Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2718
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K-DUR (Tablet, Extended Release)
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The usual dietary intake of potassium 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. Dosage should be divided if more than 20 mEq per day is given such that no more than 20 mEq is given in a single dose. Each K-DUR 20 tablet provides 20 mEq of potassium chloride. Each K-DUR 10 tablet provides 10 mEq of potassium chloride. K-DUR tablets should be taken with meals and with a glass of water or other liquid. This product should not be taken on an empty stomach because of its potential for gastric irritation . Patients having difficulty swallowing whole tablets may try one of the following alternate methods of administration: Aqueous suspension of K-DUR tablets that is not taken immediately should be discarded. The use of other liquids for suspending K-DUR tablets is not recommended.
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| dailymed-instance:descripti... |
The K-DUR 20 product is an immediately dispersing extended release oral dosage form of potassium chloride containing 1500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet. The K-DUR 10 product is an immediately dispersing extended release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. These formulations are intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced. K-DUR is an electrolyte replenisher. The chemical name of the active ingredient is potassium chloride, and the structural formula is KCl. 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-DUR is a tablet formulation (not enteric coated or wax matrix) containing individually microencapsulated potassium chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37��C and in the absence of outside agitation, K-DUR begins disintegrating into microencapsulated crystals within seconds and completely disintegrates within 1 minute. The microencapsulated crystals are formulated to provide an extended release of potassium chloride. Inactive Ingredients: Crospovidone, Ethyl-cellulose, Hydroxypropyl Cellulose, Magnesium Stearate, and Microcrystalline Cellulose.
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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 or 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, eg, 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 (eg, 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 the chloride, such as potassium bicarbonate, potassium citrate, potassium acetate, or potassium gluconate.
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K-DUR 20 mEq Extended Release Tablets are available in bottles of 100 (NDC 0085-0787-01); bottles of 500 (NDC 0085-0787-06); bottles of 1000 (NDC 0085-0787-10); and boxes of 100 for unit dose dispensing (NDC 0085-0787-81). K-DUR 20 mEq tablets are white to off-white mottled capsule-shaped tablets, imprinted "K-DUR 20" and scored on the other sidefor flexibility of dosing. K-DUR 10 mEq Extended Release Tablets are available in bottles of 100 (NDC 0085-0263-01) and boxes of 100 for unit dose dispensing (NDC 0085-0263-81). K-DUR 10 mEq tablets are white to off-white mottled capsule-shaped tablets, imprinted "K-DUR 10" on one side and plain on the other.<br/>Storage Conditions: Keep tightly closed. Store at 25��C (77��F); excursions permitted to 15���30��C (59���86��F) [see USP Controlled Room Temperature]
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Potassium Chloride
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K-DUR (Tablet, Extended Release)
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| dailymed-instance:adverseRe... |
One of the most severe adverse effects is hyperkalemia . There have also been reports of upper and lower gastrointestinal conditions including obstruction, bleeding, ulceration, and perforation . The most common adverse reactions to oral potassium salts are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea. These symptoms are due to irritation of 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.
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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 LIQUID OR EFFERVESCENT
POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A
PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. 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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K-DUR
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