially formulated polyvinylchloride. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain of its chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials.

CLINICAL PHARMACOLOGY

Potassium is the major cation of body cells (160 mEq/liter of intracellular water) and is concerned with the maintenance of body fluid composition and electrolyte balance. Potassium participates in carbohydrate utilization, protein synthesis, and is critical in the regulation of nerve conduction and muscle contraction, particularly in the heart. Chloride, the major extracellular anion, closely follows the metabolism of sodium, and changes in the acid-base of the body are reflected by changes in the chloride concentration.

Normally about 80 to 90% of the potassium intake is excreted in the urine, the remainder in the stools and to a small extent, in the perspiration. The kidney does not conserve potassium well so that during fasting, or in patients on a potassium-free diet, potassium loss from the body continues resulting in potassium depletion. A deficiency of either potassium or chloride will lead to a deficit of the other.

INDICATIONS AND USAGE

Potassium Chloride Injection is indicated in the treatment of potassium deficiency states when oral replacement is not feasible.

THIS HIGHLY CONCENTRATED, READY-TO-USE POTASSIUM CHLORIDE INJECTION IS INTENDED FOR THE MAINTENANCE OF SERUM K + LEVELS AND FOR POTASSIUM SUPPLEMENTATION IN FLUID RESTRICTED PATIENTS WHO CANNOT ACCOMMODATE ADDITIONAL VOLUMES OF FLUID ASSOCIATED WITH POTASSIUM SOLUTIONS OF LOWER CONCENTRATION.

When using these products, these patients should be on continuous cardiac monitoring and frequent testing for serum potassium concentration and acid-base balance.

CONTRAINDICATIONS

Potassium Chloride Injection is contraindicated in diseases where high potassium levels may be encountered, and in patients with hyperkalemia, renal failure and in conditions in which potassium retention is present.

WARNINGS

THIS HIGHLY CONCENTRATED, READY-TO-USE POTASSIUM CHLORIDE INJECTION IS INTENDED FOR THE MAINTENANCE OF SERUM K + LEVELS AND FOR POTASSIUM SUPPLEMENTATION IN FLUID RESTRICTED PATIENTS WHO CANNOT ACCOMMODATE ADDITIONAL VOLUMES OF FLUID ASSOCIATED WITH POTASSIUM SOLUTIONS OF LOWER CONCENTRATION.

TO AVOID POTASSIUM INTOXICATION, DO NOT INFUSE THESE SOLUTIONS RAPIDLY.

PATIENTS REQUIRING HIGHLY CONCENTRATED SOLUTIONS SHOULD BE KEPT ON CONTINUOUS CARDIAC MONITORING AND UNDERGO FREQUENT TESTING FOR SERUM POTASSIUM AND ACID-BASE BALANCE, ESPECIALLY IF THEY RECEIVE DIGITALIS.

In patients with renal insufficiency, administration of potassium chloride may cause potassium intoxication and life-threatening hyperkalemia.

Administer intravenously only with a calibrated infusion device at a slow, controlled rate. (See DOSAGE AND ADMINISTRATION.) Because pain associated with peripheral infusion of Potassium Chloride solution has been reported, whenever possible administration via a central route is recommended for thorough dilution by the blood stream and avoidance of extravasation. Highest concentrations (300 and 400 mEq/L) should be exclusively administered via central route.

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.

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