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Slow-K (Potassium Chloride) - Summary

 



SLOW-K SUMMARY

Slow-K®

Slow-K, potassium chloride extended-release tablets USP, is a sugar-coated (not enteric-coated) tablet for oral administration, containing 600 mg of potassium chloride (equivalent to 8 mEq) in a wax matrix. This formulation is intended to provide an extended-release of potassium from the matrix to minimize the likelihood of producing high, localized concentrations of potassium within the gastrointestinal tract. Slow-K is an electrolyte replenisher.

BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH EXTENDED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS.

  1. For therapeutic use in 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.


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NEWS HIGHLIGHTS

Media Articles Related to Slow-K (Potassium)

Low Potassium (Hypokalemia)
Source: MedicineNet Hyperkalemia Specialty [2008.03.12]
Title: Low Potassium (Hypokalemia)
Category: Diseases and Conditions
Created: 3/12/2008
Last Editorial Review: 3/12/2008

Hyperkalemia (High Blood Potassium)
Source: MedicineNet Addison Disease Specialty [2008.03.07]
Title: Hyperkalemia (High Blood Potassium)
Category: Diseases and Conditions
Created: 12/31/1997
Last Editorial Review: 3/7/2008

CNSBio Inc. To Present Latest Clinical Trial Data For CNSB015 At Neuropathic Pain Conference In San Francisco
Source: Clinical Trials / Drug Trials News From Medical News Today [2009.11.19]
CNSBio Inc. will present recent Phase IIa proof-of-concept clinical trial data for CNSB015, an orally administered potassium channel modulator used in combination with opioids for the treatment of neuropathic pain, at the 12th International Conference on the Mechanisms and Treatment of Neuropathic Pain on November 20-21, 2009 in San Francisco, CA. Dr.

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Published Studies Related to Slow-K (Potassium)

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.

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Clinical Trials Related to Slow-K (Potassium)

Pharmacodynamic Trial, of Slow Release ASA, in Platelet Functionalism, a Long Term Treatment Period [Completed]
Evaluation of the pharmacodynamic profile (antiaggregant profile, balance of prostanoids and nitric oxid) of a ASA-SR (slow-release)formulation in comparison with a ASA NR (normal release), 150 mg, during 12 months of treatment.

Short Term Hemodynamic Effects of Controlled Slow Breathing With Biofeedback in Patients With Heart Failure [Recruiting]
Heart failure is associated with faster breathing, which has a negative impact on the functioning of the heart. This leads to fatigue, shortness of breath, and exercise intolerance. It has been shown that when slow breathing technique was taught to patients with heart failure, they had a reduction in their sensation of shortness of breath and an improvement in their exercise performance.

The study will compare the short-term effects of controlled slow breathing with biofeedback in normal healthy subjects, acute heart failure, and chronic stable heart failure. The purpose is to see if there is any change in the objective measurements of heart function while breathing at normal rates compared to a controlled slower rate.

Randomized Controlled Trial Comparing Slow-Freezing to Vitrification of Oocytes [Recruiting]
Preservation of fertility is limited. Current methods include embryo cryopreservation and while still experimental, ovarian cryopreservation. In single women who are at risk for infertility secondary to cancer or couples who have ethical reasons to avoid embryo cryopreservation, oocyte cryopreservation is an alternative Purpose of study is to compare slow freeze to vitrification of human oocytes. Successful cryopreservation and subsequent thawing programs are characterized by avoiding ice crystal formation. Vitrification, newer alternative to slow freeze method, process by which water is prevented from forming ice.

Our hypothesis is that higher survival rate per oocyte is to be expected in the vitrification group.

Effects of Intra-Uterine Slow-Release Insemination on Pregnancy Rate in Women Designated for Artificial Insemination [Recruiting]
A couple that does not achieve pregnancy though regular attempts for a year are defined infertile couple. This condition is caused by faulty functioning of the reproduction system of the husband or wife or both. If there are no organic defects and there is no definite injury to the reproductive system (ova or spermatozoa), the specialist doctor generally decides to put the couple into a fertility treatment program. Artificial insemination is one of the important ways of achieving pregnancy.

Three common methods of artificial insemination:

1. Placement of a diaphragm that contains raw spermatozoa or isolated improved spermatozoa in an appropriate liquid solution (Cup insemination, CI) upon the cervix.

2. Spermatozoa injection (after improvement) through the vagina to the cervix (Intra-Cervical Insemination, ICI).

3. Spermatozoa injection (after improvement) directly into the uterus (IUI-Intra-Uterine Insemination).

The EVIE - Slow Release Insemination method:

The slow release insemination is utilizing a Grasby type MS16 pump for 3 hours. The release rate for motile spermatozoa is 50X103 per minute.

Advantages:

- Very close approximation of the natural procedure in which the spermatozoa arrive to

the fertilization site over a long period.

- An extended "window of opportunities" for meeting between the ovum and spermatozoa will

be longer.

- There is no loss of spermatozoa due to leaking as sometimes happens with single-time

injection practiced in the IUI method.

Primary Endpoint:

Accumulation of 50 cycles of SRI- slow release insemination (study group) in addition to 50 cycles of regular IUI (control group). Two weeks after insemination Beta hCG test

Secondary Endpoints:

Four weeks after insemination - US Viability scan

Procedure:

Subjects will be women with fertility difficulties who are designated for IUI treatment. 100 insemination cycles will be conducted. (50 regular IUI and 50 EVIE-SRI). Subjects that were treated with the IUI method and who does not become pregnant will then be treated with the EVIE-Slow Release method and vice versa.

Biventricular Tachycardias Outcome Trial [Recruiting]
This clinical investigation is a device-based open, prospective, multicenter two-arm randomized trial, comparing patients who are treated in the slow VT zone versus patients who are not treated in that zone.

The device intended to be used is the OVATIOTM CRT model 6750 but future generation of Sorin Group/ ELA Medical devices may be used provided they are CE marked. Ethics committees and health authorities will be informed prior to any use of a newer device if applicable.

All patients will have a 3-zone detection configuration programmed. The slow VT zone will be defined by programming the detection parameters as follows:

- Slow VT detection rate: 100 bpm (or if the resting rate is higher than 80 bpm, we

recommend to adjust this parameter to: resting rate + 30 bpm)

- VT detection rate: 150 bpm

PARAD+ will be the first choice for SVT/ST and VT discrimination in the VT zones.

The Fast VT and VF limits are left to investigator's judgment. Therapy on VT, fast VT and VF are also left to the investigator's judgment.

Patients will be randomized at implant to have the slow VT zone programmed as a monitoring zone (monitoring arm) or to have therapies programmed within the slow VT zone (therapy arm). The randomization table will be generated by Sorin Group/ELA Medical.

more trials >>

Page last updated: 2009-11-19

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