Potassium Chloride
Kalium® Durules®
750 mg Tablet
Sustained Release
Antihypokalemia
FORMULATION
Each tablet contains potassium chloride 750 mg (equivalent 9.8 mmol (mEq) or 393 mg K+).
PHARMACEUTICAL FORM
Prolonged release tablets.
A pale pink, circular, biconvex, film-coated tablet.
The Durules formulation provides gradual release of the active ingredient over a long period of
time. By administering potassium chloride in this form, high local concentrations of the
substance in the stomach or intestine are avoided. The gastrointestinal adverse effects are
thereby reduced.
The plastic matrix in Potassium Chloride (Kalium Durules) is completely inert in the digestive
juices but generally disintegrates under the influence of intestinal peristalsis when all active
substance has been released.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Potassium plays a major role in a number of physiological processes like the maintenance of
intracellular tonicity, the transmission of nerve impulses, the renal function and the contraction
of cardiac, skeletal and smooth muscle.
Potassium depletion may occur when the loss through renal excretion and/or the loss from the
gastrointestinal tract exceeds the potassium intake.
Pharmacokinetic properties
The bioavailability of potassium from Potassium Chloride (Kalium Durules) is similar to that of a
standard potassium chloride solution. The TMAX for excretion occurs after 1-1.5 hours after
intake of Potassium Chloride (Kalium Durules).
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INDICATIONS
Hypokalemia. Prophylaxis during treatment with saluretic diuretics, especially in combination
with digitalis.
DOSAGE AND METHOD OF ADMINISTRATION
Adults including the elderly
Prophylaxis
Individual dosage with a minimum dose of 2 tablets daily.
Hypokalemia
The dosage should be adjusted according to the serum potassium level. Suggested dosage: 2
tablets twice a day, or more, until serum potassium is restored to normal, then prophylactic
dosage.
Impaired renal function
Patients with renal impairment may require lower doses. Monitoring of the serum electrolytes is
required.
Children
There is limited experience with Potassium Chloride (Kalium Durules) in children.
The tablets should be swallowed whole, not broken or chewed, together with half a glass of
liquid. The tablets should not be administered to a patient in a supine position.
CONTRAINDICATIONS
Renal insufficiency, hyperkalemia, untreated Addison's disease, stricture of the esophagus
and/or obstructive changes in the alimentary tract. Hypersensitivity to the active substance or to
any of the excipients.
PRECAUTIONS FOR USE
The product should be used with caution in the presence of obstructive changes in the
alimentary tract, especially in patients with constriction of the esophagus, when there is a
potential risk of esophageal complications (local irritation). A liquid potassium product is
recommended as a substitute in these cases.
Monitoring of serum electrolytes is particularly necessary in patients with heart or kidney
disease.
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INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Concomitant administration of potassium salts and potassium-sparing diuretics like aldosterone
antagonists (e.g. spironolactone), amiloride or triamterene may cause severe hyperkalemia and
should be avoided.
Tacrolimus may cause hyperkalemia or increase the serum concentration of potassium, which
should be taken into account when combined with potassium salts.
ACE inhibitors may produce some increase in potassium serum levels by inhibiting aldosterone
secretion. Potassium supplements should be given to patients concomitantly taking ACE
inhibitors only with close monitoring of potassium levels.
PREGNANCY AND LACTATION
Animal reproduction studies have not been conducted with Potassium Chloride (Kalium
Durules). It is not known whether Potassium Chloride (Kalium Durules) can cause fetal harm
when administered to a pregnant woman or can affect reproductive capacity. It is unlikely that
potassium supplementation that does not lead to hyperkalemia would have an adverse effect on
the fetus or would affect reproductive capacity. Potassium Chloride (Kalium Durules) should be
given to a pregnant woman only if clearly needed and under physician's guidance with periodic
monitoring of serum level.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Potassium Chloride (Kalium Durules) has no or negligible influence on the ability to drive and
use machines.
ADVERSE REACTIONS
Uncommon:
(<1/100)
Metabolism: Hyperkalemia.
Gastrointestinal: Abdominal pain, diarrhea, nausea.
Rare:
(<1/1000)
Gastrointestinal: Ulceration, perforation and
stricture/stenosis of the esophagus or small intestine.
Skin: Rash.
OVERDOSAGE
Symptoms
Mainly cardiovascular (hypotension, shock, ventricular arrhythmias, bundle-branch block,
ventricular fibrillation leading possibly to cardiac arrest), neuromuscular and gastrointestinal.
Beside elevation of serum potassium concentration, typical ECG changes are also noted
(increasing amplitude and peaking of T waves, disappearance of P wave, widening of QRS
complex and S-T depression).
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Management
Gastric lavage, preferably with physiological saline. Continuous ECG-monitoring, dose
monitoring of electrolytes and blood gases. Infusion of physiological saline, correction of
metabolic acidosis with intravenous sodium bicarbonate. Infusion of glucose and insulin, forced
diuresis and possibly peritoneal dialysis or hemodialysis. Use of exchange resins. In case of
cramps diazepam.
STORAGE
Store at a temperature not exceeding 30 °C.
CAUTION
Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription.
AVAILABILITY
Bottle of 100s
Validity Code
CV.000-053-838.2.0
14 June 2001
Manufactured by Interphil Laboratories Inc.
Canlubang Industrial Estate, Bo Pittland, Cabuyao,
Laguna Philippines
For AstraZeneca Pharmaceuticals (Phils.), Inc.
16/F Net 3 Center, Cor. 3rd Ave & 30th St.,
Bonifacio Global City, Taguig, Philippines
Kalium is a trademark of the AstraZeneca group of companies.
Please review complete product information before prescribing.
Further information available upon request.
Kalium Durules_CV.000-053-838.2.0/14June2001
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