Microsoft word - k-10_pi _2011-03-10_.doc

PRESCRIBING INFORMATION
2011 GlaxoSmithKline Inc. All Rights Reserved ®K-10 is a registered trademark, used under license by GlaxoSmithKline Inc. PRESCRIBING INFORMATION
NAME OF DRUG
(Potassium Chloride Solution, 10%)
THERAPEUTIC CLASSIFICATION
INDICATIONS

The prevention and treatment of hypokalemic states which may occur in conjunction with diuretic
therapy, digitalis intoxication, corticosteroid therapy, inadequate dietary intake, loss of potassium
due to vomiting and diarrhea, hypochloremic alkalosis, diabetic acidosis, and familial periodic
paralysis as well as other causes.
CONTRAINDICATIONS
Potassium chloride is contraindicated in patients with: Adrenal insufficiency (Addison’s disease), congenital myotonia, dehydration, exacerbations of peptic ulcer disease, gastrointestinal bleeding (see WARNINGS AND PRECAUTIONS), heat cramps, hyperkalemia, hypersensitivity to any of the preparation’s ingredient, hyponatremia, hypovolemia, metabolic acidosis (due to uncontrolled diabetes), renal failure, structural or functional disorders obstructing the passage of the drug through the gastrointestinal tract, concomitant treatment with a potassium-sparing diuretic alone or in combination with a saluretic-diuretic agent (see INTERACTIONS). INTERACTIONS
Potassium serum concentration should be periodically measured during concomitant administration of drugs which interact with this product. Increase of potassium serum concentration may occur when potassium chloride is used simultaneously with: potassium sparing diuretics, angiotensin-converting-enzyme (ACE) inhibitors, angiotensin-II receptor blockers, indomethacin, glucocorticosteroids, heparin, cardiac glycosides, β-adrenolytics and other potassium-containing products. Potassium-sparing diuretics Concomitant use of potassium chloride and potassium-sparing diuretics such as amiloride, canrenone, spironolactone, triamterene (alone or in combination) is contraindicated (see CONTRAINDICATIONS). Risk of potentially lethal hyperkalemia is particularly high in patients with kidney failure (added effects of potassium-sparing diuretics). ACE inhibitors Concomitant use of potassium chloride with ACE inhibitors is not recommended except in the case of hypokalemia. Concomitant use of these medicinal products induces a risk of potentially lethal hyperkalemia particularly in patients with kidney failure. Cardiac glycosides Special caution should be used in concomitant use of the potassium chloride and cardiac glycosides. Hyperkalemia reduces the inotropic activity of cardiac glycosides (digoxin) and may cause atrioventricular conductivity disorders. Non-steroidal anti-inflammatory drugs Special caution should be used in concomitant use of the potassium chloride and non-steroid anti-inflammatory drugs. Non-steroid anti-inflammatory drugs may cause hyperkalemia. During concomitant treatment with these drugs control of serum potassium concentration is necessary. Calcium Concomitant administration of parenteral calcium salts may cause arrhythmias. Sodium chloride A diet rich in sodium chloride increases potassium excretion. WARNINGS AND PRECAUTIONS
Potassium must be administered cautiously, since the degree of deficiency or the ideal daily dosage often is not accurately known. Excessive dosage may give rise to potassium intoxication. Frequent checks of the clinical status of the patient, and the periodic ECG and/or serum potassium levels should be made. Potassium intoxication may result from overdosage of potassium or from therapeutic dosage in conditions stated under CONTRAINDICATIONS. Ability to perform tasks that require judgement, motor or cognitive skills The drug has no effect on the ability to drive vehicles and operate machinery. Cardiac This drug should be used with caution in the presence of cardiac disease. Elderly Potassium chloride should be used with special caution in elderly patients. Fertility There are no relevant data available. Gastrointestinal
Potassium chloride should be withdrawn in the presence of severe abdominal pain, hematemesis
and black feces (see CONTRAINDICATIONS).
Lactation
The drug may be given to breast-feeding women only if in the physician's judgement the benefit
for the mother outweighs the potential risk to the fetus.
Pregnancy
The drug may be given to pregnant women only if in the physician's judgement the benefit for the
mother outweighs the potential risk to the fetus. There is no data on the risk for the fetus in
humans and animals, as no properly controlled clinical trials have been conducted.
Renal
The administration of lower potassium doses should be considered in patients with renal disorders.
Kalemia, ECG and renal function should periodically be monitored during therapy with potassium
preparation (see CONTRAINDICATIONS and DOSAGE AND ADMINISTRATION).


ADVERSE REACTIONS
Cardiac disorders Arrhythmia, atrioventricular conduction disorders. Gastrointestinal disorders Nausea, vomiting, flatulence, abdominal pain, abdominal discomfort, diarrhea, burning sensation in the stomach and esophagus, constipation and small intestine erosions. Metabolism and nutrition disorders Hyperkalemia (with risk of sudden death). Hyperkalemia should be prevented by monitoring potassium levels (see WARNINGS AND PRECAUTIONS). Skin and subcutaneous tissue disorders Skin rash OVERDOSAGE
Symptoms The severity of symptoms depends on the severity of hyperkalemia. The signs and symptoms of potassium intoxication include weakening of muscle tone, and sensory disorders, paresthesia of the extremities, listlessness, mental confusion, flaccid paralysis, fall in blood pressure, cardiac arrhythmia, and heart block. In severe hyperkalemia (over 6,0 mmol/l), cardiac arrest may occur. Treatment The drug should be withdrawn if overdose symptoms occur. Considerable overdose requires hospitalization. The following methods may be used in the treatment of hyperkalemia: 1. Dextrose solution. 10% to 25%, containing 10 units of crystalline insulin/20 g dextrose, given intravenously in a dose of 300 to 500 ml/hr. 2. Absorption and exchange of potassium using sodium or ammonium cycle cation exchange resin, orally and as retention enema. (Caution: Ammonium compounds should not be used in patients with hepatic cirrhosis.) 3. Hemodialysis and peritoneal dialysis. 4. Eliminate the use of potassium-containing foods or drugs. In case of digitalization, too rapid a lowering of plasma potassium concentration can cause digitalis toxicity. For management of a suspected drug overdose, contact your regional Poison Control Centre. DOSAGE AND ADMINISTRATION

Adults: Take as directed by a physician. One tablespoonful (15 mL) twice daily, dissolved
completely in 100-250 mL of cold water, juice or other liquid. Take with food or immediately
after meals and drink slowly (to minimize gastrointestinal irritation and prevent too rapid
absorption). Deviation from this recommendation may be indicated since no average total daily
dose can be defined but must be governed by close observation for clinical effects. In determining
dosage, it is well to remember that fruits, vegetables and their juices contain potassium. Patients
should be cautioned to follow directions explicitly in regard to dilution of K-10® to prevent
gastrointestinal injury.
Children: There are no relevant data available.
Elderly: Potassium chloride should be used with special caution in elderly patients.

Renal impairment: Potassium chloride is contraindicated in patients with renal failure (see
CONTRAINDICATIONS and INTERACTIONS).
Hepatic impairment: There are no relevant data available.
AVAILABILITY
Each tablespoon (15 mL) contains potassium chloride 1.5 g (supplying 20 mEq of elemental potassium) and the following non-medicinal ingredients: calcium cyclamate, citric acid, glycerin, lemon flavour, orange flavour, and sodium benzoate. Bottles of 500 mL.

Source: http://www.gsk.ca/english/docs-pdf/K_10_2011.pdf