HomeNDC LookupIngredientsPotassium Chloride › 00338-0705-48
Potassium Chloride 14.9 g/1000mL Injection, Solution — NDC 00338-0705-48 package photo

Potassium Chloride 14.9 g/1000mL Injection, Solution

by Baxter Healthcare Corporation · 24 BAG in 1 CARTON (0338-0705-48) / 100 mL in 1 BAG
NDC 00338-0705-48
🏷️ FDA NDC (as labeled) 0338-0705-48 billing pads the labeler segment with a zero
This package
Contains100 mL in 1 bag Medicaid pays$0.1742 / unit · 12 mo Per package$418.08 / 2400 ml · Medicaid Pack sizes2 compare ↓
Also priced by: Part D plans $0.0438/unit — full pricing hub ↓
Also comes in: 50 ml 00338-0705-41
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 →
⚠️
Other active recalls for Potassium Chloride (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class I · Oct 29, 2025 — Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq (Otsuka ICU Medical LLC) · FDA recall D-0181-2026
Class I · Oct 29, 2025 — Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq (Otsuka ICU Medical LLC) · FDA recall D-0180-2026
Class I · Feb 13, 2025 — Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq (ICU Medical, Inc.) · FDA recall D-0268-2025
Class I · Feb 13, 2025 — Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container. (ICU Medical, Inc.) · FDA recall D-0267-2025
Class II · Jan 30, 2025 — Failed Dissolution Specifications. (The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories) · FDA recall D-0221-2025
Class I · Jun 25, 2024 — Failed Dissolution Specifications (Amerisource Health Services LLC) · FDA recall D-0619-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 0338-0705-48
Product NDC 0338-0705
11-digit billing NDC 00338070548
NCPDP billing unit ML — per mL (volume)
UNII 660YQ98I10
Application # NDA019904
SPL Set ID 092ddee4-572d-4771-8d95-880cea01097e
Established class (EPC) Osmotic Laxative; Potassium Salt
Mechanism of action Osmotic Activity
Physiologic effect Increased Large Intestinal Motility; Inhibition Large Intestine Fluid/Electrolyte Absorption
Chemical class Potassium Compounds
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1989-12-26
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance POTASSIUM CHLORIDE
GPI-14 79700030002055
GPI class Potassium Chloride
GCN Seq No 015363
GCN 03282
HICL code 044754
Ingredient (HICL) Potassium Chloride In Water
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C1
Therapeutic class — intermediate (HIC2) Drugs Affecting Electrolyte Balance
HIC3 code C1D
Therapeutic class — specific (HIC3) Potassium Replacement
AHFS code 40:12.00.00
AHFS class Replacement Preparations
FDB label name POTASSIUM CL 20 MEQ/100 ML SOL
FDB brand name Potassium Chloride
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 0338-0705-48 — 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 → 00338-0705-48. 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, Electrolyte solutions
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

LabelerBaxter Healthcare Corporation
Application holderBAXTER HEALTHCARE CORP
FDA applicationNDA019904 (NDA)
Labeler code00338
First marketedDec 1989
Product typeHuman Prescription Drug
Portfolio282 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 CL 20 MEQ/100 ML SOL Ingredient Potassium Chloride In Water
📖 What it is MedlinePlus · NLM

Potassium chloride is used to prevent or treat low levels of potassium in the body. Potassium chloride is in a class of medications called electrolytes. It works by to provide potassium to the body to maintain fluid and electrolyte balance.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • You're right that food is the first line — bananas, potatoes, and leafy greens are all rich in potassium. But sometimes diet alone isn't enough, especially if you're taking a diure...
  • Why did my doctor prescribe potassium chloride? I thought potassium just came from bananas.
  • Yes — always take oral tablets or capsules with a meal or right after eating. Taking them on an empty stomach can irritate or even ulcerate the lining of your stomach or intestines...
  • Do I have to take it with food? What happens if I forget?
📖 Read our full Potassium Chloride 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.

🧪 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 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

1 inactive ingredient 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 mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $0.1742 $418.08 / 2400 ml
Medicare drug plans payPart D · Q2 2026 $0.0438 $105.12 / 2400 ml
Medicare Part B allowsASP · J3480 $0.136 / J3480 unit
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.

🧾 Billing & reimbursement

FDA NDC (as labeled)0338-0705-48
11-digit billing NDC00338-0705-48
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ3480
DescriptorINJECTION, POTASSIUM CHLORIDE, PER 2 MEQ
Billing units / pkg0.1 units
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Potassium Chloride 14.9 g/1000mLthis 00338-0705-48 Baxter 100 ml AP FDA listed
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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

🏛️
1989
On the market since
Dec 1989
📍
2026
Currently FDA-listed
37 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

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 00338-0705-48, 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
10.1K
Units reimbursed last 4 qtrs
2M
Gross reimbursed last 4 qtrs
$343.7K
Avg / prescription
$33.89
Avg / unit
$0.1742
Latest quarter Q4 2025
1.9KRx
Fee-for-service vs managed care
16% FFS 84% MCO
Fee-for-service · 1,611 Rx Managed care · 8,532 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 1,900 units · 24.3 per 100k residents WA Idaho: 4,400 units · 224 per 100k residents ID Montana: no data reported MT North Dakota: 2,500 units · 319 per 100k residents ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 39,180 units · 200 per 100k residents NY Vermont: 7,580 units · 1,172 per 100k residents VT New Hampshire: 3,600 units · 257 per 100k residents NH Oregon: 1,300 units · 30.7 per 100k residents OR Nevada: 51,710 units · 1,619 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 27,040 units · 843 per 100k residents IA Illinois: 1,600 units · 12.8 per 100k residents IL Indiana: 1,420 units · 20.7 per 100k residents IN Ohio: 263,350 units · 2,235 per 100k residents OH Pennsylvania: 49,950 units · 385 per 100k residents PA New Jersey: 163,100 units · 1,756 per 100k residents NJ Massachusetts: 22,100 units · 316 per 100k residents MA California: 63,138 units · 162 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 23,370 units · 1,181 per 100k residents NE Missouri: 105,900 units · 1,709 per 100k residents MO Kentucky: 15,138 units · 334 per 100k residents KY West Virginia: 3,310 units · 187 per 100k residents WV Virginia: 13,750 units · 158 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: 3,200 units · 151 per 100k residents NM Kansas: 11,900 units · 405 per 100k residents KS Arkansas: 1,300 units · 42.4 per 100k residents AR Tennessee: 726,113 units · 10,190 per 100k residents TN North Carolina: 113,130 units · 1,044 per 100k residents NC South Carolina: no data reported SC Delaware: 10,100 units · 980 per 100k residents DE Oklahoma: 1,620 units · 40.0 per 100k residents OK Louisiana: 26,370 units · 577 per 100k residents LA Mississippi: 6,984 units · 238 per 100k residents MS Alabama: 15,940 units · 312 per 100k residents AL Georgia: 1,900 units · 17.2 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 97,740 units · 320 per 100k residents TX Florida: 91,050 units · 403 per 100k residents FL
Units reimbursed · per 100k residents
12.810,190
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 Tennessee 10,190 /100k
2 Ohio 2,235 /100k
3 New Jersey 1,756 /100k
4 Missouri 1,709 /100k
5 Nevada 1,619 /100k
6 Nebraska 1,181 /100k
7 Vermont 1,172 /100k
8 North Carolina 1,044 /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.
1 ml this page00338-0705-48 10,143 Rx · $343,709
5 ml00338-0705-41 746 Rx · $17,398
Drug total (last 4 qtrs): 10,889 Rx · 2,042,803 units · $361,107 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 Chloride — the program that covers self-administered drugs. 42 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 Chloride. 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
$78.71M
Claims incl. refills
3.7M
Beneficiaries
2.4M
Spend / beneficiary
$33.46
Spend / claim
$21.47
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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Potassium Chloride — the ingredient across all brands.

Top reported reactions

Nausea9,006
Diarrhoea8,604
Dyspnoea8,414
Fatigue8,118
Vomiting6,603
Death5,805
Pneumonia5,556

Reporter sex

120,818 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Death16,417
Life-threatening6,633
Disabling2,798
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 8,102 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00338-0705-41 24 BAG in 1 CARTON (0338-0705-41) / 50 mL in 1 BAG 1989-12-26 Active
00338-0705-48 You're viewing this 24 BAG in 1 CARTON (0338-0705-48) / 100 mL in 1 BAG 1989-12-26 Active

In Medicaid, this is the most-dispensed pack of this product — about 93% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 00338-0705-48?
NDC 00338-0705-48 is listed by the FDA — 24 bag in 1 carton / 100 ml in 1 bag.
What NDC number is used to bill for this package of Potassium Chloride 14.9 g/1000mL Injection, Solution?
Bill NDC 00338-0705-48 — the 11-digit billing format is 00338070548. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
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) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ Available
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

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
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 0338-0705-48, 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: 00338-0705-48, written without dashes as 00338070548. 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 00338-0705-48, the first segment (00338) is the labeler code FDA assigned to Baxter Healthcare Corporation; the middle segment (0705) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (48) 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 Baxter Healthcare Corporation. 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 1 other package presentation of this same product, including 50 ml (00338-0705-41). 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?
Baxter Healthcare Corporation 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.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J3480 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
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 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 82 words

INDICATIONS AND USAGE Potassium Chloride Injection is indicated in the treatment of potassium deficiency states when oral replacement is not feasible. THIS HIGHLY CONCENTRATED, READY-TO-USE POTASSIUM CHLORIDE INJECTION IS INTENDED FOR THE MAINTENANCE OF SERUM K + LEVELS AND FOR POTASSIUM SUPPLEMENTATION IN FLUID RESTRICTED PATIENTS WHO CANNOT ACCOMMODATE ADDITIONAL VOLUMES OF FLUID ASSOCIATED WITH POTASSIUM SOLUTIONS OF LOWER CONCENTRATION. When using these products, these patients should be on continuous cardiac monitoring and frequent testing for serum potassium concentration and acid-base balance.

⏱️ Dosage and Administration ~1 min read

DOSAGE AND ADMINISTRATION The dose and rate of administration are dependent upon the specific condition of each patient. Administer intravenously only with a calibrated infusion device at a slow, controlled rate. Highest concentrations (400 mEq/L) should be exclusively administered via central intravenous route.

Whenever possible, administration via a central route is recommended for all concentrations of Potassium Chloride Injection for thorough dilution by the blood stream and decreasing the risk of extravasation and to avoid pain and phlebitis associated with peripheral infusion (see WARNINGS ). Correct placement of the catheter should be verified before administration. Recommended administration rates should not usually exceed 10 mEq per hour or 200 mEq for a 24 hour period if the serum potassium level is greater than 2.5 mEq per liter.

In urgent cases where the serum potassium level is less than 2.0 mEq per liter or where severe hypokalemia is a threat, (serum potassium level less than 2.0 mEq per liter and electrocardiographic changes and/or muscle paralysis) rates up to 40 mEq per hour or 400 mEq over a 24 hour period can be administered very carefully when guided by continuous monitoring of the EKG and frequent serum K + determinations to avoid hyperkalemia and cardiac arrest. Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit.

Do not administer unless solution is clear and seal is intact. Use of a final filter is recommended during administration of all parenteral solutions where possible. Do not add supplementary medication.

Contraindications 18 words

CONTRAINDICATIONS Potassium Chloride Injection is contraindicated in patients with: • hyperkalemia • known hypersensitivity to Potassium Chloride Injection

⚠️ Warnings ~2 min read

WARNINGS Hyperkalemia THIS HIGHLY CONCENTRATED, READY-TO-USE POTASSIUM CHLORIDE INJECTION IS INTENDED FOR THE MAINTENANCE OF SERUM K + LEVELS AND FOR POTASSIUM SUPPLEMENTATION IN FLUID RESTRICTED PATIENTS WHO CANNOT ACCOMMODATE ADDITIONAL VOLUMES OF FLUID ASSOCIATED WITH POTASSIUM SOLUTIONS OF LOWER CONCENTRATION. TO AVOID POTASSIUM INTOXICATION, DO NOT INFUSE THESE SOLUTIONS RAPIDLY. Potassium Chloride Injection should be administered with extreme caution, if at all, to patients with conditions predisposing to hyperkalemia and/or associated with increased sensitivity to potassium, such as patients with: • severe renal impairment, • acute dehydration, • extensive tissue injury or burns, • certain cardiac disorders such as congestive heart failure or AV block, • potassium-aggravated skeletal muscle channelopathies (e.g., hyperkalemic periodic paralysis, paramyotonia congenita, and potassium-aggravated myotonia/paramyotonia).

Potassium Chloride Injection should be administered with caution to patients who are at risk of experiencing hyperosmolality, acidosis, or undergo correction of alkalosis (conditions associated with a shift of potassium from intracellular to extracellular space) and patients treated concurrently or recently with agents or products that can cause hyperkalemia (see PRECAUTIONS , Drug Interactions ). If used in high-risk patients, especially close monitoring and careful dose selection and adjustment is required. PATIENTS REQUIRING HIGHLY CONCENTRATED SOLUTIONS SHOULD BE KEPT ON CONTINUOUS CARDIAC MONITORING AND UNDERGO FREQUENT TESTING FOR SERUM POTASSIUM AND ACID-BASE BALANCE, ESPECIALLY IF THEY RECEIVE DIGITALIS.

Administration of concentrated potassium solutions can cause cardiac conduction disorders (including complete heart block) and other cardiac arrhythmias at any time during infusion. Continuous cardiac monitoring is performed to aid in the detection of cardiac arrhythmias due to a sudden increase in serum potassium concentration (e.g., when potassium infusion is started), or transient or sustained hyperkalemia (see ADVERSE REACTIONS and OVERDOSAGE ). Frequently, mild or moderate hyperkalemia is asymptomatic and may be manifested only by increased serum potassium concentrations and, possibly, characteristic EKG changes.

However, fatal arrhythmias can develop at any time during hyperkalemia. Serum potassium levels are not necessarily indicative of tissue potassium levels. Tissue Damage and Thrombophlebitis When infusing concentrated potassium solutions, including Potassium Chloride Injection, care must be taken to prevent paravenous administration or extravasation because such solutions may be associated with tissue damage, which may be severe and include vascular, nerve, and tendon damage, leading to surgical intervention, including amputation.

Secondary complications including pulmonary embolism from thrombophlebitis have been reported as a consequence of tissue damage from potassium chloride. Administer intravenously only with a calibrated infusion device at a slow, controlled rate. (see DOSAGE AND ADMINISTRATION ) .

Highest concentrations (400 mEq per L) should be exclusively administered via central intravenous route. Whenever possible, administration via a central route is recommended for all concentrations of Potassium Chloride Injection for thorough dilution by the blood stream and decreasing the risk of extravasation and to avoid pain and phlebitis associated with peripheral infusion. Correct placement of the catheter should be verified before administration.

Hyponatremia Monitoring of serum sodium is particularly important for hypotonic fluids. Potassium Chloride Injection has an osmolarity of 200 to 799 mOsmol/L (see DESCRIPTION ). Potassium Chloride Injection may cause hyponatremia.

The risk for hyponatremia is increased, in pediatric patients, elderly patients, postoperative patients, those with psychogenic polydipsia and in patients treated with medications that increase the risk of hypon…

🤒 Adverse Reactions 151 words

ADVERSE REACTIONS The following adverse reactions associated with the use of Potassium Chloride Injection were identified in postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure. Immune system disorders: Hypersensitivity, as manifested by rash and angioedema Metabolism and nutrition disorders: Hyperkalemia, hyponatremia Cardiac disorders: Cardiac arrest*, asystole*, ventricular fibrillation*, bradycardia *as a manifestation of rapid intravenous administration and/or of hyperkalemia Respiratory, Thoracic, and Mediastinal Disorders: Dyspnea General disorders and administration site conditions: Chest pain, infusion site thrombosis, infusion site phlebitis, infusion site erythema, infusion site swelling, infusion site pain, infusion site irritation, and/or a burning sensation.

Nervous System Disorders: Hyponatremic encephalopathy The following adverse reactions were reported in association with extravasation: Skin necrosis, skin ulcer, soft tissue necrosis, muscle necrosis, nerve injury, tendon injury, and vascular injury.

🔄 Drug Interactions 174 words

Drug Interactions Other Products that Cause Hyperkalemia Administration of Potassium Chloride Injection in patients treated concurrently or recently with other products that can cause hyperkalemia or increase the risk of hyperkalemia (e.g., potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, cyclosporine and tacrolimus) increases the risk of severe and potentially fatal hyperkalemia, in particular in the presence of other risk factors for hyperkalemia (see WARNINGS ). Avoid use of Potassium Chloride injection in patients receiving such products.

If use cannot be avoided, monitor serum potassium concentrations. Other Drugs that Increase the Risk of Hyponatremia Administration of Potassium Chloride Injection in patients treated concomitantly with drugs associated with hyponatremia may increase the risk of developing hyponatremia (see WARNINGS ). Avoid use of Potassium Chloride Injection in patients receiving drugs that may increase the risk of hyponatremia, such as diuretics and antiepileptics.

Drugs that increase the vasopressin effect reduce renal electrolyte free water excretion and may also increase the risk of hyponatremia following treatment with intravenous fluids. If use cannot be avoided, monitor serum sodium concentrations.

🤰 Pregnancy 64 words

Pregnancy There are no adequate, well controlled studies with Potassium Chloride Injection in pregnant women and animal reproduction studies have not been conducted with this drug. Therefore, it is not known whether potassium chloride injection can cause fetal harm when administered to a pregnant woman. Potassium Chloride Injection should be given during pregnancy only if potential benefit justifies the potential risk to the fetus.

🧒 Pediatric Use 32 words

Pediatric Use These products should not be used in children at this time. Safety and effectiveness of Potassium Chloride Injection in pediatric patients have not been established by adequate and well-controlled studies.

🆘 Overdosage ~1 min read

OVERDOSAGE Potassium overdose can cause potentially fatal hyperkalemia. Manifestations of hyperkalemia include: • Disturbances in cardiac conduction and arrhythmias, including bradycardia, heart block, asystole, ventricular tachycardia, ventricular fibrillation • Hypotension • Muscle weakness up to and including muscular and respiratory paralysis, paresthesia • Gastrointestinal symptoms (ileus, nausea, vomiting, abdominal pain) Frequently, mild or moderate hyperkalemia is asymptomatic and may be manifested only by increased serum potassium concentrations and, possibly, characteristic electrocardiographic changes.

However, fatal arrhythmias can develop at any time. In addition to arrhythmias and conduction disorders, the EKG shows progressive changes that occur with increasing potassium levels. Possible changes include: • peaking of T waves, • loss of P waves, and • QRS widening.

However, the correlation between potassium levels and EKG changes is not precise, and whether or at which potassium level certain EKG signs develop depends on factors such as patient sensitivity, the presence of other electrolyte disorders, and the rapidity of the development of hyperkalemia. The presence of any EKG findings that are suspected to be caused by hyperkalemia should be considered a medical emergency. In the event of hyperkalemia, discontinue the infusion immediately and institute close EKG, laboratory and other monitoring and, as necessary, corrective therapy to reduce serum potassium levels as necessary.

The use of potassium containing foods or medications must also be eliminated. Treatment of mild to severe hyperkalemia with signs and symptoms of potassium intoxication includes the following: 1. Dextrose Injection, USP, 10% or 25%, containing 10 units of crystalline insulin per 20 grams of dextrose administered intravenously, 300 to 500 mL per hour.

2. Absorption and exchange of potassium using sodium or ammonium cycle cation exchange resin, orally and as retention enema. 3.

Hemodialysis and peritoneal dialysis. In cases of digitalization, too rapid a lowering of plasma potassium concentration can cause digitalis toxicity.

🧬 Clinical Pharmacology 148 words

CLINICAL PHARMACOLOGY Potassium is the major cation of body cells (160 mEq/liter of intracellular water) and is concerned with the maintenance of body fluid composition and electrolyte balance. Potassium participates in carbohydrate utilization, protein synthesis, and is critical in the regulation of nerve conduction and muscle contraction, particularly in the heart. Chloride, the major extracellular anion, closely follows the metabolism of sodium, and changes in the acid-base of the body are reflected by changes in the chloride concentration.

Normally about 80 to 90% of the potassium intake is excreted in the urine, the remainder in the stools and to a small extent, in the perspiration. The kidney does not conserve potassium well so that during fasting, or in patients on a potassium-free diet, potassium loss from the body continues resulting in potassium depletion. A deficiency of either potassium or chloride will lead to a deficit of the other.

📦 How Supplied / Storage and Handling 63 words

HOW SUPPLIED Potassium Chloride Injection in Viaflex Plus plastic containers is available as follows: 10 mEq/100 mL NDC 0338-0709-48 10 mEq/50 mL NDC 0338-0705-41 20 mEq/100 mL NDC 0338-0705-48 20 mEq/50 mL NDC 0338-0703-41 40 mEq/100 mL NDC 0338-0703-48 Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended that this product be stored at room temperature (25°C).

📋 Description ~1 min read

DESCRIPTION This Potassium Chloride Injection, is a sterile, nonpyrogenic, highly concentrated, ready-to-use, solution of Potassium Chloride, USP in Water for Injection, USP for electrolyte replenishment in a single dose container for intravenous administration. It contains no antimicrobial agents. Potassium Chloride Injection mEq Potassium/Container Composition (g/L) Potassium Chloride, USP (KCl) Osmolarity Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L.

Administration of substantially hypertonic solutions (≥ 600 mOsmol/L) may cause vein damage. (mOsmol/L) (calc) pH Ionic Concentration (mEq/L) Potassium Chloride 10 mEq/100 mL 7.46 200 5.0 (4.0 to 8.0) 100 100 10 mEq/50 mL 20 mEq/100 mL 14.9 400 5.0 (4.0 to 8.0) 200 200 20 mEq/50 mL 40 mEq/100 mL 29.8 799 5.0 (4.0 to 8.0) 400 400 This Viaflex Plus plastic container is fabricated from a specially formulated polyvinyl chloride. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content.

Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly.

Solutions in contact with the plastic container may leach out certain of its chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials.

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.