Dextrose Monohydrate
Medical Purchasing Solutions, Llc
Human Prescription Drug
NDC 71872-7282Dextrose Monohydrate is a human prescription drug labeled by 'Medical Purchasing Solutions, Llc'. National Drug Code (NDC) number for Dextrose Monohydrate is 71872-7282. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Dextrose Monohydrate drug includes Dextrose Monohydrate - 25 g/50mL . The currest status of Dextrose Monohydrate drug is Active.
Drug Information:
| Drug NDC: | 71872-7282 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Dextrose Monohydrate |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Dextrose Monohydrate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Medical Purchasing Solutions, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Injection, Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | DEXTROSE MONOHYDRATE - 25 g/50mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAVENOUS
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 11 Nov, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | ANDA203451 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Medical Purchasing Solutions, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 727517
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| UNII: | LX22YL083G
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 71872-7282-1 | 1 SYRINGE in 1 BAG (71872-7282-1) / 50 mL in 1 SYRINGE | 01 Mar, 2022 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Dextrose monohydrate dextrose monohydrate hydrochloric acid sodium hydroxide water dextrose monohydrate anhydrous dextrose
Indications and Usage:
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.
Warnings:
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
Read more... should be administered via central vein only after suitable dilution.
Dosage and Administration:
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,
Read more...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 .
Contraindications:
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.
Adverse Reactions:
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:
Overdosage in the event of overhydration or solute overload during therapy, re-evalutate the patient and institute appropriate corrective measures. see warnings and precautions
Description:
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. may contain hydrochloric acid and/or sodium hydroxide for ph adjustment. 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 c 6 h 12 o 6 ⢠h 2 o (d-glucose monohydrate), a hexose sugar freely soluble in water. dextrose, hydrous has the following formula: water for injection, usp is chemically designated h 2 o. the delivery device is composed of a 50 ml glass syringe barrel with rubber stopper, and custom molded ims injector with luer connector. structure
Clinical Pharmacology:
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.
How Supplied:
How supplied 50% dextrose injection, usp 25 g/50 ml (0.5 g/ml) is supplied in single-dose prefilled syringes as follows: ndc no. stock no. container size needle 76329-3302-1 3302 50 ml none one shrink wrapped package containing 10 unit cartons, each containing a luer-jet⢠luer-lock prefilled syringe. syringe assembly directions: use aseptic technique do 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.] revised 01/21 6933010e © international medication systems, ltd., 2021 international medication systems, ltd. south el monte, ca 91733, usa an amphastar pharmaceuticals company printed in usa instructions
Package Label Principal Display Panel:
Principal display panel - outer package ndc 71872-7282-1 luer-lock prefilled syringe rx only 1 x 50 ml single-dose prefilled syringe 50% dextrose injection, usp 25 g/50 ml (0.5 g/ml) for intravenous use single use, do not reuse or resterilize. luer-jet⢠luer-lock prefilled syringe 7282.jpg