POTASSIUM CHLORIDE JUNO, Study notes of Medicine

Download POTASSIUM CHLORIDE JUNO and more Study notes Medicine in PDF only on Docsity! Juno Pharmaceuticals NZ Pty Ltd Datasheet – New Zealand Potassium Chloride Data Sheet 1 POTASSIUM CHLORIDE JUNO NEW ZEALAND DATA SHEET 1. PRODUCT NAME POTASSIUM CHLORIDE 0.75 g/10 mL Solution for Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 0.75 g (10 mmol) of Potassium Chloride in 10 mL Sterile Potassium Chloride Concentrate is a sterile solution of potassium chloride in Water for Injections, containing no preservatives. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for Injection 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. The treatment of hypokalaemia 2. Treatment of digitalis intoxication. The IV route is indicated when the patient is unable to take potassium orally or if hypokalaemia is severe. 4.2 DOSE AND METHOD OF ADMINISTRATION MUST BE DILUTED BEFORE ADMINISTRATION This product contains no antimicrobial preservative and should be used in one patient on one occasion only. Sterile Potassium Chloride Concentrate is a concentrated solution and must be diluted before use. Sterile Potassium Chloride Concentrate is administered intravenously only after dilution in a large volume of 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. Juno Pharmaceuticals NZ Pty Ltd Datasheet – New Zealand Potassium Chloride Data Sheet 2 In critical states, potassium may be infused in saline (unless saline is contraindicated) rather than in glucose solutions, as the latter may decrease serum potassium concentrations. To reduce microbiological hazard, use as soon as practical after dilution. If storage is necessary, hold at 2-8°C for not more than 24 hours. Diluents Compatibility Potassium Chloride Injection has been reported to be compatible with the following IV infusion fluids: • Glucose-Ringer’s injection combinations • Glucose-lactated Ringer’s injection combinations • Glucose 5% in lactated Ringer’s injection • Glucose - saline combinations • Glucose 5% in sodium chloride 0.9% • Glucose 2.5% in water • Glucose 5% in water • Glucose 10% in water • Glucose 20% in water • Ringer’s injection • Lactated Ringer’s injection • Sodium chloride 0.45% • Sodium chloride 0.9% • Sodium chloride 3% Potassium Chloride Injection has been reported to be incompatible with the following IV infusion fluids: • Mannitol • Sterile fat emulsions containing soya oil and lecithin. 4.3 CONTRAINDICATIONS Renal impairment with oliguria or azotaemia, ventricular fibrillation, atrioventricular or intraventricular heart block, 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, hyperkalaemia of any aetiology and hyperchloraemia. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Only use with specialist advice. Solutions of potassium chloride MUST BE DILUTED before use according to dilution instructions on individual labels. Careful and thorough mixing of solution after dilution is essential. In patients with impaired mechanisms for excreting potassium, administration of potassium salts can produce hyperkalaemia and cardiac arrest. This is of particular concern in patients Juno Pharmaceuticals NZ Pty Ltd Datasheet – New Zealand Potassium Chloride Data Sheet 5 Pain or phlebitis may occur if solutions containing more than 30 mmol/L of potassium are given intravenously. REPORTING OF SUSPECTED ADVERSE REACTIONS Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions https://nzphvc.otago.ac.nz/reporting/. 4.9 OVERDOSE SYMPTOMS If excretory mechanisms are impaired or if IV potassium is administered too rapidly, potentially fatal hyperkalaemia can result (See sections 4.3 and 4.4). However, hyperkalaemia 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-wave, depression of S-T segment and prolongation of the QT interval). Late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest. Other symptoms that may occur are paraesthesia of the extremities, listlessness, mental confusion, weakness or heaviness of the legs, cold skin, grey pallor, peripheral vascular collapse, fall in blood pressure, cardiac arrhythmias and heart block, due to which patients may deteriorate rapidly. Should any of these manifestations occur, discontinue potassium administration immediately. Extremely high plasma potassium concentrations (8-11 mmol/litre) may cause death from cardiac depression, arrhythmias or arrest. TREATMENT If hyperkalaemia develops, the following measures should be considered: elimination of foods and medications containing potassium and of potassium-sparing diuretics; IV administration of 300 to 500 mL/hour of 10% glucose solution containing 10 to 20 units of insulin/1000 mL; correction of acidosis, if present, with IV sodium bicarbonate, use of exchange resins, haemodialysis, or peritoneal dialysis. Cardiac arrhythmias or a serum concentration above 6.5 mmol/L require immediate attention and may be treated by intravenous administration over 1- 5 minutes of 10-20 mL of 10% calcium gluconate solution. Continuous ECG monitoring is mandatory. In treating hyperkalaemia in digitalised patients, too rapid a lowering of the serum potassium concentration can produce digitalis toxicity. MONITORING • Measure urea, electrolytes and creatinine • Monitor potassium levels regularly (2 to 3 hourly if raised) • Continuous 12 lead ECG • Observe asymptomatic patients for at least 6 hours. For advice on the management of overdose please contact the National Poisons Centre on 0800 POISON (0800 764 766). 5. PHARMACOLOGICAL PROPERTIES 5.1 PHARMACODYNAMIC PROPERTIES Juno Pharmaceuticals NZ Pty Ltd Datasheet – New Zealand Potassium Chloride Data Sheet 6 Potassium ion is the principal intracellular ion of most body tissues. Potassium ions are involved in a number of essential physiological processes, including the maintenance of intracellular tonicity, the transmission of nerve impulses, the contraction of cardiac, skeletal, and smooth muscle and the maintenance of normal renal function. Excretion of potassium occurs mainly via the kidneys and normally any amounts given in excess of intracellular requirements are rapidly eliminated. 5.2 PHARMACOKINETIC PROPERTIES After intravenous administration, potassium is actively transported from extracellular fluid into cells where concentrations reach up to 40 times that of extracellular fluid. It is excreted mainly by the kidneys and is secreted in the distal tubule where it is involved in the sodium- potassium exchange process. Some potassium is excreted in the faeces and small amounts may also be excreted in the sweat, saliva, bile and pancreatic juice. 5.3 PRECLINICAL SAFETY DATA CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY No data are available. Both potassium and chloride ions are essential constituents of human tissues and body fluids. At physiological levels, neither of these ions is known to have a carcinogenic or genotoxic activity or to cause an adverse effect on fertility. 6. PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Hydrochloric acid Water for injection 6.2 INCOMPATABILITIES Potassium chloride solution has been reported to be incompatible when diluted in solutions containing the following medicines: • Amikacin sulfate • Amphotericin B • Amoxicillin sodium • Benzylpenicillin • Diazepam • Dobutamine hydrochloride • Ergotamine tartrate • Etoposide with cisplatin and mannitol • Methylprednisolone sodium succinate • Phenytoin sodium • Promethazine hydrochloride • Sodium nitroprusside • Streptomycin sulphate Juno Pharmaceuticals NZ Pty Ltd Datasheet – New Zealand Potassium Chloride Data Sheet 7 The above list may not be complete. 6.3 SHELF-LIFE 36 months. 6.4 SPECIAL PRECAUTION FOR STORAGE Store below 25°C 6.5 NATURE AND CONTENTS OF CONTAINER Polypropylene ampoules in packs of 50 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL Any unused medicine or waste material should be disposed of in accordance with local requirements. 7 MEDICINE SCHEDULE General Sale Medicine 8 SPONSOR Juno Pharmaceuticals NZ Limited P O Box 76261 Manukau City Auckland 2241 9. DATE OF FIRST APPROVAL 7 September 1989 10. DATE OF REVISION OF THE TEXT 01 May 2020 API: 13 September 2013 SUMMARY TABLE OF CHANGES Section changed Summary of new information