This medicinal Product is used as a source of the potassium cation for the treatment or
prevention of potassium depletion in patients for whom dietary measures or oral
medication are inadequate. Potassium salts may also be used cautiously in those taking
digoxin where potassium depletion may cause arrhythmias. Potassium Chloride
Concentrate 15% must be administered by slow IV, as a dilute solution..

Adults (including elderly)and Children:
This medicinal Product must be diluted by adding to a large volume intravenous
fluid before use. For example, 10mls diluted with not less than 500mls 0.9% Sodium
Chloride Intravenous Infusion BP, or other suitable diluents, and mixed well.
Dosage depends on the serum ionogram value and the acid-base state.
A potassium deficiency is calculated according to the formula:
MMOL Potassium = KG BW x 0.2 x 2 x (4.5 – actual serum potassium (MMOL)).

(The extracellular volume is calculated from the body weight in KG x 0.2).
It is recommended not to exceed 2-3 MMOL potassium per kg body weight in 24 hours.

This medicinal Product must not be injected undiluted.
Plasma potassium concentration must be measured at regular intervals to avoid the
development of hyperkalaemia, especially in patients with renal impairment.
ECG monitoring facilities should be available.
Initial potassium replacement therapy should not involve glucose infusions,
because glucose may cause a further decrease in the plasma potassium
concentration.
Potassium supplements should be administered with caution in patients with
cardiac disease and in patients who are receiving potassium sparing diuretics or
other medications which may increase plasma potassium levels.

Potassium supplements should not be administered with potassium sparing diuretics
(such as amiloride, spironolactone and triamterene), particularly in patients with
impaired renal function. Any patients on this combination require close monitoring in
order to diagnose a potential hyperkalaemic condition as soon as possible.
Angiotensin-converting enzyme inhibitors and angiotensin II receptor antagonists:
Patients taking ACE-inhibitors or angiotensin II receptor antagonists,
especially those with impaired renal function, should be closely monitored, as
the potassium sparing effect in combination with potassium infusion may
result in hyperkalaemia.

Ciclosporin:
Concurrent use of ciclosporin may increase the risk of hyperkalaemia.

Glucose Infusion:
Concomitant use of glucose infusions in hypokalaemic patients may cause a further
decrease in plasma potassium concentrations.

This medicinal Product may be used during pregnancy and lactation under the
supervision of the prescribing physician.

Not Known.

Pain at the injection site and phlebitis may occur during IV administration of
solutions containing 30 MMOL potassium or more per litre.
Hyperkalaemia is the most common and
serious hazard of potassium therapy.
To report any side effect(s):
Saudi Arabia:
The National Pharmacovigilance and Drug Safety Centre (NPC)
Fax: +966-11-205-7662
Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.
Toll free phone: 8002490000
E-mail: npc.drug@sfda.gov.sa
Website: www.sfda.gov.sa/npc
Other GCC States:
Please contact the relevant competent authority.

Clinical signs and symptoms of potassium overdosage include: Paraesthesia of the
extremities, listlessness, mental confusion, weakness or heaviness of the legs, flaccid
paralysis, cold skin, grey pallor, peripheral vascular collapse, fall in blood pressure,
cardiac arrhythmias and heart block. Extremely high plasma potassium concentrations
(8-11 MMOL/litre) may cause death from cardiac depression, arrhythmias or arrest.
Cardiac arrhythmias or a serum concentration above 6.5 MMOL/litre, require

immediate attention and may be treated by intravenous injection over 1 – 5 minutes
of 10 – 20 ml of 10% Calcium Gluconate Injection B.P. with E.C.G. monitoring. Serum
concentrations may be reduced by infusion of 300 – 500 mls per hour of 10% - 25%
glucose solutions containing up to 10 units of insulin for each 20 g of glucose, or by
the infusion of sodium bicarbonate solution.

Potassium is the major cation of intracellular fluid and is essential for maintenance
of acid-base balance, isotonicity and the electrodynamic characteristics of the cell.
Potassium chloride is used as a source of the potassium cation for treatment or
prevention of potassium depletion in patients in whom dietary measures are
inadequate. Potassium chloride may also be used cautiously to abolish arrhythmias or
cardiac glycoside toxicity precipitated by a loss of potassium.

Potassium chloride is generally readily absorbed from the gastro-intestinal tract.
Potassium is excreted mainly by the kidneys; it is secreted in the distal tubules
which are also the site of sodium-potassium exchange. The capacity of the kidneys
to conserve potassium is poor and urinary excretion of potassium continues even
when there is severe depletion. Tubular secretion of potassium is influenced by
several factors, including chloride ion concentration, hydrogen ion exchange, acidbase
equilibrium and adrenal hormones. Some potassium is excreted in the faeces
and small amounts may also be excreted in saliva, sweat, bile and pancreatic juice.

No further information other than that which is included in the Summary of Product
Characteristics.

Water for Injections

The compatibility of the large volume IV fluid intended for dilution should be checked
before use.

Do not store above 30°C.

Polyethylene Plastic Ampoules filled with 5 ml, 10 ml or 20 ml of Solution.

Use as directed by a physician.