Slow-K

Texto original en francés.

Producto de salud natural autorizado en Canadá

Titular

Novartis Pharmaceuticals Canada Inc.

NPN o DIN-HM

80040226

Estado

Licencia no activa

Fecha de licencia

21 de febrero de 2013

Fecha de revisión

31 de marzo de 2016

Forma

Dragée

Vía de administración

Orale

Tipo de solicitud

Non traditionnelle

Composición

Composición medicinal no indicada.

Ingredientes no medicinales

Talc, Sucrose, Gélatine, Dioxyde de titanium, acacia, Alcool cétostéarylique, Stéarate de magnésium, Cire de Carnauba, Oxyde de fer (Fe2O3), Oxyde de Fer Jaune

Dosis recomendadas en Canadá

Usos autorizados en Canadá

Treatment of potassium depletion in patients with hypokalemia and metabolic alkalosis. Helps to Prevent potassium deficiency due to low dietary intake. Helps to prevent potassium deficiency (hypokalemia) not resulting from a dietary deficiency

Texto original en inglés.

Un uso autorizado en Canadá no es una declaración de propiedades saludables autorizada en la Unión Europea. Consulte el registro de declaraciones de propiedades saludables.

Advertencias en Canadá

Cautions and Warnings : To be taken only on the advice of a physician. Consult a health care practitioner prior to use if you have a kidney or heart condition. Do not use if you have adrenal insufficiency or uncontrolled diabetes mellitus. Do not use if you are taking medications which increase serum potassium such as potassium-sparing diuretics or angiotensin converting enzyme (ACE) inhibitors. Do not use with other potassium-containing supplements or with potassium-containing salt-substitutes. Do not use if you have a gastrointestinal ulceration or obstruction. Do not use if you have trouble swallowing (dysphagia) or if you are at a high risk for potassium chloride-induced gastric lesions (e.g. due to recent gastric surgery). Consult a health care practitioner prior to use if you are pregnant or breastfeeding. Discontinue use and consult a health care practitioner immediately if you experience numbness of the extremities, muscle weakness, paralysis, cardiac arrhythmias, low blood pressure, or confusion. Cardiovascular Potassium supplements should be used with caution in diseases associated with heart block since increased serum potassium may increase the degree of block. Endocrine and Metabolism In patients with impaired mechanisms for excreting potassium, the administration of potassium salts can produce hyperkalemia and cardiac arrest. This occurs most commonly in patients given potassium by the intravenous route but may also occur in patients given potassium orally. Potentially fatal hyperkalemia can develop rapidly and be asymptomatic. The use of potassium salts in patients with chronic renal disease, or any other condition which impairs potassium excretion, requires particularly careful monitoring of the serum potassium concentration and appropriate dosage adjustment. SLOW-K should be used with caution in patients receiving any drug known to have a potential for hyperkalemia, such as ACE inhibitors, angiotensin-IIreceptor-antagonists, NSAIDs (e.g. indomethacin), beta-blockers, heparin, digoxin and cyclosporine. ypokalemia in patients with metabolic acidosis should be treated with an alkalinizing potassium salt such as potassium acetate, potassium bicarbonate or potassium citrate. Clinical signs of hypokalemia (plasma potassium concentrations less than 3.5 mEq/Litre) include impaired neuromuscular function, which may vary from minimal weakness to frank paralysis; intestinal dilatation and ileus; and, more frequently, abnormalities of myocardial function with disturbed ECG patterns characterized by an exaggerated U wave, a broad and flat T wave, and a depressed ST segment. In some patients, diuretic-induced magnesium deficiency will prevent the restoration of intracellular deficits of potassium, so that hypomagnesemia should be corrected at the same time as hypokalemia.

Texto original en inglés.

Contra-Indications : Hypersensitivity to potassium administration, e.g., in adynamia episodica hereditaria or congenital paramyotonia or patients who are hypersensitive to any ingredient in the formulation or component of the container. Hyperkalemia of any etiology, since a further increase in the serum potassium concentration in such patients can produce cardiac arrhythmia and cardiac arrest. Hyperkalemia may complicate any of the following conditions: marked renal failure, untreated Addison's disease, hyperadrenalism associated with adrenogenital syndrome, hyporeninemic hypoaldosteronism, extensive tissue breakdown (as in severe burns, trauma, massive hemolysis, rhabdomyolysis, tumour lysis), acute dehydration, heat cramps, metabolic acidosis. Renal impairment with oliguria or azotemia. Concomitant administration of SLOW-K and potassium-sparing diuretics (e.g. spironolactone, triamterene or amiloride) Patients in whom there is cause for arrest or delay in tablet passage through the gastrointestinal tract. These states include: Partial or complete esophageal obstruction, for example by carcinomas (esophageal, post-cricoidal, thyroidal), aortic aneurysm, left-atrial enlargement, inflammatory stricture due to reflux esophagitis, and esophageal displacement due to cardiac surgery (e.g. valve replacement). Stenosis or atony in any part of the gastrointestinal tract (e.g. pyloric stenosis, intestinal strictures). In these instances, potassium supplementation should be with a liquid preparation

Texto original en inglés.

Cautions and Warnings : Monitoring and Laboratory Tests Periodic serum potassium determinations are recommended during long-term potassium supplementation. When blood samples are taken for the analysis of plasma potassium, it is important to remember that artifactual elevations can occur after an improper venipuncture technique or as a result of in-vitro hemolysis of the sample. The correction of hypokalemia, particularly in the presence of cardiac disease, renal disease or acidosis requires careful attention to acid-base balance and appropriate monitoring of serum electrolytes, the electrocardiogram and the clinical status of the patient. Overdosage Overdosage from therapeutic doses of solid oral potassium salts in persons with normal excretory mechanisms rarely occurs. However, if excretory mechanisms are impaired, potentially fatal hyperkalemia may occur. Acute (accidental or intentional) overdosages of solid oral potassium salts have resulted in severe and/or fatal hyperkalemia. In case of moderate/severe hyperkalemia, standard treatment should be initiated with monitoring of the serum potassium levels. Rare cases of pharmacobezoar have been reported in association with large overdose of Slow-K tablets.

Texto original en inglés.

Known Adverse Reactions : Gastrointestinal The most common adverse reactions to oral potassium salts are nausea, vomiting, flatulence, abdominal discomfort and diarrhea. There have also been reports of esophageal and gastrointestinal obstruction, haemorrhage ulceration with or without perforation of the upper or lower gastrointestinal tract. Small bowel lesions have been reported following the administration of SLOW-K (slow-release potassium chloride). The incidence is much lower than that reported for enteric-coated potassium chloride tablets. Electrolytes One of the most severe adverse effects is hyperkalemia. Skin Pruritus and/or skin rash, as well as urticarial, have been reported rarely.

Texto original en inglés.

Cautions and Warnings : Gastrointestinal Since anticholinergic agents have the potential to reduce gastrointestinal motility, they should be prescribed with caution when given concomitantly with solid oral potassium preparations, particularly in high doses. A probable association exists between the use of coated tablets containing potassium salts, with or without thiazide diuretics, and the incidence of serious small bowel ulceration. Such preparations should be used only when adequate dietary supplementation is not practical, and should be discontinued if abdominal pain, distention, nausea, vomiting or gastrointestinal bleeding occurs. SLOW-K is a wax matrix tablet formulated to provide a controlled rate of release of potassium chloride and thus to minimize the possibility of a high local concentration of potassium near the bowel wall. While the reported frequency of small bowel lesions is very much less with wax matrix tablets (less than one per 100,000 patient years) than with enteric-coated potassium chloride tablets (40-50 per 100,000 patient years), a few cases associated with wax matrix tablets have been reported. SLOW-K should be discontinued immediately and the possibility of bowel obstruction or perforation considered if pronounced nausea, severe vomiting, diarrhea, abdominal pain, distention or gastrointestinal bleeding occurs. Such risks may be increased in patients with esophageal stasis, known peptic and/or gastric ulcers, delayed intestinal transit, or intestinal ischemia due to generalized atherosclerotic vascular disease. Patients with ostomies may have an altered intestinal transit time and are better treated with other forms of potassium salt. Sensitivity/Resistance SLOW-K contains sucrose (=saccharose). Patients with rare hereditary disorders like fructose-intolerance, glucose-galactose malabsorption, or sucraseisomaltase insufficiency should not use this medicine. Special Populations Pregnant Women: For 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. In general, no drug should be taken during the first trimester, and the benefits and risks of drug administration should be carefully considered throughout pregnancy. Pregnancy is associated with gastrointestinal hypomotility. Solid oral potassium supplements should therefore only be given to pregnant women if such therapy is considered essential. Nursing Women: The excretion of potassium in milk has not been studied in animals or human The normal K+ content of human milk is approximately 13 mEq/Litre. Since oral potassium becomes part of the body's potassium pool, provided the body potassium is not excessive, the contribution of 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. Pediatrics: Safety and effectiveness in children have not been established. SLOW-K is therefore not recommended for pediatric use. Geriatrics: As renal function, and hence the potential for maintaining potassium balance may decrease with age, serum potassium levels should be monitored regularly and dosage adjusted as appropriate. As gastrointestinal motility may also be affected by age, elderly patients should be reminded to swallow solid oral potassium salts with adequate amounts of fluid.

Texto original en inglés.

Fuente

Ficha oficial de Health Canada, licencia 80040226

Base de datos de productos de salud natural autorizados (BDPSNH), Health Canada: productos autorizados, ingredientes, dosis, usos y advertencias, consultado el 27 de octubre de 2026.

Contient des informations visées par la Licence du gouvernement ouvert – Canada (Santé Canada, BDPSNH)

Texto original en francés.

La fórmula vendida en Europa con el mismo nombre puede ser diferente. Esta información no sustituye el consejo de un médico o farmacéutico.

Lista en la revisión oficial del 31 de marzo de 2016 (registro: Base de datos de productos de salud natural autorizados (BDPSNH), Health Canada: productos autorizados, ingredientes, dosis, usos y advertencias).

Fotografiar el envase