Label: POTASSIUM CHLORIDE capsule, extended release
- NDC Code(s): 68382-701-01, 68382-701-05, 68382-702-01, 68382-702-05
- Packager: Zydus Pharmaceuticals (USA) Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application Authorized Generic
Updated January 1, 2020
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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES
Initial U.S. Approval: 1948
INDICATIONS AND USAGE
Potassium Chloride Extended-Release Capsules, USP contain potassium chloride, 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 does reduction is insufficient. (1)
DOSAGE AND ADMINISTRATION
Monitor serum potassium and adjust dosage accordingly (2.1)
If serum potassium concentration is <2.5 mEq/L, use intravenous potassium instead of oral supplementation (2.1)
Treatment of hypokalemia:
- Adults: Typical doses range from 40-100 mEq/day in 2-5 divided doses; limit doses to 40 mEq per dose. (2.2)
- Pediatric patients: 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. (2.3)
Maintenance or Prophylaxis of hypokalemia:
DOSAGE FORMS AND STRENGTHS
- Extended-release capsules: 600 mg (8 mEq) and 750 mg (10 mEq)
- Concomitant use with triamterene and amiloride. (4)
WARNINGS AND PRECAUTIONS
- Gastrointestinal Irritation: Take with meals (5.1)
Most common adverse reactions are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals USA Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
See 17 for PATIENT COUNSELING INFORMATION.
Table of Contents
FULL PRESCRIBING INFORMATION: CONTENTS*
- Sections or subsections omitted from the full prescribing information are not listed.
- 1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Administration and 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 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.
Take with meals and with a full glass of water or other liquid. Do not take on an empty stomach because of the potential for gastric irritation. (5.1)
Patients who have difficulty swallowing capsules may sprinkle the contents of the capsule onto a spoonful of soft food. The soft food, such as applesauce or pudding, should be swallowed immediately without chewing and followed with a glass of water or juice to ensure complete swallowing of the microcapsules. Do not added to hot foods. Any microcapsule/food mixture should be used immediately and not stored for future use.
2.2 Adult Dosing
Treatment of hypokalemia: Typical dose range is 40-100 mEq per day.
Maintenance or Prophylaxis: Typical dose is 20 mEq per day.
2.3 Pediatric Dosing
Treatment of hypokalemia: The recommended initial dose is 2 to 4 mEq/kg/day in divided doses. If deficits are severe or ongoing losses are great, consider intravenous therapy.
Maintenance or Prophylaxis: Typical dose is 1 mEq/kg/day.
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
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 intoxications, 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, hepatic cirrhosis with ascites, states of aldosterone excess with normal renal function, potassium-losing nephropathy, and certain diarrheal states).
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.
Hyperkalemia [see Overdosage (10)].
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 adjustments.
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 is in contact with the gastrointestinal mucosa for a prolonged period of time. 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 capsules and consider possibility of ulceration, obstruction or perforation.
Potassium chloride extended-release capsules 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 of hyperkalemia and of upper and lower gastrointestinal conditions including, obstruction, bleeding, ulceration, and perforation.
Skin rash has been reported rarely.
7 DRUG INTERACTIONS
7.1 Amiloride and Triamterene
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-aldosternone system (RAAS) including angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), spironolactone, eplerenone, or aliskiren produces potassium retention by inhibiting aldosterone production. Closely monitor potassium in patients taking drugs that inhibit RAAS.
8 USE IN SPECIFIC POPULATIONS
There are no human data related to use of potassium chloride extended-release capsules during pregnancy and animal reproductive 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.
The normal potassium ion content of human milk is about 13 mEq per liter. Since oral potassium becomes part of the body potassium pool, as 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
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.
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. Patients with impaired renal function, particularly if the patient is on RAAS inhibitors 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 [see Drug Interactions (7.2), (7.3)]. The serum potassium level should be monitored frequently. Renal function should be assessed periodically.
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.
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).
- Monitor closely for arrhythmias and electrolyte changes.
- Eliminate foods and medications containing potassium and any agents with potassium-sparing properties such as potassium-sparing diuretics, ARBs, ACE inhibitors, NSAIDs, certain nutritional supplements, and many others.
- Administer intravenous calcium gluconate if the patient is at no risk or low risk of developing digitalis toxicity.
- Administer 300 to 500 mL/hr of 10% dextrose solution containing 10 to 20 units of crystalline insulin per 1,000 mL.
- Correct acidosis, if present, with intravenous sodium bicarbonate.
- Use exchange resins, hemodialysis, or peritoneal dialysis.
The extended-release feature means that absorption and toxic effects may be delayed for hours. Consider standard measures to remove any unabsorbed drug.
Potassium chloride extended-release capsules are an oral dosage form of microencapsulated potassium chloride containing 600 mg and 750 mg of potassium chloride, USP, equivalent to 8 mEq and 10 mEq of potassium, respectively.
The chemical name of the active ingredient is potassium chloride and the structural formula is KCl. It has a molecular mass of 74.55. Potassium chloride, USP, occurs as a white granular powder or as 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: edible ink, ethylcellulose, FD&C Blue No. 2 aluminum lake, FD&C Yellow No. 6, gelatin, magnesium stearate, sodium lauryl sulfate, titanium dioxide. May contain FD&C Red No. 40 and FD&C Yellow No. 6 aluminum lakes.
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.
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.
16 HOW SUPPLIED/STORAGE AND HANDLING
Table 1: How Supplied Dose
600 mg (8 mEq)
"002" - body
"002" - cap
750 mg (10 mEq)
"001" – body
"001" - cap
17 PATIENT COUNSELING INFORMATION
- Inform patients to take each dose with meals and with a full glass of water or other liquid.
- Advise patients seek medical attention if tarry stools or other evidence of gastrointestinal toxicity is noticed.
Dispense in tight, light-resistant container as defined in the USP, with a child-resistant closure.
Manufactured and Distributed By:
Nesher Pharmaceuticals USA LLC.
St. Louis, MO 63044
Zydus Pharmaceuticals USA Inc.
Pennington, NJ 08534
Part #: RA-SUB2
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Potassium Chloride Extended-Release Capsules, USP
8 mEq (600 mg)
Potassium Chloride Extended-Release Capsules, USP
10 mEq (750 mg)
Potassium Chloride Extended-Release Capsules, USP
10 mEq (750 mg)
INGREDIENTS AND APPEARANCE
potassium chloride capsule, extended release
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-702 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORIDE 600 mg Inactive Ingredients Ingredient Name Strength ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) MAGNESIUM STEARATE (UNII: 70097M6I30) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C RED NO. 40 (UNII: WZB9127XOA) ALUMINUM OXIDE (UNII: LMI26O6933) Product Characteristics Color ORANGE (pale orange) Score no score Shape CAPSULE Size 23mm Flavor Imprint Code 002;002 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68382-702-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 10/25/2010 2 NDC:68382-702-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 10/25/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA authorized generic NDA018238 10/25/2010 POTASSIUM CHLORIDE
potassium chloride capsule, extended release
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-701 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORIDE 750 mg Inactive Ingredients Ingredient Name Strength ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) MAGNESIUM STEARATE (UNII: 70097M6I30) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C RED NO. 40 (UNII: WZB9127XOA) ALUMINUM OXIDE (UNII: LMI26O6933) Product Characteristics Color ORANGE (pale orange) , WHITE (opaque white) Score no score Shape CAPSULE Size 23mm Flavor Imprint Code 001;001 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68382-701-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 10/25/2010 2 NDC:68382-701-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 10/25/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA authorized generic NDA018238 10/25/2010 Labeler - Zydus Pharmaceuticals (USA) Inc. (156861945) Registrant - Nesher Pharmaceuticals (USA) LLC (969028351)