POTASSIUM CHLORIDE

The dosage is dependent on age, weight and clinical condition of the patient, especially those with renal or cardiac insufficiency. Dosage and rate of infusion should be determined by ECG and serum electrolyte monitoring. Adequate urine flow must be ensured.

Adults:

The following recommendations are general guidelines on potassium, however prescribing should follow local guidelines. /24 h. /day should be supplied. In cases where more potassium is needed, other strengths should be considered as well.

Paediatric population:

The volume and rate of infusion will depend upon the requirements of the individual patient. Reduced volumes and rates of infusion may be required. 5 mmol/kg bw per hour should not be exceeded. Continuous ECG monitoring should be applied during infusion.

Maximum daily dose The maximum recommended dose of potassium is 3 mmol/kg BW per 24 hours. In any case the limits for daily fluid intake must not be exceeded. Elderly Basically the same dosage as for adults applies, but caution should be exercised in patients suffering from further diseases like cardiac insufficiency or renal insufficiency that may frequently be associated with advanced age.

See section 4. 4). 35 mmol/l/h. Duration of use This medicinal product may be administered as long as there is an indication for electrolyte and fluid administration. Method and route of administration Intravenous use. 9% w/v Solution for Infusion administration via peripheral lines is 10 mmol potassium per hour.

For greater infusion rates, the solutions should be infused via a central line. As a matter of principle, infusion pumps should be used for the infusion of potassium in the setting of correction therapy.

When used accordingly no adverse drug reactions are to be expected.

Undesirable effects are listed according to their frequencies as follows:

Very Common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1,000) Very rare (< 1/10,000) Not known (frequency cannot be estimated from the available data) General disorders and administration site conditions Not known: Local reactions at the infusion site, including local pain, venous irritation and occasionally thrombophlebitis may occur.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.

9% w/v Solution for Infusion should only be administrated with caution in cases of: • Hypernatraemia • patients with oedematous states • pulmonary oedema • disorders where restriction of sodium intake is indicated, such as cardiac insufficiency, generalised oedema, pulmonary oedema, hypertension, pre-eclampsia, severe renal insufficiency or liver cirrhosis.

Solutions containing potassium should be administered slowly and only after renal function has been established and proved adequate. In patients with renal impairment, its use must be carefully controlled by frequent determinations of plasma potassium concentrations and periodic ECGs.

The infusion must be discontinued if signs of renal insufficiency develop during infusion. 5). Sodium chloride supplementation must be exercised slowly in patients with chronic hyponatraemia as too rapid correction of serum sodium levels may in rare cases lead to osmotic side effects.

As a slightly hypertonic solution the infusion should also be administered with care in patients with hypertonic dehydration. Special caution must be exercised if the solution is administered to acidotic patients. Caution should be exercised when the solution is administered to patients with Addison’s disease as these patients are predisposed to hyperkalaemia.

Paediatric population:

Premature or term infants may retain an excess of sodium due to immature renal function. In premature or term infants, repeated infusion of sodium chloride should therefore only be given after determination of the serum sodium level.

Elderly patients:

Elderly patients, who are more likely to suffer from cardiac insufficiency and renal impairment, should be closely monitored during treatment, and the dosage should be carefully adjusted, in order to avoid cardio circulatory and renal complications resulting from fluid overload.

− Hyperkalaemia, − Severe renal impairment with oliguria, anuria, or azotaemia, − Hyperchloraemia and severe hypernatraemia, − Hyperhydration.