Potassium Chloride in Dextrose and Sodium 150 mg/100mL; 5 g/100mL; 200 mg/100mL Injection, Solution, 1000 mL — NDC 00338-0663-04 package photo

Potassium Chloride in Dextrose and Sodium 150 mg/100mL; 5 g/100mL; 200 mg/100mL Injection, Solution, 1000 mL

by Baxter Healthcare Company · 1000 mL in 1 BAG (0338-0663-04)
NDC 00338-0663-04
🏷️ FDA NDC (as labeled) 0338-0663-04 billing pads the labeler segment with a zero
This package
Contains1000 mL Medicaid pays$0.0144 / unit · 12 mo Per package$14.40 / 1000 ml · Medicaid Pack sizes2 compare ↓
Also priced by: Part D plans $0.0098/unit — full pricing hub ↓
Also comes in: 500 ml 00338-0663-03
Rx only Brand 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) 0338-0663-04
Product NDC 0338-0663
11-digit billing NDC 00338066304
NCPDP billing unit ML — per mL (volume)
UNII LX22YL083G, 451W47IQ8X, 660YQ98I10
Application # NDA018037
SPL Set ID c553fed1-3de5-4826-8eff-633b5923bf0b
Mechanism of action Osmotic Activity
Physiologic effect Increased Large Intestinal Motility; Inhibition Large Intestine Fluid/Electrolyte Absorption
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1979-02-02
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance POTASSIUM CHLORIDE; DEXTROSE MONOHYDRATE; SODIUM CHLORIDE
GCN Seq No 002013
GCN 62723
HICL code 014780
Ingredient (HICL) Potassium Chloride/D5-0.2%Nacl
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 KCL 20 MEQ/L-D5W-0.2% NACL
FDB brand name Kcl-D5W-0.2% Nacl
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 0338-0663-04 — 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 → 00338-0663-04. 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 Other irrigating solutions class.

Drug family (ATC) Other irrigating solutions, Tests for diabetes, Carbohydrates
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 Company
Application holderBAXTER HEALTHCARE CORP
FDA applicationNDA018037 (NDA)
Labeler code00338
First marketedFeb 1979
Product typeHuman Prescription Drug
Portfolio121 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 KCL 20 MEQ/L-D5W-0.2% NACL Ingredient Potassium Chloride/D5-0.2%Nacl
📗 Our plain-language guide HelloPharmacist
  • This IV solution is a way to give your body what it needs when you can't eat or drink normally. It delivers three things directly into your bloodstream: dextrose (a simple sugar fo...
  • Why am I being given this IV fluid? What does it actually do?
  • Yes — a few things. Tell your nurse or doctor right away if you feel your heart beating irregularly, feel unusual muscle weakness or tingling, develop a severe headache or feel con...
  • Is there anything I need to watch out for while I'm getting this drip?
📖 Read our full Dextrose / Potassium Chloride / Sodium 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 $0.0144 $14.40 / 1000 ml
Medicare drug plans payPart D · Q2 2026 $0.0098 $9.80 / 1000 ml
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 Chloride in Dextrose and Sodium Chloride 150 mg/100mL; 5 g/100mL; 200 mg/100mLthis 00338-0663-04 Baxter 1000 ml AP FDA listed
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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

🏛️
1979
On the market since
Feb 1979
📍
2026
Currently FDA-listed
47 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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 00338-0663-04, 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
94
Units reimbursed last 4 qtrs
188K
Gross reimbursed last 4 qtrs
$2.7K
Avg / prescription
$28.81
Avg / unit
$0.0144
Latest quarter Q4 2025
0Rx
Fee-for-service vs managed care
100% FFS
Fee-for-service · 94 Rx Managed care · 0 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: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: 188,000 units · 5,886 per 100k residents 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: no data reported 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
5,8865,886
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 Nevada 5,886 /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 page00338-0663-04 94 Rx · $2,708
5 ml00338-0663-03 No Medicaid data
Drug total (last 4 qtrs): 94 Rx · 188,000 units · $2,708 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

🔬 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 in Dextrose and Sodium Chloride (this brand).

Top reported reactions

Death16
Infusion Related Reaction4
Product Packaging Confusion3
Blood Potassium Increased2
Dyspnoea2
Flushing2
Physical Product Label Issue2

Age at onset

Adult1
Elderly1

Reporter sex

43 reports
Male · 47%
Female · 53%

Serious outcomes

Death17
Hospitalization9
Life-threatening2
Disabling1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 5 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
00338-0663-03 500 mL in 1 BAG (0338-0663-03) 1979-02-02 Discontinued by firm
00338-0663-04 You're viewing this 1000 mL in 1 BAG (0338-0663-04) 1979-02-02 Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 00338-0663-04?
NDC 00338-0663-04 contains 1000 mL — 1000 ml in 1 bag.
What is the difference between NDC 00338-0663-04 and NDC 00338-0663-03?
Both are Potassium Chloride in Dextrose and Sodium 150 mg/100mL; 5 g/100mL; 200 mg/100mL Injection, Solution — the drug itself is identical. NDC 00338-0663-04 is the 1000 mL package, while NDC 00338-0663-03 is the 500 ml package.
What NDC number is used to bill for this package of Potassium Chloride in Dextrose and Sodium 150 mg/100mL; 5 g/100mL; 200 mg/100mL Injection, Solution?
Bill NDC 00338-0663-04 — the 11-digit billing format is 00338066304. 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 — 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

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 0338-0663-04, 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: 00338-0663-04, written without dashes as 00338066304. 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 00338-0663-04, the first segment (00338) is the labeler code FDA assigned to Baxter Healthcare Company; the middle segment (0663) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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 Company. 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 500 ml (00338-0663-03). 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 Company 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.
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 43 words

1 INDICATIONS AND USAGE Potassium Chloride in Dextrose and Sodium Chloride Injection is indicated as a source of water, electrolytes and calories. Potassium Chloride in Dextrose and Sodium Chloride Injection is indicated as a source of water, electrolytes and calories. ( 1 )

⏱️ Dosage and Administration ~3 min read

2 DOSAGE AND ADMINISTRATION • Only for intravenous infusion. ( 2.1 , 5.2 ) • See full prescribing information for information on preparation, administration, dosing considerations and instructions for use. ( 2.1 , 2.2 , 2.3 )

2.1Important Administration Instructions • Potassium Chloride in Dextrose and Sodium Chloride Injection is only for intravenous infusion [see Warnings and Precautions (5.2) ]. • The osmolarity of Potassium Chloride in Dextrose and Sodium Chloride Injection, ranges from 361 to 641 mOsmol/L (calc). Peripheral administration is generally acceptable; however; consider central vein administration if there is peripheral vein irritation, phlebitis, and/or associated pain especially with higher potassium concentrations. • Do not administer Potassium Chloride in Dextrose and Sodium Chloride Injection simultaneously with blood products through the same administration set because of the possibility of pseudoagglutination or hemolysis. • To prevent air embolism, use a non-vented infusion set or close the vent on a vented set, avoid multiple connections, do not connect flexible containers in series, fully evacuate residual gas in the container prior to administration, do not pressurize the flexible container to increase flow rates, and if administration is controlled by a pumping device, turn off pump before the container runs dry. • Prior to infusion, visually inspect the solution for particulate matter.

The solution should be clear and there should be no precipitates. Do not administer unless solution is clear and container is undamaged. • Use of a final filter is recommended during administration of parenteral solutions, where possible.

2.2Recommended Dosage The choice of the specific potassium chloride, sodium chloride, and dextrose concentrations, rate and volume depends on the age, weight, clinical and metabolic conditions of the patient and concomitant therapy. Electrolyte supplementation may be indicated according to the clinical needs of the patient. The administration rate should be governed, especially for premature infants with low birth weight, during the first few days of therapy, by the patient’s tolerance to dextrose.

Increase the infusion rate gradually as indicated by frequent monitoring of blood glucose concentrations [see Warnings and Precautions (5.1) , Use in Specific Populations (8.4) ].

2.3Instructions for Use To Open • Do not remove container from overwrap until ready to use. • Tear overwrap down side at slit and remove solution container. • Visually inspect the container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety.

The opacity will diminish gradually. Evaluate the following: o If the outlet port protector is damaged, detached, or not present, discard container. o Check to ensure the solution is clear and there are no precipitates. Discard if there is a color change and/or the appearance of precipitates, insoluble complexes or crystals. o Check for minute leaks by squeezing inner bag firmly.

If leaks are found, discard container. Preparation for Administration 1. Suspend container from eyelet support.

2. Remove protector from outlet port at bottom of container. 3.

Attach administration set. Refer to complete directions accompanying set. To Add Medication • Additives may be incompatible.

Complete information is not available. Do not use additives known or determined to be incompatible. • Consult with pharmacist, if available. If, in the informed judgment of the healthcare provider, it is deemed advisable to introduce additives, use aseptic technique. • When introducing additives, consult the instructions for use of the medication to be added and other relevant literature. • Before adding a substance or medication, verify that it is soluble and/or stable in Potassium Chloride in Dextrose and Sodium Chloride Injection and that the pH range of Potassium Chloride in Dex…

💊 Dosage Forms and Strengths 173 words

3 DOSAGE FORMS AND STRENGTHS Potassium Chloride in Dextrose and Sodium Chloride Injection, USP are clear solutions in 500 mL and 1000 mL single-dose, flexible containers: 500 mL flexible container • 10 mEq/500 mL Potassium Chloride, 5% Dextrose and 0.2% Sodium Chloride • 10 mEq/500 mL Potassium Chloride, 5% Dextrose and 0.33% Sodium Chloride • 10 mEq/500 mL Potassium Chloride, 5% Dextrose and 0.45% Sodium Chloride 1000 mL flexible container • 20 mEq/L Potassium Chloride, 5% Dextrose and 0.2% Sodium Chloride • 10 mEq/L Potassium Chloride, 5% Dextrose and 0.45% Sodium Chloride • 20 mEq/L Potassium Chloride, 5% Dextrose and 0.45% Sodium Chloride • 30 mEq/L Potassium Chloride, 5% Dextrose and 0.45% Sodium Chloride • 40 mEq/L Potassium Chloride, 5% Dextrose and 0.45% Sodium Chloride • 20 mEq/L Potassium Chloride, 5% Dextrose and 0.9% Sodium Chloride • 40 mEq/L Potassium Chloride, 5% Dextrose and 0.9% Sodium Chloride Potassium Chloride in Dextrose and Sodium Chloride Injection is available in multiple strengths.

See full prescribing information for detailed description of each formulation. ( 3 )

Contraindications 84 words

4 CONTRAINDICATIONS Potassium Chloride in Dextrose and Sodium Chloride Injection is contraindicated in patients with: • known hypersensitivity to potassium chloride, dextrose and/or sodium chloride [see Warnings and Precautions 5.1) ] • clinically significant hyperkalemia [see Warnings and Precautions (5.2) ] • clinically significant hyperglycemia [see Warnings and Precautions (5.3) ] • Known hypersensitivity to potassium chloride, dextrose, or sodium chloride ( 4 , 5.1 ) • Clinically significant hyperkalemia ( 4 , 5.2 ) • Clinically significant hyperglycemia ( 4 , 5.3 )

⚠️ Warnings and Cautions ~3 min read

5 WARNINGS AND PRECAUTIONS • Hypersensitivity Reactions : monitor for signs and symptoms and discontinue infusion if reactions occur. ( 5.1 ) • Hyperkalemia : May result in cardiac arrhythmias. Avoid use in patients with, or at risk for, hyperkalemia.

If use cannot be avoided, use a product with a low amount of potassium chloride, infuse slowly and monitor serum potassium concentrations and ECGs. ( 5.2 ) • Hyperglycemia or Hyperosmolar Hyperglycemic State : Monitor blood glucose and administer insulin as needed. ( 5.3 , 8.4 ) • Hyponatremia, Hypernatremia and Hyperchloremia : Avoid in patients with or at risk for hypo-/hypernatremia.

If use cannot be avoided, monitor serum sodium concentrations. ( 5.4 , 5.5 , 8.4 ) • Fluid Overload : Avoid in patients with or at risk for fluid and/or solute overloading. If use cannot be avoided, monitor daily fluid balance and electrolyte, concentrations and acid-base balance, as needed and especially during prolonged use.

( 5.6 ) • Refeeding Syndrome : Monitor severely undernourished patients and slowly increase nutrient intake. ( 5.7 )

5.1Hypersensitivity Reactions Hypersensitivity and infusion reactions, including anaphylaxis, have been reported with Potassium Chloride in Dextrose and Sodium Chloride Injection [see Adverse Reactions (6) ]. Stop the infusion immediately if signs or symptoms of a hypersensitivity or infusion reaction develops [see Contraindications (4) ]. Appropriate therapeutic countermeasures must be instituted as clinically indicated.

5.2Hyperkalemia Potassium-containing solutions, including Potassium Chloride in Dextrose and Sodium Chloride Injection may increase the risk of hyperkalemia. Hyperkalemia can be asymptomatic and manifest only by increased serum potassium concentrations and/or characteristic electrocardiographic (ECG) changes. Cardiac arrhythmias, some fatal, can develop at any time during hyperkalemia.

To avoid life threatening hyperkalemia, do not administer Potassium Chloride in Dextrose and Sodium Chloride Injection as an intravenous push (i.e., intravenous injection manually with a syringe connected to the intravenous access, without quantitative infusion device [see Dosage and Administration (2.1) ]. Patients at increased risk of developing hyperkalemia and cardiac arrhythmias include those: • with severe renal impairment, acute dehydration, extensive tissue injury or burns, and certain cardiac disorders such as congestive heart failure or AV block (especially if they receive digoxin). • with hyperosmolality, acidosis, or undergoing correction of alkalosis (conditions associated with a shift of potassium from intracellular to extracellular space). • treated concurrently or recently with agents or products that can cause or increase the risk of hyperkalemia [see Drug Interactions (7.1) ].

Avoid use of Potassium Chloride in Dextrose and Sodium Chloride Injection in patients with, or at risk for, hyperkalemia. If use cannot be avoided, use a product with a low amount of potassium chloride, infuse slowly and monitor serum potassium concentrations and ECGs.

5.3Hyperglycemia and Hyperosmolar Hyperglycemic State The use of dextrose infusions in patients with impaired glucose tolerance may worsen hyperglycemia. Administration of dextrose at a rate exceeding the patient’s utilization rate may lead to hyperglycemia, coma, and death. Hyperglycemia is associated with an increase in serum osmolality, resulting in osmotic diuresis, dehydration and electrolyte losses [see Warnings and Precautions (5.6) ].

Patients with underlying central nervous system disease and renal impairment who receive dextrose infusions, may be at greater risk of developing hyperosmolar hyperglycemic state. Monitor blood glucose concentrations and treat hyperglycemia to maintain concentrations within normal limits while administering Potassium Chloride in Dextrose and Sodium Chloride Injection. Insulin may be administered or adjusted to maintain optimal blood glucose concentrations.

5.4 Hypo…

🤒 Adverse Reactions 220 words

6 ADVERSE REACTIONS The following adverse reactions associated with the use of Potassium Chloride in Dextrose and Sodium 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 reliably estimate their frequency or establish a causal relationship to drug exposure. The following clinically significant adverse reactions are described elsewhere in the labeling: • Hypersensitivity Reactions : anaphylaxis, rash and pruritus [see Warnings and Precautions (5.1) ]. • Metabolism and Nutrition Disorders : hyperkalemia [see Warnings and Precautions (5.2) ], hyperglycemia and hyperosmolar hyperglycemic state [see Warnings and Precautions (5.3) ], hyponatremia and hyponatremic encephalopathy [see Warnings and Precautions (5.4) ], fluid overload [see Warnings and Precautions (5.6) ] and refeeding syndrome [see Warnings and Precautions (5.2) ].

Hypernatremia and hyperchloremia acidosis [see Warnings and Precautions (5.5) ] have been observed in solutions containing 0.9% sodium chloride. • Cardiac Disorder : cardiac arrest as a manifestation of rapid intravenous administration and/or of hyperkalemia [see Warnings and Precautions (5.2) ]. • Infusion Site Reactions : injection site vesicles, extravasation, venous thrombosis or phlebitis, infusion site pain. Adverse reactions include electrolyte imbalances, hyperglycemia, and hypervolemia and injection site reactions.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions ~1 min read

7 DRUG INTERACTIONS • Other Products that Cause Hyperkalemia : Avoid use in patients receiving such products. If use cannot be avoided, monitor serum potassium concentrations. ( 7.1 ) • Lithium : Decreased lithium concentrations with concomitant use; monitor serum lithium concentrations.

( 7.2 ) • Other Products that Affect Glycemic Control, Vasopressin or Fluid and/or Electrolyte Balance : Monitor blood glucose concentrations, fluid balance serum electrolyte concentrations and acid-base balance. ( 7.3 )

7.1Other Products that Cause Hyperkalemia Administration of Potassium Chloride in Dextrose and Sodium 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, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers) increases the risk of severe and potentially fatal hyperkalemia, in particular in the presence of other risk factors for hyperkalemia [see Warnings and Precautions (5.2) ].

Avoid use of Potassium Chloride in Dextrose and Sodium Chloride Injection in patients receiving such products. If use cannot be avoided, monitor serum potassium concentrations.

7.2Lithium Renal sodium and lithium clearance may be increased during administration of Potassium Chloride in Dextrose and Sodium Chloride Injection resulting in decreased serum lithium concentrations. Monitor serum lithium concentrations during concomitant use.

7.3Other Products that Affect Glycemic Control, Vasopressin or Fluid and/or Electrolyte Balance Potassium Chloride in Dextrose and Sodium Chloride Injection can affect glycemic control, vasopressin and fluid and/or electrolyte balance [see Warnings and Precautions (5.3 , 5.4 , 5.5 , 5.6 )]. Monitor blood glucose concentrations, fluid balance, serum electrolyte concentrations and acid-base balance when using Potassium Chloride in Dextrose and Sodium Chloride Injection in patients treated with other substances that affect glycemic control, vasopressin or fluid and/or electrolyte balance.

👥 Use in Specific Populations ~2 min read

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Appropriate administration of Potassium Chloride in Dextrose Sodium Chloride Injection during pregnancy is not expected to cause adverse developmental outcomes, including congenital malformations. Animal reproduction studies have not been conducted with Potassium Chloride in Dextrose Sodium Chloride Injection. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

8.2Lactation Risk Summary Sodium and potassium are present in human breast milk. There are no data on the effects of Potassium Chloride in Sodium Chloride and Glucose on a breastfed infant or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Potassium Chloride in Dextrose and Sodium Chloride Injection and any potential adverse effects on the breastfed infant from Potassium Chloride in Dextrose and Sodium Chloride Injection or from the underlying maternal condition.

8.4Pediatric Use The safety profile of Potassium Chloride in Dextrose and Sodium Chloride Injection in pediatric patients is similar to adults. Neonates, especially premature infants with low birth weight, are at increased risk of developing hypo- or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose solutions to ensure adequate glycemic control in order to avoid potential long term adverse effects. Closely monitor plasma electrolyte concentrations in pediatric patients who may have impaired ability to regulate fluids and electrolytes.

In very low birth weight infants, excessive or rapid administration of Potassium Chloride in Dextrose and Sodium Chloride Injection may result in increased serum osmolality and risk of intracerebral hemorrhage. Children (including neonates and older children) are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy.

8.5Geriatric Use Clinical studies of Potassium Chloride in Dextrose and Sodium Chloride Injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Elderly patients are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy [see Warnings and Precautions (5.4) ]. Potassium Chloride in Dextrose and Sodium Chloride Injection is known to be substantially excreted by the kidney, and the risk of adverse reactions to this product may be greater in patients with impaired renal function [see Warnings and Precautions (5.2) ].

Dose selection for an elderly patient should be cautious, starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

8.6Renal Impairment Administration of Potassium Chloride in Dextrose and Sodium Chloride Injection in patients with renal impairment may result in hyponatremia, hyperkalemia and/or fluid overload. Monitor patients with renal impairment for development of these adverse reactions [see Warnings and Precautions (5.2 , 5.5 , 5.6 )].

🤰 Pregnancy 100 words

8.1Pregnancy Risk Summary Appropriate administration of Potassium Chloride in Dextrose Sodium Chloride Injection during pregnancy is not expected to cause adverse developmental outcomes, including congenital malformations. Animal reproduction studies have not been conducted with Potassium Chloride in Dextrose Sodium Chloride Injection. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

🧒 Pediatric Use 132 words

8.4Pediatric Use The safety profile of Potassium Chloride in Dextrose and Sodium Chloride Injection in pediatric patients is similar to adults. Neonates, especially premature infants with low birth weight, are at increased risk of developing hypo- or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose solutions to ensure adequate glycemic control in order to avoid potential long term adverse effects. Closely monitor plasma electrolyte concentrations in pediatric patients who may have impaired ability to regulate fluids and electrolytes.

In very low birth weight infants, excessive or rapid administration of Potassium Chloride in Dextrose and Sodium Chloride Injection may result in increased serum osmolality and risk of intracerebral hemorrhage. Children (including neonates and older children) are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy.

🧓 Geriatric Use 134 words

8.5Geriatric Use Clinical studies of Potassium Chloride in Dextrose and Sodium Chloride Injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Elderly patients are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy [see Warnings and Precautions (5.4) ]. Potassium Chloride in Dextrose and Sodium Chloride Injection is known to be substantially excreted by the kidney, and the risk of adverse reactions to this product may be greater in patients with impaired renal function [see Warnings and Precautions (5.2) ].

Dose selection for an elderly patient should be cautious, starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🆘 Overdosage 209 words

10 OVERDOSAGE An increased infusion rate of Potassium Chloride in Dextrose and Sodium Chloride Injection can cause: Hyperkalemia • Manifestations of hyperkalemia may include: o disturbances in cardiac conduction and arrhythmias, including bradycardia, heart block, asystole, ventricular tachycardia, ventricular fibrillation, o hypotension, o muscle weakness up to and including muscular and respiratory paralysis, paresthesia of extremities, o gastrointestinal symptoms (ileus, nausea, vomiting, abdominal pain) The presence of any ECG findings that are suspected to be caused by hyperkalemia should be considered a medical emergency.

If hyperkalemia is present or suspected, discontinue the infusion immediately and institute close ECG, laboratory and other monitoring and, as necessary, corrective therapy to reduce serum potassium concentrations [see Warnings and Precautions (5.2) ]. Other Electrolyte and Fluid Disorders • hyponatremia, manifestations may include seizures, coma, cerebral edema and death). • hypernatremia, especially in patients with severe renal impairment. • fluid overload (which can lead to central and/or peripheral edema). • Hyperglycemia, hyperosmolality, and adverse effects on water and electrolyte balance, and corresponding complications, which can be fatal [see Warnings and Precautions (5.3 , 5.6 )].

Interventions include discontinuation of the infusion, dose reduction, monitoring of fluid balance, electrolyte concentrations and acid-base balance and institution of appropriate corrective measures such as administration of exogenous insulin.

🧬 Clinical Pharmacology 37 words

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Potassium Chloride in Dextrose and Sodium Chloride Injection is a source of water, electrolytes and calories. It is capable of inducing diuresis depending on the clinical condition of the patient.

🧬 Mechanism of Action 34 words

12.1Mechanism of Action Potassium Chloride in Dextrose and Sodium Chloride Injection is a source of water, electrolytes and calories. It is capable of inducing diuresis depending on the clinical condition of the patient.

📦 How Supplied / Storage and Handling 151 words

16 HOW SUPPLIED/STORAGE AND HANDLING Potassium Chloride in Dextrose and Sodium Chloride Injection, are clear solutions in 500 mL and 1000 mL single-dose, flexible containers available as follows: Code Size (mL) NDC mEq Potassium Product Name 2B1614 2B1613 1000 500 0338-0663-04 0338-0663-03 20 mEq/L 10 mEq/L Potassium Chloride in 5% Dextrose and 0.2% Sodium Chloride Injection, USP 2B1473 500 0338-0603-03 10 mEq/L Potassium Chloride in 5% Dextrose and 0.33% Sodium Chloride Injection, USP 2B1644 1000 0338-0669-04 10 mEq/L 2B1654 2B1653 2B1664 1000 500 1000 0338-0671-04 0338-0671-03 0338-0673-04 20 mEq/L 10 mEq/L 30 mEq/L Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 2B1674 1000 0338-0675-04 40 mEq/L 2B2434 1000 0338-0803-04 20 mEq/L Potassium Chloride in 5% Dextrose and 2B2454 1000 0338-0807-04 40 mEq 0.9% Sodium Chloride Injection, USP Storage : Avoid excessive heat.

Store at room temperature (25°C); brief exposure up to 40°C does not adversely affect the product.

📋 Description ~2 min read

11 DESCRIPTION Potassium Chloride in Dextrose and Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in a single dose container for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1.

Table 1 Table 1 mEq Potassium/container size Size (mL) Composition (g/L) pH Ionic Concentration (mEq/L) ** Dextrose Hydrous, USP Sodium Chloride, USP (NaCl) Potassium Chloride, USP (KCl) Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Osmolarity (mOsmol/L) (calc.) Sodium Potassium Chloride Caloric Content (kCal/L) Potassium Chloride in 5% Dextrose and 0.2% Sodium Chloride Injection, USP 20 mEq/L 1000 50 2 1.5 361 4.5 (3.5 to 6.5) 34 20 54 170 10 mEq/500 mL 500 50 2 1.5 361 4.5 (3.5 to 6.5) 34 20 54 170 Potassium Chloride in 5% Dextrose and 0.33% Sodium Chloride Injection, USP 10 mEq/500 mL 500 50 3.3 1.5 405 4.5 (3.5 to 6.5) 56 20 76 170 Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 10 mEq/L 1000 50 4.5 0.75 426 4.5 (3.5 to 6.5) 77 10 87 170 20 mEq/L 1000 50 4.5 1.5 447 4.5 (3.5 to 6.5) 77 20 97 170 10 mEq/500 mL 500 50 4.5 1.5 447 4.5 (3.5 to 6.5) 77 20 97 170 30 mEq/L 1000 50 4.5 2.24 466 4.5 (3.5 to 6.5) 77 30 107 170 40 mEq/L 1000 50 4.5 3 487 4.5 (3.5 to 6.5) 77 40 117 170 Potassium Chloride in 5% Dextrose and 0.9% Sodium Chloride Injection, USP 20 mEq/L 1000 50 9 1.5 601 4.5 (3.5 to 6.5) 154 20 174 170 0.9% Sodium Chloride Injection, USP 40 mEq/L 1000 50 9 3 641 4.5 (3.5 to 6.5) 154 40 194 170 Dextrose is derived from corn.

The VIAFLEX Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). VIAFLEX Plus on the container indicates the presence of a drug additive in a drug vehicle. The VIAFLEX Plus plastic container system utilizes the same container as the VIAFLEX plastic container system.

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 can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.

Image of D-Glucose monohydrate Structural Formula

💬 Information for Patients 89 words

17 PATIENT COUNSELING INFORMATION Inform patients, caregivers or home healthcare providers of the following risks of Potassium Chloride in Dextrose and Sodium Chloride Injection: • Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] • Hyperkalemia [see Warnings and Precautions (5.2) ] • Hyperglycemia and hyperosmolar hyperglycemic state [see Warnings and Precautions (5.3) ] • Hyponatremia [see Warnings and Precautions (5.4) ] • Hypernatremia and hyperchloremia [see Warnings and Precautions (5.5) ] • Fluid overload [see Warnings and Precautions (5.6) ] • Refeeding syndrome [see Warnings and Precautions (5.7) ]

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.