Dextrose also known as Dextrose Monohydrate is a human prescription drug labeled by 'Fresenius Kabi Usa, Llc'. National Drug Code (NDC) number for Dextrose is 63323-624. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Dextrose drug includes Dextrose Monohydrate - 50 mg/mL . The currest status of Dextrose drug is Active.

Dextrose dextrose monohydrate dextrose monohydrate anhydrous dextrose

Drug interactions additives may be incompatible. consult with pharmacist, if available. when introducing additives, use aseptic technique, mix thoroughly and do not store. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit (see precautions ).

Indications and usage: intravenous solutions containing dextrose are indicated for parenteral replenishment of fluid and minimal carbohydrate calories as required by the clinical condition of the patient.

Warnings: excessive administration of potassium-free solutions may result in significant hypokalemia. the intravenous administration of these 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 of administered parenteral solutions. the risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.

Dosage and administration: the dose is dependent upon the age, weight and clinical condition of the patient. as reported in the literature, the dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/hypoglycemia. drug interactions additives may be incompatible. consult with pharmacist, if available. when introducing additives, use aseptic technique, mix thoroughly and do not store. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit (see precautions ).

Contraindications: 5% 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.

Adverse reactions: 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.

Drug interactions additives may be incompatible. consult with pharmacist, if available. when introducing additives, use aseptic technique, mix thoroughly and do not store. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit (see precautions ).

Pregnancy teratogenic effects 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.

Pediatric use the safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. in neonates or very small infants the volume of fluid may affect fluid and electrolyte balance. frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants. in very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolarity and possible intracerebral hemorrhage.

Geriatric use an evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Overdosage: in the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures (see warnings , precautions , and adverse reactions ).

Description: 5% dextrose injection, usp solution is sterile and nonpyrogenic. it is a parenteral solution containing dextrose in water for injection intended for intravenous administration. each 100 ml of 5% dextrose injection, usp, contains dextrose monohydrate, 5 g in water for injection. the caloric value is 170 kcal/l. the osmolarity is 252 mosmol/l (calc.), which is slightly hypotonic. the solution ph is 4.3 (3.2 to 6.5). this solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only as a single-dose injection. when smaller doses are required the unused portion should be discarded. 5% dextrose injection, usp is a parenteral fluid and nutrient replenisher. dextrose, usp is chemically designated d-glucose monohydrate (c 6 h 12 o 6 • h 2 o), a hexose sugar freely soluble in water. it has the following structural formula: water for injection, usp is chemically designated h 2 o. the flexible container is fabricated from a specially formulated non-plasticized film containing polypropylene and thermoplastic elastomers ( free flex ® bag). the amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. solutions in contact with the flexible container can leach out certain of the container’s chemical components in very small amounts within the expiration period. the suitability of the container material has been confirmed by tests in animals according to usp biological tests for plastic containers. structure

Clinical pharmacology: when administered intravenously, these solutions provide a source of water and carbohydrate. isotonic and hypertonic concentrations of dextrose are suitable for parenteral maintenance of water requirements when salt is not needed or should be avoided. 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 injected parenterally 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 requirements range from two to three liters (1 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 bod Read more...

Carcinogenesis, mutagenesis, impairment of fertility studies with 5% dextrose injection, usp have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.

How supplied: 5% dextrose injection, usp is supplied in single dose flexible plastic containers as follows: product code unit of sale strength each 624650 ndc 63323-624-50 package of 60 freeflex ® bags 2.5 grams per 50 ml (50 mg per ml) ndc 63323-624-05 50ml fill in a 100 ml freeflex ® bag 624661 ndc 63323-624-61 package of 50 freeflex ® bags 5 grams per 100 ml (50 mg per ml) ndc 63323-624-06 one 100 ml freeflex ® bag 624674 ndc 63323-624-74 package of 30 freeflex ® bags 12.5 grams per 250 ml (50 mg per ml) ndc 63323-624-04 one 250 ml freeflex ® bag 624675 ndc 63323-624-75 package of 20 freeflex ® bags 25 grams per 500 ml (50 mg per ml) ndc 63323-624-07 one 500 ml freeflex ® bag 624610 ndc 63323-624-10 package of 10 freeflex ® bags 50 grams per 1,000 ml (50 mg per ml) ndc 63323-624-03 one 1,000 ml freeflex ® bag store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. exposure of pharmaceutical products to heat should be minimi Read more...

Package label - principal display panel - 5% dextrose bag label 5% dextrose injection, usp ndc 63323-624-06 5 grams per 100 ml (50 mg per ml) for intravenous use. rx only bag