PHEBRA

What it is

Phebra Potassium Chloride 22.3% is a concentrated injection for infusion containing 2.23 g of potassium chloride in 10 mL. Each vial contains 30 mmol potassium ions and 30 mmol chloride ions. The preparation is a clear colourless sterile solution. This is a concentrated solution and may be dangerous if used undiluted.

Approved indications

— Treatment of potassium depletion in patients with hypokalaemia. — Treatment of digitalis intoxication.

Dosing overview

Phebra Potassium Chloride 22.3% is a concentrated solution and must be diluted before use, administered intravenously only after dilution in a large volume parenteral fluid. The dose and rate of injection are dependent upon the individual patient's condition. The usual maximum concentration is 40 mmol/L. In patients whose serum potassium concentration is above 2.5 mmol/L, the rate of infusion should not exceed 10 mmol/hour. The total dose should not exceed 200 mmol/24 hours. If urgent treatment is required (serum potassium concentration less than 2 mmol/L with ECG changes or paralysis), infuse potassium in a suitable concentration at a rate of 40 mmol/hour, up to a rate of 400 mmol/24-hour-period.

Key safety warnings

In patients with impaired mechanisms for excreting potassium, administration of potassium salts can produce hyperkalaemia and cardiac arrest, which is an important concern in patients given intravenous potassium. Potentially fatal hyperkalaemia can develop rapidly and be asymptomatic. In patients being given potassium, especially by intravenous administration, monitoring of serum electrolytes, the electrocardiogram and the patient's clinical status is indicated. 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. Hypokalaemia should not be treated by the concomitant administration of potassium salts and potassium-sparing diuretics (such as spironolactone or triamterene), since the simultaneous administration of these agents can produce severe hyperkalaemia. 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 electrocardiogram 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.

Contraindications

Phebra Potassium Chloride 22.3% is contraindicated in renal impairment with oliguria or azotaemia, ventricular fibrillation, untreated Addison's disease, hyperadrenalism associated with adrenogenital syndrome, extensive tissue breakdown as in severe burns, acute dehydration, heat cramps, increased sensitivity to potassium administration as in adynamia episodica hereditaria or congenital paramyotonia, and hyperkalaemia of any aetiology.

Regulatory history

Phebra Potassium Chloride 22.3% (ARTG 23073) was first listed on 1991-10-14.