POTASSIUM CHLORIDE- potassium chloride tablet, extended release

United States - English - NLM (National Library of Medicine)

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Active ingredient:
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)
Available from:
REMEDYREPACK INC.
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
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. - 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. - 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 ha
Product summary:
Potassium chloride extended-release tablets, USP 20 mEq are available in bottles of 100 (NDC 68462-472-01) and 500 (NDC 68462-472-05). Potassium chloride extended-release tablets, USP 20 mEq are white to off-white, capsule-shaped biconvex tablets debossed with ‘472’ on one side and scored on the other side. Potassium chloride extended-release tablets, USP 10 mEq are available in bottles of 100 (NDC 68462-471-01) and 500 (NDC 68462-471-05). Potassium chloride extended-release tablets, USP 10 mEq are white to off-white, capsule-shaped biconvex tablets debossed with ‘471’ on one side and plain on the other side. Keep tightly closed. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
Authorization status:
Abbreviated New Drug Application
Authorization number:
70518-2234-0

POTASSIUM CHLORIDE- potassium chloride tablet, extended release

REMEDYREPACK INC.

----------

Potassium Chloride Extended-release Tablets, USP

10 mEq and 20 mEq

Rx Only

DESCRIPTION

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.

The potassium chloride extended-release tablets, USP 10 mEq 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.

Potassium chloride 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,

crystalline powder. It is odorless and has a saline taste. It is freely soluble in water and practically

insoluble in ethanol.

Potassium chloride 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, potassium chloride tablets begin

disintegrating into microencapsulated crystals within seconds and completely disintegrate within 1

minute. The microencapsulated crystals are formulated to provide an extended-release of potassium

chloride.

This product complies with USP assay preparation 2.

Inactive Ingredients: crospovidone, ethylcellulose, hydroxypropyl cellulose, magnesium stearate,

microcrystalline cellulose and talc.

CLINICAL PHARMACOLOGY

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, 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.

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.

INDICATIONS AND USAGE

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.

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.

CONTRAINDICATIONS

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

OVERDOSAGE).

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 PRECAUTIONS: Information for Patients, and DOSAGE

AND ADMINISTRATION sections).

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.

WARNINGS

Hyperkalemia (see OVERDOSAGE)

In patients with impaired mechanisms for excreting potassium, the administration of potassium salts can

produce hyperkalemia and cardiac arrest. This occurs most commonly in patients given potassium by the

intravenous route but may also occur in patients given potassium orally. Potentially fatal hyperkalemia

can develop rapidly and be asymptomatic. The use of potassium salts in patients with chronic renal

disease, or any other condition which impairs potassium excretion, requires particularly careful

monitoring of the serum potassium concentration and appropriate dosage adjustment.

Interaction with Potassium-Sparing Diuretics

Hypokalemia should not be treated by the concomitant administration of potassium salts and a potassium-

sparing diuretic (e.g., spironolactone, triamterene, or amiloride) since the simultaneous administration

of these agents can produce severe hyperkalemia.

Interaction with Renin- Angiotensin Aldosterone System Inhibitors

Drugs that inhibit the renin-angiotensin-aldosterone system (RAAS) including angiotensin converting

enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), spironolactone, eplerenone, or

aliskiren produce potassium retention by inhibiting aldosterone production. Closely monitor potassium

in patients receiving concomitant RAAS therapy.

Interaction with Nonsteroidal Anti-Inflammatory Drugs: Nonsteroidal anti-inflammatory drugs

(NSAIDs) may produce potassium retention by reducing renal synthesis of prostaglandin E and

impairing the renin-angiotensin system. Closely monitor potassium in patients receiving concomitant

NSAID therapy.

Gastrointestinal Lesions

Solid oral dosage forms of potassium chloride can produce ulcerative and/or stenotic lesions of the

gastrointestinal tract. Based on spontaneous adverse reaction reports, enteric-coated preparations of

potassium chloride are associated with an increased frequency of small bowel lesions (40 to 50 per

100,000 patient years) compared to sustained release wax matrix formulations (less than one per

100,000 patient years). Because of the lack of extensive marketing experience with microencapsulated

products, a comparison between such products and wax matrix or enteric-coated products is not

available. Potassium chloride is a tablet formulated to provide a controlled rate of release of

microencapsulated potassium chloride and thus to minimize the possibility of a high local concentration

of potassium near the gastrointestinal wall.

Prospective trials have been conducted in normal human volunteers in which the upper gastrointestinal

tract was evaluated by endoscopic inspection before and after 1 week of solid oral potassium chloride

therapy. The ability of this model to predict events occurring in usual clinical practice is unknown.

Trials which approximated usual clinical practice did not reveal any clear differences between the wax

matrix and microencapsulated dosage forms. In contrast, there was a higher incidence of gastric and

duodenal lesions in subjects receiving a high dose of a wax matrix controlled-release formulation under

conditions which did not resemble usual or recommended clinical practice (i.e., 96 mEq per day in

divided doses of potassium chloride administered to fasted patients, in the presence of an

anticholinergic drug to delay gastric emptying). The upper gastrointestinal lesions observed by

endoscopy were asymptomatic and were not accompanied by evidence of bleeding (Hemoccult testing).

The relevance of these findings to the usual conditions (i.e., non-fasting, no anticholinergic agent,

smaller doses) under which controlled-release potassium chloride products are used is uncertain;

epidemiologic studies have not identified an elevated risk, compared to micro-encapsulated products,

for upper gastrointestinal lesions in patients receiving wax matrix formulations. Potassium chloride

extended-release tablets should be discontinued immediately and the possibility of ulceration,

obstruction, or perforation should be considered if severe vomiting, abdominal pain, distention, or

gastrointestinal bleeding occurs.

Metabolic Acidosis

Hypokalemia in patients with metabolic acidosis should be treated with an alkalinizing potassium salt

such as potassium bicarbonate, potassium citrate, potassium acetate, or potassium gluconate.

PRECAUTIONS

General

The diagnosis of potassium depletion is ordinarily made by demonstrating hypokalemia in a patient with

a clinical history suggesting some cause for potassium depletion. In interpreting the serum potassium

level, the physician should bear in mind that acute alkalosis per se can produce hypokalemia in the

absence of a deficit in total body potassium while acute acidosis per se can increase the serum

potassium concentration into the normal range even in the presence of a reduced total body potassium.

The treatment of potassium depletion, particularly in the presence of cardiac disease, renal disease, or

acidosis requires careful attention to acid-base balance and appropriate monitoring of serum

electrolytes, the electrocardiogram, and the clinical status of the patient.

Information for Patients

Physicians should consider reminding the patient of the following:

To take each dose with meals and with a full glass of water or other liquid.

To take each dose without crushing, chewing, or sucking the tablets. If those patients are having

difficulty swallowing whole tablets, they may try one of the following alternate methods of

administration:

1. Break the tablet in half, and take each half separately with a glass of water.

2. Prepare an aqueous (water) suspension as follows:

1. Place the whole tablet(s) in approximately 1/2 glass of water (4 fluid ounces).

2. Allow approximately 2 minutes for the tablet(s) to disintegrate.

3. Stir for about half a minute after the tablet(s) has disintegrated.

4. Swirl the suspension and consume the entire contents of the glass immediately by drinking or by

the use of a straw.

5. Add another 1 fluid ounce of water, swirl, and consume immediately.

6. Then, add an additional 1 fluid ounce of water, swirl, and consume immediately.

Aqueous suspension of potassium chloride that is not taken immediately should be discarded. The use

of other liquids for suspending potassium chloride tablets is not recommended.

To take this medicine following the frequency and amount prescribed by the physician. This is

especially important if the patient is also taking diuretics and/or digitalis preparations.

To check with the physician at once if tarry stools or other evidence of gastrointestinal bleeding is

noticed.

Laboratory Tests

When blood is drawn for analysis of plasma potassium it is important to recognize that artifactual

elevations can occur after improper venipuncture technique or as a result of in vitro hemolysis of the

sample.

Drug Interactions

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

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, mutagenicity, and fertility studies in animals have not been performed. Potassium is a

normal dietary constituent.

Pregnancy

Animal reproduction studies have not been conducted with potassium chloride. It is unlikely that

potassium supplementation that does not lead to hyperkalemia would have an adverse effect on the fetus

or would affect reproductive capacity.

Nursing Mothers

The normal potassium ion content of human milk is about 13 mEq per liter. Since oral potassium

becomes part of the body potassium pool, so long as body potassium is not excessive, the contribution

of potassium chloride supplementation should have little or no effect on the level in human milk.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of potassium chloride did not include sufficient numbers of subjects aged 65 and over

to determine whether they respond differently from younger subjects. Other reported clinical

experience has not identified differences in responses between the elderly and younger patients. In

general, dose selection for an elderly patient should be cautious, usually starting at the low end of the

dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of

concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug

may be greater in patients with impaired renal function. Because elderly patients are more likely to have

decreased renal function, care should be taken in dose selection; and it may be useful to monitor renal

function.

ADVERSE REACTIONS

One of the most severe adverse effects is hyperkalemia (see CONTRAINDICATIONS,

WARNINGS, and OVERDOSAGE). There have also been reports of upper and lower gastrointestinal

conditions including obstruction, bleeding, ulceration, and perforation (see CONTRAINDICATIONS

and WARNINGS). 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.

OVERDOSAGE

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

CONTRAINDICATIONS and WARNINGS). It is important to recognize that hyperkalemia is usually

asymptomatic and may be manifested only by an increased serum potassium concentration (6.5 mEq to 8

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).

Late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest (9 mEq to

Late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest (9 mEq to

12 mEq/L).

Treatment measures for hyperkalemia include the following:

Patients should be closely monitored for arrythmias and electrolyte changes.

1. 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.

2. Intravenous calcium gluconate if the patient is at no risk or low risk of developing digitalis toxicity.

3. Intravenous administration of 300 to 500 mL/hr of 10% dextrose solution containing 10 units to 20

units of crystalline insulin per 1,000 mL.

4. Correction of acidosis, if present, with intravenous sodium bicarbonate.

5. Use of exchange resins, hemodialysis, or peritoneal dialysis.

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.

The extended-release feature means that absorption and toxic effects may be delayed for hours.

Consider standard measures to remove any unabsorbed drug.

DOSAGE AND ADMINISTRATION

The usual dietary intake of potassium by the average adult is 50 mEq to 100 mEq per day. Potassium

depletion sufficient to cause hypokalemia usually requires the loss of 200 mEq or more 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 mEq to 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 potassium chloride extended-release tablet, USP 20 mEq provides 20 mEq of potassium.

Each potassium chloride extended-release tablet, USP 10 mEq provides 10 mEq of potassium.

Potassium chloride tablets, USP 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

WARNINGS).

Patients having difficulty swallowing whole tablets may try one of the following alternate methods of

administration:

1. Break the tablet in half, and take each half separately with a glass of water.

2. Prepare an aqueous (water) suspension as follows:

1. Place the whole tablet(s) in approximately 1/2 glass of water (4 fluid ounces).

2. Allow approximately 2 minutes for the tablet(s) to disintegrate.

3. Stir for about half a minute after the tablet(s) has disintegrated.

4. Swirl the suspension and consume the entire contents of the glass immediately by drinking or by

the use of a straw.

5. Add another 1 fluid ounce of water, swirl, and consume immediately.

6. Then, add an additional 1 fluid ounce of water, swirl, and consume immediately.

HOW SUPPLIED

Potassium chloride extended-release tablets, USP 20 mEq are available in bottles of 100 (NDC 68462-

472-01) and 500 (NDC 68462-472-05).

Potassium chloride extended-release tablets, USP 20 mEq are white to off-white, capsule-shaped

biconvex tablets debossed with ‘472’ on one side and scored on the other side.

Potassium chloride extended-release tablets, USP 10 mEq are available in bottles of 100 (NDC 68462-

471-01) and 500 (NDC 68462-471-05).

Potassium chloride extended-release tablets, USP 10 mEq are white to off-white, capsule-shaped

biconvex tablets debossed with ‘471’ on one side and plain on the other side.

Storage Conditions

Keep tightly closed. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59°

to 86°F) [See USP Controlled Room Temperature].

Manufactured by:

Glenmark Pharmaceuticals Ltd.

Colvale-Bardez, Goa 403 513, India

Manufactured for:

Glenmark Pharmaceuticals Inc., USA

Mahwah, NJ 07430

Questions? 1 (888)721-7115

www.glenmarkpharma.com/usa

April 2019

DRUG: potassium chloride

GENERIC: potassium chloride

DOSAGE: TABLET, EXTENDED RELEASE

ADMINSTRATION: ORAL

NDC: 70518-2234-0

COLOR: white

SHAPE: CAPSULE

SCORE: No score

SIZE: 15 mm

IMPRINT: 471

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

POTASSIUM CHLORIDE 750mg in 1

INACTIVE INGREDIENT(S):

CROSPOVIDONE (15 MPA.S AT 5%)

MAGNESIUM STEARATE

MICROCRYSTALLINE CELLULOSE

ETHYLCELLULOSE, UNSPECIFIED

HYDROXYPROPYL CELLULOSE, UNSPECIFIED

TALC

POTASSIUM CHLORIDE

potassium chloride tablet, extended release

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:70 518 -2234(NDC:6 8 46 2-471)

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PO TASSIUM CHLO RIDE (UNII: 6 6 0 YQ9 8 I10 ) (POTASSIUM CATION - UNII:29 5O53K152)

POTASSIUM CHLORIDE

750 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CRO SPO VIDO NE ( 15 MPA.S AT 5%) (UNII: 6 8 40 19 6 0 MK)

ETHYLCELLULO SE, UNSPECIFIED (UNII: 7Z8 S9 VYZ4B)

HYDRO XYPRO PYL CELLULO SE, UNSPECIFIED (UNII: 9 XZ8 H6 N6 OH)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

TALC (UNII: 7SEV7J4R1U)

REMEDYREPACK INC.

Product Characteristics

Color

white (to o ff-white)

S core

no sco re

S hap e

CAPSULE (capsule-shaped, bico nvex)

S iz e

15mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:70 518 -2234-0

30 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

0 7/25/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 356 2

0 7/25/20 19

Labeler -

REMEDYREPACK INC. (829572556)

Revised: 7/2019

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