CompoAtlas

APO-K 600mg

Producto de salud natural autorizado en Canadá

Titular
Apotex Inc.
NPN o DIN-HM
00602884
Estado
Licencia activa
Fecha de licencia
30 de julio de 2008
Fecha de revisión
No indicada
Forma
Comprimé
Vía de administración
Orale
Tipo de solicitud
DIN de transition

Si este producto se vendiera en Francia

No se ha detectado ningún punto según las normas que aplicamos.

Solo se calcula una cantidad diaria para una posología oral explícita para adultos, expresada por día y en una unidad sólida correspondiente a la forma del producto. No se extrapolan las unidades ambiguas, los líquidos, los polvos ni las dosis pediátricas. Una cantidad no calculada no se compara con los límites de dosis. Este análisis no constituye una autorización de venta en Francia ni una evaluación de seguridad o eficacia.

Composición

Composición medicinal no indicada.

Ingredientes no medicinales

Dioxyde de titane, Sunset Yellow FCF Aluminium Lake, Quinoline Yellow WS, Silicon dioxide colloïdal, Stéarate de magnésium, Hypromellose, Poly(éthylène glycol), Hydroxypropylcellulose, Ethylcellulose

Dosis recomendadas en Canadá

PoblaciónEdadCantidad por tomaFrecuencia

Adultos

Traducido automáticamente del francés.

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Adultes

Base de datos de productos de salud natural autorizados (BDPSNH), Health Canada: productos autorizados, ingredientes, dosis, usos y advertencias ·

No especificada

Traducido automáticamente del francés.

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Non précisée

Base de datos de productos de salud natural autorizados (BDPSNH), Health Canada: productos autorizados, ingredientes, dosis, usos y advertencias ·

Traducción no disponible. Texto original, idioma: francés.

minimum : 5 Comprimé ; maximum : 12 Comprimé

Base de datos de productos de salud natural autorizados (BDPSNH), Health Canada: productos autorizados, ingredientes, dosis, usos y advertencias ·

Adultos

Traducido automáticamente del francés.

Ver el original
Adultes

Base de datos de productos de salud natural autorizados (BDPSNH), Health Canada: productos autorizados, ingredientes, dosis, usos y advertencias ·

No especificada

Traducido automáticamente del francés.

Ver el original
Non précisée

Base de datos de productos de salud natural autorizados (BDPSNH), Health Canada: productos autorizados, ingredientes, dosis, usos y advertencias ·

Usos autorizados en Canadá

Traducción no disponible. Texto original, idioma: francés.

Potassium Supplement.

Base de datos de productos de salud natural autorizados (BDPSNH), Health Canada: productos autorizados, ingredientes, dosis, usos y advertencias ·

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

Traducción no disponible. Texto original, idioma: francés.

Précautions et mises en garde : In patients with impaired mechanisms for excreting potassium, administration of potassium salts can produce hyperkalemia and cardiac arrest. This occurs commonly in patients given potassium by the i.v. route but may also occur in patients given potassium orally. Potentially fatal hyperkalemia can develop rapidly and by 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. ACE inhibitors (e.g. captopril, enalapril) will produce some potassium retention by inhibiting aldoterone production. In patients receiving ACE inhibitors, therefore potassium supplements should only be given under close monitoring. Hypokalemia in patients with metabolic acidosis should be treated with an alkalinizing potassium salt such as potassium acetate, potassium bicarbonate or potassium citrate. A probable assocation 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. Apo-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 1/100,000 patient years) than with enteric coated potassium chloride tablets (40 to 50/100,000 patient years), a few cases associated with wax matrix tablets have been reported. Apo-K should be discontinued immediately and the possibility of bowel obstruction or perforation considered if pronounced nausea, severe vomiting, diarrhea, abdominal pain, distention 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. Precautions - Periodic serum potassium deteminations are recommended during long-term potassium supplementation. When blood samples are taken for the analysis of plasma potassium, it is important to remember that artificial elevations can occur after an improper venipuncture technique or as a result in vitro hemolysis of the sample.

Base de datos de productos de salud natural autorizados (BDPSNH), Health Canada: productos autorizados, ingredientes, dosis, usos y advertencias ·

Traducción no disponible. Texto original, idioma: francés.

Précautions et mises en garde : 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. Potassium supplements should be used with caution in diseases associated with heart block since increased serum potassium may increase the degree of block. Patients with ostomies may have an altered intestinal transit time and are better treated with other forms of potassium salt. 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. Pregnancy - In general, no drug should be taken during the first trimester, and the benefits and risks or drug administration should be carefully considered throughout pregnancy. Lactation - The normal K+ content of human milk is approximately 13 mEq/L. Since oral potassium becomes part of the body's potassium pool, provided the body potassium is not excessive, the contribution of Apo-K can be expected to have little or no effect on the potassium level in human milk. Drug Interactions - Concomitant treatment with potassium sparing diuretics is contraindicated. Apo-K should be used with caution in patient's receiving agents known to have a potential for hyperkalemia, such as ACE inhibitors (e.g. captopril, enalpril; see Warnings), NSAIDS (e.g. indomethacin), beta-blockers, Heparin and digoxin. Since anticholinergic agents have the potential to reduce gastrointestinal motility, they should be prescribed with caution when given concomitantly with sold oral potassium preparations, particularly in high doses. Children - Safety and effectiveness in children have not been established. 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.

Base de datos de productos de salud natural autorizados (BDPSNH), Health Canada: productos autorizados, ingredientes, dosis, usos y advertencias ·

Traducción no disponible. Texto original, idioma: francés.

Contre-indications : Hypersensitivity to potassium administration, e.g. in adynamia episodica hereditaria or congenital paramyotonia. Hyperkalemia of any entiology, 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, hypoeninemic 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 Apo-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 displacement due to cardiac surgery (e.g. valve replacement); stenosis or atony in any part of the gastrointestinal tract (e.g. pyloric stenosis, intestinal structures). In these instances, potassium supplementation should be with a liquid preparation.

Base de datos de productos de salud natural autorizados (BDPSNH), Health Canada: productos autorizados, ingredientes, dosis, usos y advertencias ·

Traducción no disponible. Texto original, idioma: francés.

Effets indésirables connus : The most common adverse reactions to oral potassium salts are nausea, vomiting, flatulence, abdominal discomfort and diarrhea. These symptoms are due to irritation of the gastrointestinal tract and are best avoided by increasing fluid intake when possible, taking the dose with meals or reducing the dose. One of the most severe adverse effects is hyperkalemia (see Warnings). There have also been reports of esophageal and gastrointestinal obstruction, bleeding, ulceration or perforation (see Warnings). Small bowel lesions have been reported following the administration of Apo-K, the incidence is much lower than that reported for enteric-coated potassium chloride tablets (see Warnings). Pruritus and/or skin rash, as well as urticaria, have been reported rarely.

Base de datos de productos de salud natural autorizados (BDPSNH), Health Canada: productos autorizados, ingredientes, dosis, usos y advertencias ·

Fuente

Ficha oficial de Health Canada, licencia 00602884

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)

Licence du gouvernement ouvert – Canada 2.0 (OGL-Canada 2.0)

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

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