NDC 76329-3301 Dextrose Monohydrate

Dextrose Monohydrate

NDC Product Code 76329-3301

NDC 76329-3301-1

Package Description: 1 SYRINGE in 1 CARTON > 50 mL in 1 SYRINGE

NDC Product Information

Dextrose Monohydrate with NDC 76329-3301 is a a human prescription drug product labeled by International Medication Systems, Limited. The generic name of Dextrose Monohydrate is dextrose monohydrate. The product's dosage form is injection and is administered via parenteral form.

Labeler Name: International Medication Systems, Limited

Dosage Form: Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.

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 Monohydrate 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 500 mg/mL

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.

  • Parenteral - Administration by injection, infusion, or implantation.

Product Labeler Information

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

Labeler Name: International Medication Systems, Limited
Labeler Code: 76329
Marketing Category: UNAPPROVED DRUG OTHER - 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: 06-01-2000 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 Monohydrate 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

Rx OnlyConcentrated Dextrose for Intravenous Administration NOTE: This solution is hypertonic − See Warnings and Precautions.

Revised 7/11© International Medication Systems, Ltd., 2011International Medication Systems, Ltd.South El Monte, CA 91733, USAAn Amphastar Pharmaceuticals CompanyPrinted in USA

Description

50% Dextrose Injection, USP is a sterile, nonpyrogenic, hypertonic solution of dextrose in water for injection for intravenous injection as a fluid and nutrient replenisher.Each mL of fluid contains 0.5 g dextrose, hydrous which delivers 3.4 kcal/gram. The solution has an osmolarity of 2.5 mOsmol/mL (calc.) and a pH of 3.2-6.5.The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose injection. When smaller doses are required, the unused portion should be discarded with the entire unit.Dextrose, USP is chemically designated C6H12O6 • H2O (D-glucose monohydrate), a hexose sugar freely soluble in water. Dextrose, hydrous has the following formula:Water for Injection, USP is chemically designated H2O.The delivery device is composed of a 50 mL glass syringe barrel with rubber stopper, and custom molded IMS injector with Luer Connector.

Clinical Pharmacology

When administered intravenously this solution restores blood glucose levels in hypoglycemia and provides a source of carbohydrate calories.Carbohydrate in the form of dextrose may aid in minimizing liver glycogen depletion and exerts a protein-sparing action. Dextrose injection 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 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

50% Dextrose Injection is indicated in the treatment of insulin hypoglycemia (hyperinsulinemia or insulin shock) to restore blood glucose levels.The solution is also indicated, after dilution, for intravenous infusion as a source of carbohydrate calories in patients whose oral intake is restricted or inadequate to maintain nutritional requirements. Slow infusion of hypertonic solutions is essential to ensure proper utilization of dextrose and avoid production of hyperglycemia.

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 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

50% Dextrose Injection is hypertonic and may cause phlebitis and thrombosis at the site of injection.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.Additives may be incompatible. Consult with pharmacist if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.For peripheral vein administration:The solution should be given slowly, preferably through a small bore needle into a large vein, to minimize venous irritation.For central venous administration:Concentrated dextrose should be administered via central vein only after suitable dilution.

Precautions

Do not use unless the solution is clear and seal is intact. Discard unused portion.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.To minimize hyperglycemia and consequent glycosuria, it is desirable to monitor blood and urine glucose and if necessary, add insulin.When a concentrated dextrose infusion is abruptly withdrawn, it is advisable to follow with the administration of 5% to 10% dextrose injection to avoid rebound hypoglycemia.Solutions containing dextrose should be used with caution in patients with known subclinical or overt diabetes mellitus.Care should be exercised to ensure that the needle is well within the lumen of the vein and that extravasation does not occur. If thrombosis should occur during administration, the injection should be stopped and corrective measures instituted.Concentrated dextrose solutions should not be administered subcutaneously or intramuscularly.

Carcinogenesis, Mutagenesis, Impairment Of Fertility:

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.

Nursing Mothers:

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when 50% Dextrose Injection, USP is administered to a nursing mother.

Adverse Reactions

Hyperosmolar syndrome, resulting from excessively rapid administration of concentrated dextrose may cause 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-evalutate the patient and institute appropriate corrective measures. See WARNINGS AND PRECAUTIONS.

Dosage And Administration

For peripheral vein administration:Injection of the solution should be made slowly. The maximum rate at which dextrose can be infused without producing glycosuria is 0.5 g/kg of body weight/hour. About 95% of the dextrose is retained when infused at a rate of 0.8 g/kg/hr.In insulin-induced hypoglycemia, intravenous injection of 10 to 25 grams of dextrose (20 to 50 mL of 50% dextrose) is usually adequate. Repeated doses and supportive treatment may be required in severe cases. A specimen for blood glucose determination should be taken before injecting the dextrose. In such emergencies, dextrose should be administered promptly without awaiting pretreatment test results.For central vein administration:For total parenteral nutrition 50% Dextrose Injection, USP is administered by slow intravenous infusion (a) after admixture with amino acid solutions via an indwelling catheter with the tip positioned in a large central vein, preferably the superior vena cava, or (b) after dilution with sterile water for injection. Dosage should be adjusted to meet individual patient requirements.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.The maximum rate of dextrose administration which does not result in glycosuria is the same as cited above.Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See CONTRAINDICATIONS.

How Supplied

50% DEXTROSE INJECTION, USP is supplied in single-dose containers as follows: Stock No.Container SizeNeedle  330150 mL Prefilled Syringe 500 mg/mL NDC 76329-3301-1NoneTen cartons per package.Syringe Assembly Directions:USE ASEPTIC TECHNIQUEDo not assemble until ready to use.*CAUTION: IMPROPER ENGAGING MAY CAUSE GLASS BREAKAGE AND SUBSEQUENT INJURY.Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Principle Display Panel: Syringe Label

Osmolarity (approx.) 2.50 mOsmols per mL (calc.)Rx OnlyFOR INTRAVENOUS USE / SEE INSERTSINGLE DOSE / NO PRESERVATIVE ADDEDUSE ONLY IF SOLUTION IS CLEARIMS, LIMITEDSo. El Monte, CA 91733, U.S.A.7633010B 7-1150 mL   25g   0.5g/mLDEXTROSE INJECTION, USP, 50%DeliveredApprox. mL 0   5   10   15   20   25   30   35   40   45WARNING: THIS AND OTHER HYPERTONIC SOLUTIONS MAY CAUSE VEIN DAMAGE

Principle Display Panel: Carton

Luer-Lock Prefilled SyringeRx OnlyNDC 76329-3301-1SOCK NO. 330150% DEXTROSE INJECTION, USP (0.5g/mL)25 g per 50 mLSingle use, do not reuse or resterilizeLUER-JET™ LUER-LOCK PREFILLED SYRINGEFOR INTRAVENOUS USEAN ANTIHYPOGLYCEMIC AGENT

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