Label: POTASSIUM CHLORIDE tablet, extended release
- NDC Code(s): 70934-747-90
- Packager: Denton Pharma, Inc. dba Northwind Pharmaceuticals
- This is a repackaged label.
- Source NDC Code(s): 64380-861
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated July 6, 2020
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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, USP 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) (1)
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)
DOSAGE FORMS AND STRENGTHS
Tablets: 600 mg (8 mEq) and 750 mg (10 mEq) (3) (3)
- Concomitant use with triamterene and amiloride (4)
WARNINGS AND PRECAUTIONS
- Gastrointestinal Irritation: Take with meals (5.1)
- The most common adverse reactions are nausea, vomiting, flatulence, abdominal pain/discomfort and diarrhea. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Strides Pharma Inc. at 1-877-244-9825 or go to www.strides.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. (6)
- 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)
USE IN SPECIFIC POPULATIONS
- 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)
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 Potassium Chloride Extended-release Tablets, USP with meals and with a glass of water or other liquid. Do not take Potassium Chloride Extended-release Tablets, USP 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.
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, USP 8 mEq [600mg] are blue colored, circular biconvex film coated tablets plain on one side and debossed "P8" on another side.
Potassium Chloride Extended Release Tablets, USP 10 mEq [750mg] are yellow colored, circular biconvex film coated tablets plain on one side and debossed "P10" on another side.
- 4 CONTRAINDICATIONS
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 K-TAB and consider possibility of ulceration, obstruction or perforation.
K-TAB 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
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.
8 USE IN SPECIFIC POPULATIONS
There are no human data related to use of Potassium Chloride Extended-release Tablets, USP 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.
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.
8.5 Geriatric Use
Clinical studies of Potassium Chloride extended-release 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 [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.
Potassium Chloride Extended-Release Tablets, USP 750 mg contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.
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).
- Elimination of foods and medications containing potassium and of any agents with potassium-sparing properties.
- Intravenous administration of 300 to 500 mL/hr of 10% dextrose solution containing 10 to 20 units of crystalline insulin per 1,000 mL.
- Correction of acidosis, if present, with intravenous sodium bicarbonate.
- Use of 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 Tablets, USP 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, USP 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 Type 1, Ethylcellulose (10cP), Ethylcellulose (100cP), Silicon Dioxide, Talc, Magnesium Stearate. The 600 mg tablets also contain Polyvinyl Alcohol, Titanium dioxide, Macrogol / PEG, Talc, FD&C Blue #1 / Brilliant Blue FCF Aluminum Lake, FD&C Blue #2 / Indigo Carmine Al 3% - 5% and the 750 mg tablets also contain of Polyvinyl Alcohol, Titanium dioxide, Macrogol / PEG, Talc, FD&C Yellow #5 / Tartrazine Aluminum Lake and FD&C Yellow #6 / Sunset Yellow FCF Aluminum Lake.
"FDA approved dissolution test specifications differ from USP." and "FDA approved acceptance criteria for assay differs from USP test."
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.
The potassium chloride in Potassium Chloride extended-release 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 is compared to that of a true solution the extent of absorption is similar.
The extended-release properties of Potassium Chloride extended-release 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 dose as compared to the solution.
Increased urinary potassium excretion is first observed 1 hour after administration of Potassium Chloride extended-release, 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.
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
16 HOW SUPPLIED/STORAGE AND HANDLING
Potassium Chloride Extended Release Tablets,
750 mg potassium chloride (equivalent to 10 mEq) are available in bottles of 90 (NDC 70934-747-90),
Store at 25ºC (77ºF) [See USP Controlled Room Temperature]. Protect from light and moisture.
Dispense in a tight container as defined in the USP with a child resistant closure.
17 PATIENT COUNSELING INFORMATION
- 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.
Strides Pharma Science Limited.
Bengaluru -562106, India.
Strides Pharma Inc.,
East Brunswick, NJ 08816
- Principal Display Panel
INGREDIENTS AND APPEARANCE
potassium chloride tablet, extended release
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70934-747(NDC:64380-861) 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 ETHYLCELLULOSE (10 MPA.S) (UNII: 3DYK7UYZ62) ETHYLCELLULOSE (100 MPA.S) (UNII: 47MLB0F1MV) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color yellow Score no score Shape ROUND (biconvex) Size 12mm Flavor Imprint Code P10 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70934-747-90 90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/27/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210733 05/27/2020 Labeler - Denton Pharma, Inc. dba Northwind Pharmaceuticals (080355546) Registrant - Denton Pharma, Inc. dba Northwind Pharmaceuticals (080355546) Establishment Name Address ID/FEI Business Operations Denton Pharma, Inc. dba Northwind Pharmaceuticals 080355546 repack(70934-747)