DESCRIPTION

Potassium chloride extended-release capsules, USP room an dental dosage kind of microencapsulated potassium chloride include 600 mg and also 750 mg that potassium chloride, USP, equivalent to 8 mEq and 10 mEq the potassium, respectively.

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Dispersibility the potassium chloride (KCl) is achieved by microencapsulation and also a dispersing agent. The resultant flow characteristics of the KCl microcapsules and the controlled release of K+ ions by the microcapsular membrane space intended to stop the possibility that excessive amounts of KCl have the right to be localized in ~ any point on the mucosa the the cradle tract.

Each decision of KCl is microencapsulated through a patented process with one insoluble polymeric coating which attributes as a semi-permeable membrane; it permits for the managed release that potassium and also chloride ions over one eight- come ten-hour period. Fluids pass through the membrane and gradually dissolve the potassium chloride within the microcapsules. The resulting potassium chloride solution progressively diffuses outward through the membrane. Potassium chloride extended-release capsules, USP, room electrolyte replenishers. The chemical name of the active ingredient is potassium chloride and also the structural formula is KCl. Potassium chloride, USP, occurs together a white granular flour or as colorless crystals. The is odorless and has a saline taste. Its options are neutral to litmus. The is freely soluble in water and also insoluble in alcohol.

Inactive ingredients: edible ink, ethylcellulose, FD&C Blue No. 2 aluminum lake, FD&C Yellow No. 6, gelatin, magnesium stearate, salt lauryl sulfate, titanium dioxide. May contain FD&C Red No. 40 and FD&C Yellow No. 6 aluminum lakes.


CLINICAL PHARMACOLOGY

Potassium ion is the principal intracellular cation of many body tissues. Potassium ions get involved in a variety of essential physiological processes, consisting of the maintenance of intracellular tonicity; the transmission of nerve impulses; the convulsion of cardiac, skeletal and also smooth muscle; and also the maintain of common renal function.

The intracellular concentration the potassium is approximately 150 come 160 mEq per liter. The regular adult plasma concentration is 3.5 to 5 mEq every liter. An active ion transport device maintains this gradient throughout the plasma membrane.

Potassium is a typical dietary constituent and under steady-state conditions the lot of potassium absorbed from the gastrointestinal street is same to the lot excreted in the urine. The normal dietary entry of potassium is 50 to 100 mEq per day.

Potassium depletion will happen whenever the price of potassium loss v renal excretion and/or loss indigenous the gastrointestinal street exceeds the rate of potassium intake. Together depletion usually establishes slowly as a consequence of therapy with diuretics, primary or secondary hyperaldosteronism, diabetic ketoacidosis, or poor replacement of potassium in patient on lengthy parenteral nutrition. Depletion can build rapidly with major diarrhea, specifically if connected with vomiting. Potassium depletion as result of these causes is generally accompanied through a concomitant loss of chloride and also is manifested by hypokalemia and also metabolic alkalosis. Potassium depletion may develop weakness, fatigue, disturbances that cardiac rhythm (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 regulated by correcting the fundamental cause of the deficiency (e.g., wherein the patient requires long-term diuretic therapy), supplemental potassium in the type of high potassium food or potassium chloride may have the ability to restore common potassium levels.

In rare situations (e.g., patients through renal tubular acidosis) potassium depletion may be connected with metabolic acidosis and hyperchloremia. In such patients potassium replacement must be achieved with potassium salts various other than the chloride, such together potassium bicarbonate, potassium citrate, potassium acetate, or potassium gluconate.


INDICATIONS and USAGE

BECAUSE the REPORTS that INTESTINAL and GASTRIC ULCERATION and also BLEEDING with CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, these DRUGS must BE reserved FOR THOSE PATIENTS who CANNOT pardon OR REFUSE to TAKE liquid OR EFFERVESCENT POTASSIUM prepare OR because that PATIENTS IN who THERE IS A difficulty OF COMPLIANCE through THESE PREPARATIONS.

For the treatment of patients with hypokalemia, through or without metabolic alkalosis, in digitalis intoxications, and also in patients v hypokalemic familial regular paralysis. If hypokalemia is the result of diuretic therapy, consideration should be offered to the usage of a lower dose the diuretic, which may be enough without causing hypokalemia.For the avoidance of hypokalemia in patients who would it is in at details risk if hypokalemia to be to develop, (e.g., digitalized patients or patients with far-reaching cardiac arrhythmias, hepatic cirrhosis v ascites, states of aldosterone excess v normal renal function, potassium-losing nephropathy, and specific diarrheal states).

The usage of potassium salts in patients receiving diuretics for uncomplicated essential hypertension is regularly unnecessary as soon as such patients have actually a typical dietary pattern and when short doses that the diuretic room used. Serum potassium should be confirm periodically, however, and also if hypokalemia occurs, dietary supplementation v potassium-containing foods may be sufficient to regulate milder cases. In much more severe cases, and also if dose adjustment of the diuretic is ineffective or unwarranted, supplementation with potassium salts might be indicated.


CONTRAINIDICATIONS

Potassium supplements room contraindicated in patients v hyperkalemia because a further increase in serum potassium concentration in such patients can develop cardiac arrest. Hyperkalemia may complicate any type of of the complying with conditions: chronic renal failure, systemic acidosis such together diabetic acidosis, acute dehydration, substantial tissue malfunction as in major burns, adrenal insufficiency, or the management of a potassium-sparing diuretic (e.g., spironolactone, triamterene, amiloride) (see OVERDOSAGE).

Controlled-release formulations that potassium chloride have developed esophageal ulceration in certain cardiac patients v esophageal compression as result of an enlarged left atrium. Potassium supplementation, when suggested in such patients, must be given as a fluid preparation.

All solid oral dosage develops of potassium chloride room contraindicated in any type of patient in who there is structural, pathological (e.g., diabetic gastroparesis) or pharmacologic (e.g., use of anticholinergic agents or other agents through anticholinergic nature at adequate doses come exert anticholinergic effects) cause for arrest or delay in capsule passage through the gastrointestinal tract.


WARNINGS

Hyperkalemia (see OVERDOSAGE)

In patients with impaired mechanisms because that excreting potassium, the management of potassium salts can create hyperkalemia and cardiac arrest. This wake up most frequently in patients offered potassium by the intravenous route yet may likewise occur in patients provided potassium orally. Perhaps fatal hyperkalemia can develop rapidly and be asymptomatic. The usage of potassium salts in patients v chronic renal disease, or any type of other condition which impairs potassium excretion, requires an especially careful monitoring of the serum potassium concentration and also appropriate dosage adjustments.

Interaction v Potassium-Sparing Diuretics

Hypokalemia have to not be cure by the concomitant management of potassium salts and a potassium-sparing diuretic (e.g., spironolactone, triamterene or amiloride) since the simultaneous management of these agents can develop severe hyperkalemia.

Interaction v Angiotensin convert Enzyme Inhibitors

Angiotensin convert enzyme (ACE) inhibitors (e.g., captopril, enalapril) will produce some potassium retention through inhibiting aldosterone production. Potassium supplements must be provided to patients receiving ACE inhibitors just with nearby monitoring.

Gastrointestinal Lesions

Solid dental dosage creates of potassium chloride can create ulcerative and/or stenotic lesions that the cradle tract. Based upon spontaneous disadvantage reaction reports, enteric-coated preparations of potassium chloride are linked with an enhanced frequency of tiny bowel lesions (40-50 per 100,000 patience years) compared to sustained-release wax procession formulations (less than one per 100,000 patience years). Because of the lack of comprehensive marketing endure with microencapsulated products, a comparison between such products and wax matrix or enteric-coated products is not available. Potassium chloride extended-release capsules, USP, room microencapsulated capsules recipe to provide a managed rate of release of microencapsulated potassium chloride and also thus to minimize the possibility of high regional concentration the potassium close to the gastrointestinal wall.

Prospective trials have been performed in normal human being volunteers in i m sorry the upper gastrointestinal tract to be evaluated through endoscopic inspection before and after one week of solid dental potassium chloride therapy. The capacity of this version to guess events emerging in normal clinical exercise is unknown. Trials i m sorry approximated usual clinical practice did not reveal any clear differences between the wax matrix and microencapsulated dosage forms. In contrast, there to be a greater incidence that gastric and duodenal lesions in topics receiving a high dose of a wax matrix controlled-release formulation under problems which did not resemble usual or encourage clinical practice (i.e., 96 mEq every day in split doses that potassium chloride administered to fasted patients, in the existence of one anticholinergic drug to hold-up gastric emptying). The top gastrointestinal lesions it was observed by endoscopy were asymptomatic and were not accompanied by evidence of bleeding (hemoccult testing). The relevance of this findings come the usual conditions (i.e., non-fasting, no anticholinergic agent, smaller sized doses) under which controlled-release potassium chloride products are provided is uncertain; epidemiologic studies have not identified an elevated risk, contrasted to microencapsulated products, for upper gastrointestinal lesions in patients receiving wax procession formulations. Potassium chloride extended-release capsules, USP, should be discontinued immediately and also the opportunity of ulceration, obstruction or perforation taken into consideration if serious vomiting, ab pain, distention, or cradle bleeding occur.

Metabolic Acidosis

Hypokalemia in patients through metabolic acidosis should be treated through an alkalinizing potassium salt, such together potassium bicarbonate, potassium citrate, potassium acetate or potassium gluconate.


PRECAUTIONS

General

The diagnosis the potassium depletion is ordinarily made by demonstrating hypokalemia in a patient v a clinical background suggesting some reason for potassium depletion. In interpreting the serum potassium level, the physician must bear in mind the acute alkalosis every se can produce hypokalemia in the lack of a deficit in complete body potassium, if acute acidosis every se deserve to increase the serum potassium concentration into the normal variety even in the presence of a reduced full body potassium. The treatment of potassium depletion, an especially in the visibility of cardiac disease, renal disease, or acidosis, requires cautious attention come acid-base balance and appropriate monitoring of serum electrolytes, the electrocardiogram, and the clinical condition of the patient.


Information because that Patients

Physicians should consider reminding the patience of the following:

 To take each dose with meals and also with a full glass the water or other perfect liquid. To take each sheep without crushing, chewing, or suck the capsules. To take this medicine complying with the frequency and amount prescribed by the physician. This is particularly important if the patient is also taking diuretics and/or digitalis preparations. To examine with the medical professional if over there is problem swallowing capsules or if the capsules seem come stick in the throat. To check with the medical professional at as soon as if tarry stools or other evidence of cradle bleeding is noticed.

Laboratory Tests

Regular serum potassium determinations are recommended, especially in patients through renal insufficiency or diabetic nephropathy.

When blood is drawn for analysis of plasma potassium that is essential to recognize that artifactual elevations can happen after not correct venipuncture an approach or together a an outcome of in vitro hemolysis the the sample.


Drug Interactions

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


Carcinogenesis, Mutagenesis, handicap of Fertility

Carcinogenicity, mutagenicity and also fertility studies in animals have no been performed. Potassium is a regular dietary constituent.


Pregnancy

Teratogenic Effects: category C

Animal reproduction studies have actually not been carried out with potassium chloride extended-release capsules, USP. The is unlikely that potassium supplementation that does not lead to hyperkalemia would have an adverse result on the fetus or would affect reproductive capacity.


Nursing Mothers

The typical potassium ion contents of human milk is around 13 mEq every liter. Due to the fact that oral potassium becomes component of the human body potassium pool, so lengthy as human body potassium is no excessive, the donation of potassium chloride supplementation should have little or no effect on the level in human being milk.


Geriatric Use

Clinical researches of potassium chloride extended-release capsules, USP, did not include sufficient number of topics aged 65 and also over to identify whether they respond in different way from younger subjects. Various other reported clinical experience has not established differences in responses between the elderly and also younger patients. In general, dose an option for one elderly patient need to be cautious, usually beginning at the low finish of the dosing range, showing the greater frequency of lessened hepatic, renal, or cardiac function, and of concomitant condition or various other drug therapy.

This medicine is known to be significantly excreted by the kidney, and the danger of toxicity reactions to this drug may be better in patients through impaired renal function. Due to the fact that elderly patient are much more likely come have reduced renal function, care should be taken in dose selection, and it may be beneficial to monitor renal function.


ADVERSE REACTIONS

One the the most severe adverse results is hyperkalemia (see CONTRAINDICATIONS, WARNINGS, and also OVERDOSAGE).

Gastrointestinal bleeding and also ulceration have actually been report in patient treated with potassium chloride extended-release capsules, USP (see CONTRAINDICATIONS and WARNINGS). In enhancement to cradle bleeding and also ulceration, perforation and also obstruction have been reported in patients cure with various other solid KCl dosage forms, and also may happen with potassium chloride extended-release capsules, USP.

The most typical adverse reactions to the dental potassium salts space nausea, vomiting, flatulence, abdominal muscle discomfort, and also diarrhea. This symptoms are due to irritation of the gastrointestinal tract and are ideal managed by acquisition the dose v meals, or reduce the amount taken at one time. Skin rash has been reported hardly ever with potassium preparations.


OVERDOSAGE

The management of dental potassium salts to persons with normal excretory mechanisms for potassium rarely causes serious hyperkalemia. However, if excretory mechanisms space impaired, or if potassium is administered too promptly intravenously, perhaps fatal hyperkalemia can an outcome (see CONTRAINDICATIONS and also WARNINGS). That is necessary to recognize that hyperkalemia is generally asymptomatic and may be shown up only by an boosted serum potassium concentration (6.5 - 8.0 mEq/L) and also characteristic electrocardiographic alters (peaking that T-waves, loss of P-waves, depression the ST segment, and also prolongation the the QT interval). So late manifestations incorporate muscle paralysis and also cardiovascular collapse indigenous cardiac arrest (9 - 12 mEq/L).

Treatment steps for hyperkalemia incorporate the following: (1) removed of foods and also medications containing potassium and of any type of agents v potassium-sparing properties; (2) intravenous administration of 300 to 500 mL/hr that 10% dextrose systems containing 10 come 20 units of crystalline insulin per 1,000 mL; (3) convey of acidosis, if present, with intravenous sodium bicarbonate; (4) use of exchange resins, hemodialysis, or peritoneal dialysis. In treating hyperkalemia, it have to be recalled that in patient who have actually been stabilized ~ above digitalis, too quick a lowering the the serum potassium concentration can develop digitalis toxicity.

The extended release feature way that absorption and toxic results may it is in delayed because that hours. Take into consideration standard measures to remove any unabsorbed drug.


DOSAGE and also ADMINISTRATION

The usual dietary entry of potassium by the median adult is 50 come 100 mEq every day. Potassium depletion enough to cause hypokalemia usually calls for the lose of 200 mEq or more of potassium indigenous the full body store.

Dosage have to be readjusted to the individual needs of each patient. The dose for the prevention of hypokalemia is generally in the selection of 20 mEq per day. Doses of 40 to 100 mEq every day or more are provided for the treatment of potassium depletion. Dosage need to be divided if more than 20 mEq per day is given such the no more than 20 mEq is given in a single dose. Since of the potential for gastric wake up (see WARNINGS), potassium chloride extended-release capsules, USP, have to be taken with meals and with a complete glass that water or other liquid.

Patients who have challenge swallowing capsules may sprinkle the components of the capsule ~ above a spoonful the soft food. The soft food, such as applesauce or pudding, have to be swallowed immediately without chewing and also followed v a glass that cool water or juice to ensure complete swallowing that the microcapsules. The food used must not be hot and should it is in soft sufficient to it is in swallowed without chewing. Any kind of microcapsule/food mixture have to be provided immediately and also not stored because that future use.

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HOW SUPPLIED

Potassium chloride extended-release capsules, USP, comprise 600 mg the microencapsulated potassium chloride (equivalent come 8 mEq K), space pale orange capsules, imprinted "002" on the cap and body, packaged as follows:

NDC 51477-002-04 party of 100 capsules

NDC 51477-002-03 party of 500 capsules

Potassium chloride extended-release capsules, USP, comprise 750 mg that microencapsulated potassium chloride (equivalent to 10 mEq K), are pale orange and also opaque white capsules, imprinted "001" ~ above the cap and also body, packaged together follows:

NDC 51477-001-04 party of 100 capsules

NDC 51477-001-03 party of 500 capsules

NDC 51477-001-11 unit sheep packages of 100 capsules

Store at 20° - 25°C (68° - 77°F).

Dispense in tight container as characterized in the USP.

 

Nesher Pharmaceuticals Inc.St. Louis, MO 63044

P10009-108/11


Principal display Panel 8 mEq, 100-Count bottle Label

NDC 51477-002-04

Potassium ChlorideExtended-Release Capsules, USP

8 mEq (600 mg)

100 Capsules Rx Only


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