- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Fertility, pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- Administrative data
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
Adults:The dosage of Slow-K should be adapted to the cause, degree and duration of potassium depletion. 2 to 3 tablets daily are usually an adequate supplement. In states of severe potassium deficiency, a higher dose of 9 to 12 tablets daily may be needed.If the dosage exceeds 16mmol K+ (2 tablets) it should be taken in divided doses. Where intermittent diuretic therapy is being used, it is advisable to give Slow-K on intervening days between administration of the diuretic. The response to treatment should preferably be monitored by repeat determination of plasma potassium and Slow-K continued until the hypokalaemia has been corrected.
Renal impairment:In patients with a Glomerular Filtration Rate (GFR) <60mL/min, Slow K should be given with extreme caution, with frequent serum potassium monitoring due to increased risk of hyperkalaemia. Slow-K is contraindicated in patients with a GFR <20mL/min (see also section 4.3 Contraindications).
Hepatic impairment:No studies have been performed in hepatically impaired patients. Paediatric population: Safety and effectiveness in children has not been established, Slow-K is therefore not recommended for paediatric use.Older people: Slow-K should be given with caution and with frequent serum potassium monitoring due to increased risk of hyperkalaemia.
PregnancyFor Slow-K no clinical data on exposed pregnancies are available.There is no indication in animal studies of direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see also section 5.3 Preclinical safety data).Pregnancy is associated with gastrointestinal hypomotility. In pregnant women, therefore, solid forms of oral potassium preparations should be given to pregnant women only if clearly needed.
LactationThe excretion of potassium in milk has not been studied in animals or human.The normal K+ content of human milk is about 13mmol/litre. Since oral potassium becomes part of the body's potassium pool, provided this is not excessive, Slow-K can be expected to have little or no effect on the potassium level in human milk.Slow-K should only be given during breast-feeding when the expected benefit to the mother outweighs the potential risk to the baby.
FertilityNo data is available.
|Gastrointestinal disorders||Gastrointestinal obstruction, gastrointestinal haemorrhage, gastrointestinal ulcer, with or without perforation of the upper or lower GIT1Gastro-intestinal disturbances (nausea, vomiting, abdominal pains, diarrhoea)2|
|Skin and subcutaneous tissue disorders||Urticaria Skin rash Pruritus|
|Metabolism and nutrition disorders||Hyperkalaemia3|
Reporting of suspected adverse reactionsReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspect adverse reactions via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard.
General features:Nausea, vomiting and abdominal pain. Patients may deteriorate rapidly. Gastritis and gastric/ small bowel ulceration may occur.
Cardiac effects:Hypotension, shock, cardiac conduction abnormalities and dysrhythmias are the major hazards, particularly ventricular tachycardia and fibrillation. ECG changes include PR and QRS prolongation, peaked T waves and disappearance of P waves.
Neuromuscular effects:Paraesthesiae, convulsions, areflexia, flaccid paralysis of striated muscle leading possibly to paralysis and respiratory arrest.
Management:• Where the practical expertise exists, consider gastric lavage within 1 hour of ingestion of 300 mg/kg potassium (4 mmol/kg K+), providing the airway can be protected. NOTE: Activated charcoal does not adsorb potassium.• In all cases of suspected ingestion, measure U&Es and creatinine urgently. Monitor cardiac rhythm. In all patients the potassium concentration should be repeated at regular intervals after an acute overdose (i.e. 2-3 hourly if elevated). Intravenous fluids should be administered to all patients.• Perform a 12 lead ECG and examine carefully for potassium-induced toxicity (PR and QRS prolongation, peaked T waves, disappearance of P waves). Manage QRS prolongation conventionally.• All patients should be observed for at least 12 hours after ingestion. • Treat severe hyperkalaemia conventionally.• If at any time the potassium concentration is more than 6.5 mmol/L or ECG changes are present the following treatment options should be considered:o Paediatric cases (children less than 12 years) early discussion with local paediatric teams is recommended.o Discuss with local poisons information service.• Haemodialysis or haemofiltration: If hyperkalaemia is not improving with conventional measures or there are life threatening arrhythmias or evidence of renal failure then haemodialysis or haemofiltration should be considered
Absorption:The potassium chloride in Slow-K has been shown to be completely absorbed; occasionally patients may notice ghost tablet cores in the faeces, these do not contain any potassium.Following a single dose of Slow-K, potassium chloride is released over a period of approximately 4 hours. Renal excretion of potassium chloride following ingestion of Slow-K occurs 30 to 60 minutes later than when the same dose is given in the form of a solution.
Elimination:In the presence of a normal potassium balance, 90% of the potassium supplied by Slow-K is excreted renally within 8 hours, and more than 98% by 24 hours.
Older people:No pharmacokinetics studies of potassium chloride are reported in the elderly population. However, these patients are more likely to develop hyperkalaemia due to physiological changes, and reduced renal function.
Paediatric population:No pharmacokinetics studies of potassium chloride are reported in the paediatric population.
Hepatic impairment:No pharmacokinetics studies of potassium chloride are reported in patients with hepatic impairment.
Renal impairment:Potassium is almost completely excreted via urine and its excretion rate correlates with the glomerular filtration rate. Considering the possibility of hyperkalaemia in these patients and severity of outcome, Slow-K is contraindicated in patients with a GFR <20mL/min. If used in patients with a GFR <60mL/min, extreme caution along with frequent serum potassium monitoring is recommended.
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