NDC 0990-7918 Dextrose

Dextrose

NDC Product Code 0990-7918

NDC 0990-7918-19

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

NDC Product Information

Dextrose with NDC 0990-7918 is a a human prescription drug product labeled by Icu Medical Inc.. The generic name of Dextrose is dextrose. 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.

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 70 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.

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: NDA018561 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: 10-01-2019 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: 12-31-2020 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’.

* Please review the disclaimer below.

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

1 Indications And Usage

Dextrose Injection 20%, 30%, 40%, 50% and 70%, mixed with amino acids or other compatible intravenous fluids, is indicated as a source of calories for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.

2.1 Important Preparation And Administration Instructions

  • Dextrose Injection is supplied in the following five strengths: 20%, 30%, 40%, 50% and 70% [see How Supplied/Storage and Handling (16)]. Prior to administration, Dextrose Injection must be diluted with other compatible intravenous fluids or used as an admixture with amino acids. It is not for direct intravenous infusion.Preparation Prior to Administration •Because additives may be incompatible, evaluate all additions to the plastic container for compatibility and stability of the resulting preparation. Consult with a pharmacist, if available. If it is deemed advisable to introduce additives, use aseptic technique and mix thoroughly. •Inspect Dextrose Injection to ensure precipitates have not formed during the mixing or addition of additives. Discard the bag if precipitates are observed. Some opacity of the plastic container (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. •Use promptly after admixing or dilution. •For single use only; discard unused portionImportant Administration Instructions •Set the vent to the closed position on a vented intravenous administration set to prevent air embolism. •Use a dedicated line without any connections to avoid air embolism. •Prior to infusion, visually inspect the diluted dextrose 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. •The choice of a central or peripheral venous route of infusion should depend on the osmolarity of the final infusate. Solutions with greater than 5% dextrose or with osmolarity of greater than or equal to 900 mOsm/L must be infused through a central catheter [see Warnings and Precautions (5.5)].

2.2 Dosing Information

Caution: Dextrose Injection is not for direct intravenous infusion. Prior to administration, Dextrose Injection must be diluted with other compatible intravenous fluids or used as an admixture with amino acids.Individualize the dosage of Dextrose Injection based on the patient's clinical condition (ability to adequately metabolize dextrose), body weight, nutritional and fluid requirements, as well as additional energy given orally or enterally to the patient.The administration rate should be governed, especially during the first few day of therapy, by the patient's tolerance to dextrose. Daily intake of amino acids and dextrose should be increased gradually to the maximum required dose as indicated by frequent determinations of blood glucose levels.

2.3 Discontinuation Of Dextrose Injection

To reduce the risk of hypoglycemia, a gradual decrease in flow rate in the last hour of infusion should be considered.

3 Dosage Forms And Strengths

  • Dextrose Injection 20%, 30%, 40%, 50%, and 70% USP are sterile, non-pyrogenic, hypertonic solutions of dextrose in single-dose, partial-fill, flexible containers.500 mL fill volume in 1000 mL flexible container •20% (0.2 grams/mL): 20 grams of dextrose hydrous per 100 mL •30% (0.3 grams/mL): 30 grams of dextrose hydrous per 100 mL •40% (0.4 grams/mL): 40 grams of dextrose hydrous per 100 mL •50% (0.5 grams/mL): 50 grams of dextrose hydrous per 100 mL •70% (0.7 grams/mL): 70 grams of dextrose hydrous per 100 mL

4 Contraindications

  • The use of Dextrose Injection is contraindicated in patients: •who are severely dehydrated as hypertonic dextrose solution can worsen the patient's hyperosmolar state. •with known hypersensitivity to dextrose [see Warnings and Precautions (5.2)].

5.1 Hyperglycemia And Hyperosmolar Hyperglycemic State

The use of dextrose infusions in patients with diabetes mellitus or 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. Patients with underlying confusion and renal impairment who receive dextrose infusions, may be at greater risk of developing hyperosmolar hyperglycemic state. Monitor blood glucose levels and treat hyperglycemia to maintain optimum levels while administering Dextrose Injection. Insulin may be administered or adjusted to maintain optimal blood glucose levels during Dextrose Injection administration.

5.2 Hypersensitivity Reactions

Hypersensitivity reactions including anaphylaxis have been reported with dextrose infusions. Stop infusion immediately and treat patient accordingly if signs or symptoms of a hypersensitivity reaction develop. Signs or symptoms may include: tachypnea, dyspnea, hypoxia, bronchospasm, tachycardia, hypotension, cyanosis, vomiting, nausea, headache, sweating, dizziness, altered mentation, flushing, rash, urticaria, erythema, pyrexia, and chills.

5.3 Risk Of Infections

Patients who require parenteral nutrition are at high risk of infections because the nutritional components of these solutions can support microbial growth. The risk of infection is increased in patients with malnutrition-associated immunosuppression, hyperglycemia exacerbated by dextrose infusion, long-term use and poor maintenance of intravenous catheters, or immunosuppressive effects of other concomitant conditions, drugs, or other components of the parenteral formulation (e.g., lipid emulsion).To decrease the risk of infectious complications, ensure aseptic technique in catheter placement and maintenance, as well as aseptic technique in the preparation and administration of the nutritional formula.Monitor for signs and symptoms (including fever and chills) of early infections, including laboratory test results (including leukocytosis and hyperglycemia) and frequent checks of the parenteral access device and insertion site for edema, redness and discharge.

5.4 Refeeding Syndrome

Refeeding severely undernourished patients may result in refeeding syndrome, characterized by the intracellular shift of potassium, phosphorus, and magnesium as the patient becomes anabolic. Thiamine deficiency and fluid retention may also develop. To prevent these complications, monitor severely undernourished patients and slowly increase nutrient intakes.

5.5 Vein Damage And Thrombosis

Dextrose Injection is for admixture with amino acids or dilution with other compatible intravenous fluids. It is not for direct intravenous infusion. Administer solutions containing more than 5% dextrose or with an osmolarity of ≥ 900 mOsm/L through a central vein [see Dosage and Administration (2.1)]. The infusion of hypertonic solutions into a peripheral vein may result in vein irritation, vein damage, and/or thrombosis. The primary complication of peripheral access is venous thrombophlebitis, which manifests as pain, erythema, tenderness or a palpable cord. Remove the catheter as soon as possible, if thrombophlebitis develops.

5.6 Aluminum Toxicity

Dextrose Injection contains no more than 25 mcg/L of aluminum. However, with prolonged parenteral administration in patients with renal impairment, the aluminum contained in Dextrose Injection may reach toxic levels. Preterm infants are at greater risk because their kidneys are immature, and they require large amounts of concomitant calcium and phosphate solutions that contain aluminum. Patients with renal impairment, including preterm infants, 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 of total parenteral nutrition products.

5.7 Risk Of Parenteral Nutrition Associated Liver Disease

Parenteral Nutrition Associated Liver Disease (PNALD) has been reported in patients who receive parenteral nutrition for extended periods of time, especially preterm infants, and can present as cholestasis or steatohepatitis. The exact etiology is not entirely clear and is likely multifactorial. If Dextrose Injection-treated patients develop abnormal liver function tests consider discontinuation or dosage reduction.

5.8 Electrolyte Imbalance And Fluid Overload

Electrolyte deficits, particularly in serum potassium and phosphate, may occur during prolonged use of concentrated dextrose solutions.Depending on the volume and rate of infusion, the intravenous administration of concentrated dextrose 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 concentrations in the administered solution. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations in the solution. Monitor blood electrolyte levels, correct fluid and electrolyte imbalances, and administer essential vitamins and minerals as needed. Monitor daily fluid balance.

6 Adverse Reactions

  • The following adverse reactions from voluntary reports or clinical studies have been reported with Dextrose Injection. Because many of 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. •Hyperglycemia and hyperosmolar hyperglycemic state [see Warnings and Precautions (5.1)]. •Hypersensitivity reactions [see Warnings and Precautions (5.2)]. •Risk of infections [see Warnings and Precautions (5.3)]. •Refeeding syndrome [see Warnings and Precautions (5.4)]. •Vein damage and thrombosis [see Warnings and Precautions (5.5)]. •Aluminum toxicity [see Warnings and Precautions (5.6)]. •Risk of parenteral nutrition associated liver disease [see Warnings and Precautions (5.7)]. •Electrolyte imbalance and fluid overload [see Warnings and Precautions (5.8)].

8.1 Pregnancy

Risk SummaryThere are no data with Dextrose Injection in pregnant women. In addition, animal reproduction studies have not been conducted with dextrose. 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.Clinical ConsiderationsDisease-Associated Maternal and/or Embryo/Fetal RiskConsider parenteral nutrition in cases of severe maternal malnutrition where nutritional requirements cannot be fulfilled by the enteral route because of the risks to the fetus associated with severe malnutrition, including preterm delivery, low birth weight, intrauterine growth restriction, congenital malformations, and perinatal mortality.

8.2 Lactation

There are no data regarding the presence of dextrose in human milk, the effects 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 Dextrose Injection and any potential adverse effects on the breastfed infant from Dextrose Injection or from the underlying maternal condition.

8.4 Pediatric Use

Neonates, especially those born premature and with low birth weight are at increased risk of developing hypo – or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose infusions to ensure adequate glycemic control in order to avoid potential long term adverse effects. Hypoglycemia in the newborn can cause prolonged seizures, coma and brain damage. Hyperglycemia has been associated with intraventricular hemorrhage, late onset bacterial and fungal infection, retinopathy of prematurity, necrotizing enterocolitis, bronchopulmonary dysplasia, prolonged length of hospital stay, and death. Plasma electrolyte concentrations should be closely monitored in the pediatric population as this population may have impaired ability to regulate fluids and electrolytes. In very low birth weight infants, excessive or rapid administration of Dextrose Injection may result in increased serum osmolality and possible intracerebral hemorrhage.Because of immature renal function, preterm infants receiving prolonged treatment with Dextrose Injection, may be at risk aluminum toxicity [see Warnings and Precautions (5.6)].Patients, including pediatric patients, may be at risk for Parenteral Nutrition Associated Liver Disease (PNALD) [see Warnings and Precautions (5.7)].

8.5 Geriatric Use

Clinical studies of Dextrose Injection did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from other younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

10 Overdosage

An increased infusion rate of Dextrose Injection or administration of a concentrated dextrose solution can cause hyperglycemia, hyperosmolality, and adverse effects on water and electrolyte balance [see Warnings and Precautions (5.1, 5.8)].Severe hyperglycemia and severe dilutional hyponatremia, and their complications, can be fatal.Discontinue infusion and institute appropriate corrective measures in the event of overhydration or solute overload during therapy, with particular attention to respiratory and cardiovascular systems.For current information on the management of poisoning or overdosage, contact the National Poison Control Center at 1-800-222-1222 or www.poison.org.

11 Description

Dextrose Injection, USP 20%, 30%, 40%, 50% and 70% are sterile, nonpyrogenic, hypertonic solutions of Dextrose, USP in Water for Injection in a polyvinylchloride flexible plastic container for intravenous administration after appropriate admixture or dilution [see Dosage and Administration (2.1)].Partial-fill containers, designed to facilitate admixture or dilution to provide dextrose in various concentrations, are available in various sizes. See Table 1 for the content and characteristics of these concentrated solutions. The solutions contain no bacteriostatic, antimicrobial agent or added buffer and are intended only for use as a single-dose injection following admixture or dilution. The pH is 4.3 (range is 3.2 to 6.5).Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly.Table 1. Contents and Characteristics of Dextrose Injection 20%, 30%, 40%, 50%, and 70%StrengthFill VolumeAmount of Dextrose Hydrous per ContainerkcalCaloric value calculated on the basis of 3.4 kcal/g of dextrose, hydrous.per ContainermOsmol per liter20% (0.2 grams/mL)500 mL100 grams340100930% (0.3 grams/mL)500 mL150 grams510151440% (0.4 grams/mL)500 mL200 grams680201850% (0.5 grams/mL)500 mL250 grams850252370% (0.7 grams/mL)500 mL350 grams11903532Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 • H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula:Dextrose may be derived from corn.Water for Injection, USP is chemically designated H2O.Dextrose Injection contains no more than 25 mcg/L of aluminum.

12.1 Mechanism Of Action

Dextrose Injection is used to supplement nutrition by providing glucose parenterally. Dextrose is oxidized to carbon dioxide and water, yielding energy.

16 How Supplied/Storage And Handling

Dextrose Injection, 20%, 30%, 40%, 50%, and 70% USP are sterile hypertonic solutions of dextrose supplied in single-dose, partial-fill flexible containers (see Tables 1 and 2) for intravenous administration after appropriate admixture or dilution [see Dosage and Administration (2.1)].Do not remove container from the overwrap until intended for use.Table 2: Strengths, Fill Volume, and NDC # of Dextrose Injection 20%, 30%, 40%, 50%, and 70%StrengthFill VolumeNDC#20% (0.2 grams/mL)500 mL0409-7935-190990-7935-1930% (0.3 grams/mL)500 mL0409-8004-150990-8004-1540% (0.4 grams/mL)500 mL0409-7937-190990-7937-1950% (0.5 grams/mL)500 mL0409-7936-190990-7936-1970% (0.7 grams/mL)500 mL0409-7918-190990-7918-19ICU 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. Use the product immediately after mixing and the introduction of additives.Store between 20°C to 25°C (68°F to 77°F). [See USP controlled room temperature.]Do not freeze.

17 Patient Counseling Information

  • Inform patients, caregivers, or home healthcare providers of the following risks of Dextrose Injection: •Hyperglycemia and hyperosmolar hyperglycemic state [see Warnings and Precautions (5.1)] •Hypersensitivity reactions [see Warnings and Precautions (5.2)] •Risk of infection [see Warnings and Precautions (5.3)] •Vein damage and thrombosis [see Warnings and Precautions (5.5)] •Aluminum toxicity [see Warnings and Precautions (5.6)] •Risk of parenteral nutrition associated liver disease [see Warnings and Precautions (5.7)] •Fluid overload and electrolyte imbalance [see Warnings and Precautions (5.8)]                                                                                EN-4695ICU Medical, Inc., Lake Forest, Illinois, 60045, USA

* Please review the disclaimer below.