POTASSIUM CHLORIDE

Posology The dosage is dependent on age, weight and clinical condition of the patient, especially those with renal or cardiac insufficiency. Fluid balance, serum glucose, serum sodium and other electrolytes may need to be monitored before and during administration, especially in patients with increased non-osmotic vasopressin release (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients co-medicated with vasopressin agonist drugs due to the risk of hyponatraemia.

Monitoring of serum sodium is particularly important for physiologically hypotonic fluids. 8). 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. 5 mmol/l The maximum recommended dose of potassium is 2 – 3 mmol/kgBW/24 h. Fluid Generally, not more than 40 ml fluid/kg BW/d should be supplied. In cases where more potassium is needed, other strengths should be considered as well.

3% w/v, respectively).

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 potassium 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

General 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. 4). 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

4. Duration of use This medicinal product may be administered as long as there is an indication for energy, potassium and fluid administration. Method of administration Intravenous use. As a matter of principle, infusion pumps should be used for the infusion of potassium in the setting of correction therapy.

4 Special warnings and precautions for use Special warnings 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). Care must be exercised in the administration of large volume infusion of hypotonic fluids to patients with congested states or pulmonary oedema.

Solutions with low electrolyte content, especially sodium, should also be administered with care in patients with hyponatraemia. Care should be taken to avoid a rapid marked decrease of the serum sodium level as this may be associated with the risk of osmotic central nervous damage.

15 % w/v) and Glucose 50 mg/ml (5% w/v) Solution for Infusion to prevent hyponatraemia. 15% w/v and Glucose 5% w/v Solution for Infusion is an isotonic solution. 2). Depending on the tonicity of the solution, the volume and rate of infusion and depending on a patient's underlying clinical condition and capability to metabolise glucose, intravenous administration of these solutions can cause electrolyte disturbances most importantly hypo- or hyperosmotic hyponatraemia.

g. 5) are at particular risk of acute hyponatraemia upon infusion of hypotonic fluids. Acute hyponatraemia can lead to acute hyponatraemic encephalopathy (brain oedema) characterized by headache, nausea, seizures, lethargy and vomiting.

Patients with brain oedema are at particular risk of severe, irreversible and life-threatening brain injury. g. meningitis, intracranial bleeding, and cerebral contusion) are at particular risk of the severe and life-threatening brain swelling caused by acute hyponatraemia.

5). Blood glucose monitoring will be required. Due to the risk of developing a severe lactic acidosis and/or a Wernicke encephalopathy a preexisting thiamin (Vitamin B1) deficiency must be corrected before infusion of glucose containing solutions.

Solutions containing glucose should not be administered simultaneously with, before or after an administration of blood through the same infusion equipment because of the possibility of pseudoagglutination. Administration of glucose solutions is not recommended after acute ischaemic strokes as hyperglycaemia was reported to worsen ischaemic brain damage and impair recovery.

g. Addison’s disease or sickle cell anaemia. Paediatric population Solutions with low salt, especially sodium, should only be administered with special caution to children and close monitoring of electrolyte and fluid balance should be performed.

Intravenous fluid therapy should be closely monitored in the paediatric population as they may have impaired ability to regulate fluids and electrolytes. The infusion of hypotonic fluids together with the non-osmotic secretion of ADH (for example in pain, anxiety, the post-operative state, nausea, vomiting) may result in hyponatraemia.

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.

Precautions for use Clinical supervision should include ECGs, regular checks of fluid balance, serum electrolytes and monitoring of blood glucose.

− Hyperkalaemia − Severe renal impairment with oliguria and anuria − Severe hyperchloraemia − Head trauma (first 24 hours) − Hyperhydration − Hyperglycaemia