KLOREF® GRANULES (EFFERVESCENT GRANULES)
SCHEDULING STATUS:
S2
PROPRIETARY NAME
(and dosage form):
KLOREF® GRANULES (EFFERVESCENT GRANULES)
COMPOSITION
Each sachet contains: Potassium bicarbonate 1350mg, Potassium chloride 500mg, Betaine hydrochloride 2070mg
Each sachet in solution provides 1,5g KCl ( = 20 mmol K+ and Cl-)
PHARMACOLOGICAL CLASSIFICATION
A 24 Mineral substitutes, electrolytes
PHARMACOLOGICAL ACTION
Potassium supplementation in cases of potassium depletion.
INDICATIONS
Treatment of potassium depletion and/or hypokalaemia. Hypokalaemia may occur due to inadequate intake of potassium or due to increased gastrointestinal loss (vomiting, diarrhoea, fistulae, administration of diuretics including furosemide, ethacrynic acid, chlorthalidone and the thiazides)
CONTRAINDICATIONS
Hyperchloraemia.
Acidosis - renal tubular or metabolic - where the chloride ion might worsen the deficiency of bicarbonate ions.
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
1 or 2 Sachets daily (20 - 40 mmol K+ and Cl-) preferably after meals. A few patients may need higher doses. Each sachet should be dissolved in at least 200mL of cold water.
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 crystalline powder with an odour of lemon and lime. The reconstituted solution is colourless, slightly opalescent with an odour of lemon and lime.
PRESENTATION
Cartons containing 30sachets.
STORAGE INSTRUCTIONS
Store in a cool, dry place below 25°C.
KEEP OUT OF REACH OF CHILDREN
REGISTRATION NUMBER
29/24/0626
NAME AND BUSINESS ADDRESS OF THE APPLICANT
KNOLL PHARMACEUTICALS SA (PTY) LTD
PO Box 3030, Halfway House, 1685
DATE OF PUBLICATION OF THIS PACKAGE INSERT
18 November 1996
5060925 |
