DEXTROSE MONOHYDRATE- dextrose monohydrate injection, solution

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

Dextrose monohydrate (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)

Disponible depuis:

International Medication Systems, Limited

Mode d'administration:

INTRAVENOUS

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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. 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.

Descriptif du produit:

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

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

DEXTROSE MONOHYDRATE - DEXTROSE MONOHYDRATE INJECTION, SOLUTION
INTERNATIONAL MEDICATION SYSTEMS, LIMITED
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50% Dextrose Injection, USP
Concentrated Dextrose for Intravenous Administration
NOTE: THIS SOLUTION IS HYPERTONIC − SEE WARNINGS AND PRECAUTIONS.
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 H
O • H 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 O.
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
sodi