INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
MICRO-K EXTENCAPS CAPSULES

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

MICRO-K EXTENCAPS CAPSULES

COMPOSITION:
Each capsule contains 600 mg (Equivalent to 8 mEq K) potassium chloride.

PHARMACOLOGICAL CLASSIFICATION:
A 24 Mineral substitutes, electrolytes.

PHARMACOLOGICAL ACTION:
Potassium ion is the principal intracellular cation of most tissues. Potassium ions participate in a number of essential physiological processes, including the maintenance of intracellular tonicity, the transmission of nerve impulses, the contraction of cardiac, skeletal and smooth muscle and the maintenance of normal renal function.
Potassium depletion may occur whenever the rate of potassium loss through renal excretion and/or loss from the gastro-intestinal tracts, exceeds the rate of potassium intake. Micro-K Extencaps contains dispersible small crystalline particles of potassium chloride. Each particle is microencapsulated with a polymeric coating which allows for controlled release of potassium and chloride ions.
The polymeric coating forming the microcapsules functions as a water-permeable membrane and gradually dissolves the potassium chloride within the microcapsules. The resulting potassium chloride solution slowly diffuses outward through the membrane.

INDICATIONS:
For Potassium Supplementation:

–	During diuretic therapy when potassium falls below 3 mmol/L.
–	When potassium falls below 3,2 mmol/L during digitalis therapy or when symptoms of or ECG changes indicative of hypokalaemia occur. (In acute potassium loss, which may be life-threatening, potassium must be administered intravenously).
–	Familial hypokalaemia.

CONTRA-INDICATIONS:
All forms of hyperkalaemia, as encountered in marked renal failure, in conditions involving extensive cell destruction (e.g. severe burns, crush syndrome, massive haemolysis), in untreated Addison's disease, as well as in metabolic acidosis and acute dehydration.
Renal failure, even where it is not yet accompanied by manifest hyperkalaemia. All states in which passage through the digestive tract is retarded or obstructed (e.g. owing to diverticula or compression of the oesophagus by an enlarged atrium, to stenosis or atony in various gastro-intestinal segments).

WARNINGS:
If a patient treated with Micro-K Extencaps develops pronounced nausea, severe vomiting, severe abdominal pains or flatulence, diarrhoea or gastro-intestinal haemorrhage, the preparation should be withdrawn at once, because these signs and symptoms may point to the presence of ulceration or perforation in the gastro-intestinal tract.
Owing to the risk of hyperkalaemia, potassium salts should not be given concomitantly with potassium-sparing diuretics (aldosterone antagonists, triamterene, or amiloride). Micro-K Extencaps should not be administered concomitantly with intravenous potassium.

DOSAGE AND DIRECTIONS FOR USE:
The dosage of Micro-K Extencaps should be adapted to the cause and degree of the manifest potassium deficiency state. Depending on the patient's individual requirements, a daily dosage of 6 to 12 capsules in several fractional doses, should be given.
The capsules should be swallowed whole with fluid during meals. The medication should be continued until the potassium deficiency has been overcome.
Note :
Although this medicine contains potassium chloride, it has not been proven that this dosage will necessarily prevent a significant potassium loss or correct an existing deficiency of potassium.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The most common adverse reactions to oral potassium salts are nausea, vomiting, abdominal discomfort and cramps and diarrhoea.
Intestinal bleeding, ulceration, perforation and obstruction may occur with Micro-K Extencaps. One of the most severe adverse effects of potassium supplementation is hyperkalaemia. Skin rash has been reported with potassium preparations.
In patients with impaired renal function, and in elderly individuals special care should be exercised when prescribing potassium salts in view of the risk of their producing hyperkalaemia. Monitoring of the serum electrolytes is indicated in cases of protracted substitution therapy with high doses of potassium, and must invariably be carried out in patients with impaired renal function or heart disease.
Caution should be exercised when prescribing solid oral potassium preparations, particularly in high dosages, in patients concurrently receiving anticholinergics because of their potential to slow gastro-intestinal motility.
Because of the possibility of their causing gastro-intestinal irritation, Micro-K Extencaps should be prescribed with particular caution in patients with a history of peptic ulcer.
Children:
Safety and efficacy in children have not been established.
Pregnancy:
Solid dosage forms of oral potassium preparations should be given to pregnant women only if clearly needed because of gastro-intestinal hypomotility associated with pregnancy.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Signs and Symptoms:
Mainly cardiovascular (hypotension, shock, ventricular arrhythmias, bundlebranch block, ventricular fibrillation leading possibly to cardiac arrest) and neuromuscular (paraesthesiae, convulsions, areaflexia, flaccid paralysis of striated muscle leading possibly to respiratory paralysis). Besides elevation of the serum potassium concentration, typical E.C.G. changes are also encountered (increased amplitude and peaking of T waves, disappearance of P wave, widening of QRS complex, and S-T depression). Gastro-intestinal ulceration.
Treatment:
Gastric lavage, administration of cation-exchange agents, infusion of glucose and insulin, forced diuresis, and possibly peritoneal dialysis or haemodialysis.

CONDITIONS OF REGISTRATION:
Advertising to the professions only.

IDENTIFICATION:
Clean, shiny, evenly filled hard gelatin capsules with an opaque peach-coloured body and cap. Capsule shall be monogrammed Micro-K CE with black ink.

PRESENTATION:
Securitainers containing 100 capsules.

STORAGE INSTRUCTIONS:
Store at controlled temperature 15° to 30°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
T/24/157.

NAME AND BUSINESS ADDRESS OF APPLICANT:
Continental Ethicals (Pty) Ltd
7 Fairclough Road
PORT ELIZABETH
6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
27 July 1987.

        M218
        L.LTD.L. 22148

First displayed on this site December 1995
Current: September 2004
Source: Pharmaceutical Industry
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