Dextrose Monohydrate And Sodium Chloride
FDA Drug Information • Also known as: Dextrose And Sodium Chloride
- Brand Names
- Dextrose And Sodium Chloride
- Route
- INTRAVENOUS
- Dosage Form
- INJECTION, SOLUTION
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
DESCRIPTION 5% Dextrose and 0.45% Sodium Chloride Injection, USP solutions are sterile and nonpyrogenic. They are large volume parenteral solutions containing 5 grams per 100 mL of Dextrose monohydrate and 0.45 grams per 100 mL of Sodium Chloride in water for injection intended for intravenous administration. Each 100 mL of 5% Dextrose and 0.45% Sodium Chloride Injection, USP contains dextrose, hydrous 5 g and sodium chloride 0.45 g in water for injection. Electrolytes per 1000 mL: sodium (Na + ), 77 mEq; chloride (Cl - ) 77 mEq. The osmolarity is 406 mOsmol/L (calc.), which is hypertonic. The caloric value is 170 kcal/L. The pH is 4.3 (3.5 to 6.5). 5% Dextrose and 0.45% Sodium Chloride Injection, USP 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 and 0.45% Sodium Chloride Injection, USP is a parenteral fluid, nutrient and electrolyte replenisher. Dextrose, USP is chemically designated D-glucose monohydrate (C 6 H 12 O 6
What Is Dextrose Monohydrate And Sodium Chloride Used For?
INDICATIONS AND USAGE Intravenous solutions containing dextrose and sodium chloride are indicated for parenteral replenishment of fluid, minimal carbohydrate calories, and sodium chloride as required by the clinical condition of the patient.
Dosage and Administration
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. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS . Drug Interactions Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store. INSTRUCTIONS FOR USE: Check flexible container solution composition, lot number, and expiry date. Do not remove solution container from its overwrap until immediately before use. Use sterile equipment and aseptic technique. To Open 1. Turn solution container over so that the text is face down. Using the pre-cut corner tabs, peel open the overwrap and remove solution container. 2. Check the solution container for leaks by squeezing firmly. If leaks are found, or if the seal is not intact, discard the solution. 3. Do not use if the solution is cloudy or a precipitate is present. To Add Medication 1. Identify WHITE Additive Port with arrow pointing toward container. 2. Immediately before injecting additives, break off WHITE Additive Port Cap with the arrow pointing toward container. 3. Hold base of WHITE Additive Port horizontally. 4. Insert needle horizontally through the center of WHITE Additive Port's septum and inject additives. 5. Mix container contents thoroughly. Preparation for Administration 1. Immediately before inserting the infusion set, break off BLUE Infusion Port Cap with the arrow pointing away from container. 2. Use a non-vented infusion set or close the air-inlet on a vented set. 3. Close the roller clamp of the infusion set. 4. Hold the base of BLUE Infusion Port. 5. Insert spike through BLUE Infusion Port by rotating wrist slightly until the spike is inserted. NOTE : See full directions accompanying administration set. WARNING: Do not use flexible container in series connections.
Side Effects (Adverse Reactions)
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.
Warnings and Precautions
WARNINGS Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention. Excessive administration of potassium-free solutions may result in significant hypokalemia. In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention. 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.
Drug Interactions
Drug Interactions Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.
Contraindications
CONTRAINDICATIONS None known.
Pregnancy and Breastfeeding
Pregnancy. Animal reproduction studies have not been conducted with dextrose or sodium chloride. It is also not known whether dextrose or sodium chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dextrose or sodium chloride should be given to a pregnant woman only if clearly needed.
Overdosage
OVERDOSAGE In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. See WARNINGS , PRECAUTIONS , and ADVERSE REACTIONS .
How Supplied
HOW SUPPLIED 5% Dextrose and 0.45% Sodium Chloride Injection, USP is supplied in single-dose flexible plastic containers in 250 mL, 500 mL and 1000 mL sizes as follows: Product Code Unit of Sale Each 1727173405 NDC 17271-734-05 Package of 30 NDC 17271-734-05 One 250 mL free flex ® bag 1727173406 NDC 17271-734-06 Package of 20 NDC 17271-734-06 One 500 mL free flex ® bag 1727173407 NDC 17271-734-07 Package of 10 NDC 17271-734-07 One 1,000 mL free flex ® bag The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile. 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.] Becton, Dickinson and Company 1 Becton Drive Franklin Lakes, NJ 07417 USA For product inquiry: 1-800-523-0502 Distributed by BD. Manufactured by Fresenius Kabi. Revised: February 2024 Fresenius Kabi Logo
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.