DESCRIPTION

Potassium chloride extended-release capsules, USP, 10 mEq is an dental dosage kind of microencapsulated potassium chloride include 750 mg the potassium chloride USP indistinguishable to 10 mEq the potassium.

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Dispersibility the potassium chloride (KCl) is achieved by microencapsulation and also a dispersing agent. The resultant flow qualities of the KCl microcapsules and also the managed release that K+ ion by the microcapsular membrane room intended to avoid the possibility that excessive amounts of KCl can be localized in ~ any allude on the mucosa the the cradle tract.

Each crystal of KCl is microencapsulated by a process with an insoluble polymeric coating which functions as a semi-permeable membrane; it permits for the managed release that potassium and also chloride ions over one eight-to-ten-hour period. Fluids pass v the membrane and also gradually dissolve the potassium chloride in ~ the micro-capsules. The resulting potassium chloride solution progressively diffuses external through the membrane. Potassium chloride extended-release capsules, USP, 10 mEq are electrolyte replenishers. The chemical surname of the active ingredient is potassium chloride USP and the structure formula is KCl. Potassium chloride USP occurs as a granular crystalline powder. That is openly soluble in water and virtually insoluble in ethanol.

The inactive ingredients are, ethylcellulose, FD&C red #3, FD&C yellow # 6, gelatin, magnesium stearate, sodium lauryl sulfate, talc and also titanium dioxide.

The imprinting ink consists of the following: black iron oxide, potassium hydroxide and also shellac.


CLINICAL PHARMACOLOGY

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

The intracellular concentration of potassium is about 150 to 160 mEq per liter. The normal adult plasma concentration is 3.5 to 5 mEq every liter. An energetic ion transport device maintains this gradient throughout the plasma membrane.

Potassium is a normal dietary constituent and also under steady-state conditions the lot of potassium absorbed from the gastrointestinal street is same to the quantity excreted in the urine. The normal dietary intake of potassium is 50 come 100 mEq every day.

Potassium depletion will take place whenever the rate of potassium loss through renal excretion and/or loss native the gastrointestinal street exceeds the rate of potassium intake. Such depletion usually establishes slowly together a consequence of therapy with diuretics, main or an additional hyperaldosteronisms, diabetic ketoacidosis, or inadequate replacement of potassium in patient on prolonged parenteral nutrition.

Depletion can develop rapidly with severe diarrhea, particularly if associated with vomiting. Potassium depletion due to these reasons is usually accompanied by a concomitant loss of chloride and also is shown up by hypokalemia and metabolic alkalosis. Potassium depletion may produce weakness, fatigue, disturbances that cardiac valuation (primarily ectopic beats), significant U-waves in the electrocardiogram, and in advanced cases, flaccid paralysis and/or impaired ability to concentration urine.

If potassium depletion linked with metabolic alkalosis can not be managed by correcting the fundamental cause the the deficiency, e.g., whereby the patient requires long-term diuretic therapy, supplemental potassium in the form of high potassium food or potassium chloride may be able to restore regular potassium levels.

In rare circumstances (e.g., patients with renal tubular acidosis) potassium depletion might be connected with metabolic acidosis and also hyperchloremia. In such patients potassium replacement should be achieved with potassium salts various other than the chloride, such as potassium bicarbonate, potassium citrate, potassium acetate, or potassium gluconate.


INDICATIONS and USAGE

BECAUSE the REPORTS of INTESTINAL and also GASTRIC ULCERATION and BLEEDING v CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, these DRUGS need to BE scheduled FOR THOSE PATIENTS that CANNOT forgive OR REFUSE to TAKE fluid OR EFFERVESCENT POTASSIUM prepare OR because that PATIENTS IN who THERE IS A problem OF COMPLIANCE through THESE PREPARATIONS.

1.For the treatment of patients v hypokalemia with or without metabolic alkalosis, in digitalis intoxications, and also in patients v hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the usage of a lower dose that diuretic, which might be enough without leading to hypokalemia.2.For the avoidance of hypokalemia in patients who would be at details risk if hypokalemia to be to develop e.g., digitalized patients or patients with far-ranging cardiac arrhythmias, hepatic cirrhosis through ascites, says of aldosterone excess v normal renal function, potassium-losing nephropathy, and particular diarrheal states.

The usage of potassium salt in patient receiving diuretics because that uncomplicated essential hypertension is frequently unnecessary once such patients have a common dietary pattern and also when low doses that the diuretic room used. Serum potassium need to be confirm periodically, however, and also if hypokalemia occurs, dietary supplementation v potassium-containing foods may be sufficient to manage milder cases. In an ext severe cases, and if dose adjustment the the diuretic is ineffective or unwarranted, supplementation v potassium salts might be indicated.


CONTRAINDICATIONS

Potassium supplements space contraindicated in patients v hyperkalemia due to the fact that a further increase in serum potassium concentration in together patients can create cardiac arrest. Hyperkalemia might complicate any of the adhering to conditions: chronic renal failure, systemic acidosis such together diabetic acidosis, acute dehydration, substantial tissue malfunction as in severe burns, adrenal insufficiency, or the administration of a potassium-sparing diuretic (e.g., spironolactone, triamterene, amiloride) (see OVERDOSAGE).

Controlled-release formulations that potassium chloride have created esophageal ulceration in particular cardiac patients v esophageal compression as result of an enlarged left atrium. Potassium supplementation, when indicated in such patients, have to be given as a liquid preparation.

All solid oral dosage creates of potassium chloride room contraindicated in any type of patient in whom there is structural, pathological (e.g., diabetic gastroparesis) or pharmacologic (use of anticholinergic agents or various other agents with anticholinergic nature at sufficient doses to exert anticholinergic effects) reason for arrest or delay in capsule passage v the cradle tract.


Hyperkalemia

(see OVERDOSAGE)

In patients v impaired mechanisms because that excreting potassium, the management of potassium salts can create hyperkalemia and cardiac arrest. This occurs most generally in patients offered potassium through the intravenous route yet may likewise occur in patients provided potassium orally. Possibly fatal hyperkalemia can develop rapidly and be asymptomatic. The use of potassium salts in patients with chronic renal disease, or any kind of other condition which impairs potassium excretion, requires particularly careful surveillance of the serum potassium concentration and appropriate dosage adjustments.


Interaction with Potassium-Sparing Diuretics

Hypokalemia have to not be treated by the concomitant administration of potassium salts and a potassium-sparing diuretic (e.g., spironolactone, triamterene, or amiloride), because the simultaneous administration of this agents can produce severe hyperkalemia.


Interaction through Angiotensin converting Enzyme Inhibitors

Angiotensin converting enzyme (ACE) inhibitors (e.g., captopril, enalapril) will develop some potassium retention by inhibiting aldosterone production. Potassium supplements should be offered to patients receiving ACE inhibitors just with near monitoring.


Gastrointestinal Lesions

Solid dental dosage creates of potassium chloride can create ulcerative and/or stenotic lesions of the gastrointestinal tract. Based on spontaneous disadvantage reaction reports, enteric coated prepare of potassium chloride are linked with an boosted frequency of small bowel lesions (40 to 50 every 100,000 patience years) compared to sustained-release wax procession formulations (less than one per 100,000 patient years). Since of the absence of extensive marketing experience with microencapsulated products, a comparison between such products and also wax procession or enteric coated commodities is no available. Potassium chloride extended-release capsules, USP, 10 mEq space microencapsulated capsules recipe to carry out a managed rate of relax of microencapsulated potassium chloride and also thus to minimize the opportunity of high regional concentration that potassium near the gastrointestinal wall.

Prospective trials have been performed in normal human being volunteers in i beg your pardon the upper gastrointestinal tract was evaluated by endoscopic investigate before and after one main of solid oral potassium chloride therapy. The capability of this version to guess events arising in usual clinical practice is unknown. Trials which approximated normal clinical practice did no reveal any type of clear differences in between the wax matrix and microencapsulated dosage forms. In contrast, there was a greater incidence that gastric and duodenal lesions in subjects receiving a high sheep of a wax procession controlled-release formulation under conditions which did no resemble normal or encourage clinical practice (i.e., 96 mEq every day in separated doses of potassium chloride administered come fasted patients, in the visibility of one anticholinergic drug to delay gastric emptying). The upper gastrointestinal lesions it was observed by endoscopy to be asymptomatic and also were no accompanied by proof of bleeding (hemoccult testing). The relevance of this findings come the usual conditions (i.e., non-fasting, no anticholinergic agent, smaller doses) under i m sorry controlled-release potassium chloride products are used is uncertain; epidemiologic studies have not determined an elevated risk, compared to microencapsulated products, for top gastrointestinal lesions in patient receiving wax matrix formulations. Potassium chloride extended-release capsules, USP, 10 mEq need to be discontinued immediately and the possibility of ulceration, obstruction or perforation taken into consideration if severe vomiting, abdominal muscle pain, distention, or gastrointestinal bleeding occur.


Metabolic Acidosis

Hypokalemia in patients v metabolic acidosis have to be treated through an alkalinizing potassium salt such as potassium bicarbonate, potassium citrate, potassium acetate, or potassium gluconate.


General

The diagnosis of potassium depletion is ordinarily make by demonstrating hypokalemia in a patient v a clinical history suggesting some reason for potassium depletion. In interpreting the serum potassium level, the physician must bear in mind the acute alkalosis every se can create hypokalemia in the lack of a deficit in total body potassium, when acute acidosis every se have the right to increase the serum potassium concentration right into the normal selection even in the presence of a reduced total body potassium. The therapy of potassium depletion, particularly in the existence of cardiac disease, renal disease, or acidosis, requires mindful attention to acid-base balance and appropriate security of serum electrolytes, the electrocardiogram, and the clinical standing of the patient.


Information for Patients

Physicians should think about reminding the patience of the following: To take it each dose with meals and with a full glass the water or other suitable liquid. To take it each dose without crushing, chewing, or suck the capsules. To take it this medicine complying with the frequency and amount prescribed by the physician. This is specifically important if the patience is also taking diuretics and/or digitalis preparations.

To check with the medical professional if over there is trouble swallowing capsules or if the capsules seem to stick in the throat.

To check with the medical professional at once if tarry stools or other evidence of cradle bleeding is noticed.


Laboratory Tests

Regular serum potassium determinations room recommended, specifically in patients with renal insufficiency or diabetic nephropathy. Once blood is attracted for analysis of plasma potassium it is necessary to acknowledge that artifactual elevations can take place after wrong venipuncture method or as a result of in vitro hemolysis of the sample.


Drug Interactions

Potassium-sparing diuretics, angiotensin converting enzyme inhibitors (see WARNINGS).


Carcinogenesis, Mutagenesis, handicap of Fertility

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


Category C

Animal reproduction studies have actually not been performed with potassium chloride extended-release capsules, USP, 10 mEq. That is unlikely that potassium supplementation that does not bring about hyperkalemia would have an adverse effect on the fetus or would influence reproductive capacity.


Nursing Mothers

The common potassium ion content of human being milk is around 13 mEq per liter. Due to the fact that oral potassium becomes part of the body potassium pool, so long as human body potassium is not excessive, the donation of potassium chloride supplementation should have little or no effect on the level in person milk.


Geriatric Use

Clinical researches of potassium chloride extended-release capsules walk not incorporate sufficient numbers of topics aged 65 and over to recognize whether they respond differently from younger subjects. Other reported clinical experience has not determined differences in responses in between the elderly and also younger patients. In general, dose choice for one elderly patient need to be cautious, usually starting at the low end of the dosing range, reflecting the better frequency of reduced hepatic, renal, or cardiac function, and of concomitant an illness or various other drug therapy.

This drug is well-known to be dramatically excreted through the kidney, and also the threat of toxic reactions come this drug may be greater in patients through impaired renal function. Because elderly patients are an ext likely to have lessened renal function, care should it is in taken in dose selection, and it may be advantageous to screen renal function.


ADVERSE REACTIONS

One of the most severe adverse impacts is hyperkalemia (see CONTRAINDICATIONS, WARNINGS, ANDOVERDOSAGE).

Gastrointestinal bleeding and ulceration have actually been reported in patients treated v potassium chloride extended-release capsules, USP, 10 mEq (see CONTRAINDICATIONS and WARNINGS). In enhancement to gastrointestinal bleeding and also ulceration, perforation and also obstruction have actually been report in patients cure with other solid KCl dosage forms, and also may take place with potassium chloride extended-release capsules, USP, 10 mEq. The most usual adverse reactions to the dental potassium salts are nausea, vomiting, flatulence, abdominal discomfort, and also diarrhea. These symptoms are as result of irritation of the cradle tract and are finest managed by acquisition the dose v meals, or reduce the amount taken at one time. Skin rash has actually been reported hardly ever with potassium preparations.


OVERDOSAGE

The administration of dental potassium salts to persons v normal excretory mechanisms because that potassium rarely reasons serious hyperkalemia. However, if excretory mechanisms space impaired or if potassium is administered too rapidly intravenously, perhaps fatal hyperkalemia can result (see CONTRAINDICATIONS and WARNINGS). It is important to recognize that hyperkalemia is commonly asymptomatic and also may be shown up only by an enhanced serum potassium concentration (6.5 come 8.0 mEq/L) and also characteristic electrocardiographic alters (peaking of T-waves, loss of P-waves, depression of ST segment, and also prolongation that the QT interval).

Late manifestations include muscle paralysis and also cardiovascular collapse from cardiac arrest (9 come 12 mEq/L).

Treatment procedures for hyperkalemia incorporate the following: (1) removed of foods and medications include potassium and of any kind of agents through potassium-sparing properties; (2) intravenous management of 300 come 500 mL/hr that 10% dextrose systems containing 10 come 20 units of crystalline insulin per 1,000 mL; (3) correction of acidosis, if present, with intravenous salt bicarbonate; (4) use of exchange resins, hemodialysis, or peritoneal dialysis. In treating hyperkalemia, it should be recalled that in patients who have been stabilized top top digitalis, too rapid a lowering that the serum potassium concentration can produce digitalis toxicity. The extended release feature way that absorption and also toxic impacts may be delayed for hours. Take into consideration standard actions to remove any type of unabsorbed drug.


DOSAGE and ADMINISTRATION

The usual dietary intake of potassium through the average adult is 50 to 100 mEq every day. Potassium depletion sufficient to cause hypokalemia usually calls for the ns of 200 or more mEq that potassium from the complete body store.

Dosage should be changed to the individual requirements of every patient. The dose for the avoidance of hypokalemia is typically in the variety of 20 mEq every day. Doses of 40 come 100 mEq per day or much more are used for the therapy of potassium depletion. Dosage need to be separated if more than 20 mEq per day is offered such the no more than 20 mEq is provided in a single dose. Due to the fact that of the potential because that gastric irritation (see WARNINGS), potassium chloride extended-release capsules, USP, 10 mEq have to be taken v meals and also with a complete glass that water or other liquid.

Patients that have difficulty swallowing capsules may sprinkle the components of the capsule top top a spoonful the soft food. The soft food, such together applesauce or pudding, must be swallowed instantly without chewing and followed with a glass that cool water or juice come ensure complete swallowing that the microcapsules. The food used must not it is in hot and also should it is in soft enough to it is in swallowed without chewing. Any type of microcapsule/food mixture need to be provided immediately and not stored because that future use.


HOW SUPPLIED

Potassium chloride extended-release capsules, USP, 10 mEq are hard gelatin capsules through opaque white body through ‘357’ imprinted in black and opaque orange cap v ‘G’ imprinted in black, each containing 750 mg microencapsulated potassium chloride (equivalent to 10 mEq K) in party of 90 (NDC 68462-357-90), bottles of 100 (NDC 68462-357-01) and also bottles the 500 (NDC 68462-357-05).


Store in ~ 20° come 25°C (68° come 77°F); excursions allowed to 15° come 30°C (59° come 86°F) .

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Dispense in tight container.

Manufactured by:Glenmark Pharmaceuticals Ltd.Plot No.2, Phase-2, Pharma ar SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India

Manufactured for:

Glenmark Pharmceuticals Inc., USAMahwah, NJ 07430

Questions? 1 (888)721-7115

www.glenmarkpharma.com/usa

April 2016


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