These highlights do not include all the information needed to use POTASSIUM CHLORIDE safely and effectively. See full prescribing information for POTASSIUM CHLORIDE Initial U.S. Approval:1948

These highlights do not include all the information needed to use POTASSIUM CHLORIDE safely and effectively. See full prescribing information for POTASSIUM CHLORIDE Initial U.S. Approval:1948

Drug Labeling and Warnings

Drug Details

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POTASSIUM CHLORIDE- potassium chloride solution 
Lupin Pharmaceuticals,Inc.

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use POTASSIUM CHLORIDE safely and effectively. See full prescribing information for POTASSIUM CHLORIDE 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 are insufficient (1)

DOSAGE AND ADMINISTRATION

Dilute prior to administration (2.1, 5.1)

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

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 20 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

          Oral Solution: 10%; 1.3 mEq potassium per mL (3)

          Oral Solution: 20%; 2.6 mEq potassium per mL (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 Lupin Pharmaceuticals, Inc. at 1-866-403-7592 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. (6)

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)

Revised: 10/2018

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

Potassium chloride is indicated for the treatment and prophylaxis of hypokalemia in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.

2 DOSAGE AND ADMINISTRATION

2.1 Administration and Monitoring

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.

Administration

Dilute the potassium chloride solution with at least 4 ounces of cold water [see Warnings and Precautions (5.1)].

Take with meals or immediately after eating.

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

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

Oral Solution 10%: 1.3 mEq potassium per mL.

Oral Solution 20%: 2.6 mEq potassium per mL.

4 CONTRAINDICATIONS

Potassium chloride is contraindicated in patients on potassium sparing diuretics

5 WARNINGS AND PRECAUTIONS

5.1 Gastrointestinal Irritation

May cause gastrointestinal irritation if administered undiluted. 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.

8.3 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.

8.4 Pediatric Use

The safety and effectiveness of potassium chloride have been demonstrated in children with diarrhea and malnutrition from birth to 16 years.

8.5 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.

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 powder or colorless crystals. It is freely soluble in water and practically insoluble in alcohol. Chemically, potassium chloride is K-Cl with a molecular weight of 74.55.

Oral Solution 10%: Each 15 mL of solution contains 1.5 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow #6, glycerin, methylparaben, natural/artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose.

Oral Solution 20%: Each 15 mL of solution contains 3.0 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow #6, glycerin, methylparaben, natural/artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, 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.

16 HOW SUPPLIED/STORAGE AND HANDLING

Potassium chloride is a clear, orange colored solution with an orange flavor, available in two strengths as follows:

10%: 20 mEq/15 mL oral solution

NDC# 43386-168-01 Bottle of 473 mL

20%: 40 mEq/15 mL oral solution

NDC# 43386-169-01- Bottle of 473 mL

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:

Novel Laboratories, Inc.

Somerset, NJ.

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, MD 21202

PI1690000201

Rev. 06/2018

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

20 meq container label

20meq

40 meq container label

40meq

POTASSIUM CHLORIDE 
potassium chloride solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 43386-168
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORIDE20 meq  in 15 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ORANGE (UNII: 5EVU04N5QU)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorORANGEScore    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 43386-168-01473 mL in 1 BOTTLE; Type 0: Not a Combination Product09/24/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20978609/24/2018
POTASSIUM CHLORIDE 
potassium chloride solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 43386-169
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORIDE40 meq  in 15 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ORANGE (UNII: 5EVU04N5QU)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorORANGEScore    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 43386-169-01473 mL in 1 BOTTLE; Type 0: Not a Combination Product09/24/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20978609/24/2018
Labeler - Lupin Pharmaceuticals,Inc. (089153071)
Registrant - Novel Laboratories, Inc. (793518643)
Establishment
NameAddressID/FEIBusiness Operations
Novel Laboratories, Inc.793518643ANALYSIS(43386-168, 43386-169) , MANUFACTURE(43386-168, 43386-169) , PACK(43386-168, 43386-169)

Revised: 12/2018
 
Lupin Pharmaceuticals,Inc.


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