Potassium Chloride (Potassium Chloride)

Trade Name : Potassium Chloride

NuCare Pharmaceuticals, Inc.

TABLET, EXTENDED RELEASE

Strength 20 meq/1

POTASSIUM CHLORIDE Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Potassium Chloride (Potassium Chloride) which is also known as Potassium Chloride and Manufactured by NuCare Pharmaceuticals, Inc.. It is available in strength of 20 meq/1 per ml. Read more

Potassium Chloride (Potassium Chloride) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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The Potassium Chloride Extended Release Tablets USP, 20 mEq 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.
This formulation is 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.
Potassium Chloride Extended Release Tablets USP, 20 mEq 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.
Potassium Chloride Extended Release Tablets USP, 20 mEq 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 37u00b0C and in the absence of outside agitation, Potassium Chloride Extended Release Tablets USP, 20 mEq begin 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:

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.n n n n 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.n n n n 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.n n n n 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.n n n n 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.n n n n 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 the chloride, such as potassium bicarbonate, potassium citrate, potassium acetate, or potassium gluconate.n nn

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.
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.n n n 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.n n n 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.n nn

Potassium supplements are contraindicated in patients with hyperkalemia since a 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. spironolactone, triamterene, amiloride) (see n n n ).n n n n Controlled-release formulations of potassium chloride have produced esophageal ulceration in certain cardiac patients with esophageal compression due to enlarged left atrium. Potassium supplementation, when indicated in such patients, should be given as a liquid preparation or as an aqueous (water) suspension of Potassium Chloride (see n n n : n n n , andu00a0n n n sections).n n n n All solid oral dosage forms of potassium chloride are contraindicated in any patient in whom there is structural, pathological (e.g. diabetic gastroparesis), or pharmacologic (use of anticholinergic agents or other agents with anticholinergic properties at sufficient doses to exert anticholinergic effects) cause for arrest or delay in tablet passage through the gastrointestinal tract.n nn

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One of the most severe adverse effects is hyperkalemia (see n n n , n n n , and n n n ). There have also been reports of upper and lower gastrointestinal conditions including obstruction, bleeding, ulceration, and perforation (seeu00a0n n n u00a0and n n n ). 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.n nn
Call your doctor for medical advice about side effects. To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or n n n n

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 hyperkalemia can result (see n n n u00a0and n n n ). 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-waves, depression of S-T segment and prolongation of the QT-interval). n nn
Late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest (9-12 mEq/L).
Treatment measures for hyperkalemia include the following:n n n 1. Patients should be closely monitored for arrhythmias and electrolyte changes.n n n 2. Elimination of foods and medications containing potassium and of any agents with potassium-sparing properties such as potassium-sparing diuretics, ARBS, ACE inhibitors, NSAIDS, certain nutritional supplements and many others.n n n 3. Intravenous calcium gluconate if the patient is at no risk or low risk of developing digitalis toxicity.n n n 4. Intravenous administration of 300 to 500 mL/hr of 10% dextrose solution containingn n n 10-20 units of crystalline insulin per 1,000 mL.n n n 5. Correction of acidosis, if present, with intravenous sodium bicarbonate.n n n 6. Use of exchange resins, hemodialysis, or peritoneal dialysis.n nn
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. n n n The extended release feature means that absorption and toxic effects may be delayed for hours. n n n Consider standard measures to remove any unabsorbed drug.n nn

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.n n n n 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.n n n n Each Potassium Chloride Extended Release Tablet USP, 20 mEq provides 20 mEq of potassium chloride.n n n n Potassium Chloride Extended Release Tablets USP, 20 mEq 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 (see n n n n ).n nn
Patients having difficulty swallowing whole tablets may try one of the following alternate methods of administration:
a. Break the tablet in half, and take each half separately with a glass of water. n n n b. Prepare an aqueous (water) suspension as follows:n n n u00a0u00a0u00a0 1. Place the whole tablet(s) in approximately 1/2 glass of water (4 fluid ounces).n n n u00a0u00a0u00a0 2. Allow approximately 2 minutes for the tablet(s) to disintegrate.n n n u00a0u00a0u00a0 3. Stir for about half a minute after the tablet(s) has disintegrated.n n n u00a0u00a0u00a0 4. Swirl the suspension and consume the entire contents of the glass immediately by drinking or by the use of a straw.n n n u00a0u00a0u00a0 5. Add another 1 fluid ounce of water, swirl, and consume immediately.n n n u00a0u00a0u00a0 6. Then, add an additional 1 fluid ounce of water, swirl, and consume immediately. n nn
Aqueous suspension of Potassium Chloride Extended Release Tablets USP, 20 mEq that is not taken immediately should be discarded. The use of other liquids for suspending Potassium Chloride Extended Release Tablets USP, 20 mEq is not recommended.

Potassium Chloride Extended Release Tablets USP, 20 mEq are available in bottles of 30 (NDC 66267-681-30) and bottles of 60 (NDC 66267-681-60). Potassium Chloride Extended Release Tablets USP, 20 mEq are capsule shaped, white to off-white tablets, with u201cABRS-123u201d imprinted on one side and scored on the other side for flexibility of dosing.
Storage Conditions: Keep tightly closed. Store at 25u00b0C (77u00b0F); excursions permitted to 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [See USP Controlled Room Temperature].
Contains: MICROCAPS drug delivery product
Manufactured by:n nAdare Pharmaceuticals, Inc.n nVandalia, OH 45377 USAn
Distributed by:n nActavis Pharma, Inc.n nParsippany, NJ 07054 USAn
Revised: October 2015n n nMICROCAPS is a registered trademark of Adare Pharmaceuticals S.r.l., an affiliate of Adare Pharmaceuticals, Inc.n

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Potassium Chloride (Potassium Chloride)

Trade Name : Potassium Chloride

TABLET, EXTENDED RELEASE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

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About GNH

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Potassium Chloride (Potassium Chloride)

Trade Name : Potassium Chloride

TABLET, EXTENDED RELEASE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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