Source: Health Products Regulatory Authority (ZA) Revision Year: 2020 Publisher: PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead 2191
PLENISH-K 600 SR is contraindicated in:
Concomitant administration with intravenous potassium.
In patients with impaired mechanisms for excreting potassium, the administration of potassium salts can produce hyperkalaemia and cardiac arrest. This arises most commonly in patients given potassium by the intravenous route, but it may also occur in patients receiving potassium orally. Potentially fatal hyperkalaemia can develop rapidly and may be asymptomatic. Hyperkalaemia may develop in patients having difficulty with either renal potassium excretion or potassium metabolism (see SIDE EFFECTS).
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.
PLENISH-K 600 SR should be used with caution in patients receiving any medicine known to cause hyperkalaemia, i.e. other potassium chloride supplements, potassium sparing diuretics, nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g. indomethacin), ACE inhibitors, angiotensin-II-receptor antagonists, lithium, beta-blockers, heparin, digoxin and cyclosporine (see INTERACTIONS).
Caution should be observed in treating patients with renal or adrenal insufficiency, acute dehydration or heat cramp. In the presence of reduced renal function hyperkalaemia may be produced.
If a patient under treatment with PLENISH-K 600 SR develops severe vomiting, severe abdominal pains or flatulence, diarrhoea or gastrointestinal haemorrhage, PLENISH-K 600 SR should be withdrawn at once, because these signs and symptoms may point to the presence of ulceration or perforation in the gastrointestinal tract (see SIDE EFFECTS). Such risks may be increased in patients with oesophageal stasis, known peptic and/or gastric ulcers, delayed intestinal transit, or intestinal ischaemia due to generalised atherosclerotic vascular disease.
Since anticholinergic medicines may reduce gastrointestinal motility, they should be prescribed with great care when given concomitantly with PLENISH-K 600 SR, particularly in high doses (see INTERACTIONS).
Patients with ostomies or other conditions which alter intestinal transit times are better treated with other forms of potassium salts.
Hypokalaemia in patients with metabolic acidosis should be managed not with potassium chloride, but with an alkalinising potassium salt, such as potassium bicarbonate, potassium citrate or potassium acetate.
Periodic serum potassium determinations are recommended during long-term potassium supplementation, especially in clinical conditions, which carry a risk of hyperkalaemia (e.g. impairment of renal function, elderly individuals, heart disease) (see INTERACTIONS). In addition, careful attention should be paid to the acid-base balance, to other serum electrolyte levels (e.g. magnesium), to the ECG, and to the clinical status of the patient. When blood samples are taken for analysis of plasma potassium, it is important to bear in mind that artificial elevations can occur after an improper venipuncture technique or as a result of in-vitro haemolysis of the sample.
Careful attention should be paid to any pointers to gastrointestinal intolerance when prescribing PLENISH-K 600 SR. Thus for example, before administering the tablets one should preclude the possibility that the patient may be suffering from active ulceration in the gastrointestinal tract or from a condition in which passage through the tract may be obstructed to such an extent as to compromise the transit of substances given by the oral route. PLENISH-K 600 SR should be prescribed with particular caution in patients with a history of peptic ulcer because of the possibility of their causing gastrointestinal ulceration.
In some patients, diuretic-induced magnesium deficiency will prevent the restoration of intracellular deficits of potassium, so that hypomagnesaemia should be corrected at the same time as hypokalaemia.
Patients should not drive, use machinery or perform any tasks that require concentration until they are certain that PLENISH-K 600 SR does not adversely affect their ability to do so safely (see SIDE EFFECTS).
Concomitant treatment with potassium-sparing diuretics (e.g. triamterene and amiloride) and aldosterone antagonists (e.g. spironolactone and eplerenone) is contraindicated (see CONTRAINDICATIONS). Medicines which interfere with potassium excretion may promote hyperkalaemia when given together with PLENISH-K 600 SR.
Combined treatment with the following medicines increase the risk of hyperkalaemia: ACE inhibitors, angiotensin-II-receptor antagonists, ciclosporin, NSAIDs (e.g. indomethacin), beta- blockers, heparin, digoxin, direct renin inhibitors (e.g. aliskerin), medicines that contain potassium such as potassium salts of penicillin and ciclosporin and proton pump inhibitors (see WARNINGS AND SPECIAL PRECAUTIONS). Thus, caution should be exercised in their concomitant use.
Similarly, the concomitant use of potassium containing salt substitutes for flavouring food should be avoided.
Caution should be exercised when prescribing PLENISH-K 600 SR, particularly in high dosage, in patients concurrently receiving anticholinergics, because of their potential to slow gastrointestinal motility (see WARNINGS AND SPECIAL PRECAUTIONS).
The safety of PLENISH-K 600 SR in pregnancy and lactation has not been established.
No clinical data on potassium chloride exposed pregnancies are available.
There is no indication in pre-clinical studies of direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Pregnancy is associated with gastrointestinal hypomotility. In pregnant women, therefore, solid forms of oral potassium preparations, such as PLENISH-K 600 SR should be given to pregnant women only if clearly needed.
The excretion of potassium in milk has not been studied in animals or humans. The normal potassium (K+) content of human milk is about 13 mmol/litre. Since oral potassium, such as PLENISH-K 600 SR, becomes part of the body’s potassium pool, provided this is not excessive, PLENISH-K 600 SR can be expected to have little or no effect on the potassium level in human milk.
PLENISH-K 600 SR should only be given during breastfeeding when the expected benefit to the mother outweighs the potential risk to the baby.
No data is available.
Frequency unknown: Hyperkalaemia
Frequency unknown: Gastrointestinal obstruction, gastrointestinal haemorrhage, gastrointestinal ulcer, with or without perforation of the upper or lower GIT1, gastrointestinal disturbances (nausea, flatulence, vomiting, abdominal pains and cramps, diarrhoea)2
1 usually associated with other factors known to predispose a patient to these effects (e.g. delayed GIT transit time, obstruction of GIT).
2 necessitating either a reduction in dosage or withdrawal of medicine (see WARNINGS AND SPECIAL PRECAUTIONS).
Frequency unknown: Urticaria, skin rash, pruritus
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