POTASSIUM CHLORIDE

1 mg K +. The dosage of this solution depends on the age, weight, clinical and biological (acid-base balance) conditions of the patient, concomitant therapy and in particular the patient’s hydration state. General posology The recommended dosage for the treatment of carbohydrates and fluid depletion is - for adults: 500 ml to 3 litres/24 h - for babies and children: 0 - 10 kg body weight: 100 ml/kg/24 h 10 - 20 kg body weight: 1000 ml + (50 ml/kg over 10 kg) /24 h > 20 kg body weight: 1500 ml + (20 ml/kg over 20 kg)/24 h The infusion rate should not exceed the patient’s glucose oxidation capacities in order to avoid hyperglycaemia.

Therefore the maximum dose ranges from 5 mg/kg/min for adults to 10 - 18 mg/kg/min for babies and children depending on the age and the total body mass. Posology for prevention and treatment of potassium depletion Adults, Older people and Adolescents A typical dose of potassium for the prevention of hypokalaemia may be up to 50 mmol daily and similar doses may be adequate in mild potassium deficiency.

The maximal recommended dose of potassium is 2 to 3 mmol/kg/24 h. e. 7-10 mmol/h) under ECG control. The maximum recommended administration rate should not exceed 15- 20 mmol/h. Patients with renal impairment should receive lower doses.

In any case, the dosage given under “General Posology” should not be exceeded. /h. The dose has to be adjusted on frequently obtained lab values. /day. 4). Method of administration Route of administration The administration is performed by intravenous route using sterile and non- pyrogenic equipment.

Intravenous potassium should be administered via a large peripheral or central vein to diminish the risk of causing sclerosis. If infused through a central vein, be sure the catheter is not in the atrium or ventricle to avoid localised hyperkalaemia.

Solutions containing potassium should be administered slowly. Rate of administration As administered intravenously, potassium should not be given faster than 15 to 20 mmol/h to avoid dangerous hyperkalaemia. Monitoring Adequate urine flow must be ensured and careful monitoring of plasma- potassium and other electrolyte concentrations is essential.

Higher dosage or high speed infusion must be performed under ECG control. 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 products with lower sodium concentration compared to serum sodium concentration. 3% w/v & Glucose 5% w/v a rapid active glucose transport into the body cells occurs. 8).

Adverse reactions may be associated to the technique of administration, including febrile response, infection at the site of injection, local pain or reaction, vein irritation, venous thrombosis or phlebitis extending from the site of injection, extravasation, and hypervolemia.

In case of undesirable effect(s), the infusion must be discontinued. 1 1 Reported for similar solutions containing dextrose. 4. 2. 5). 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.

Intravenous 5% glucose-infusions are isotonic. Glucose solutions with higher glucose concentration are hypertonic. In the body, however, glucose containing fluids can lead to an effect which can be considered as supply of free water due to a rapid active glucose transport into the body cells.

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 metabolize glucose, intravenous administration of glucose can cause electrolyte disturbances most importantly hypo- or hyperosmotic hyponatraemia.

g. 5) are at particular risk of acute hyponatraemia upon infusion of physiologically 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.

High volume infusion must be used under specific monitoring in patients with cardiac or pulmonary failure. Administration should be carried out under regular and careful surveillance. Regular monitoring of clinical status, blood glucose level, plasma electrolyte concentrations, plasma creatinine levels, BUN level, acid-base balance and ECG is essential in patients receiving potassium therapy, particularly those with cardiac or renal impairment.

Adequate urine flow must be ensured and fluid balance should be monitored. g. myocardial infarction, cardiac arrhythmias) or conditions predisposing to hyperkalemia such as renal or adrenocortical insufficiency, acute dehydration, or extensive tissue destruction as occurs with severe burns.

In patients under digitalis therapy regular monitoring of the plasma potassium level is mandatory. Infusion of solutions containing glucose could be contraindicated in the first 24 hours following head trauma and blood glucose concentration should be closely monitored during intracranial hypertension episodes.

Administration of glucose containing solutions may lead to hyperglycaemia. In this case, it is recommended not to use this solution after acute ischemic strokes as hyperglycaemia has been implicated in increasing cerebral ischemic brain damage and impairing recovery.

If hyperglycaemia occurs, rate of infusion should be adjusted or insulin administered. In diabetic patients, the amount of infused glucose has to be taken into account and insulin requirements may be modified. During long term treatment, a convenient nutritive treatment supply must be given to the patient.

15% w/v & Glucose 5% w/v Solution for Infusion contains glucose derived from corn. 8). Paediatric Population Newborns – especially those born premature and with low birth weight -are at increased risk of developing hypo- or hyperglycaemia and therefore need close monitoring during treatment with intravenous glucose solutions to ensure adequate glycaemic control in order to avoid potential long term adverse effects.

Hypoglycaemia in the newborn can cause prolonged seizures, coma and brain damage. Hyperglycaemia has been associated with intraventricular haemorrhage, late onset bacterial and fungal infection, retinopathy of prematurity, necrotizing enterocolitis, bronchopulmonary dysplasia, prolonged length of hospital stay, and death.

In order to avoid potentially fatal over infusion of intravenous fluids to the neonate, special attention needs to be paid to the method of administration. When using a syringe pump to administer intravenous fluids or medicines to neonates, a bottle of fluid should not be left connected to the syringe.

When using an infusion pump all clamps on the intravenous administration set must be closed before removing the administration set from the pump, or switching the pump off. This is required regardless of whether the administration set has an anti free flow device.

The intravenous infusion device and administration equipment must be frequently monitored. Plasma electrolyte concentrations should be closely monitored in the paediatric population as this population may have impaired ability to regulate fluids and electrolytes.

The infusion of hypotonic fluids together with the non- osmotic secretion of ADH may result in hyponatraemia. Hyponatraemia can lead to headache, nausea, seizures, lethargy, coma, cerebral oedema and death, therefore acute symptomatic hyponatraemic encephalopathy is considered a medical emergency.

Hyperchloremia and hyperkalaemia - Severe renal insufficiency (with oliguria/anuria) - Uncompensated cardiac failure - Addison’s disease The solution is also contraindicated in cases of uncompensated diabetes, other known glucose intolerances (such as metabolic stress situations), hyperosmolar coma, hyperglycaemia, hyperlactatemia.