Dextrose And Sodium Chloride

Generic Name: dextrose and sodium chloride

Over-the-Counter (OTC)

Brand Names:

Dextrose And Sodium Chloride

11 DESCRIPTION Dextrose and Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in single-dose containers for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1 . Table 1. Size (mL) Composition (g/L) Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L.

Overview

11 DESCRIPTION Dextrose and Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in single-dose containers for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1 . Table 1. Size (mL) Composition (g/L) Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L.

Uses

1 INDICATIONS AND USAGE Dextrose and Sodium Chloride Injection is indicated as a source of water, electrolytes and calories. Dextrose and Sodium Chloride Injection is indicated as a source of water, electrolytes and calories. ( 1 )

Dosage

2 DOSAGE AND ADMINISTRATION • Only for intravenous infusion. ( 2.1 ) • See full prescribing information for information on preparation, administration, dosing considerations and instructions for use. ( 2.1 , 2.2 , 2.3 ) 2.1 Important Administration Instructions • Dextrose and Sodium Chloride Injection is only for intravenous infusion. • The osmolarity of Dextrose and Sodium Chloride Injection, ranges from 280 to 560 mOsmol/L (calc). Peripheral administration is generally acceptable; however; consider central vein administration if there is peripheral vein irritation, phlebitis, and/or associated pain.

Side Effects

6 ADVERSE REACTIONS - Anaphylactic reaction, hypersensitivity, and chills - Hyponatremia (applies to solutions containing less than 0.9% Sodium Chloride) 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. Adverse reactions include electrolyte imbalances, hyperglycemia, and hypervolemia and injection site reactions.

Interactions

7 DRUG INTERACTIONS • Other Products that Affect Glycemic Control, Vasopressin or Fluid and/or Electrolyte Balance : Monitor blood glucose concentrations, fluid balance serum electrolyte concentrations and acid-base balance. ( 7.1 ) • Lithium : Decreased lithium concentrations with concomitant use; monitor serum lithium concentrations. ( 7.2 ) 7.1 Other Products that Affect Glycemic Control, Vasopressin or Fluid and/or Electrolyte Balance Dextrose and Sodium Chloride Injection can affect glycemic control, vasopressin and fluid and/or electrolyte balance [see Warnings and Precautions (5.2 , 5.3 , 5.4 , 5.5 , 5.6) ] .

Warnings

5 WARNINGS AND PRECAUTIONS • Hypersensitivity Reactions : Monitor for signs and symptoms and discontinue infusion if reactions occur. ( 5.1 ) • Hyperglycemia or Hyperosmolar Hyperglycemic State : Monitor blood glucose and administer insulin as needed. ( 5.2 , 8.4 ) • Hyponatremia, Hypokalemia, Hypernatremia and Hyperchloremia : Avoid in patients with or at risk for hypo-/hypernatremia and hypokalemia. If use cannot be avoided, monitor serum sodium and potassium concentrations. ( 5.3 , 5.4 , 5.5 , 8.4 ) • Fluid Overload : Avoid in patients with or at risk for fluid and/or solute overloading. If use cannot be avoided, monitor daily fluid balance and electrolyte, concentrations and acid-base balance, as needed and especially during prolonged use. 4 CONTRAINDICATIONS Dextrose and Sodium Chloride Injection is contraindicated in patients with: • known hypersensitivity to dextrose and/or sodium chloride [see Warnings and Precautions 5.1) ] • clinically significant hyperglycemia [see Warnings and Precautions (5.2) ] • Known hypersensitivity to dextrose, or sodium chloride ( 4 , 5.1 ) • Clinically significant hyperglycemia ( 4 , 5.2 )

Pregnancy

8.1 Pregnancy Risk Summary Appropriate administration of Dextrose and Sodium Chloride Injection during pregnancy is not expected to cause adverse developmental outcomes, including congenital malformations. Animal reproduction studies have not been conducted with Dextrose and Sodium Chloride Injection. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.

Storage

16 HOW SUPPLIED/STORAGE AND HANDLING Dextrose and Sodium Chloride Injection are clear solutions in 250 mL, 500 mL and 1000 mL single-dose, flexible containers available as follows: Code Size (mL) NDC Product Name 2B1024 1000 0338-0073-04 2.5% Dextrose and 0.45% Sodium Chloride Injection, USP 2B1092 250 0338-0077-02 5% Dextrose and 0.2% Sodium Chloride Injection, USP 2B1094 1000 0338-0077-04 2B1073...

Frequently Asked Questions

What is Dextrose And Sodium Chloride used for?

1 INDICATIONS AND USAGE Dextrose and Sodium Chloride Injection is indicated as a source of water, electrolytes and calories. Dextrose and Sodium Chloride Injection is indicated as a source of water, electrolytes and calories. ( 1 )

What are the side effects of Dextrose And Sodium Chloride?

6 ADVERSE REACTIONS - Anaphylactic reaction, hypersensitivity, and chills - Hyponatremia (applies to solutions containing less than 0.9% Sodium Chloride) 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. Adverse reactions include electrolyte imbalances, hyperglycemia, and hypervolemia and injection site reactions.

Can I take Dextrose And Sodium Chloride during pregnancy?

8.1 Pregnancy Risk Summary Appropriate administration of Dextrose and Sodium Chloride Injection during pregnancy is not expected to cause adverse developmental outcomes, including congenital malformations. Animal reproduction studies have not been conducted with Dextrose and Sodium Chloride Injection. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.

What are the important warnings for Dextrose And Sodium Chloride?

5 WARNINGS AND PRECAUTIONS • Hypersensitivity Reactions : Monitor for signs and symptoms and discontinue infusion if reactions occur. ( 5.1 ) • Hyperglycemia or Hyperosmolar Hyperglycemic State : Monitor blood glucose and administer insulin as needed. ( 5.2 , 8.4 ) • Hyponatremia, Hypokalemia, Hypernatremia and Hyperchloremia : Avoid in patients with or at risk for hypo-/hypernatremia and hypokalemia. If use cannot be avoided, monitor serum sodium and potassium concentrations. ( 5.3 , 5.4 , 5.5 , 8.4 ) • Fluid Overload : Avoid in patients with or at risk for fluid and/or solute overloading. If use cannot be avoided, monitor daily fluid balance and electrolyte, concentrations and acid-base balance, as needed and especially during prolonged use. 4 CONTRAINDICATIONS Dextrose and Sodium Chloride Injection is contraindicated in patients with: • known hypersensitivity to dextrose and/or sodium chloride [see Warnings and Precautions 5.1) ] • clinically significant hyperglycemia [see Warnings and Precautions (5.2) ] • Known hypersensitivity to dextrose, or sodium chloride ( 4 , 5.1 ) • Clinically significant hyperglycemia ( 4 , 5.2 )

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Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.