PHARMACOLOGICAL CLASSIFICATION A 24 Mineral substitutes, electrolytes.
PHARMACOLOGICAL ACTION Potassium supplementation.
Potassium supplements must be given as the chloride since potassium may not be retained unless chloride is present in adequate amounts. Potassium without the chloride will not correct the alkalosis that frequently accompanies and perpetuates hypokalaemia. Enteric-coated potassium chloride tablets, because of their use of solid potassium chloride, carry a risk of intestinal ulceration and stenosis. Effervescent potassium tablets are of no value unless they contain chloride. KLOREF has been specially formulated to provide potassium with chloride in physiologically balanced quantities. Because of Kloref's unique formulation, potentially ulcerogenic solid potassium chloride is avoided and the two essential ions are separately released from the tablet's principal constituents when water is added. At the same time, effervescence takes place and a pleasantly-flavoured solution is produced.
INDICATIONS Hypokalaemia such as can result from administration of diuretics, including frusemide, ethacrynic acid, chlorthalidone and the thiazides; or resulting from excessive vomiting or diarrhoea.
CONTRA-INDICATIONS Hyperchloraemia.
Acidosis - renal tubular or metabolic - where the chloride ion might make worse the deficiency of bicarbonate ion.
WARNINGS Hyperkalaemia: In patients with impaired mechanisms for excreting potassium, the administration of potassium salts can produce hyperkalaemia and cardiac arrest. Potentially fatal hyperkalaemia can develop rapidly and may 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 adjustments.
DOSAGE AND DIRECTIONS FOR USE Each Kloref tablet, when added to half a glass of cold water, dissolves quickly with effervescence to produce a pleasant-tasting solution containing equal amounts of the two essential ions, approximately 6,7 mEq K+ and Cl- (equivalent to a solution of 500 mg potassium chloride), with no other electrolyte present.
In most cases of potassium deficiency a dosage of 1 - 2 Kloref tablets three times a day (20 - 40 mEq K+ and Cl-) will be adequate, but a few patients may need larger doses.
The tablets should be dissolved in half a glass of cold water and the resulting solution drunk when effervescence is completed. The tablets should not be swallowed undissolved.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS Excessive administration of potassium may lead to development of hyperkalaemia. Symptoms include paraesthesia of the extremities, muscle weakness, paralysis, hypotension, cardiac arrhythmias, heart block and cardiac arrest.
Nausea, vomiting, diarrhoea and abdominal cramps may occur following oral administration of potassium salts.
Special precautions Potassium salts should be administered with care to patients with renal or adrenal insufficiency, cardiac disease, acute dehydration, heart cramps, extensive tissue destruction as occurs with severe burns or to patients receiving potassium-sparing diuretics. Attention should be paid to the concurrent use of other medicines that either contain potassium or have the potential for hyperkalaemia. Treatment should be discontinued if severe nausea, vomiting or abdominal distress develops.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT See "side-effects and Special Precautions".
The treatment of overdosage is as follows:
i)
Removal of all potassium-containing foods from the diet.
ii)
Further treatment is symptomatic and supportive. Severe hyperkalaemia should be treated by haemodialysis or peritoneal dialysis.
IDENTIFICATION White circular flat, bevelled-edge uncoated tablet, engraved with "KLOREF" on one face.
PRESENTATION Securitainers containing 60 and 100 tablets.
STORAGE DIRECTIONS Store in a cool, dry place below 25°C. Keep out of reach of children.
REGISTRATION NUMBER B/24/175
NAME AND BUSINESS ADDRESS OF APPLICANT KNOLL Pharmaceutocals South Africa (Pty) Ltd
P.O. Box 3030
Halfway House 1685
DATE OF PUBLICATION OF THIS PACKAGE INSERT 15 January 1998
KLOREF Effervescent Tablets