PLENISH-K Tablet Ref.[115298] Active ingredients: Potassium chloride

The dosage should be adapted to the cause and degree of the manifest hypokalaemic state. Provided no signs of intolerance occur, the medicine should be continued until the hypokalaemia has been corrected.

Depending on the patient’s individual requirements, a daily dosage of 6 to 12 tablets, in several divided doses should be given. Not more than 2 tablets should be given in a single dose.

The tablets should be swallowed whole with fluid during meals while the patient is in an upright position. Adequate fluid intake during treatment with PLENISH-K 600 SR is essential. The adequacy of PLENISH-K 600 SR as an oral potassium replacement in hypokalaemia states, must be assessed by periodic monitoring of serum potassium levels.

Paediatric population

Safety and effectiveness in children have not been established. PLENISH-K 600 SR is therefore not recommended for paediatric use.

Symptoms

The clinical picture of acute overdosage (intoxication) with potassium is characterised chiefly by hyperkalaemia together with cardiovascular and neuromuscular disturbances which, in the presence of renal impairment, may already develop following relatively low doses of PLENISH-K 600 SR.

General features

Nausea, vomiting and abdominal pain. Patients may deteriorate rapidly. Gastritis and gastric/small bowel ulceration may occur.

Cardiac effects

Ventricular dysrhythmias, bundle-branch block and ventricular fibrillation, accompanied by hypotension and shock, possibly leading to cardiac arrest. Cardiac conduction abnormalities and dysrhythmias are the major hazards, particularly ventricular tachycardia and fibrillation. Besides elevation of the serum potassium concentration, typical ECG changes are also encountered (increased amplitude of peaking of T wave, disappearance of P wave, widening of QRS complex and ST segment depression).

Neuromuscular effects

Paraesthesiae, convulsions, areflexia, flaccid paralysis of striated muscle leading possibly to respiratory paralysis and respiratory arrest.

Treatment

In cases of acute poisoning, remove and/or inactivate excess potassium by:

• Induction of vomiting.
• NOTE: Activated charcoal does not adsorb potassium.
• In all cases of suspected ingestion, measure U&Es (Urea and Electrolytes) and creatinine urgently. Monitor cardiac rhythm. In all patients the potassium concentration should be repeated at regular intervals after an acute overdose (i.e. 2 to 3 hourly if elevated). Intravenous fluids should be administered to all patients.
• Perform a 12 lead ECG and examine carefully for potassium-induced toxicity (PR and QRS prolongation, peaked T waves, disappearance of P waves). Manage QRS prolongation conventionally.
• All patients should be observed for at least 12 hours after ingestion.
• Administration of cation exchange resin by mouth or gastric instillation (e.g. 20 g sodium polystyrene sulfonate with 20 ml 70% sorbitol solution three to four times per day).

In moderately severe hyperkalaemia (plasma potassium between 6,5 and 8 mmol/L, as well as T wave peaking as the only ECG abnormality):

• Promote transcellular shift of potassium by administering i.v. 300 to 500 ml/hour of 10% dextrose solution containing 10 to 20 units of insulin per 1000 ml.
• Correct acidosis, if present, with i.v. sodium bicarbonate (44 to 132 mmol/L of glucose solution).
• Correct hyponatraemia and hypovolaemia, if present.

In severe hyperkalaemia (plasma potassium exceeding 8 mmol/L or ECG abnormalities including absence of P wave, presence of widened QRS complex, disappearance of T wave, or ventricular dysrhythmia):

• Infuse glucose (with insulin) and/or bicarbonate i.v. as described above.
• Administer 10 to 30 ml 10% calcium gluconate i.v. over 1 to 5 minutes under continuous ECG monitoring; administer cation exchange resin by high retention enema as follows: 30 to 50 g sodium polystyrene sulfonate suspended in 100 ml warm aqueous sorbitol solution should be kept in the sigmoid colon for several hours, if possible. The colon is then irrigated with a non-sodium-containing solution to remove the resin. Repeated enemas can be administered, or the resin given repeatedly by mount, in order to maintain a physiological potassium concentration.
• Haemodialysis or peritoneal dialysis may be of use, particularly in patients with renal failure.

When treating hyperkalaemia, it should be borne in mind that, in patients who have been stabilised on digitalis, lowering the serum potassium concentration too rapidly can produce digitalis toxicity.

Store at or below 25°C.

Protect from moisture.

Keep in original packaging until required for use.

KEEP OUT OF REACH OF CHILDREN.

500 tablets are packed in an amber polyvinyl chloride (PVC) jar with a leaflet, rayon and sealed with a white high-density polyethylene crab claw cap.

100 tablets are packed in a white polypropylene securitainer with a leaflet, rayon, and sealed with a white low-density polyethylene cap with a tamper evident seal.

60 tablets are packed in 12’s in a PVC/PVdC/Alu (silver) blister with five blister strips in a cardboard carton.

60 tablets are packed in 10’s in a PVC/PVdC/Alu (silver) blister with six blister strips in a cardboard carton.

28 tablets are packed in a metalized layflat and sealed with a Ziploc.

56 tablets are packed in a metalized layflat and sealed with a Ziploc.

84 tablets are packed in a metalized layflat and sealed with a Ziploc.

Not all packs and pack sizes are necessarily marketed.