Source: Health Products Regulatory Authority (IE) Revision Year: 2020 Publisher: Essential Pharma (M) Limited, Vision Exchange Building, Triq it-Territorjals, Zone 1, Central Business District, Birkirkara, CBD 1070, Malta
For use in patients requiring supplemental potassium therapy.
Uses include:
Supplement to potassium depleting diuretics.
Hypokalaemia associated with prolonged corticosteroid therapy.
Where there is inadequate dietary intake due to poor dietary habits or malnutrition. Increased gastrointestinal potassium loss due for example to vomiting (except pyloric stenosis) or diarrhoea.
Increased renal potassium loss in primary or secondary hyperaldosteronism, Cushing’s syndrome and renal tubular disease.
Altered transcellular shifts of potassium as in hypokalaemic familial periodic paralysis.
It is important that the tablets should be swallowed whole, with fluid during meals, whilst the patient is sitting upright.
The dosage of Slow-K should be adjusted to the individual needs of each patient. 2-3 tablets daily are usually an adequate supplement to prevent hypokalaemia. In states of potassium deficiency doses of 5 to 6 tablets daily may be needed increasing up to 12 tablets daily in severe deficiency. 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.
In patients with mild to moderate renal impairment, Slow K should be given with extreme caution with frequent serum potassium monitoring due to increased risk of hyperkalemia. Slow-K is contraindicated in patients with severe renal impairment (see also section 4.3 Contraindications).
No studies have been performed in hepatically impaired patients. However, Slow-K should be given with caution due to increased likelihood of electrolyte disturbances in patients with hepatic impairment (see also section 4.3 Contraindications).
Safety and effectiveness in children have not been established, Slow-K is therefore not recommended for paediatric use.
Slow-K should be given with caution and with frequent serum potassium monitoring due to increased risk of hyperkalemia.
Slow-K is advised to be given with or after food to minimize gastric irritation. The sugar-coated tablets must not be crushed, chewed, or sucked, but should be swallowed whole with an adequate amount of fluid while the patient is sitting upright.
The clinical picture of acute overdosage (intoxication) with potassium is characterized chiefly by hyperkalemia together with cardiovascular and neuromuscular disturbances, which, in the presence of renal impairment, may already develop after relatively low doses of Slow-K. Presence of radiopaque tablets on abdominal X-ray, will confirm the ingestion.
Hypotension, shock, ventricular arrhythmias, bundle-branch block, ventricular fibrillation leading possibly to cardiac arrest. Besides elevation of serum potassium concentration, typical ECG changes are also encountered (increasing amplitude and peaking of T waves, disappearance of P wave, widening of QRS complex and S-T segment depression).
Paraesthesiae, convulsions, areflexia, flaccid paralysis of striated muscle leading possibly to respiratory paralysis.
Rare cases of pharmacobezoar have been reported in association with large overdose of Slow-K tablets. Formation of pharmacobezoar may cause continual release of potassium chloride, hours after drug ingestion.
In cases of acute poisoning, remove and/or inactivate excess potassium by:
3 years.
Do not store above 30°C.
Store in the original container.
Keep the container tightly closed.
Securitainer (PP) in packs of 500.
No special requirements.
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