POTASSIUM CHLORIDE EXTENDED RELEASE- 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:
Cardinal Health
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Potassium chloride extended-release tablets is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient. Potassium chloride is contraindicated in patients on triamterene and amiloride. Risk Summary There are no human data related to use of potassium chloride extended-release tablets during pregnancy, and animal reproduction studies have not been conducted. Potassium supplementation that does not lead to hyperkalemia is not expected to cause fetal harm. The background risk for major birth defects and miscarriage in the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Risk Summary The normal potassium ion content of human mil
Product summary:
Potassium chloride extended-release tablets (potassium chloride, USP) contains 600 mg or 750 mg of potassium chloride (equivalent to 8 mEq and 10 mEq respectively. Potassium chloride extended-release tablets is provided as extended release tablets. Table 1: How Supplied Dose Shape Color Debossment Count NDC# 750 mg (10 mEq) round Yellow “9Q3” Overbagged with 10 tablets per bag 55154-6709-0 Store at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature.]. Protect from light and moisture. Dispense in a tight, light-resistant container with a child-resistant closure.
Authorization status:
Abbreviated New Drug Application
Authorization number:
55154-6709-0

POTASSIUM CHLORIDE EXTENDED RELEASE- potassium chloride tablet, extended release

Cardinal Health

----------

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use POTASSIUM CHLORIDE EXTENDED-

RELEASE TABLETS, USP safely and effectively. See full prescribing information for POTASSIUM CHLORIDE

EXTENDED-RELEASE TABLETS, USP.

Potassium chloride extended-release tablets, USP for oral use

Initial U.S. Approval: 1948

INDICATIONS AND USAGE

Potassium Chloride Extended-release Tablets is a potassium salt, indicated for the treatment and prophylaxis of

hypokalemia with or without metabolic alkalosis in patients for whom dietary management with potassium-rich foods or

diuretic dose reduction is insufficient. (1)

DOSAGE AND ADMINISTRATION

DOSAGE FORMS AND STRENGTHS

Tablets: 600 mg (8 mEq) and 750 mg (10 mEq) (3)

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

Gastrointestinal Irritation: Take with meals (5.1) (5)

ADVERSE REACTIONS

The most common adverse reactions are nausea, vomiting, flatulence, abdominal pain/discomfort and diarrhea. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088

or www.fda.gov/medwatch.

DRUG INTERACTIONS

USE IN SPECIFIC POPULATIONS

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 3/2020

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

Monitor serum potassium and adjust dosages accordingly (2.1)

If serum potassium is less than 2.5 mEq/L, use intravenous potassium instead of oral supplementation (2.1)

Take with meals and with a glass of water or other liquid. Swallow tablets whole without crushing, chewing or sucking.

(2.1)

Treatment of hypokalemia: Doses range from 40-100 mEq/day in divided doses. Limit doses to 40 mEq per dose.

(2.2)

Prevention of hypokalemia: Typical dose is 20 mEq per day. (2.2)

Concomitant use with triamterene and amiloride (4)

Triamterene and amiloride: Concomitant use is contraindicated (7.1)

Renin-angiotensin-aldosterone inhibitors: Monitor for hyperkalemia (7.2)

Nonsteroidal anti-inflammatory drugs: Monitor for hyperkalemia (7.3)

Cirrhosis: Initiate therapy at the low end of the dosing range (8.6)

Renal Impairment: Initiate therapy at the low end of the dosing range (8.7)

2.1 Administration and Monitoring

2.2 Dosing

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Gastrointestinal Adverse Reactions

6 ADVERSE REACTIONS

7 DRUG INTERACTIONS

7.1 Triamterene or amiloride

7.2 Renin-angiotensin-aldosterone Inhibitors

7.3 Nonsteroidal Anti-inflammatory Drugs (NSAIDs)

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Cirrhotics

8.7 Renal Impairment

10 OVERDOSAGE

10.1 Symptoms

10.2 Treatment

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

Potassium chloride extended-release tablets is indicated for the treatment and prophylaxis of

hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with

potassium-rich foods or diuretic dose reduction is insufficient.

2 DOSAGE AND ADMINISTRATION

2.1 Administration and Monitoring

If serum potassium concentration is less than 2.5 mEq/L, use intravenous potassium instead of oral

supplementation.

Monitoring

Monitor serum potassium and adjust dosages accordingly. Monitor serum potassium periodically during

maintenance therapy to ensure potassium remains in desired range.

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

Sections or subsections omitted from the full prescribing information are not listed.

acidosis, requires careful attention to acid-base balance, volume status, electrolytes, including

magnesium, sodium, chloride, phosphate, and calcium, electrocardiograms, and the clinical status of the

patient. Correct volume status, acid-base balance, and electrolyte deficits as appropriate.

Administration

Take potassium chloride extended-release tablets with meals and with a glass of water or other liquid.

Do not take potassium chloride extended-release tablets on an empty stomach because of its potential

for gastric irritation [see Warnings and Precautions(5.1)].

Swallow tablets whole without crushing, chewing or sucking.

2.2 Dosing

Dosage must be adjusted to the individual needs of each patient. Dosages greater than 40 mEq per day

should be divided such that no more than 40 mEq is given in a single dose.

Treatment of Hypokalemia: Typical dose range is 40-100 mEq per day.

Maintenance or Prophylaxis: Typical dose range is 20 mEq per day.

3 DOSAGE FORMS AND STRENGTHS

Potassium chloride extended-release tablets are supplied as:

600 mg (8 mEq) are film coated, round light blue, tablets debossed with “1G5”

750 mg (10 mEq) are film coated, round yellow, tablets debossed with “9Q3”

4 CONTRAINDICATIONS

Potassium chloride is contraindicated in patients on triamterene and amiloride.

5 WARNINGS AND PRECAUTIONS

5.1 Gastrointestinal Adverse Reactions

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

gastrointestinal tract, particularly if the drug maintains contact with the gastrointestinal mucosa for

prolonged periods. Consider the use of liquid potassium in patients with dysphagia, swallowing

disorders, or severe gastrointestinal motility disorders.

If severe vomiting, abdominal pain, distention, or gastrointestinal bleeding occurs, discontinue

potassium chloride extended-release tablets and consider possibility of ulceration, obstruction or

perforation.

Potassium chloride extended-release tablets should not be taken on an empty stomach because of its

potential for gastric irritation [see Dosage and Administration (2.1)].

6 ADVERSE REACTIONS

The following adverse reactions have been identified with use of oral potassium salts. Because these

reactions are reported voluntarily from a population of uncertain size, it is not always possible to

reliably estimate their frequency or establish a causal relationship to drug exposure.

The most common adverse reactions to oral potassium salts are nausea, vomiting, flatulence, abdominal

pain/discomfort, and diarrhea.

There have been reports hyperkalemia and of upper and lower gastrointestinal condition including

obstruction, bleeding, ulceration, perforation.

Skin rash has been reported rarely.

7 DRUG INTERACTIONS

7.1 Triamterene or amiloride

Use with triamterene or amiloride can produce severe hyperkalemia. Concomitant use is contraindicated

[see Contraindications (4)].

7.2 Renin-angiotensin-aldosterone 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 on concomitant RAAS inhibitors.

7.3 Nonsteroidal Anti-inflammatory Drugs (NSAIDs)

NSAIDS may produce potassium retention by reducing renal synthesis of prostaglandin E and impairing

the renin-angiotensin system. Closely monitor potassium in patients on concomitant NSAIDs.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

There are no human data related to use of potassium chloride extended-release tablets during

pregnancy, and animal reproduction studies have not been conducted. Potassium supplementation that

does not lead to hyperkalemia is not expected to cause fetal harm.

The background risk for major birth defects and miscarriage in the indicated population is unknown. All

pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general

population, the estimated background risk of major birth defects and miscarriage in clinically

recognized pregnancies is 2-4% and 15-20%, respectively.

8.2 Lactation

Risk Summary

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.

8.4 Pediatric Use

Safety and effectiveness in the pediatric population have not been established.

8.5 Geriatric Use

Clinical studies of potassium chloride extended-release tablets 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.

8.6 Cirrhotics

Based on publish literature, the baseline corrected serum concentrations of potassium measured over 3

hours after administration in cirrhotic subjects who received an oral potassium load rose to

approximately twice that of normal subjects who received the same load. Patients with cirrhosis should

usually be started at the low end of the dosing range, and the serum potassium level should be monitored

frequently [see Clinical Pharmacology (12.3)].

8.7 Renal Impairment

Patients with renal impairment have reduced urinary excretion of potassium and are at substantially

increased risk of hyperkalemia [see Warnings and Precautions (5.2)]. Patients with impaired renal

function, particularly if the patient is on RAAS inhibitors or NSAIDs, should usually be started at the

low end of the dosing range because of the potential for development of hyperkalemia [see Drug

Interactions (7.2, 7.3)]. The serum potassium level should be monitored frequently. Renal function

should be assessed periodically.

10 OVERDOSAGE

10.1 Symptoms

The administration of oral potassium salts to persons with normal excretory mechanisms for potassium

rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired, 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 to 8.0 mEq/L) and characteristic electrocardiographic

changes (peaking of T-waves, loss of P-wave, depression of S-T segment and prolongation of the QT

interval). Late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest

(9 to 12 mEq/L).

10.2 Treatment

Treatment measures for hyperkalemia include the following:

1. Elimination of foods and medications containing potassium and of any agents with potassium-sparing

properties.

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

crystalline insulin per 1,000 mL.

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

4. 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.

11 DESCRIPTION

Potassium chloride extended-release tablets are a solid oral dosage form of potassium chloride. Each

contains 600 mg or 750 mg of potassium chloride equivalent to 8 mEq or 10 mEq of potassium in a wax

matrix tablet.

Potassium chloride extended-release tablets are an electrolyte replenisher. The chemical name is

potassium chloride, and the structural formula is KCl. Potassium chloride, USP is a white, granular

powder or 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.

Inactive Ingredients: hydrogenated vegetable oil, magnesium stearate, polyethylene glycol, polyvinyl

alcohol, silicon dioxide, talc, and titanium dioxide. The 10 mEq (750 mg) tablets also contain D&C

Yellow No.10 aluminum lake and FD&C Yellow No. 6 aluminum lake. The 8 mEq (600 mg) tablets also

contain FD&C Blue No. 1 aluminum lake and FD&C Blue No. 2 aluminum lake.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

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.

12.3 Pharmacokinetics

The potassium chloride in potassium chloride extended-release tablets is completely absorbed before it

leaves the small intestine. The wax matrix is not absorbed and is excreted in the feces; in some instances

the empty matrices may be noticeable in the stool. When the bioavailability of the potassium ion from

the potassium chloride extended-release tablets is compared to that of a true solution the extent of

absorption is similar.

The extended-release properties of potassium chloride extended-release tablets are demonstrated by

the finding that a significant increase in time is required for renal excretion of the first 50% of the

potassium chloride extended-release tablets dose as compared to the solution.

Increased urinary potassium excretion is first observed 1 hour after administration of potassium

chloride extended-release tablets, reaches a peak at approximately 4 hours, and extends up to 8 hours.

Mean daily steady-state plasma levels of potassium following daily administration of potassium

chloride extended-release tablets cannot be distinguished from those following administration of

potassium chloride solution or from control plasma levels of potassium ion.

Specific Populations

Cirrhotics

Based on publish literature, the baseline corrected serum concentrations of potassium measured over 3

hours after administration in cirrhotic subjects who received an oral potassium load rose to

approximately twice that of normal subjects who received the same load.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

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

normal dietary constituent.

16 HOW SUPPLIED/STORAGE AND HANDLING

Potassium chloride extended-release tablets (potassium chloride, USP) contains 600 mg or 750 mg of

potassium chloride (equivalent to 8 mEq and 10 mEq respectively. Potassium chloride extended-release

tablets is provided as extended release tablets.

Table 1: How Supplied

Dose

Shape

Color

Debossment

Count

NDC#

750 mg (10 mEq)

round

Yellow

“9Q3”

Overbagged with 10

tablets per bag

55154-6709-0

Store at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature.]. Protect from light and

moisture.

Dispense in a tight, light-resistant container with a child-resistant closure.

17 PATIENT COUNSELING INFORMATION

Manufactured by

Perrigo®

Minneapolis, MN 55427

2202937

Distributed by:

Cardinal Health

Dublin, OH 43017

L55345400719

Rev 05-18C

1G500 RC J3

Revised 05/2018

Package/Label Display Panel

Potassium Chloride Extended-Release Tablets, USP

10 mEq (750 mg)

10 Tablets

Inform patients to take each dose with meals and with a full glass of water or other liquid, and to

not crush, chew, or suck the tablets. Inform patients that the wax matrix is not absorbed and is

excreted in the feces; in some instances the empty matrices may be noticeable in the stool.

Advise patients seek medical attention if tarry stools or other evidence of gastrointestinal

bleeding is noticed.

POTASSIUM CHLORIDE EXTENDED RELEASE

potassium chloride tablet, extended release

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:55154-6 70 9 (NDC:0 574-0 275)

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

10 meq

Inactive Ingredients

Ingredient Name

Stre ng th

HYDRO GENATED CO TTO NSEED O IL (UNII: Z8 2Y2C6 5EA)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

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

PO LYVINYL ALCO HO L, UNSPECIFIED (UNII: 532B59 J9 9 0 )

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

TALC (UNII: 7SEV7J4R1U)

ALUMINUM O XIDE (UNII: LMI26 O6 9 33)

Cardinal Health

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

Product Characteristics

Color

YELLOW

S core

no sco re

S hap e

ROUND

S iz e

13mm

Flavor

Imprint Code

9 Q3

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:55154-6 70 9 -0

10 in 1 BAG

0 5/0 5/20 16

1

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

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 59 9 3

12/11/20 15

Labeler -

Cardinal Health (603638201)

Revised: 6/2020

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