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K-Sol

Generic Name: potassium chloride
Dosage Form: oral solution

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

K-Sol™ (potassium chloride oral solution,
US
P)
Laser Pharmaceuticals, LLC 


Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA.

K-Sol™
Potassium Chloride Oral Solution, USP 10% AND 20%

Rx only

K-Sol Description

K-Sol™, 10% Sugar Free, Dye Free, Alcohol Free – Each 15 mL (tablespoonful) contains: 20 mEq of potassium chloride (provided by potassium chloride 1.5 g), in a palatable, orange flavored, sugar free, dye free, alcohol free vehicle.

Inactive Ingredients: glycerin, methyl- paraben, orange flavor, propylene glycol, propylparaben, purified water, sodium citrate, sodium saccharin.

K-Sol™, 20% Sugar Free, Red, Alcohol Free – Each 15 mL (tablespoonful) contains: 40 mEq of potassium chloride (provided by potassium chloride 3 g), in a palatable, cherry flavored, sugar free, alcohol free vehicle.

Inactive Ingredients: cherry flavor, citric acid, D&C Red #33, FD&C Red #40, glycerin, purified water, sodium benzoate, sodium saccharin, sorbitol.

K-Sol™ 10% and 20% are electrolyte replenishers. The chemical name is potassium chloride and the structural formula is KCI. Potassium chloride, USP occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol.

K-Sol - Clinical Pharmacology

The potassium ion is the principal intracellular cation of most body tissues. Potassium ions participate in a number of essential physiological processes including the maintenance of intracellular tonicity, the transmission of nerve impulses, the contraction of cardiac, skeletal and smooth muscle and the maintenance of normal renal function.

The intracellular concentration of potassium is approximately 150 to 160 mEq per liter. The normal adult plasma concentration is 3.5 to 5 mEq per liter. An active ion transport system maintains this gradient across the plasma membrane.

Potassium is a normal dietary constituent and under steady state conditions the amount of potassium absorbed from the gastrointestinal tract is equal to the amount excreted in the urine. The usual dietary intake of potassium is 50 to 100 mEq per day.

Potassium depletion will occur whenever the rate of potassium loss through renal excretion and/or loss from the gastrointestinal tract exceeds the rate of potassium intake. Such depletion usually develops as a consequence of therapy with diuretics, primary or secondary hyperaldosteronism, diabetic ketoacidosis, or inadequate replacement of potassium in patients on prolonged parenteral nutrition. Depletion can develop rapidly with severe diarrhea, especially if associated with vomiting. Potassium depletion due to these causes is usually accompanied by a concomitant loss of chloride and is manifested by hypokalemia and metabolic alkalosis. Potassium depletion may produce weakness, fatigue, disturbances of cardiac rhythm (primarily ectopic beats), prominent U-waves in the electrocardiogram, and, in advanced cases, flaccid paralysis and/or impaired ability to concentrate urine.

If potassium depletion associated with metabolic alkalosis cannot be managed by correcting the fundamental cause of the deficiency, e.g., where the patient requires long term diuretic therapy, supplemental potassium in the form of high potassium food or potassium chloride may be able to restore normal potassium levels.

In rare circumstances (e.g., patients with renal tubular acidosis) potassium depletion may be associated with metabolic acidosis and hyperchloremia. In such patients potassium replacement should be accomplished with potassium salts other than chloride, such as potassium bicarbonate, potassium citrate, potassium acetate, or potassium gluconate.

Indications and Usage for K-Sol

  1. For the treatment of patients with hypokalemia, with or without metabolic alkalosis; in digitalis intoxication; and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia.
  2. For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias.

The use of potassium salts in patients receiving diuretics for uncomplicated essential hypertension is often unnecessary when such patients have a normal dietary pattern and when low doses of the diuretic are used. Serum potassium should be checked periodically, however, and if hypokalemia occurs, dietary supplementation with potassium- containing foods may be adequate to control milder cases. In more severe cases, and if dose adjustment of the diuretic is ineffective or unwarranted, supplementation with potassium salts may be indicated.

Contraindications

Potassium supplements are contra- indicated in patients with hyperkalemia since further increase in serum potassium concentration in such patients can produce cardiac arrest. Hyperkalemia may complicate any of the following conditions: chronic renal failure, systemic acidosis such as diabetic acidosis, acute dehydration, extensive tissue breakdown as in severe burns, adrenal insufficiency, or the administration of a potassium-sparing diuretic (e.g., pironolactone, triamterene, amiloride) (see OVERDOSAGE).

Warnings

WARNINGS
DO NOT ADMINISTER FULL STRENGTH. K-Sol™ 10% AND 20% LIQUIDS WILL CAUSE GASTROINTESTINAL IRRITATION IF ADMINISTERED UNDILUTED. FOR DETAILS REGARDING ADEQUATE DILUTION, SEE DOSAGE AND ADMINISTRATION.

Hyperkalemia (see OVERDOSAGE)
In patients with impaired mechanisms for excreting potassium, the administration of potassium salts can produce hyperkalemia and cardiac arrest. This occurs most commonly in patients given potassium by the intravenous route but may also occur in patients given potassium orally. Potentially fatal hyperkalemia can develop rapidly and be asymptomatic. The use of potassium salts in patients with chronic renal disease, or any other condition which impairs potassium excretion, requires particularly careful monitoring of the serum potassium concentration and appropriate dosage adjustment.

Interaction with Potassium Sparing Diuretics
Hypokalemia should not be treated by the concomitant administration of potassium salts and a potassium sparing diuretic (e.g., spironolactone, triamterene or amiloride) since the simultaneous administration of these agents can produce severe hyperkalemia.

Interaction with Angiotensin Converting Enzyme Inhibitors
Angiotensin converting enzyme (ACE) inhibitors (e.g., captopril, enalapril) will produce some potassium retention by inhibiting aldosterone production. Potassium supplements should be given to patients receiving ACE inhibitors only with close monitoring.

Metabolic Acidosis
Hypokalemia in patients with metabolic acidosis should be treated with an alkalinizing potassium salt such as potassium bicarbonate, potassium citrate, potassium acetate or potassium gluconate.

Precautions

General

The diagnosis of potassium depletion is ordinarily made by demonstrating hypokalemia in a patient with a clinical history suggesting some cause for potassium depletion. In interpreting serum potassium level, the physician should bear in mind that acute alkalosis per se can produce hypokalemia in the absence of a deficit in total body potassium while acute acidosis per se can increase the serum potassium concentration into the normal range even in the presence of a reduced total body potassium. The treatment of potassium depletion, particularly in the presence of cardiac disease, renal disease, or acidosis requires careful attention to acid-base balance and appropriate monitoring of serum electrolytes, the electrocardiogram, and the clinical status of the patient.

Laboratory Tests

When blood is drawn for analysis of plasma potassium it is important to recognize that artifactual elevations can occur after improper venipuncture technique or as a result of in vitro hemolysis of the sample.

Drug Interactions

Potassium-sparing diuretic, angiotensin converting enzyme inhibitors: see WARNINGS.

Carcinogenesis, Mutagenesis, Impair- ment of Fertility

Carcinogenicity, mutagenicity and fertility studies in animals have not been performed. Potassium is a normal dietary constituent.

Pregnancy Category C

Animal reproduction studies have not been conducted with K-Sol™ 10% and 20%. It is unlikely that potassium supplementation that does not lead to hyperkalemia would have an adverse effect on the fetus or would affect reproduction capacity.

Nursing Mothers

The normal potassium content of human milk is about 13 mEq per liter. Since oral potassium becomes part of the body potassium pool, so long as body potassium is not excessive, the contribution of potassium chloride supplementation should have little or no effect on the level in human milk.

Pediatric Use

Safety and effectiveness in children have not been established.

Adverse Reactions

One of the most severe adverse effects is hyperkalemia (see CONTRAINDICATIONS, WARNINGS, and OVERDOSAGE). There also have been reports of upper and lower gastrointestinal conditions including obstruction, bleeding, ulceration and perforation (see CONTRAINDICATIONS and WARNINGS).

The most common adverse reactions to the potassium salts are nausea, vomiting, flatulence, abdominal pain/discomfort and diarrhea. These symptoms are due to irritation to the gastrointestinal tract and are best managed by diluting the preparation further, taking the dose with meals, or reducing the amount taken at one time.

Overdosage

The administration of oral potassium salts to persons with normal excretory mechanisms for potassium rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired, or if potassium is administered too rapidly intravenously, potentially fatal hyper- kalemia can result (see CONTRA- INDICATIONS and WARNINGS). It is important to recognize that hyperkalemia is usually asymptomatic and may be manifested only by an increased serum potassium concentration (6.5-8.0 mEq/L) and characteristic electrocardiographic changes (peaking of T-waves, loss of P-wave, depression of S-T segment, and prolongation of the QT interval). Late manifestations include paralysis and cardiovascular collapse from cardiac arrest (9-12 mEq/L).

Treatment measures for hyperkalemia include the following:

  1. Elimination of foods and medications containing potassium and of any agents with potassium-sparing properties;
  2. Intravenous administration of 300 to 500 mL/hr of 10% dextrose solution containing 10-20 units of crystalline insulin per 1,000 mL;
  3. Correction of acidosis, if present, with intravenous sodium bicarbonate;
  4. Use of exchange resins, hemodialysis, or peritoneal dialysis.

In treating hyperkalemia, it should be recalled that in patients who have been stabilized on digitalis, too rapid a lowering of the serum potassium concentration can produce digitalis toxicity.

K-Sol Dosage and Administration

The usual dietary potassium intake by the average adult is 50 to 100 mEq per day. Potassium depletion sufficient to cause hypokalemia usually requires the loss of 200 or more mEq of potassium from the total body store. Dosage must be adjusted to the individual needs of each patient. The dose for the prevention of hypokalemia is typically in the range of 20 mEq per day. Doses of 40-100 mEq per day or more are used for the treatment of potassium depletion.

K-Sol™ 10%
To minimize gastrointestinal irritation, patients must follow directions regarding dilution. Each tablespoonful (15 mL) should be diluted with three (3) fluid ounces or more of water or other liquid.

One (1) tablespoonful (15 mL) twice daily (after morning and evening meals) supplies 40 mEq of potassium chloride.

K-Sol™ 20%
To minimize gastrointestinal irritation, patients must follow directions regarding dilution. Each tablespoonful should be diluted with six (6) fluid ounces or more of water or other liquid.

One (1) tablespoonful (15 mL) per day (after the morning meal) supplies 40 mEq of potassium chloride. One tablespoonful twice a day, provides 80 mEq of potassium chloride.

Deviations from these recommendations may be indicated, since no average total daily dose can be defined but must be governed by close observation for clinical effects. However, potassium intoxication may result from any therapeutic dosage. See OVERDOSAGE and PRECAUTIONS.

How is K-Sol Supplied

In pint bottles.

K-Sol™ (potassium chloride oral solution, USP) 10% (473 mL) – 16477-301-16

K-Sol™ (potassium chloride oral solution, USP) 20% (473 mL) – 16477-302-16

Dispense in a tight, light-resistant container as defined in the USP/NF.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid freezing.

Manufactured for:
Laser Pharmaceuticals, LLC Greenville, SC 29615

LS3012.0        Rev. N114

Principal Display Panel

NDC 16477-301-16
K-Sol™
(potassium chloride
oral solution, USP)
10 %
Rx only
1 PINT (473 mL)

Principal Display Panel

NDC 16477-302-16
K-Sol™
(potassium chloride
oral solution, USP)
20 %
Rx only
1 PINT (473 mL)

K-Sol 
potassium chloride liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:16477-301
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POTASSIUM CHLORIDE (POTASSIUM CATION) POTASSIUM CHLORIDE 20 meq  in 15 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN  
METHYLPARABEN  
PROPYLENE GLYCOL  
PROPYLPARABEN  
WATER  
SODIUM CITRATE, UNSPECIFIED FORM  
SACCHARIN SODIUM  
Product Characteristics
Color      Score     
Shape Size
Flavor ORANGE Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:16477-301-16 473 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 01/22/2015 12/31/2015
K-Sol 
potassium chloride liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:16477-302
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POTASSIUM CHLORIDE (POTASSIUM CATION) POTASSIUM CHLORIDE 40 meq  in 15 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE  
D&C RED NO. 33  
FD&C RED NO. 40  
GLYCERIN  
WATER  
SODIUM BENZOATE  
SACCHARIN SODIUM  
SORBITOL  
Product Characteristics
Color      Score     
Shape Size
Flavor CHERRY Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:16477-302-16 473 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 01/22/2015 12/31/2015
Labeler - Laser Pharmaceuticals, LLC (614417132)
Revised: 10/2015
 
Laser Pharmaceuticals, LLC
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