Dextrose Monohydrate, Sodium Chloride
Generic Name: dextrose monohydrate, sodium chloride
Brand Names:
Dextrose And Sodium Chloride
11 DESCRIPTION 2.5% Dextrose and 0.45% 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. * Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L.
Overview
11 DESCRIPTION 2.5% Dextrose and 0.45% 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. * Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L.
Uses
1 INDICATIONS AND USAGE 2.5% Dextrose and 0.45% Sodium Chloride Injection is indicated as a source of water, electrolytes and calories. 2.5% Dextrose and 0.45% 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 2.5% Dextrose and 0.45% Sodium Chloride Injection is only for intravenous infusion. The osmolarity of 2.5% Dextrose and 0.45% Sodium Chloride Injection, is 280 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 The following adverse reactions associated with the use of 2.5% Dextrose and 0.45% Sodium Chloride Injection were identified in postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions: anaphylaxis, rash and pruritus [see Warnings and Precautions ( 5.1 )] .
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 2.5% Dextrose and 0.45% 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 Hyper glycemic 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 2.5% Dextrose and 0.45% 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 2.5% Dextrose and 0.45% Sodium Chloride Injection during pregnancy is not expected to cause adverse developmental outcomes, including congenital malformations. Animal reproduction studies have not been conducted with 2.5% Dextrose and 0.45% 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
Storage: Avoid excessive heat. Store at 20° to 25°C (68° to 77°F) [ see USP Controlled Room Temperature]; brief exposure up to 40°C/104°F does not adversely affect the product. The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile.
Frequently Asked Questions
What is Dextrose Monohydrate, Sodium Chloride used for?▼
1 INDICATIONS AND USAGE 2.5% Dextrose and 0.45% Sodium Chloride Injection is indicated as a source of water, electrolytes and calories. 2.5% Dextrose and 0.45% Sodium Chloride Injection is indicated as a source of water, electrolytes and calories. ( 1 )
What are the side effects of Dextrose Monohydrate, Sodium Chloride?▼
6 ADVERSE REACTIONS The following adverse reactions associated with the use of 2.5% Dextrose and 0.45% Sodium Chloride Injection were identified in postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions: anaphylaxis, rash and pruritus [see Warnings and Precautions ( 5.1 )] .
Can I take Dextrose Monohydrate, Sodium Chloride during pregnancy?▼
8.1 Pregnancy Risk Summary Appropriate administration of 2.5% Dextrose and 0.45% Sodium Chloride Injection during pregnancy is not expected to cause adverse developmental outcomes, including congenital malformations. Animal reproduction studies have not been conducted with 2.5% Dextrose and 0.45% 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 Monohydrate, Sodium Chloride?▼
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Monitor for signs and symptoms and discontinue infusion if reactions occur. ( 5.1 ) Hyperglycemia or Hyperosmolar Hyper glycemic 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 2.5% Dextrose and 0.45% 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.