POTASSIUM CHLORIDE FOR ORAL SOLUTION powder, for solution

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

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Active ingredient:
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698)
Available from:
Belcher Pharmaceuticals LLC
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Potassium Chloride 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 potassium sparing diuretics. Pregnancy Category C 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. 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. Clinical trial data from published literature have demonstrated the safety and effectiveness of potassium chloride in children with diarrhea and malnutrition f
Product summary:
Potassium Chloride for Oral Solution, is a light pink to orange powder available in one strength as follows: 20 mEq NDC# 62250-690-34 pouch. Each pouch contains 1.5 g of potassium chloride providing potassium 20 mEq and chloride 20 mEq NDC# 62250-690-32 carton of 30 pouches NDC# 62250-690-33 carton of 100 pouches Storage Store at 25°C (77°F); excursions are permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP PROTECT from LIGHT. Rx only Manufactured by: Belcher Pharmaceuticals LLC Largo, FL 33777 USA Revised December 2018 L67I D-1812
Authorization status:
Abbreviated New Drug Application
Authorization number:
62250-690-32, 62250-690-33, 62250-690-34

POTASSIUM CHLORIDE FOR ORAL SOLUTION- potassium chloride for oral

solution powder, for solution

Belcher Pharmaceuticals LLC

----------

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use POTASSIUM CHLORIDE FOR ORAL

SOLUTION safely and effectively. See full prescribing information for POTASSIUM CHLORIDE FOR ORAL

SOLUTION.

POTASSIUM CHLORIDE for oral solution

Initial U.S. Approval: 1948

INDICATIONS AND USAGE

Potassium Chloride 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

Dilute prior to administration. (2.1, 5.1)

Monitor serum potassium and adjust dosage accordingly (2.2, 2.3)

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

Treatment of hypokalemia:

Adults: Initial doses range from 40-100 mEq/day in 2-5 divided doses: limit doses to 40 mEq per dose. Total daily dose

should not exceed 200 mEq (2.2)

Pediatric patients aged birth to 16 years old: 2-4 mEq/kg/day in divided doses; not to exceed 1 mEq/kg as a single dose or

40 mEq whichever is lower; if deficits are severe or ongoing losses are great, consider intravenous therapy. Total daily

dose should not exceed 100 mEq (2.3)

Maintenance or Prophylaxis of hypokalemia:

Adults: Typical dose is 20 mEq per day (2.2)

Pediatric patients aged birth to 16 years old: typical dose is 1 mEq/kg/day. Do not to exceed 3 mEq/kg/day (2.3)

DOSAGE FORMS AND STRENGTHS

Potassium Chloride for Oral Solution, USP 20 mEq: Each pouch contains 1.5 g of Potassium Chloride providing potassium

20 mEq and chloride 20 mEq. (3)

CONTRAINDICATIONS

Concomitant use with potassium sparing diuretics. (4)

WARNINGS AND PRECAUTIONS

Gastrointestinal Irritation: Dilute before use, take with meals (5.1)

ADVERSE REACTIONS

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

To report SUSPECTED ADVERSE REACTIONS, contact Belcher Pharmaceuticals, LLC. at 1-727-471-0850 or

FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Potassium sparing diuretics: Avoid concomitant use (7.1)

Angiotensin converting enzyme inhibitors: Monitor for hyperkalemia (7.2)

Angiotensin receptor blockers: Monitor for hyperkalemia (7.3)

USE IN SPECIFIC POPULATIONS

Cirrhosis: Initiate therapy at the low end of the dosing range (8.5)

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

Revised: 12/2018

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Administration and Monitoring

2.2 Adult Dosing

2.3 Pediatric Dosing

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Gastrointestinal Irritation

6 ADVERSE REACTIONS

7 DRUG INTERACTIONS

7.1 Potassium-Sparing Diuretics

7.2 Angiotensin-Converting Enzyme Inhibitors

7.3 Angiotensin Receptor Blockers

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Nursing Mothers

8.3 Pediatric Use

8.4 Geriatric Use

8.5 Cirrhotics

8.6 Renal Impairment

10 OVERDOSAGE

10.1 Symptoms

10.2 Treatment

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.3 Pharmacokinetics

16 HOW SUPPLIED/STORAGE AND HANDLING

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

Potassium Chloride 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 <2.5 mEq/L, use intravenous potassium instead of oral

supplementation.

Monitoring

Monitor serum potassium and adjust dosages accordingly. For treatment of hypokalemia, monitor

potassium levels daily or more often depending on the severity of hypokalemia until they return to

normal. Monitor potassium levels monthly to biannually for maintenance or prophylaxis.

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

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.

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

Administration

Dilute the potassium chloride for oral solution with at least 4 ounces of cold water [see Warnings and

Precautions (5.1)].

Take with meals or immediately after eating.

2.2 Adult Dosing

Treatment of hypokalemia:

Daily dose range from 40 to 100 mEq. Give in 2 to 5 divided doses: limit doses to 40 mEq per dose.

The total daily dose should not exceed 200 mEq in a 24 hour period.

Maintenance or Prophylaxis

Typical dose is 20 mEq per day. Individualize dose based upon serum potassium levels.

Studies support the use of potassium replacement in digitalis toxicity. When alkalosis is present,

normokalemia and hyperkalemia may obscure a total potassium deficit. The advisability of use of

potassium replacement in the setting of hyperkalemia is uncertain.

2.3 Pediatric Dosing

Treatment of hypokalemia:

Pediatric patients aged birth to 16 years old: The initial dose is 2 to 4 mEq/kg/day in divided doses; do

not exceed as a single dose 1 mEq/kg or 40 mEq, whichever is lower; maximum daily doses should not

exceed 100 mEq. If deficits are severe or ongoing losses are great, consider intravenous therapy.

Maintenance or Prophylaxis

Pediatric patients aged birth to 16 years old: Typical dose is 1 mEq/kg/day. Do not exceed 3

mEq/kg/day.

3 DOSAGE FORMS AND STRENGTHS

Each pouch contains 1.5 g of potassium chloride supplying 20 mEq of potassium and 20 mEq of

chloride.

4 CONTRAINDICATIONS

Potassium chloride is contraindicated in patients on potassium sparing diuretics.

5 WARNINGS AND PRECAUTIONS

5.1 Gastrointestinal Irritation

May cause gastrointestinal irritation. Increased dilution of the solution and taking with meals may reduce

gastrointestinal irritation [see Dosage and Administration (2.1)].

6 ADVERSE REACTIONS

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

pain/discomfort, and diarrhea.

7 DRUG INTERACTIONS

7.1 Potassium-Sparing Diuretics

Use with potassium-sparing diuretic can produce severe hyperkalemia. Avoid concomitant use.

7.2 Angiotensin-Converting Enzyme Inhibitors

Use with angiotensin converting enzyme (ACE) inhibitors produces potassium retention by inhibiting

aldosterone production. Potassium supplements should be given to patients receiving ACE inhibitors

only with close monitoring.

7.3 Angiotensin Receptor Blockers

Use with angiotensin receptor blockers (ARBs) produces potassium retention by inhibiting aldosterone

production. Potassium supplements should be given to patients receiving ARBs only with close

monitoring.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C

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.

8.2 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.

8.3 Pediatric Use

Clinical trial data from published literature have demonstrated the safety and effectiveness of potassium

chloride in children with diarrhea and malnutrition from birth to 18 years.

8.4 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.

8.5 Cirrhotics

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)].

8.6 Renal Impairment

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

increased risk of hyperkalemia. Patients with impaired renal function, particularly if the patient is on

ACE inhibitors, ARBs, or nonsteroidal anti-inflammatory drugs, should usually be started at the low end

of the dosing range because of the potential for development of hyperkalemia. 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 or if potassium is

administered too rapidly potentially fatal hyperkalemia can result.

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). Late manifestations

include muscle paralysis and cardiovascular collapse from cardiac arrest (9–12 mEq/L).

10.2 Treatment

Treatment measures for hyperkalemia include the following:

1. Monitor closely for arrhythmias and electrolyte changes.

2. Eliminate 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.

3. Administer intravenous calcium gluconate if the patient is at no risk or low risk of developing

digitalis toxicity.

4. Administer intravenously 300 to 500 mL/hr of 10% dextrose solution containing 10 to 20 units of

crystalline insulin per 1000 mL.

5. Correct acidosis, if present, with intravenous sodium bicarbonate.

6. Use exchange resins, hemodialysis, or peritoneal dialysis.

In patients who have been stabilized on digitalis, too rapid a lowering of the serum potassium

concentration can produce digitalis toxicity.

11 DESCRIPTION

Potassium Chloride is a white crystalline or colorless solid. It is soluble in water and slightly soluble

in alcohol. Chemically, Potassium Chloride is K-Cl with a molecular mass of 74.55.

Each pouch of light pink to orange powder contains 1.5 g of potassium chloride, USP, which is

equivalent to potassium 20 mEq and chloride 20 mEq and the following inactive ingredients: citric acid

anhydrous, colloidal silicon dioxide, FD&C Yellow #6, natural and artificial orange flavor, and

sucralose.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

The potassium ion (K ) 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

Based on published literature, the rate of absorption and urinary excretion of potassium from KCl oral

solution were higher during the first few hours after dosing relative to modified release KCl products.

The bioavailability of potassium, as measured by the cumulative urinary excretion of K over a 24 hour

post dose period, is similar for KCl solution and modified release products.

Specific Populations

Cirrhotics

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

3 h after administration in cirrhotic subjects who received an oral potassium load rose to approximately

twice that of normal subjects who received the same load.

16 HOW SUPPLIED/STORAGE AND HANDLING

Potassium Chloride for Oral Solution, is a light pink to orange powder available in one strength as

follows:

20 mEq

NDC# 62250-690-34 pouch. Each pouch contains 1.5 g of potassium chloride providing potassium 20

mEq and chloride 20 mEq

NDC# 62250-690-32 carton of 30 pouches

NDC# 62250-690-33 carton of 100 pouches

Storage

Store at 25°C (77°F); excursions are permitted to 15° to 30°C (59° to 86°F). [See USP Controlled

Room Temperature.]

Dispense in a tight, light-resistant container as defined in the USP

PROTECT from LIGHT.

Rx only

Manufactured by:

Belcher Pharmaceuticals LLC

Largo, FL 33777

Revised December 2018

L67I D-1812

NDC# 62250-690-34

Potassium Chloride for Oral Solution

20 mEq

Rx only

Single Dose (1.5 g)

Belcher Pharmaceuticals LLC

POTASSIUM CHLORIDE FOR ORAL SOLUTION

potassium chloride for oral solution powder, for solution

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:6 2250 -6 9 0

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of

Stre ng th

Stre ng th

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

CHLORIDE ION - UNII:Q32ZN48 6 9 8 )

POTASSIUM

CHLORIDE

1.5 g

in 1.58 g

Inactive Ingredients

Ingredient Name

Stre ng th

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

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

O RANGE (UNII: 5EVU0 4N5QU)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

Product Characteristics

Color

o range (light pink to o range)

S core

S hap e

S iz e

Belcher Pharmaceuticals LLC

Flavor

ORANGE

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 2250 -6 9 0 -32

30 in 1 CARTON

0 6 /0 6 /20 18

1

NDC:6 2250 -6 9 0 -34

1.58 g in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:6 2250 -6 9 0 -33

10 0 in 1 CARTON

0 6 /0 6 /20 18

2

NDC:6 2250 -6 9 0 -34

1.58 g in 1 POUCH; 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

ANDA21218 3

0 6 /0 6 /20 18

Labeler -

Belcher Pharmaceuticals LLC (965082543)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Belcher Pharmaceuticals LLC

9 6 50 8 2543

manufacture(6 2250 -6 9 0 ) , analysis(6 2250 -6 9 0 )

Revised: 12/2018

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