HomeNDC LookupIngredientsPotassium Citrate › 00591-2682-01
Potassium Citrate 5 meq Tablet, Extended Release, 100-count — NDC 00591-2682-01 package photo

Potassium Citrate 5 meq Tablet, Extended Release, 100-count

by Actavis Pharma, Inc. · 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0591-2682-01)
NDC 00591-2682-01
🏷️ FDA NDC (as labeled) 0591-2682-01 billing pads the labeler segment with a zero
This package
Contains100-count Cost per ea$0.1336 NADAC Per package$13.36 / 100 tablets Pack sizes3 compare ↓
Also priced by: Medicaid pays $0.3263/unit · Part D plans $0.2772/unit — full pricing hub ↓
On market Non-controlled
🗂️ Data synced Sep 10, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 0591-2682-01
Product NDC 0591-2682
11-digit billing NDC 00591268201
NCPDP billing unit EA — each (per item)
SPL Set ID ac173781-486b-461c-97ae-8b5c69e20792
DEA schedule Non-controlled
Marketing category DRUG FOR FURTHER PROCESSING
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-05-30
Dosage form TABLET, EXTENDED RELEASE
Substance POTASSIUM CITRATE
GPI-14 56202010200420
GPI class Potassium Citrate ER
GCN Seq No 008250
GCN 14950
HICL code 000548
Ingredient (HICL) Potassium Citrate
HIC1 code R
Therapeutic class — broad (HIC1) Kidney/Urinary Tract
HIC2 code R1
Therapeutic class — intermediate (HIC2) Affect Primarily Kidneys/Urinary Tract
HIC3 code R1S
Therapeutic class — specific (HIC3) Urinary Ph Modifiers
AHFS code 40:08.00.00
AHFS class Alkalinizing Agents
FDB label name POTASSIUM CITRATE ER 5 MEQ TAB
FDB brand name Potassium Citrate Er
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 0591-2682-01 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00591-2682-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerActavis Pharma, Inc.
Labeler code00591
First marketedMay 2018
Product typeDrug For Further Processing
Portfolio324 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name POTASSIUM CITRATE ER 5 MEQ TAB Ingredient Potassium Citrate
📖 What it is MedlinePlus · NLM

Potassium is essential for the proper functioning of the heart, kidneys, muscles, nerves, and digestive system. Usually the food you eat supplies all of the potassium you need. However, certain diseases (e.g., kidney disease and gastrointestinal disease with vomiting and diarrhea) and drugs, especially diuretics ('water pills'), remove potassium from the body. Potassium supplements are taken to replace potassium losses and prevent potassium deficiency. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Great question. Potassium citrate works in two main ways. First, it increases the amount of citrate in your urine — citrate acts like a natural stone-fighter by grabbing onto calci...
  • What exactly is potassium citrate doing to stop my kidney stones?
  • Yes, it really does matter. You should take your dose with meals or within 30 minutes after eating — or with a bedtime snack if you have a dose then. Taking it on an empty stomach...
  • Do I have to take this with food? Does it really matter?
📖 Read our full Potassium Citrate guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color brown
ShapeOval
ImprintA96
Size2 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII R12CBM0EIZ
    A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.

2 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.134 $13.36 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.3263 $32.63 / 100 tablets
Medicare drug plans payPart D · Q2 2026 $0.2772 $27.72 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.622 $0.122
▼ Down 76% over the last 23 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Potassium Citrate 5 meq 00245-0070-11 Upsher-Smith 100 tablets $0.134 AB Availability likely
Potassium Citrate 5 meqthis 00591-2682-01 Actavis 100 tablets $0.134 Availability likely
Potassium Citrate 540 mg 16571-0864-01 Rising 100 tablets $0.134 AB Availability likely
Potassium Citrate 5 meq 31722-0129-01 Camber 100 tablets $0.134 AB Availability likely
Potassium Citrate Extended Release 5 meq 42543-0406-01 Strides 100 tablets $0.134 AB Availability likely
Potassium Citrate 5 meq 68382-0536-01 Zydus 100 tablets $0.134 AB Availability likely
Potassium Citrate 5 meq 51407-0449-01 Golden 100 tablets AB FDA listed
Potassium Citrate 5 meq 65841-0536-01 Zydus 100 tablets AB FDA listed
Potassium Citrate 5 meq 72162-2122-01 Bryant 100 tablets AB FDA listed
Potassium Citrate Extended Release 5 meq 72162-2476-01 Bryant 100 tablets AB FDA listed
Potassium Citrate 5 meq 72865-0191-01 XLCare 100 tablets AB FDA listed
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2018
On the market since
May 2018
📍
2026
Currently FDA-listed
8 years listed
🔓
·
Generic versions listed
see equivalents
Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00591-2682-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
157
Units reimbursed last 4 qtrs
10.5K
Gross reimbursed last 4 qtrs
$3.4K
Avg / prescription
$21.77
Avg / unit
$0.3263
Latest quarter Q4 2025
13Rx
Medicaid pays / ea
$0.3263
gross reimbursed
vs
NADAC / ea
$0.1336
acquisition cost
=
Spread
+$0.1927
+144% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
36% FFS 64% MCO
Fee-for-service · 56 Rx Managed care · 101 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 1,255 units · 6.4 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 405 units · 9.6 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 2,500 units · 21.2 per 100k residents OH Pennsylvania: 4,302 units · 33.2 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 1,364 units · 3.5 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 650 units · 5.9 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
3.533.2
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Pennsylvania 33.2 /100k
2 Ohio 21.2 /100k
3 Oregon 9.6 /100k
4 New York 6.4 /100k
5 Georgia 5.9 /100k
6 California 3.5 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
Drug total (last 4 qtrs): 157 Rx · 10,476 units · $3,418 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Potassium Citrate ER (matched by generic name) — the program that covers self-administered drugs. 10 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Potassium Citrate ER. CMS lists 2 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$7.98M
Claims incl. refills
152.3K
Beneficiaries
107.8K
Spend / beneficiary
$74.01
Spend / claim
$52.37
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
00591-2682-01 You're viewing this 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0591-2682-01) $0.1336 / ea $13.36 2018-05-30 Active
00591-2682-00 7825 TABLET, EXTENDED RELEASE in 1 DRUM (0591-2682-00) Active
00591-2682-77 18780 TABLET, EXTENDED RELEASE in 1 CONTAINER (0591-2682-77) Active

You're viewing the smallest of 3 pack sizes for this product.

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 00591-2682-01?
NDC 00591-2682-01 is a 100-count package — 100 tablet, extended release in 1 bottle.
What is the difference between NDC 00591-2682-01 and NDC 00591-2682-00?
Both are Potassium Citrate 5 meq Tablet, Extended Release — the drug itself is identical. NDC 00591-2682-01 is the 100-count package, while NDC 00591-2682-00 is the 7825 tablets package.
What NDC number is used to bill for this package of Potassium Citrate 5 meq Tablet, Extended Release?
Bill NDC 00591-2682-01 — the 11-digit billing format is 00591268201. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 About this NDC listing & data coverage

Listed for further processing / repackaging

What "drug for further processing" means

FDA lists this package under the "drug for further processing" marketing category: Actavis Pharma, Inc. supplies it to other companies for further processing or repackaging (blister cards that are later repackaged or co-packaged are a common example). The units themselves are a finished dosage form — which is why pricing or Medicaid data can still appear — but this exact package code may not be the presentation a retail pharmacy dispenses.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) ✓ Available
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Drug For Further Processing". Products approved under an application carry an NDA, ANDA, or BLA number.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 0591-2682-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00591-2682-01, written without dashes as 00591268201. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00591-2682-01, the first segment (00591) is the labeler code FDA assigned to Actavis Pharma, Inc.; the middle segment (2682) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Actavis Pharma, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 7825 tablets (00591-2682-00), 18780 tablets (00591-2682-77). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Actavis Pharma, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full FDA label FDA SPL

The complete FDA label for this product, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 132 words

1 INDICATIONS AND USAGE Potassium Citrate extended-release tablets are a citrate salt of potassium indicated for the management of: Renal tubular acidosis (RTA) with calcium stones ( 1.1 ) Hypocitraturic calcium oxalate nephrolithiasis of any etiology ( 1.2 ) Uric acid lithiasis with or without calcium stones ( 1.3 )

1.1Renal Tubular Acidosis (RTA) with Calcium Stones Potassium citrate is indicated for the management of renal tubular acidosis [see Clinical Studies ( 14.1 )].

1.2Hypocitraturic Calcium Oxalate Nephrolithiasis of any Etiology Potassium citrate is indicated for the management of hypocitraturic calcium oxalate nephrolithiasis [see Clinical Studies ( 14.2 )].

1.3Uric Acid Lithiasis with or without Calcium Stones Potassium citrate is indicated for the management of uric acid lithiasis with or without calcium stones [see Clinical Studies ( 14.3 )].

⏱️ Dosage and Administration ~2 min read

2 DOSAGE AND ADMINISTRATION Objective: To restore normal urinary citrate (greater than 320 mg/day and as close to the normal mean of 640 mg/day as possible), and to increase urinary pH to a level of 6.0 to 7.0. Severe hypocitraturia (urinary citrate < 150 mg/day): therapy should be initiated at 60 mEq per day; a dose of 30 mEq two times per day or 20 mEq three times per day with meals or within 30 minutes after meals or bedtime snack ( 2.2 ) Mild to moderate hypocitraturia (urinary citrate > 150 mg/day): therapy should be initiated at 30 mEq per day; a dose of 15 mEq two times per day or 10 mEq three times per day with meals or within 30 minutes after meals or bedtime snack ( 2.3 )

2.1Dosing Instructions Treatment with extended release potassium citrate should be added to a regimen that limits salt intake (avoidance of foods with high salt content and of added salt at the table) and encourages high fluid intake (urine volume should be at least two liters per day). The objective of treatment with Potassium Citrate extended-release tablets is to provide Potassium Citrate extended-release tablets in sufficient dosage to restore normal urinary citrate (greater than 320 mg/day and as close to the normal mean of 640 mg/day as possible), and to increase urinary pH to a level of 6.0 or 7.0.

Monitor serum electrolytes (sodium, potassium, chloride and carbon dioxide), serum creatinine and complete blood counts every four months and more frequently in patients with cardiac disease, renal disease or acidosis. Perform electrocardiograms periodically. Treatment should be discontinued if there is hyperkalemia, a significant rise in serum creatinine or a significant fall in blood hematocrit or hemoglobin.

2.2Severe Hypocitraturia In patients with severe hypocitraturia (urinary citrate < 150 mg/day), therapy should be initiated at a dosage of 60 mEq/day (30 mEq two times/day or 20 mEq three times/day with meals or within 30 minutes after meals or bedtime snack). Twenty-four hour urinary citrate and/or urinary pH measurements should be used to determine the adequacy of the initial dosage and to evaluate the effectiveness of any dosage change. In addition, urinary citrate and/or pH should be measured every four months.

Doses of Potassium Citrate extended-release tablets greater than 100 mEq/day have not been studied and should be avoided.

2.3Mild to Moderate Hypocitraturia In patients with mild to moderate hypocitraturia (urinary citrate > 150 mg/day) therapy should be initiated at 30 mEq/day (15 mEq two times/day or 10 mEq three times/day with meals or within 30 minutes after meals or bedtime snack). Twenty-four hour urinary citrate and/or urinary pH measurements should be used to determine the adequacy of the initial dosage and to evaluate the effectiveness of any dosage change. Doses of Potassium Citrate extended-release tablets greater than 100 mEq/day have not been studied and should be avoided.

💊 Dosage Forms and Strengths 90 words

3 DOSAGE FORMS AND STRENGTHS 5 mEq tablets are tan to yellowish, speckled, uncoated, round shaped tablets, debossed with “A67” on one side and plain on the other side. 10 mEq tablets are tan to yellowish, speckled, uncoated, modified capsule shaped tablets, debossed with “A94” on one side and plain on the other side. 15 mEq tablets are tan to yellowish, speckled, uncoated, modified oval shaped tablets, debossed with “A96” on one side and plain on the other side.

Tablets: 5 mEq, 10 mEq and 15 mEq ( 3 )

Contraindications ~1 min read

4 CONTRAINDICATIONS Potassium citrate is contraindicated: In patients with hyperkalemia (or who have conditions predisposing them to hyperkalemia), as a further rise in serum potassium concentration may produce cardiac arrest. Such conditions include: chronic renal failure, uncontrolled diabetes mellitus, acute dehydration, strenuous physical exercise in unconditioned individuals, adrenal insufficiency, extensive tissue breakdown or the administration of a potassium-sparing agent (such as triamterene, spironolactone or amiloride).

In patients in whom there is cause for arrest or delay in tablet passage through the gastrointestinal tract, such as those suffering from delayed gastric emptying, esophageal compression, intestinal obstruction or stricture, or those taking anticholinergic medication. In patients with peptic ulcer disease because of its ulcerogenic potential. In patients with active urinary tract infection (with either urea-splitting or other organisms, in association with either calcium or struvite stones).

The ability of potassium citrate to increase urinary citrate may be attenuated by bacterial enzymatic degradation of citrate. Moreover, the rise in urinary pH resulting from potassium citrate therapy might promote further bacterial growth. In patients with renal insufficiency (glomerular filtration rate of less than 0.7 mL/kg/min), because of the danger of soft tissue calcification and increased risk for the development of hyperkalemia.

Patients with hyperkalemia (or who have conditions predisposing them to hyperkalemia). Such conditions include chronic renal failure, uncontrolled diabetes mellitus, acute dehydration, strenuous physical exercise in unconditioned individuals, adrenal insufficiency, extensive tissue breakdown ( 4 ) Patients for whom there is cause for arrest or delay in tablet passage through the gastrointestinal tract such as those suffering from delayed gastric emptying, esophageal compression, intestinal obstruction or stricture ( 4 ) Patients with peptic ulcer disease ( 4 ) Patients with active urinary tract infection ( 4 ) Patients with renal insufficiency (glomerular filtration rate of less than 0.7 mL/kg/min) ( 4 )

⚠️ Warnings and Cautions ~1 min read

5 WARNINGS AND PRECAUTIONS Hyperkalemia: In patients with impaired mechanisms for excreting potassium, potassium citrate administration can produce hyperkalemia and cardiac arrest. Potentially fatal hyperkalemia can develop rapidly and be asymptomatic. The use of potassium citrate in patients with chronic renal failure, or any other condition which impairs potassium excretion such as severe myocardial damage or heart failure, should be avoided ( 5.1 ) Gastrointestinal lesions: if there is severe vomiting, abdominal pain or gastrointestinal bleeding, potassium citrate should be discontinued immediately and the possibility of bowel perforation or obstruction investigated ( 5.2 )

5.1Hyperkalemia In patients with impaired mechanisms for excreting potassium, potassium citrate administration can produce hyperkalemia and cardiac arrest. Potentially fatal hyperkalemia can develop rapidly and be asymptomatic. The use of potassium citrate in patients with chronic renal failure, or any other condition which impairs potassium excretion such as severe myocardial damage or heart failure, should be avoided.

Closely monitor for signs of hyperkalemia with periodic blood tests and ECGs.

5.2Gastrointestinal Lesions Solid dosage forms of potassium chlorides have produced stenotic and/or ulcerative lesions of the small bowel and deaths. These lesions are caused by a high local concentration of potassium ions in the region of the dissolving tablets, which injured the bowel. In addition, perhaps because wax-matrix preparations are not enteric-coated and release some of their potassium content in the stomach, there have been reports of upper gastrointestinal bleeding associated with these products.

The frequency of gastrointestinal lesions with wax-matrix potassium chloride products is estimated at one per 100,000 patient-years. Experience with potassium citrate is limited, but a similar frequency of gastrointestinal lesions should be anticipated. If there is severe vomiting, abdominal pain or gastrointestinal bleeding, potassium citrate should be discontinued immediately and the possibility of bowel perforation or obstruction investigated.

🤒 Adverse Reactions 117 words

6 ADVERSE REACTIONS Some patients may develop minor gastrointestinal complaints such as abdominal discomfort, vomiting, diarrhea, loose bowel movements or nausea. These may be alleviated by taking the dose with meals or snacks or by reducing the dosage ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Postmarketing Experience Some patients may develop minor gastrointestinal complaints during potassium citrate therapy, such as abdominal discomfort, vomiting, diarrhea, loose bowel movements or nausea. These symptoms are due to the irritation of the gastrointestinal tract, and may be alleviated by taking the dose with meals or snacks, or by reducing the dosage. Patients may find intact matrices in their feces.

🔄 Drug Interactions 220 words

7 DRUG INTERACTIONS The following drug interactions may occur with potassium citrate: Potassium-sparing diuretics: concomitant administration should be avoided since the simultaneous administration of these agents can produce severe hyperkalemia ( 7.1 ) Drugs that slow gastrointestinal transit time: These agents (such as anticholinergics) can be expected to increase the gastrointestinal irritation produced by potassium salts ( 7.2 ) Renin-angiotensin-aldosterone inhibitors: Monitor for hyperkalemia ( 7.3 ) Nonsteroidal Anti-inflammatory drugs (NSAIDs): Monitor for hyperkalemia ( 7.4 )

7.1Potential Effects of Potassium Citrate on Other Drugs Potassium-sparing Diuretics: Concomitant administration of potassium citrate and a potassium-sparing diuretic (such as triamterene, spironolactone or amiloride) should be avoided since the simultaneous administration of these agents can produce severe hyperkalemia.

7.2Potential Effects of Other Drugs on Potassium Citrate Drugs that slow gastrointestinal transit time: These agents (such as anticholinergics) can be expected to increase the gastrointestinal irritation produced by potassium salts.

7.3Renin-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.

7.4Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) NSAIDs may produce potassium retention by reducing renal synthesis of prostaglandin E and impairing the renin-angiotensin system. Closely monitor potassium in patients on concomitant NSAIDs.

👥 Use in Specific Populations 211 words

8 USE IN SPECIFIC POPULATIONS Pregnant women: Animal reproduction studies have not been conducted. It is not known whether potassium citrate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Potassium citrate should be given to a pregnant woman only if clearly needed ( 8.1 ) Nursing mothers: The normal potassium ion content of human milk is about 13 mEq/L.

It is not known if potassium citrate has an effect on this content. Potassium citrate should be given to a woman who is breastfeeding only if clearly needed ( 8.3 ) Pediatric Use: Safety and effectiveness in children have not been established ( 8.4 )

8.1Pregnancy Animal reproduction studies have not been conducted. It is also not known whether potassium citrate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Potassium citrate should be given to a pregnant woman only if clearly needed.

8.3Nursing Mothers The normal potassium ion content of human milk is about 13 mEq/L. It is not known if potassium citrate has an effect on this content. Potassium citrate should be given to a woman who is breastfeeding only if clearly needed.

8.4Pediatric Use Safety and effectiveness in children have not been established.

🤰 Pregnancy 45 words

8.1Pregnancy Animal reproduction studies have not been conducted. It is also not known whether potassium citrate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Potassium citrate should be given to a pregnant woman only if clearly needed.

🧒 Pediatric Use 12 words

8.4Pediatric Use Safety and effectiveness in children have not been established.

🆘 Overdosage ~1 min read

10 OVERDOSAGE Treatment of Overdosage : The administration of potassium salts to persons without predisposing conditions for hyperkalemia rarely causes serious hyperkalemia at recommended dosages. It is important to recognize that hyperkalemia is usually asymptomatic and may be manifested only by an increased serum potassium concentration and characteristic electrocardiographic changes (peaking of T-wave, 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.

Treatment measures for hyperkalemia include the following: 1. Patients should be closely monitored for arrhythmias and electrolyte changes. 2.

Elimination of medications containing potassium and of agents with potassium-sparing properties such as potassium-sparing diuretics, ARBs, ACE inhibitors, NSAIDs, certain nutritional supplements and many others. 3. Elimination of foods containing high levels of potassium such as almonds, apricots, bananas, beans (lima, pinto, white), cantaloupe, carrot juice (canned), figs, grapefruit juice, halibut, milk, oat bran, potato (with skin), salmon, spinach, tuna and many others.

4. Intravenous calcium gluconate if the patient is at no risk or low risk of developing digitalis toxicity. 5.

Intravenous administration of 300 to 500 mL/hr of 10% dextrose solution containing 10 to 20 units of crystalline insulin per 1,000 mL. 6. Correction of acidosis, if present, with intravenous sodium bicarbonate.

7. Hemodialysis or peritoneal dialysis. 8.

Exchange resins may be used. However, this measure alone is not sufficient for the acute treatment of hyperkalemia. Lowering potassium levels too rapidly in patients taking digitalis can produce digitalis toxicity.

🧬 Clinical Pharmacology ~2 min read

12 CLINICAL PHARMACOLOGY When potassium citrate is given orally, the metabolism of absorbed citrate produces an alkaline load. The induced alkaline load in turn increases urinary pH and raises urinary citrate by augmenting citrate clearance without measurably altering ultrafilterable serum citrate. Thus, potassium citrate therapy appears to increase urinary citrate principally by modifying the renal handling of citrate, rather than by increasing the filtered load of citrate.

The increased filtered load of citrate may play some role, however, as in small comparisons of oral citrate and oral bicarbonate, citrate had a greater effect on urinary citrate. In addition to raising urinary pH and citrate, potassium citrate increases urinary potassium by approximately the amount contained in the medication. In some patients, potassium citrate causes a transient reduction in urinary calcium.

The changes induced by potassium citrate produce urine that is less conducive to the crystallization of stone-forming salts (calcium oxalate, calcium phosphate and uric acid). Increased citrate in the urine, by complexing with calcium, decreases calcium ion activity and thus the saturation of calcium oxalate. Citrate also inhibits the spontaneous nucleation of calcium oxalate and calcium phosphate (brushite).

The increase in urinary pH also decreases calcium ion activity by increasing calcium complexation to dissociated anions. The rise in urinary pH also increases the ionization of uric acid to the more soluble urate ion. Potassium citrate therapy does not alter the urinary saturation of calcium phosphate, since the effect of increased citrate complexation of calcium is opposed by the rise in pH-dependent dissociation of phosphate.

Calcium phosphate stones are more stable in alkaline urine. In the setting of normal renal function, the rise in urinary citrate following a single dose begins by the first hour and lasts for 12 hours. With multiple doses the rise in citrate excretion reaches its peak by the third day and averts the normally wide circadian fluctuation in urinary citrate, thus maintaining urinary citrate at a higher, more constant level throughout the day.

When the treatment is withdrawn, urinary citrate begins to decline toward the pre‑treatment level on the first day. The rise in citrate excretion is directly dependent on the potassium citrate dosage. Following long-term treatment, potassium citrate at a dosage of 60 mEq/day raises urinary citrate by approximately 400 mg/day and increases urinary pH by approximately 0.7 units.

In patients with severe renal tubular acidosis or chronic diarrheal syndrome where urinary citrate may be very low (< 100 mg/day), potassium citrate may be relatively ineffective in raising urinary citrate. A higher dose of potassium citrate may therefore be required to produce a satisfactory citraturic response. In patients with renal tubular acidosis in whom urinary pH may be high, potassium citrate produces a relatively small rise in urinary pH.

📦 How Supplied / Storage and Handling 131 words

16 HOW SUPPLIED/STORAGE AND HANDLING Potassium Citrate extended-release tablets USP, 5 mEq are tan to yellowish, speckled, uncoated, round shaped tablets, debossed with “A67” on one side and plain on the other side, supplied in bottles of 100 (NDC 0591-2682-01). Potassium Citrate extended-release tablets USP, 10 mEq are tan to yellowish, speckled, uncoated, modified capsule shaped tablets, debossed with “A94” on one side and plain on the other side supplied in bottles of 100 (NDC 0591-2729-01). Potassium Citrate extended-release tablets USP, 15 mEq are tan to yellowish, speckled, uncoated, modified oval shaped tablets, debossed with “A96” on one side and plain on the other side, supplied in bottles of 100 (NDC 0591-2742-01).

Storage: Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Store in a tight container.

📋 Description 84 words

11 DESCRIPTION Potassium Citrate extended-release tablets, USP are a citrate salt of potassium. It has the following chemical structure: K 3 C 6 H 5 O 7 • H 2 O M.W. 324.41 Potassium Citrate extended-release tablets, USP are tan to yellowish, oral wax-matrix tablets, contain 5 mEq (540 mg) potassium citrate, USP, 10 mEq (1080 mg) potassium citrate, USP, and 15 mEq (1620 mg) potassium citrate, USP each.

Inactive ingredients include carnauba wax and magnesium stearate. Meets USP Dissolution Test 2 . structure1

💬 Information for Patients 126 words

17 PATIENT COUNSELING INFORMATION

17.1Administration of Drug Tell patients to take each dose without crushing, chewing or sucking the tablet. Tell patients to take this medicine only as directed. This is especially important if the patient is also taking both diuretics and digitalis preparations.

Tell patients to check with the doctor if there is trouble swallowing tablets or if the tablet seems to stick in the throat. Tell patients to check with the doctor at once if tarry stools or other evidence of gastrointestinal bleeding is noticed. Tell patients that their doctor will perform regular blood tests and electrocardiograms to ensure safety.

Manufactured In India By: Watson Pharma Pvt. Ltd. Verna, Salcette, Goa, 403722, India.

Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. A 6/2022

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.