DRUG STUDY

Kalium Durules

Manufacturer

Interphil

Distributor

Zuellig

Contents

Potassium chloride.

Indications/Uses

Hypokalemia. Prophylaxis during treatment with saluretic diuretics, especially in combination

with digitalis.

Dosage/Direction for Use

Prophylaxis: Minimum Recommended Dose: 2 tablets daily.

Hypokalemia: The dosage should be adjusted according to the patient's serum potassium level.
The suggested dosage is 2 tablets twice a day or more, until the serum potassium is restored to
normal, then prophylactics dosage.

Renal Impairment: Patients with renal impairment may require lower doses. Monitoring of the
serum electrolytes is required.

Administration: The tablets should be swallowed whole, not broken or chewed, together with ½
glass of liquid. It should not be administered to a patient in a supine position.

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 electrocardiogram
(ECG) changes are also noted (increasing amplitude and peaking of T waves, disappearance of P
wave, widening of QRS complex and S-T depression).

Treatment: 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 IV sodium bicarbonate. Infusion of glucose and insulin, forced diuresis
and possibly peritoneal dialysis or hemodialysis. Use of exchange resins. In case of cramps
diazepam.

Contraindications

Hypersensitivity to potassium chloride or to any excipients of Kalium. Renal insufficiency,

hyperkalemia, untreated Addison's disease, stricture of the esophagus and/or obstructive changes
in the alimentary tract.

Special Precautions

Kalium 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.

Effects on the Ability to Drive or Operate Machinery: Kalium has no or negligible influence on
the ability to drive and use machines.

Use in pregnancy & lactation: Animal reproduction studies have not been conducted with
Kalium. It is not known whether Kalium 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. Kalium should be given to a pregnant woman only if clearly needed and
under physician's guidance with periodic monitoring of serum level.

Use in children: There is limited experience with Kalium in children.

Use in Pregnancy & Lactation

Animal reproduction studies have not been conducted with Kalium. It is not known whether
Kalium 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. Kalium should be
given to a pregnant woman only if clearly needed and under physician's guidance with periodic
monitoring of serum level.

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.

Interactions

Concomitant administration of potassium salts and potassium-sparing diuretics like aldosterone

antagonists (eg, 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.

Angiotensin-converting enzyme (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.

Storage
Store at temperatures not exceeding 30°C.

Description

Each film-coated tablet contains potassium chloride 750 mg [equivalent to potassium 9.8 mmol
(mEq) or 393 mg].

Mechanism of Action

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 side effects are thereby
reduced. The plastic matrix in Kalium is completely inert in the digestive juices but generally
disintegrates under the influence of intestinal peristalsis when all of the active substance has been
released.

Pharmacology: Pharmacodynamics: 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.

Pharmacokinetics: The bioavailability of potassium from Kalium Durules is similar to that of a

standard potassium chloride solution. The time to reach maximum concentration (Tmax) for
excretion occurs after 1-1.5 hrs after intake of Kalium.

MIMS Class

Electrolytes

ATC Classification

A12BA01 - potassium chloride; Belongs to the class of potassium-containing preparations. Used

as dietary supplements.

Regulatory Classification

Rx

Presentation/Packing

Durule 750 mg (prolonged-release, pale pink, circular, biconvex) x 100's.