APO-K 600mg

Produit de santé naturel homologué au Canada

Titulaire: Apotex Inc.
NPN ou DIN-HM: 00602884
Statut: Licence active
Date de licence: 30 juillet 2008
Date de révision: Non renseignée
Forme: Comprimé
Voie d'administration: Orale
Type de demande: DIN de transition

Si ce produit était vendu en France

Aucun point relevé par les règles que nous appliquons.

Une quantité quotidienne est calculée uniquement pour une posologie adulte orale explicite, exprimée par jour et dans une unité solide correspondant à la forme du produit. Les unités ambiguës, liquides, poudres et doses pédiatriques ne sont pas extrapolées. Une quantité non calculée n'est pas comparée aux limites de dose. Cette analyse ne constitue pas une autorisation de vente en France ni une évaluation de sécurité ou d'efficacité.

Composition

Composition médicinale non renseignée.

Ingrédients non médicinaux

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

Doses recommandées au Canada

Population	Âge	Quantité par prise	Fréquence
Adultes	Non précisée	minimum : 5 Comprimé ; maximum : 12 Comprimé	1 Tous les jours
Adultes	Non précisée	3 Comprimé	1 Tous les jours

Usages autorisés au Canada

Potassium Supplement.

Un usage autorisé au Canada n'est pas une allégation de santé autorisée dans l'Union européenne. Consultez le registre des allégations de santé.

Mises en garde au Canada

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.
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.
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.
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.