40-03700-0900-otp.qe4

KLOR-CON ®
particularly careful monitoring of the serum potassium concentration potassium is administered too rapidly intravenously, potentially fatal hyperkalemia can result (see Contraindications and Warnings). It is
Interaction with Potassium-Sparing Diuretics: Hypokalemia should
important to recognize that hyperkalemia is usually asymptomatic and Powder (Potassium Chloride for Oral Solution, USP) not be treated by the concomitant administration of potassium salts may be manifested only by an increased serum potassium and a potassium-sparing diuretic (e.g., spironolactone, triamterene or concentration and characteristic electrocardiographic changes (peaking of T-waves, loss of P-wave, depression of S-T segment and amiloride), since the simultaneous administration of these agents canproduce severe hyperkalemia.
prolongation of the QT interval). Late manifestations include muscleparalysis and cardiovascular collapse from cardiac arrest.
Metabolic Acidosis: Hypokalemia in patients with metabolic acidosis
KLOR-CON ®
should be treated with an alkalinizing potassium salt such as Treatment measures for hyperkalemia include the following: (1) potassium bicarbonate, potassium citrate or potassium acetate.
elimination of foods and medications containing potassium and of Powder (Potassium Chloride for Oral Solution, USP) potassium-sparing diuretics; (2) intravenous administration of 300 to Precautions
500 mL/hr of 10% dextrose solution containing 10-20 units of insulin General: The diagnosis of potassium depletion is ordinarily made by
per 1,000 mL; (3) correction of acidosis, if present, with intravenous demonstrating hypokalemia in a patient with a clinical history sodium bicarbonate; (4) use of exchange resins, hemodialysis or suggesting some cause for potassium depletion.
Laboratory Tests: In interpreting the serum potassium level, the
In treating hyperkalemia, it should be recalled that in patients who have physician should be aware that acute alkalosis per se can produce
been stabilized on digitalis, too rapid a lowering of the serum Description
potassium bicarbonate, potassium citrate or potassium acetate.
hypokalemia in the absence of a deficit in total body potassium, while potassium concentration can produce digitalis toxicity.
Fruit-flavored KLOR-CON® and KLOR-CON®/25 Powder (Potassium Indications and Usage
acute acidosis per se can increase the serum potassium concentration
Dosage and Administration
Chloride for Oral Solution, USP) are oral potassium supplements into the normal range even in the presence of a reduced total body 1) For therapeutic use in patients with hypokalemia with or without offered as powder for reconstitution in individual packets. Each potassium. The treatment of potassium depletion, particularly in the Dosage must be adjusted to the individual needs of each patient but metabolic alkalosis; in digitalis intoxication and in patients with packet of KLOR-CON® powder contains potassium 20 mEq and presence of cardiac disease, renal disease, or acidosis, requires is typically in the range of 20 mEq per day for the prevention of hypokalemic familial periodic paralysis.
chloride 20 mEq provided by potassium chloride 1.5 g. Each packet careful attention to acid-base balance and appropriate monitoring of hypokalemia to 40-100 mEq per day or more for the treatment of of KLOR-CON®/25 powder contains potassium 25 mEq and chloride 2) For prevention of potassium depletion when the dietary intake of serum electrolytes, the electrocardiogram, and the clinical status of the 25 mEq provided by potassium chloride 1.875 g. KLOR-CON® and potassium is inadequate in the following conditions: patients receiving The usual adult dose is 20-100 mEq of potassium per day (one KLOR-CON®/25 are sugar-free. Inactive ingredients: FD&C Yellow digitalis and diuretics for congestive heart failure; hepatic cirrhosis Carcinogenesis, Mutagenesis, Impairment of Fertility: Carcin-
KLOR-CON® 20 mEq packet 1 to 5 times daily after meals or one No. 6, malic acid, neotame, silicon dioxide, and natural and/or with ascites; states of aldosterone excess with normal renal function; ogenicity, mutagenicity and fertility studies in animals have not been KLOR-CON®/25 25 mEq packet 1 to 4 times daily after meals).
potassium-losing nephropathy and certain diarrheal states.
performed. Potassium is a normal dietary constituent.
The contents of each KLOR-CON® packet should be dissolved in at 3) The use of potassium salts in patients receiving diuretics for Clinical Pharmacology
Pregnancy: Pregnancy Category C. Animal reproduction studies have
least 4 ounces of cold water or other beverage. The contents of each uncomplicated essential hypertension is often unnecessary when such KLOR-CON®/25 packet should be dissolved in at least 5 ounces of Potassium ion is the principal intracellular cation of most body tissues.
not been conducted with potassium chloride. It is not known if patients have a normal dietary pattern. Serum potassium should be cold water or other beverage. These preparations, like other Potassium ions participate in a number of essential physiological potassium chloride causes fetal harm when administered to a checked periodically, however, and if hypokalemia occurs, dietary potassium supplements, must be properly diluted to avoid the processes, including the maintenance of intracellular tonicity, the pregnant woman or affects reproductive capacity. Potassium chloride supplementation with potassium-containing foods may be adequate to possibility of gastrointestinal irritation.
transmission of nerve impulses, the contraction of cardiac, skeletal, should be given to a pregnant woman only if clearly needed.
control milder cases. In more severe cases supplementation with and smooth muscle and the maintenance of normal renal function.
Nursing Mothers: Many drugs are excreted in human milk and
How Supplied
Potassium depletion may occur whenever the rate of potassium loss because of the potential for serious adverse reactions in nursing Contraindications
KLOR-CON® Powder (Potassium Chloride for Oral Solution, USP) through renal excretion and/or loss from the gastrointestinal tract infants from oral potassium supplements, a decision should be made 20 mEq is supplied in cartons of 30 packets (NDC 0245-0035-30) exceeds the rate of potassium intake. Such depletion usually develops Potassium supplements are contraindicated in patients with whether to discontinue nursing or discontinue the drug, taking into and cartons of 100 packets (NDC 0245-0035-01).
slowly as a consequence of prolonged therapy with oral diuretics, account the importance of the drug to the mother.
contains potassium 20 mEq and chloride 20 mEq provided by primary or secondary hyperaldosteronism, diabetic ketoacidosis, concentration in such patients can produce cardiac arrest. Hyper- Pediatric Use: Safety and effectiveness in children have not been
severe diarrhea, or inadequate replacement of potassium in patients kalemia may complicate any of the following conditions: chronic renal KLOR-CON®/25 Powder (Potassium Chloride for Oral Solution, USP) on prolonged parenteral nutrition. Potassium depletion due to these failure, systemic acidosis such as diabetic acidosis, acute dehydration, 25 mEq is supplied in cartons of 30 packets (NDC 0245-0037-30) causes is usually accompanied by a concomitant deficiency of chloride extensive tissue breakdown as in severe burns, adrenal insufficiency, Adverse Reactions
and cartons of 100 (NDC 0245-0037-01). Each packet contains and is manifested by hypokalemia and metabolic alkalosis. Potassium or the administration of a potassium-sparing diuretic (e.g., The most common adverse reactions to oral potassium salts are potassium 25 mEq and chloride 25 mEq provided by potassium depletion may produce weakness, fatigue, disturbances of cardiac spironolactone, triamterene or amiloride). Contraindicated in persons nausea, vomiting, abdominal discomfort, and diarrhea. These rhythm (primarily ectopic beats), prominent U-waves in the electro- demonstrating allergy to any of the components of the powder.
symptoms are due to irritation of the gastrointestinal tract and are best cardiogram, and in advanced cases flaccid paralysis and/or impaired managed by diluting the preparation further, taking the dose with Store at controlled room temperature, 15-30°C (59-86°F).
Warnings
Hyperkalemia: In patients with impaired mechanisms for excreting
Potassium depletion associated with metabolic alkalosis is managed One of the most severe adverse effects is hyperkalemia (see potassium, the administration of potassium salts can produce by correcting the fundamental causes of the deficiency whenever Contraindications, Warnings and Overdosage). Skin rash has been
hyperkalemia and cardiac arrest. This occurs most commonly in possible and administering supplemental potassium chloride, in the patients given potassium by the intravenous route but may also occur form of high potassium food or potassium chloride solution or tablets.
in patients given potassium orally. Potentially fatal hyperkalemia can Overdosage
1999 Upsher-Smith Laboratories, Inc. All Rights Reserved.
In rare circumstances (e.g., patients with renal tubular acidosis) develop rapidly and be asymptomatic.
potassium depletion may be associated with metabolic acidosis and The administration of oral potassium salts to persons with normal The use of potassium salts in patients with chronic renal disease, or hyperchloremia. In such patients potassium replacement should be any other condition which impairs potassium excretion, requires accomplished with potassium salts other than the chloride, such as hyperkalemia. However, if excretory mechanisms are impaired or if

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