NDC 0990-7903 Potassium Chloride In Dextrose And Sodium Chloride

Dextrose Monohydrate, Sodium Chloride, And Potassium Chloride

NDC Product Code 0990-7903

NDC CODE: 0990-7903

Proprietary Name: Potassium Chloride In Dextrose And Sodium Chloride What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Dextrose Monohydrate, Sodium Chloride, And Potassium Chloride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This product is used to treat dryness inside the nose (nasal passages). It helps add moisture inside the nose to dissolve and soften thick or crusty mucus. In babies and young children with stuffy noses who cannot blow their noses, using this product helps to make the mucus easier to remove with a nasal bulb syringe. This helps relieve stuffiness and makes breathing easier. This product contains a purified gentle salt solution (also called saline or sodium chloride solution). It does not contain any medication.
  • This medication is a mineral supplement used to treat or prevent low amounts of potassium in the blood. A normal level of potassium in the blood is important. Potassium helps your cells, kidneys, heart, muscles, and nerves work properly. Most people get enough potassium by eating a well-balanced diet. Some conditions that can lower your body's potassium level include severe prolonged diarrhea and vomiting, hormone problems such as hyperaldosteronism, or treatment with water pills/diuretics.

NDC Code Structure

  • 0990 - Icu Medical Inc.
    • 0990-7903 - Potassium Chloride In Dextrose And Sodium Chloride

NDC 0990-7903-09

Package Description: 12 POUCH in 1 CASE > 1 BAG in 1 POUCH > 1000 mL in 1 BAG

NDC Product Information

Potassium Chloride In Dextrose And Sodium Chloride with NDC 0990-7903 is a a human prescription drug product labeled by Icu Medical Inc.. The generic name of Potassium Chloride In Dextrose And Sodium Chloride is dextrose monohydrate, sodium chloride, and potassium chloride. The product's dosage form is injection, solution and is administered via intravenous form.

Labeler Name: Icu Medical Inc.

Dosage Form: Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Potassium Chloride In Dextrose And Sodium Chloride Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • DEXTROSE MONOHYDRATE 50 g/1000mL
  • SODIUM CHLORIDE 4.5 g/1000mL
  • POTASSIUM CHLORIDE 2.24 g/1000mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)
  • WATER (UNII: 059QF0KO0R)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)
  • WATER (UNII: 059QF0KO0R)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Intravenous - Administration within or into a vein or veins.
  • Intravenous - Administration within or into a vein or veins.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Osmotic Laxative - [EPC] (Established Pharmacologic Class)
  • Increased Large Intestinal Motility - [PE] (Physiologic Effect)
  • Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Osmotic Activity - [MoA] (Mechanism of Action)
  • Potassium Compounds - [CS]
  • Potassium Salt - [EPC] (Established Pharmacologic Class)
  • Osmotic Laxative - [EPC] (Established Pharmacologic Class)
  • Increased Large Intestinal Motility - [PE] (Physiologic Effect)
  • Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Osmotic Activity - [MoA] (Mechanism of Action)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Icu Medical Inc.
Labeler Code: 0990
FDA Application Number: NDA018362 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 02-01-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Potassium Chloride In Dextrose And Sodium Chloride Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

Intravenous solutions with potassium chloride (I.V. solutions with KCl) are sterile and nonpyrogenic solutions in water for injection. They are for administration by intravenous infusion only.See Tables for summary of content and characteristics of these solutions.The solutions contain no bacteriostat, antimicrobial agent or added buffer and each is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded.These solutions are parenteral fluid, nutrient and/or electrolyte replenishers.Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 • H2O), a hexose sugar freely soluble in water. It has the following structural formula:Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water.Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.Water for Injection, USP is chemically designated H2O.The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in the 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.

Clinical Pharmacology

When administered intravenously, these solutions provide a source of water and potassium chloride with carbohydrate (dextrose) and sodium chloride. See HOW SUPPLIED section for specific concentrations of these various solutions.Solutions containing carbohydrate in the form of dextrose restore blood glucose levels and provide calories. Carbohydrate in the form of dextrose may aid in minimizing liver glycogen depletion and exerts a protein-sparing action. Dextrose injected parenterally undergoes oxidation to carbon dioxide and water.Intravenous solutions containing potassium chloride are particularly intended to provide needed potassium cation (K+). Potassium is the chief cation of body cells (160 mEq/liter of intracellular water). It is found in low concentration in plasma and extracellular fluids (3.5 to 5.0 mEq/liter in a healthy adult). Potassium plays an important role in electrolyte balance. 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.Sodium chloride in water dissociates to provide sodium (Na+) and chloride (Cl−) ions. Sodium (Na+) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Chloride (Cl−) has an integral role in buffering action when oxygen and carbon dioxide exchange occurs in the red blood cells. The distribution and excretion of sodium (Na+) and chloride (Cl−) are largely under the control of the kidney which maintains a balance between intake and output.Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production).Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium.

Indications And Usage

These solutions are indicated in patients requiring parenteral administration of potassium chloride with minimal carbohydrate calories and sodium chloride.

Contraindications

Solutions containing potassium chloride are contraindicated in diseases where high potassium levels may be encountered.

Warnings

Solutions which contain potassium ions should be used with great care, if at all, in patients with hyperkalemia, severe renal failure and in conditions in which potassium retention is present.To avoid potassium intoxication, do not infuse these solutions rapidly. In patients with severe renal insufficiency or adrenal insufficiency, administration of potassium chloride may cause potassium intoxication.Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention.In patients with diminished renal function, administration of solutions containing sodium or potassium ions may result in sodium or potassium retention.The intravenous administration of these solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.The risk of dilutional states is inversely proportional to the electrolyte concentration of administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.

Precautions

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.Solutions containing dextrose should be used with caution in patients with known subclinical or overt diabetes mellitus.Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions, to patients receiving corticosteroids or corticotropin.Potassium replacement therapy should be guided primarily by serial electrocardiograms. Plasma potassium levels are not necessarily indicative of tissue potassium levels.High plasma concentrations of potassium may cause death through cardiac depression, arrhythmias or arrest.Potassium-containing solutions should be used with caution in the presence of cardiac disease, particularly in digitalized patients or in the presence of renal disease.Care should be exercised to insure that the needle (or catheter) is well within the lumen of the vein and that extravasation does not occur.Do not administer unless solution is clear and container is undamaged. Discard unused portion.

Carcinogenesis, Mutagenesis, Impairment Of Fertility:

Studies with solutions from flexible plastic containers have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.

Nursing Mothers:

Caution should be exercised when solutions from flexible plastic containers are administered to a nursing mother.

Pediatric Use:

The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. In neonates or very small infants the volume of fluid may affect fluid and electrolyte balance.Frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants.In very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolality and possible intracerebral hemorrhage.

Geriatric Use:

An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Sodium and potassium ions are known to be substantially excreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Adverse Reactions

Reactions which may occur because of the solutions or technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.Nausea, vomiting, abdominal pain and diarrhea have been reported with potassium therapy. The signs and symptoms of potassium intoxication include paresthesias of the extremities, flaccid paralysis, listlessness, mental confusion, weakness and heaviness of the legs, hypotension, cardiac arrhythmias, heart block, electrocardiographic abnormalities such as disappearance of P waves, spreading and slurring of the QRS complex with development of a biphasic curve and cardiac arrest.Potassium-containing solutions are intrinsically irritating to tissues. Therefore, extreme care should be taken to avoid perivascular infiltration. Local tissue necrosis and subsequent sloughing may result if extravasation occurs. Chemical phlebitis and venospasm have also been reported.Should perivascular infiltration occur, I.V. administration at that site should be discontinued at once. Local infiltration of the affected area with procaine hydrochloride, 1%, to which hyaluronidase may be added, will often reduce venospasm and dilute the potassium remaining in the tissues locally. Local application of heat may also be helpful.

Overdosage

In the event of potassium overdosage, discontinue the infusion immediately and institute intensive corrective therapy to reduce serum potassium levels. See WARNINGS and PRECAUTIONS.

Dosage And Administration

These solutions should be administered only by intravenous infusion and as directed by the physician. The dose and rate of injection are dependent upon the age, weight and clinical condition of the patient. If the serum potassium level is greater than 2.5 mEq/liter, potassium should be given at a rate not to exceed 10 mEq/hour in a concentration less than 30 mEq/liter. Somewhat faster rates and greater concentrations (usually up to 40 mEq/liter) of potassium may be indicated in patients with more severe potassium deficiency. The total 24-hour dose should not generally exceed 200 mEq of potassium.As reported in the literature, the dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/hypoglycemia.

Drug Interactions

Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

Instructions For Use

  • To OpenTear outer wrap at notch and remove solution container. If supplemental medication is desired, follow directions below before preparing for administration. 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.To Add MedicationPrepare additive port.Using aseptic technique and an additive delivery needle of appropriate length, puncture resealable additive port at target area, inner diaphragm and inject. Withdraw needle after injecting medication.The additive port may be protected by covering with an additive cap.Mix container contents thoroughly.Preparation for Administration(Use aseptic technique)Close flow control clamp of administration set.Remove cover from outlet port at bottom of container.Insert piercing pin of administration set into port with a twisting motion until the set is firmly seated. NOTE: See full directions on administration set carton.Suspend container from hanger.Squeeze and release drip chamber to establish proper fluid level in chamber.Open flow control clamp and clear air from set. Close clamp.Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture.Regulate rate of administration with flow control clamp.WARNING: Do not use flexible container in series connections.

How Supplied

Intravenous solutions with potassium chloride (I.V. solution with KCl) are supplied in single-dose flexible plastic containers. See Tables:TABLE 1Potassium Chloride in 5% Dextrose and 0.225% Sodium Chloride Inj., USPCOMPOSITION (g/L)Approx. Ionic Concentrations (mEq/L)mEq PotassiumSize (mL)Dextrose, HydrousSodium ChloridePotassium ChlorideCalculated Osmolarity (mOsmol/L)pHSodium (Na+)Potassium (K+)Chloride (Cl–)Approximate kcal/LNDC NO.20 mEq1000502.251.493704.2(3.5 to 6.5)38.52058.51700409-7901-09120 mEq1000502.251.493704.2(3.5 to 6.5)38.52058.51700990-7901-091TABLE 2Potassium Chloride in 5% Dextrose and 0.3% Sodium Chloride Inj., USPCOMPOSITION (g/L)Approx. Ionic Concentrations (mEq/L)mEq PotassiumSize(mL)Dextrose, HydrousSodium ChloridePotassium ChlorideCalculated Osmolarity (mOsmol/L)pHSodium (Na+)Potassium (K+)Chloride (Cl–)Approximate kcal/LNDC NO.10 mEq1000504.50.7454264.2(3.5 to 6.5)7710871700409-7993-09210 mEq1000504.50.7454264.2(3.5 to 6.5)7710871700990-7903-09210 mEq500504.51.494474.2(3.5 to 6.5)7720971700409-7902-03210 mEq500504.51.494474.2(3.5 to 6.5)7720971700990-7902-03220 mEq1000504.51.494474.2(3.5 to 6.5)7720971700409-7902-091,220 mEq1000504.51.494474.2(3.5 to 6.5)7720971700990-7902-091,230 mEq1000504.52.244674.2(3.5 to 6.5)77301071700409-7903-09130 mEq1000504.52.244674.2(3.5 to 6.5)77301071700990-7903-09140 mEq1000504.52.984874.2(3.5 to 6.5)77401171700409-7904-091,240 mEq1000504.52.984874.2(3.5 to 6.5)77401171700990-7904-091,2TABLE 4Potassium Chloride in 5% Dextrose and 0.9% Sodium Chloride Inj., USPCOMPOSITION (g/L)Approx. Ionic Concentrations (mEq/L)mEq PotassiumSize(mL)Dextrose, HydrousSodium ChloridePotassium ChlorideCalculated Osmolarity (mOsmol/L)pHSodium (Na+)Potassium (K+)Chloride (Cl–)Approximate kcal/LNDC NO.20 mEq10005091.496004.2(3.5 to 6.5)154201741700409-7107-09220 mEq10005091.496004.2(3.5 to 6.5)154201741700990-7107-09240 mEq10005092.986404.2(3.5 to 6.5)154401941700409-7109-09240 mEq10005092.986404.2(3.5 to 6.5)154401941700990-7109-092ICU Medical is transitioning NDC codes from the "0409" to a "0990" labeler code. Both NDC codes are expected to be in the market for a period of time.May contain HCl for pH adjustment.Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]  Protect from freezing. Revised: April, 20181Manufactured by ICU Medical, Inc., Lake Forest, Illinois, 60045, USA2Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045, USAEN-4622

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