KLOTRIX SUMMARY
KLOTRIX®
Potassium Chloride
Slow-Release Tablets
10 mEq (750 mg)
Klotrix® (potassium chloride) is a solid, oral dosage form of potassium chloride containing 750 mg of potassium chloride, USP (equivalent to 10 mEq of potassium) in a film-coated wax-matrix tablet. This formulation is intended to provide a controlled release of potassium from the matrix to minimize the likelihood of producing high, localized concentrations of potassium within the gastrointestinal tract. Klotrix is an electrolyte replenisher.
BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUIDS OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS.
- 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.
- For 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.
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NEWS HIGHLIGHTS
Published Studies Related to Klotrix (Potassium Chloride)
The effects of a reduced-sodium, high-potassium salt substitute on food taste and acceptability in rural northern China. [2009.04]
A potassium chloride-containing salt substitute lowers blood pressure levels, but its overall acceptability has been of concern due to its potential adverse effects on food taste. In a large-scale, blinded randomised trial evaluating the comparative effects of a salt substitute (65 % sodium chloride, 25 % potassium chloride and 10 % magnesium sulphate) and a normal salt (100 % sodium chloride) on blood pressure, we collected data on the saltiness, flavour and overall acceptability of food...
Inability of healthy subjects to deposit potassium during hypokinesia and potassium supplementation. [2009.02.01]
OBJECTIVE: To determine the effect of potassium (K+) supplementation and hypokinesia (HK; diminished movement) on muscle K+ content and K+ loss... CONCLUSION: Muscle K+ content is not decreased by the K+ deficient diet and K+ loss is not increased by the higher muscle K+ content in the body. Rather it is caused by the inability of the body to use K+ during HK and K+ supplementation.
Treatment with potassium bicarbonate lowers calcium excretion and bone resorption in older men and women. [2009.01]
CONCLUSIONS: Bicarbonate, but not potassium, had a favorable effect on bone resorption and calcium excretion. This suggests that increasing the alkali content of the diet may attenuate bone loss in healthy older adults.
Comparing the efficacy in reducing dentin hypersensitivity of a new toothpaste containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride to a commercial sensitive toothpaste containing 2% potassium ion: an eight-week clinical study in Rome, Italy. [2009]
OBJECTIVE: This paper presents the results of one of two eight-week dentin hypersensitivity clinical studies in which the efficacy of a novel toothpaste containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride as sodium monofluorophosphate (MFP) was compared to that of a benchmark commercial toothpaste containing 2% potassium ion, dosed as 3.75% potassium chloride, and 1450 ppm fluoride as sodium fluoride (NaF)... CONCLUSION: A new toothpaste containing 8.0% arginine calcium carbonate, and 1450 ppm fluoride as sodium monofluorophosphate (MFP) provides significantly increased dentin hypersensitivity relief (p < 0.05) compared to a commercial sensitive toothpaste containing 2% potassium ion after two weeks, four weeks, and eight weeks of product use.
Comparing the efficacy in reducing dentin hypersensitivity of a new toothpaste containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride to a commercial sensitive toothpaste containing 2% potassium ion: an eight-week clinical study on Canadian adults. [2009]
OBJECTIVE: This paper presents the results of one of two eight-week dentin hypersensitivity clinical studies in which the efficacy of a novel toothpaste containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride as sodium monofluorophosphate (MFP) was compared to that of a benchmark commercial toothpaste containing 2% potassium ion, dosed as 3.75% potassium chloride, and 1450 ppm fluoride as sodium fluoride (NaF)... CONCLUSION: A new toothpaste containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride, as sodium monofluorophosphate (MFP), provides significantly greater hypersensitivity relief (p < 0.05) compared to a commercial sensitive toothpaste containing 2% potassium ion after two, four, and eight weeks of product use.
Clinical Trials Related to Klotrix (Potassium Chloride)
Effects of Potassium Citrate in Urine of Children With Elevated Calcium in Urine and Kidney Stones [Completed]
High amounts of calcium in the urine (hypercalciuria) can cause development of kidney stones
in children. Treatment for these children includes plenty of fluids, a low-salt diet and
medications such as potassium citrate. A major advantage of potassium citrate, as compared to
hydrochlorothiazide, is its lack of side effects. One problem the researchers and others
have observed is that some children continue to form kidney stones despite correction of
hypercalciuria with potassium citrate. One possible explanation is that in some individuals
potassium citrate therapy results in an excessive elevation of urine pH, a situation that may
predispose to calcium phosphate stone formation. In this study, the researchers will study
the effects of potassium citrate on urine chemistries and acid-base balance in three groups
of children aged 5-17 years:
- children who are hypercalciuric stone formers;
- healthy children without a history of hypercalciuria or kidney stones.
Particular attention will be paid to try to identify those who develop a very high urine pH
(>8) and the factors leading to this metabolic reaction.
The researchers will try to learn whether it is the child’s characteristics, the disease
manifestations, the dose of the drug, or a combination of the above which may be the cause of
the development of very alkaline urine. Based on the results, the researchers hope to be able
to better “tailor” the individual treatment for each child with kidney stones.
A Pilot Study of Potassium Supplementation for Adult Patients With Rheumatoid Arthritis [Completed]
Rheumatoid arthritis is the paradigmatic immune-mediated inflammatory arthropathy. With
respect to rheumatoid arthritis (RA), patients have been described as having inappropriately
low spontaneous and stimulated cortisol secretion levels. Serum cortisol levels are decreased
in RA patients who are taking prednisolone. Also, in patients RA, of longer duration,
glucocorticoid receptor (GR) down-regulation has been reported without any change in cortisol
levels. There is a reduced capacity for local reactivation of cortisone to cortisol in RA
synovial cells. It is noteworthy that since synthetic glucocorticoids also use same
reactivation shuttle (the cortisol-cortisone shuttle), the results also apply to therapeutic
glucocorticoids.
Glucocorticoids are widely used to treat chronic inflammatory conditions including rheumatoid
arthritis. Prednisolone has a greater effect than non-steroidal, anti-inflammatory drugs on
joint tenderness and pain, whereas the difference in grip strength was not significant. There
are no qualitative differences between the effects of endogenous cortisol and exogenously
applied synthetic glucocorticoids, since all effects are transmitted via the same receptor.
Cortisol, on the other hand, plays a major role in normal potassium homeostasis.
Recent studies have highlighted a role for diet, with suggestions that diets high in
caffeine, low in antioxidants and high in red meat may contribute to an increased risk for
the development of rheumatoid arthritis. Higher intakes of complex carbohydrates, dietary
fiber, magnesium, folic acid, vitamin C and E, carotenoids and other phytochemicals have been
shown to offer distinct advantages compared to diets containing meat and other foods of
animal origin. The relation of a potassium deficiency to RA is much less well documented. The
first person to definitively link potassium with arthritis was DeCoti Marsh in a book which
purports to have numerous case histories using potassium associated with a veritable pot
pourri of anions. LaCelle, Morgan & Atwater found that the cells of 50 arthritic patients
were 30 to 50% lower than healthy people.
Our current clinical trial (clinical trial no NCT00399282) shows that most of patients with
RA do not have enough potassium intake. This condition may contribute to a subclinical lower
serum cortisol, although there is possibility that cortisol serum levels might be unchanged
due to a sufficient "cortisol homeostasis" and "potassium homeostasis".
Phase III Randomized, Double-Blind Study of Potassium Phosphate Vs Potassium Citrate for Absorptive Hypercalciuria [Completed]
OBJECTIVES: I. Evaluate the ability of a slow-releasing formulation of neutral potassium
phosphate to correct hypercalciuria and prevent recurrent stone formation in patients with
absorptive hypercalciuria.
II. Evaluate the safety of this treatment. III. Compare the efficacy of potassium phosphate
to that of potassium citrate.
Safety of Continuous Potassium Chloride Infusion in Critical Care [Recruiting]
Patients in critical care often require supplemental potassium chloride if levels in their
blood are below acceptable level. Common practice is to administer a single dose of
potassium chloride under controlled conditions via a drip, before checking if a further dose
is required. The purpose of this study is to ensure that it is safe to administer potassium
chloride continuously with the dose varied according to patient needs.
Potassium Intake in Patients With Chronic Kidney Disease [Recruiting]
Chronic kidney disease is associated with high blood pressure, heart disease, and strokes.
Potassium lowers blood pressure and may help prevent heart disease and strokes in the
general population, but has not been well-studied in people with kidney disease. This study
will look at the benefits and safety of two levels of potassium intake in patients with
kidney disease. We expect that a higher level of potassium intake safely lowers blood
pressure compared to a lower level of potassium intake. We hope that this and other research
projects will help us to learn more so that guidelines can be created for potassium intake
in patients with chronic kidney disease
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Page last updated: 2009-10-20
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