Potassium Chloride for Injection Concetrate USP

POTASSIUM CHLORIDE FOR INJECTION CONCENTRATE USP

Astra

Electrolyte Replenisher

Indications And Clinical Uses: The treatment of potassium depletion in patients with hypokalemia; treatment of digitalis intoxication.

The i.v. route is indicated when the patient is unable to take potassium orally or if hypokalemia is severe.

Contra-Indications: Renal impairment with oliguria or azotemia, untreated Addison’s disease, hyperadrenalism associated with adrenogenital syndrome, extensive tissue breakdown as in severe burns, acute dehydration, heat cramps, adynamia episodica hereditaria and hyperkalemia of any etiology.

Manufacturers’ Warnings In Clinical States: In patients with impaired mechanisms for excreting potassium, administration of potassium salts can produce hyperkalemia and cardiac arrest. This is of particular concern in patients given i.v. potassium. Potentially fatal hyperkalemia can develop rapidly and be asymptomatic.

Precautions: The use of potassium salts in patients with chronic renal disease, adrenal insufficiency or any other condition which impairs potassium excretion, requires particularly careful monitoring of the serum potassium concentration and appropriate dosage adjustment.

Hypokalemia should not be treated by the concomitant administration of potassium salts and a potassium-sparing diuretic (e.g. spironolactone or triamterene), since the simultaneous administration of these agents can produce severe hyperkalemia.

In patients on a low salt diet, hypokalemic hypochloremic alkalosis is a possibility that may require chloride as well as potassium supplementation.

The treatment of potassium depletion, particularly in the presence of cardiac disease, renal disease or acidosis, requires careful attention to acid-base balance and appropriate monitoring of serum electrolytes, the ECG and the patient’s clinical status.

Potassium should be used with caution in diseases associated with heart block since increased serum potassium may increase the degree of block.

Parenteral potassium chloride solutions may cause pain if given in a small vein.

Adverse Reactions: The symptoms and signs of potassium intoxication include paresthesias of the extremities, flaccid paralysis, listlessness, mental confusion, weakness and heaviness of the legs, fall in blood pressure, cardiac arrhythmias and heart block. Hyperkalemia may exhibit the following ECG abnormalities: disappearance of the P-wave, widening and slurring of QRS complex, changes of the S-T segment, tall peaked T-waves. Nausea, vomiting, diarrhea and abdominal discomfort have been reported.

Symptoms And Treatment Of Overdose: Symptoms: If excretory mechanisms are impaired or if i.v. potassium is administered too rapidly, potentially fatal hyperkalemia can result (see Contraindications and Precautions). However, hyperkalemia is usually asymptomatic and may be manifested only by an increased serum potassium concentration and characteristic ECG changes (peaking of T-waves, loss of P-waves, depression of S-T segment, and prolongation of the QT interval). Late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest. Should any of these manifestations occur, discontinue administration immediately.Treatment: If hyperkalemia develops, the following measures should be considered: 1. Elimination of foods and medications containing potassium and of potassium-sparing diuretics. 2. I.V. administration of 300 to 500 mL/hour of 10% dextrose solution containing 10 to 20 units of insulin/1 000 mL. 3. Correction of acidosis, if present, with i.v. sodium bicarbonate. 4. Use of exchange resins, hemodialysis, or peritoneal dialysis. 5. Calcium gluconate.

In treating hyperkalemia in digitalized patients, too rapid a lowering of the serum potassium concentration can produce digitalis toxicity.

Dosage And Administration: For i.v. administration only; dilute before infusing. The dose and rate of injection are dependent upon the individual patient’s condition. In patients whose serum potassium concentration is above 2.5 mEq/L, the rate of infusion should not exceed 10 mEq/hour, in a concentration less than 30 mEq/L. The total dose should not exceed 200 mEq/24 hours.

If urgent treatment is required (serum potassium concentration less than 2 mEq/L with ECG changes or paralysis), infuse potassium in a suitable concentration at a rate of 40 mEq/hour, up to a maximum of 400 mEq/24 hour period. In critical states, potassium may be infused in saline (unless saline is contraindicated) rather than in dextrose solutions, as the latter may decrease serum potassium concentrations.

Availability And Storage: Each mL of sterile concentrated solution contains: potassium 2 mEq in water for injection. Single use glass vials and Polyamp Duofit units of 10 mL (20 mEq potassium) and 20 mL (40 mEq potassium). The osmolarity of the solutions is approximately 4.0 mOsm/mL (calc.). Store at room temperature (15 to 30°C). Discard unused portion.

POTASSIUM CHLORIDE FOR INJECTION CONCENTRATE USP Astra Electrolyte Replenisher

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