NDC 0990-7938 Dextrose

Dextrose Monohydrate

NDC Product Code 0990-7938

NDC 0990-7938-19

Package Description: 12 POUCH in 1 CASE > 1 BAG in 1 POUCH > 500 mL in 1 BAG

NDC Product Information

Dextrose with NDC 0990-7938 is a a human prescription drug product labeled by Icu Medical Inc.. The generic name of Dextrose is dextrose monohydrate. The product's dosage form is injection, solution, concentrate and is administered via intravenous form.

Labeler Name: Icu Medical Inc.

Dosage Form: Injection, Solution, Concentrate - A sterile preparation for parenteral use which, upon the addition of suitable solvents, yields a solution conforming in all respects to the requirements for Injections.

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.

Dextrose 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 10 g/100mL

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)

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.

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: NDA018080 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: 11-20-2019 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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Dextrose 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

Other

10% Dextrose Injection, USPCONCENTRATED DEXTROSE IN WATERConcentrated source of carbohydrate calories for intravenous infusion.NOTE: This solution is hypertonic − see WARNINGS and PRECAUTIONS.Partial-Fill Flexible Plastic Container                                                                                                Rx only

Description

10% Dextrose Injection, USP (concentrated dextrose in water) is a sterile, nonpyrogenic, hypertonic solution of Dextrose, USP in water for injection for intravenous administration after appropriate admixture or dilution.10% Dextrose Injection, USP is provided as a 500 mL volume in a 1000 mL partial-fill container. The container is designed to facilitate admixture or dilution.See table under HOW SUPPLIED for summary of content and characteristics of this concentrated solution.The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose injection following admixture or dilution.The flexible plastic container is fabricated from a specially formulated polyvinyl chloride. 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 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.Dextrose Injection, USP is a parenteral fluid and nutrient replenisher.Dextrose Injection, USP is chemically designated D-glucose monohydrate (C6H12O6 • H2O), a hexose sugar freely soluble in water. It has the following structural formula: Water for Injection, USP is chemically designated H2O.

Clinical Pharmacology

When administered intravenously, 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 Injection, USP undergoes oxidation to carbon dioxide and water.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, respectively).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

10% Dextrose Injection, USP (concentrated dextrose in water) in a partial-fill container is indicated for admixture with amino acids or dilution with other compatible IV fluids to provide a 5% final dextrose concentration for intravenous infusion in patients whose condition requires parenteral nutrition.

Contraindications

A concentrated dextrose solution should not be used when intracranial or intraspinal hemorrhage is present nor in the presence of delirium tremens if the patient is already dehydrated.Dextrose Injection, USP without electrolytes should not be administered simultaneously with blood through the same infusion set because of the possibility that pseudoagglutination of red cells may occur.

Warnings

Concentrated dextrose in water should be administered only after suitable dilution. Hypertonic dextrose solutions should be given slowly. Significant hyperglycemia and possible hyperosmolar syndrome may result from too rapid administration. The physician should be aware of the symptoms of hyperosmolar syndrome, such as mental confusion and loss of consciousness, especially in patients with chronic uremia and those with known carbohydrate intolerance.The intravenous administration of this solution can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.FOR PERIPHERAL VEIN ADMINISTRATIONHypertonic dextrose solutions (above 5% concentration) should be given slowly, preferably through a small bore needle into a large vein, to minimize venous irritation.FOR CENTRAL VENOUS ADMINISTRATIONConcentrated dextrose should be administered via central vein after appropriate admixture or dilution when required.

Precautions

Electrolyte deficits, particularly in serum potassium and phosphate, may occur during prolonged use of concentrated dextrose solutions. Blood electrolyte monitoring is essential, and fluid and electrolyte imbalances should be corrected. Essential vitamins and minerals also should be provided as needed.Solutions containing dextrose should be used with caution in patients with known subclinical or overt diabetes mellitus.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.Concentrated dextrose solutions should not be administered subcutaneously or intramuscularly.Do not administer unless solution is clear and container is undamaged. Discard unused portion.

Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with dextrose. It is also not known whether dextrose can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dextrose should be given to a pregnant woman only if clearly needed.This product contains no more than 25 mcg/L of aluminum.

Adverse Reactions

Hyperosmolar syndrome, resulting from excessively rapid administration of concentrated dextrose may cause hypovolemia, dehydration, mental confusion and/or loss of consciousness.Reactions which may occur because of the solution or the 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.

Overdosage

In the event of overhydration or solute overload during therapy, re-evaluate the patient and institute appropriate corrective measures. (See WARNINGS and PRECAUTIONS).

Dosage And Administration

Concentrated Dextrose in Water is administered by slow intravenous infusion (a) after admixture with amino acid solutions or (b) after dilution with other compatible IV fluids. Dosage should be adjusted to meet the requirements of each individual patient.The maximum rate at which dextrose can be infused without producing glycosuria is 0.5 g/kg of body weight /hr. About 95% of the dextrose is retained when infused at a rate of 0.8 g/kg/hr.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.A list of nutritional admixture values is appended.Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. (See PRECAUTIONS).

Drug Interaction

Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.Some opacity of the plastic due to moisture absorption during sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.WARNING: Do not use flexible container in series connections.

How Supplied

10% Dextrose Injection, USP is supplied in single-dose, partial-fill, flexible containers as follows: a 500 mL volume in a 1000 mL container. See the following table.Concentrated Dextrose In Water Content and CharacteristicsNDC No.% Conc. Fill Volume (mL)Total Grams of Dextrose Hydrous Per ContainerkcalCaloric value calculated on the basis of 3.4 kcal/g of dextrose, hydrous./100 mL(Per Container) mOsmol/liter (calc.)pH (range) 0409-7938-19105005034 (170)5054.3 (3.2 to 6.5)0990-7938-19105005034 (170)5054.3 (3.2 to 6.5)ICU 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.Nutritional Admixture Values Equal volumes of 10% Dextrose Injection, USP and Aminosyn™ 7% provide the following:DextrosePre-Dilution ConcentrationAdmixtureNon-Proteinkcal/g NAdmixtureNon-Proteinkcal/literAdmixtureg N/literAdmixture Dextrose Concentration10%311705.55%Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.Revised: November, 2018EN-4694ICU Medical, Inc., Lake Forest, Illinois, 60045, USA

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