APO-K 600mg

Natural health product licensed in Canada

Licence holder

Apotex Inc.

NPN or DIN-HM

00602884

Status

Active licence

Licence date

30 July 2008

Revision date

Not provided

Form

Comprimé

Route of administration

Orale

Application type

DIN de transition

Composition

Medicinal composition not provided.

Non-medicinal ingredients

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

Recommended doses in Canada

Uses authorised in Canada

Potassium Supplement.

A use authorised in Canada is not an authorised health claim in the European Union. See the health claims register.

Warnings in 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.

Source

Official Health Canada record, licence 00602884

Licensed Natural Health Products Database (LNHPD), Health Canada: licensed products, ingredients, doses, uses and risks, retrieved 27 October 2026.

Contains information licensed under the Open Government Licence – Canada (Health Canada, LNHPD)

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

The formula sold in Europe under the same name may differ. This information does not replace advice from a doctor or pharmacist.

The evidence date of this ingredient list is unknown.

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