POTASSIUM Chloride

POTASSIUM Chloride

750mg Tablet

DRUG CATEGORY: Antihypokalemia

BRAND NAME: Kalium® Durules®

FORMULATION

Each tablet contains potassium chloride 750mg (equivalent to approximately 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 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 is similar to that of standard potassium chloride solution. The t_max for excretion occurs after 1-1.5 hours after intake of Potassium Chloride.

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 shluld 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 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.

CONTRAINDATIONS

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 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.

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 e 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. It is not known whether Potassium Chloride 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 reproductive capacity. Potassium Chloride 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: Metabolism: Hyperkalemia.

(<1/100) Gastrointestinal: Abdominal pain, diarrhea, nausea.

Rare: Gastrointestinal: Ulceration, perforation and stricture/stenosis of the esophagus or small

(<1/1000) 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).

Management

Gastric lavage, preferably with physiological saline. Continuous ECG-monitoring, close 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^oC.