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Potassium Citrate 5 meq Tablet, 100-count

by Upsher-Smith Laboratories, LLC · 100 TABLET in 1 BOTTLE (0245-0070-11)
NDC 00245-0070-11
🏷️ FDA NDC (as labeled) 0245-0070-11 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 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) 0245-0070-11
Product NDC 0245-0070
11-digit billing NDC 00245007011
NCPDP billing unit EA — each (per item)
RxCUI 199376, 199381
UNII EE90ONI6FF
UPC 0302450071112
Application # NDA019071
SPL Set ID 2215dc1d-0b5a-469e-9b51-4d7480a51078
Established class (EPC) Anti-coagulant; Calculi Dissolution Agent
Mechanism of action Acidifying Activity; Calcium Chelating Activity
Physiologic effect Decreased Coagulation Factor Activity
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2006-09-01
Marketing end 2027-07-31
Route ORAL
Dosage form TABLET
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
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 0245-0070-11 — 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 → 00245-0070-11. 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.

🏷️ RxNorm drug class

This medicine belongs to the Potassium class.

Drug family (ATC) Potassium
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerUpsher-Smith Laboratories, LLC
Application holderMISSION PHARMACAL CO
FDA applicationNDA019071 (NDA)
Labeler code00245
First marketedSep 2006
Product typeHuman Prescription Drug
Portfolio227 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
📗 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 yellow
ShapeOval
ImprintUSL;071
Size19 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 $0.2712 $27.12 / 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 meqthis 00245-0070-11 Upsher-Smith 100 tablets $0.134 AB Availability likely
Potassium Citrate 5 meq 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: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be 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

🏛️
2006
On the market since
Sep 2006
📍
2026
Currently FDA-listed
20 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 00245-0070-11, 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
58
Units reimbursed last 4 qtrs
4.7K
Gross reimbursed last 4 qtrs
$1.3K
Avg / prescription
$21.98
Avg / unit
$0.2712
Latest quarter Q4 2025
0Rx
Medicaid pays / ea
$0.2712
gross reimbursed
vs
NADAC / ea
$0.1336
acquisition cost
=
Spread
+$0.1376
+103% 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
33% FFS 67% MCO
Fee-for-service · 19 Rx Managed care · 39 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: 1,766 units · 9.0 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported 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: no data reported OH Pennsylvania: 2,934 units · 22.6 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported 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: no data reported 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
9.022.6
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 22.6 /100k
2 New York 9.0 /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.

📊 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 Marketing startStatus
00245-0070-11 You're viewing this 100 TABLET in 1 BOTTLE (0245-0070-11) 2006-09-01 Active

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 127 words

1 INDICATIONS AND USAGE Potassium citrate is 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 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 73 words

3 DOSAGE FORMS AND STRENGTHS 5 mEq tablets are uncoated, modified ball-shaped, and tan to yellowish in color. Each 5 mEq tablet is debossed with "USL" on one side and "070" on the other side. 10 mEq tablets are uncoated, elliptical-shaped, and tan to yellowish in color. Each 10 mEq tablet is debossed with "USL" on one side and "071" on the other side. Tablets: 5 mEq and 10 mEq ( 3 )

Contraindications ~1 min read

4 CONTRAINDICATIONS Potassium citrate extended-release tablets are contraindicated: In patients with hyperkalemia (or who have conditions pre-disposing 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 extended-release tablets to increase urinary citrate may be attenuated by bacterial enzymatic degradation of citrate. Moreover, the rise in urinary pH resulting from potassium citrate extended-release tablets 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 ~2 min read

5 WARNINGS AND PRECAUTIONS Hyperkalemia: In patients with impaired mechanisms for excreting potassium, potassium citrate extended-release tablets administration can produce hyperkalemia and cardiac arrest. Potentially fatal hyperkalemia can develop rapidly and be asymptomatic. The use of potassium citrate extended-release tablets 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 extended-release tablets 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 extended-release tablets administration can produce hyperkalemia and cardiac arrest. Potentially fatal hyperkalemia can develop rapidly and be asymptomatic. The use of potassium citrate extended-release tablets 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 Because of reports of upper gastrointestinal mucosal lesions following administration of potassium chloride (wax-matrix), an endoscopic examination of the upper gastrointestinal mucosa was performed in 30 normal volunteers after they had taken glycopyrrolate 2 mg p.o. t.i.d., potassium citrate extended-release tablets 95 mEq/day, wax-matrix potassium chloride 96 mEq/day or wax-matrix placebo, in thrice daily schedule in the fasting state for one week. Potassium citrate extended-release tablets and the wax-matrix formulation of potassium chloride were indistinguishable but both were significantly more irritating than the wax-matrix placebo.

In a subsequent, similar study, lesions were less severe when glycopyrrolate was omitted. 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 extended-release tablets is limited, but a similar frequency of gastrointestinal lesions should be anticipated.

If there is severe vomiting, abdominal pain or gastrointestinal bleeding, potassium citrate extended-release tablets should be discontinued immediately and the possibility of bowel perforation or obstruction investigated.

🤒 Adverse Reactions 121 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 Upsher-Smith Laboratories, LLC at 1-855-899-9180 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 extended-release tablets 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 218 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 extended-release tablets 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.

7.3 Renin-Angiotensin-Aldosterone System Inhibitors

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 prostagladin E and impairing the renin-angiotensin system. Closely monitor potassium in patients on concomitant NSAIDs.

👥 Use in Specific Populations ~1 min read

8 USE IN SPECIFIC POPULATIONS Pregnant women: Animal reproduction studies have not been conducted. It is not known whether potassium citrate extended-release tablets can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Potassium citrate extended-release tablets 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 extended-release tablets has an effect on this content. Potassium citrate extended-release tablets should be given to a woman who is breast feeding 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 extended-release tablets can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Potassium citrate extended-release tablets 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 extended-release tablets has an effect on this content. Potassium citrate extended-release tablets should be given to a woman who is breast feeding only if clearly needed.

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

🤰 Pregnancy 49 words

8.1Pregnancy Animal reproduction studies have not been conducted. It is also not known whether potassium citrate extended-release tablets can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Potassium citrate extended-release tablets 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

12.1Mechanism of Action When potassium citrate extended-release tablets are 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 extended-release tablets 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 extended-release tablets increase urinary potassium by approximately the amount contained in the medication. In some patients, potassium citrate extended-release tablets cause a transient reduction in urinary calcium.

The changes induced by potassium citrate extended-release tablets 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 extended-release tablets 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 extended-release tablets dosage. Following long-term treatment, potassium citrate extended-release tablets 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 extended-release tablets may be relatively ineffective in raising urinary citrate. A higher dose of potassium citrate extended-release tablets 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 extended-release tablets produce a relatively small rise in urinary pH.

🧬 Mechanism of Action ~2 min read

12.1Mechanism of Action When potassium citrate extended-release tablets are 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 extended-release tablets 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 extended-release tablets increase urinary potassium by approximately the amount contained in the medication. In some patients, potassium citrate extended-release tablets cause a transient reduction in urinary calcium.

The changes induced by potassium citrate extended-release tablets 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 extended-release tablets 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 extended-release tablets dosage. Following long-term treatment, potassium citrate extended-release tablets 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 extended-release tablets may be relatively ineffective in raising urinary citrate. A higher dose of potassium citrate extended-release tablets 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 extended-release tablets produce a relatively small rise in urinary pH.

📦 How Supplied / Storage and Handling 82 words

16 HOW SUPPLIED/STORAGE AND HANDLING Potassium citrate extended-release tablets 5 mEq are uncoated, tan to yellowish in color, modified ball shaped, debossed with "USL" on one side and "070" on the other, supplied in bottles as: NDC 0245-0070-11 Bottle of 100 Potassium citrate extended-release tablets 10 mEq are uncoated, tan to yellowish in color, elliptical shaped, debossed with "USL" on one side and "071" on the other, supplied in bottles as: NDC 0245-0071-11 Bottle of 100 Storage: Store in a tight container.

📦 Storage and Handling 6 words

Storage: Store in a tight container.

📋 Description 70 words

11 DESCRIPTION Potassium citrate is a citrate salt of potassium. Its empirical formula is K 3 C 6 H 5 O 7 ∙ H 2 O, and it has the following chemical structure: Potassium citrate extended-release tablets are yellowish to tan, oral wax-matrix tablets, containing either 5 mEq (540 mg) potassium citrate or 10 mEq (1080 mg) potassium citrate each. Inactive ingredients include carnauba wax and magnesium stearate. Chemical Structure

💬 Information for Patients 103 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.

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.