Potassium Chloride

Zydus Pharmaceuticals Usa Inc
Human Prescription Drug
NDC 68382-776

Potassium Chloride is a human prescription drug labeled by 'Zydus Pharmaceuticals Usa Inc'. National Drug Code (NDC) number for Potassium Chloride is 68382-776. This drug is available in dosage form of Tablet, Film Coated, Extended Release. The names of the active, medicinal ingredients in Potassium Chloride drug includes Potassium Chloride - 600 mg/1 . The currest status of Potassium Chloride drug is Active.

Drug Information:

Drug NDC:	68382-776
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Potassium Chloride
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Potassium Chloride
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Zydus Pharmaceuticals Usa Inc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Tablet, Film Coated, Extended Release
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	POTASSIUM CHLORIDE - 600 mg/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	NDA AUTHORIZED GENERIC
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date:	16 Jan, 2014
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	26 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	NDA018279
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Zydus Pharmaceuticals USA Inc
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	198116 312529 628953
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UPC:	0368382398017 0368382320100 0368382600011 0368382776105
UPC stands for Universal Product Code.
UNII:	660YQ98I10
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class:	Increased Large Intestinal Motility [PE] Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] Osmotic Activity [MoA] Osmotic Laxative [EPC] Potassium Compounds [CS] Potassium Salt [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
68382-776-01	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-776-01)	16 Jan, 2014	N/A	No
68382-776-10	1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-776-10)	16 Jan, 2014	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Potassium Chloride Extended Release

Potassium Chloride

Tablet, Extended Release
Granules Pharmaceuticals Inc.
NDC: 70010-021

Product Elements:

Potassium chloride potassium chloride potassium chloride potassium cation castor oil d&c yellow no. 10 magnesium stearate paraffin titanium dioxide vanillin .alpha.-tocopherol polyvinyl acetate silicon dioxide ethylcellulose, unspecified a;ktab potassium chloride potassium chloride potassium chloride potassium cation castor oil silicon dioxide magnesium stearate paraffin titanium dioxide vanillin .alpha.-tocopherol polyvinyl acetate ethylcellulose, unspecified ktab potassium chloride potassium chloride potassium chloride potassium cation castor oil silicon dioxide magnesium stearate paraffin titanium dioxide vanillin .alpha.-tocopherol polyvinyl acetate d&c yellow no. 10 ethylcellulose, unspecified ktab potassium chloride potassium chloride potassium chloride potassium cation castor oil d&c yellow no. 10 magnesium stearate paraffin titanium dioxide vanillin .alpha.-tocopherol polyvinyl acetate silicon dioxide ethylcellulose, unspecified ktab;10

Drug Interactions:

7 drug interactions renin-angiotensin-aldosterone system inhibitors: monitor for hyperkalemia ( 7.2 ) nonsteroidal anti-inflammatory drugs: monitor for hyperkalemia ( 7.3 ) 7.1 triamterene and amiloride use with triamterene or amiloride can produce severe hyperkalemia. avoid concomitant use [see contraindications ( 4 )] . 7.2 renin-angiotensin-aldosterone system 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 receiving concomitant raas therapy. 7.3 nonsteroidal anti-inflammatory drugs nonsteroidal anti-inflammatory drugs (nsaids) may produce potassium retention by reducing renal synthesis of prostaglandin e and impairing the renin-angiotensin system. closely monitor potassium in patients receiving concomitant nsaid ther Read more...

apy.

Indications and Usage:

1 indications an d usage potassium chloride extended-release tablets are 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 extended-release tablets are 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 )

Warnings and Cautions:

5 warnings and precautions gastrointestinal adverse reactions: can produce ulcerative and/or stenotic lesions of the gastrointestinal tract, particularly when in prolonged contact with the gastrointestinal mucosa. take with meals. ( 5.1 ) 5.1 gastrointestinal adverse reactions solid oral dosage forms of potassium chloride can produce ulcerative and/or stenotic lesions of the gastrointestinal tract, particularly when the drug remains 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 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 Read more...

and administration ( 2.1 )] .

Dosage and Administration:

2 dosage and administration monitor serum potassium and adjust dosages accordingly ( 2.1 ) if serum potassium concentration 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. ( 2.1 ) treatment of hypokalemia: typical dose range is 40-100 meq per day in divided doses. limit doses to 20 meq per dose. ( 2.2 ) prevention of hypokalemia: typical dose is 20 meq per day ( 2.2 ) 2.1 monitoring and administration if serum potassium concentration is less than 2.5 meq/l, use intravenous potassium instead of oral supplementation. monitoring monitor serum potassium and adjust the dose based on serum potassium level. 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 bal Read more...

ance, 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 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 20 meq per day should be divided such that no more than 20 meq is given in a single dose. treatment of hypokalemia: typical dose range is 40-100 meq per day. prevention of hypokalemia: typical dose is 20 meq per day.

Dosage Forms and Strength:

3 dosage forms and strengths 8 meq (600 mg): round, yellow, debossed extended-release tablets with âk-tabâ on one side 10 meq (750 mg): ovaloid, yellow, debossed extended-release tablets with â10â on one side and âk-tabâ on the other side 10 meq (750 mg): ovaloid, yellow, debossed extended-release tablets with the âaâ logo on one side and âk-tabâ on the other side 20 meq (1500 mg): ovaloid, white, debossed extended-release tablets with âk-tabâ on one side 8 meq (600 mg) oral tablets ( 3 ) 10 meq (750 mg) oral tablets ( 3 ) 20 meq (1500 mg) oral tablets ( 3 )

Contraindications:

4 contraindications potassium chloride is contraindicated in patients on triamterene or amiloride. concomitant use with triamterene and amiloride ( 4 , 7.1 )

Adverse Reactions:

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, perforation [see warnings and precautions ( 5.1 ) and overdosage ( 10 )] . skin rash has been reported rarely. most common adverse reactions are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea ( 6 ) to report suspected adverse reactions, contact abbvie inc. at 1-800-633-9110 or fda at 1-800-fda-1088 or www.fda.gov/medwatch.

Drug Interactions:

apy.

Use in Specific Population:

8 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 ) 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 potassium from oral supplements such as potassium chloride extended Read more...

-release tablets 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 safety and effectiveness of potassium chloride extended-release tablets in children 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 doses of potassium in patients with cirrhosis produce a larger increase in potassium levels compared to the response in normal patients. based on published 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. 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 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.

Use in Pregnancy:

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.

Pediatric Use:

8.4 pediatric use safety and effectiveness of potassium chloride extended-release tablets in children have not been established.

Geriatric Use:

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.

Overdosage:

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 ( 4 ) and warnings and precautions ( 5.1 )] . 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 p-waves, depression of s-t segments, and prolongation of the qt intervals). 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: monitor closely for arrhythmias and electrolyte changes. 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. administer intravenous calcium gluconate if the patient is at no risk or low risk of developing digitalis toxicity. administer intravenously 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. 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.

Description:

11 description potassium chloride extended-release tablets are a solid oral dosage form of potassium chloride containing 600 mg, 750 mg and 1500 mg of potassium chloride, usp, equivalent to 8 meq, 10meq and 20 meq of potassium, respectively, in a film-coated (not enteric-coated), wax matrix tablet. the chemical name is potassium chloride, and the structural formula is kcl. 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. the 8 meq and 10 meq tablets also contain castor oil, cellulosic polymers, colloidal silicon dioxide, d&c yellow no. 10, magnesium stearate, paraffin, polyvinyl acetate, titanium dioxide, vanillin, and vitamin e. the 20 meq tablets also contain castor oil, cellulosic polymers, colloidal silicon dioxide, magnesium stearate, paraffin, polyvinyl acetate, titanium dioxide, vanillin, and vitamin e.

Clinical Pharmacology:

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 impulse; 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. 12.2 pharmacokinetics specific populations cirrhotics based on published literature, the baseline corrected se Read more...

rum 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 [see use in specific populations ( 8.6 )] .

Mechanism of Action:

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 impulse; 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.

Pharmacokinetics:

12.2 pharmacokinetics specific populations cirrhotics based on published 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 [see use in specific populations ( 8.6 )] .

Nonclinical Toxicology:

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.

Carcinogenesis and Mutagenesis and Impairment of Fertility:

13.1 carcinogenesis, mutagenesis, impairment of fertility carcinogenicity, mutagenicity and fertility studies in animals have not been performed. potassium is a normal dietary constituent.

How Supplied:

16 how supplied/storage and handling potassium chloride extended-release tablets, usp contain 600 mg, 750 mg and 1500 mg of potassium chloride (equivalent to 8 meq, 10 meq and 20 meq of potassium, respectively). potassium chloride extended-release tablets, usp are provided as extended-release, film-coated tablets. strength description bottle count ndc# 8 meq (600 mg) round, yellow, debossed with "k-tab" on one side 100 68382-776-01 1000 68382-776-10 10 meq (750 mg) ovaloid, yellow, debossed with the âaâ logo on one side and âk-tabâ on the other side 100 68382-600-01 1000 68382-600-10 ovaloid, yellow, debossed with â10â on one side and âk-tabâ on the other side 100 68382-320-01 1000 68382-320-10 20 meq (1500 mg) ovaloid, white, debossed with "k-tab" on one side 100 68382-398-01 500 68382-398-05 recommended storage store at room temperature 20Â° - 25Â°c (68Â° - 77Â°f) [see usp controlled room temperature].

Information for Patients:

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. advise patients to seek medical attention if tarry stools or other evidence of gastrointestinal bleeding is noticed. inform patients that the wax tablet is not absorbed and may be excreted intact in the stool. if the patient observes this, it is not an indication of lack of effect. manufactured by: abbvie ltd barceloneta, pr 00617 distributed by: zydus pharmaceuticals usa inc. pennington, nj 08534 03-b637 may, 2018

Package Label Principal Display Panel:

Ndc 68382-320-10 potassium chloride extended-release tablets, usp 10 meq (750 mg) 1000 film-coated tablets rx only zydus pharmaceuticals ndc 68382-320-10 potassium chloride extended-release tablets, usp 10 meq (750 mg) 1000 film-coated tablets rx only zydus pharmaceuticals

Ndc 68382-600-01 zygenerics potassium chloride extended-release tablets, usp 10 meq (750 mg) 100 film-coated tablets rx only ndc 68382-600-01 zygenerics potassium chloride extended-release tablets, usp 10 meq (750 mg) 100 film-coated tablets rx only

Ndc 68382-398-01 potassium chloride extended-release tablets, usp 20 meq (1500 mg) 100 film-coated tablets rx only zydus pharmaceuticals ndc 68382-398-01 potassium chloride extended-release tablets, usp 20 meq (1500 mg) 100 film-coated tablets rx only zydus pharmaceuticals

Ndc 68382-776-10 potassium chloride extended-release tablets, usp 8 meq (600 mg) 1000 film-coated tablets rx only zydus pharmaceuticals ndc 68382-776-10 potassium chloride extended-release tablets, usp 8 meq (600 mg) 1000 film-coated tablets rx only zydus pharmaceuticals

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.