Potassium Chloride, Dextrose Monohydrate And Sodium Chloride
Generic Name: potassium chloride, dextrose monohydrate and sodium chloride
Brand Names:
Potassium Chloride In Dextrose And Sodium Chloride
11 DESCRIPTION Potassium Chloride in Dextrose and Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in a single dose container for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1.
Overview
11 DESCRIPTION Potassium Chloride in Dextrose and Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in a single dose container for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1.
Uses
1 INDICATIONS AND USAGE Potassium Chloride in Dextrose and Sodium Chloride Injection is indicated as a source of water, electrolytes and calories. Potassium Chloride in 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 , 5.2 ) • 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 • Potassium Chloride in Dextrose and Sodium Chloride Injection is only for intravenous infusion [see Warnings and Precautions (5.2) ]. • The osmolarity of Potassium Chloride in Dextrose and Sodium Chloride Injection, ranges from 361 to 641 mOsmol/L (calc). Peripheral administration is generally acceptable; however; consider central vein administration if there is peripheral vein irritation, phlebitis, and/or associated pain especially with higher potassium concentrations.
Side Effects
6 ADVERSE REACTIONS The following adverse reactions associated with the use of Potassium Chloride in Dextrose and 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 Cause Hyperkalemia : Avoid use in patients receiving such products. If use cannot be avoided, monitor serum potassium concentrations. ( 7.1 ) • Lithium : Decreased lithium concentrations with concomitant use; monitor serum lithium concentrations. ( 7.2 ) • 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.
Warnings
5 WARNINGS AND PRECAUTIONS • Hypersensitivity Reactions : monitor for signs and symptoms and discontinue infusion if reactions occur. ( 5.1 ) • Hyperkalemia : May result in cardiac arrhythmias. Avoid use in patients with, or at risk for, hyperkalemia. If use cannot be avoided, use a product with a low amount of potassium chloride, infuse slowly and monitor serum potassium concentrations and ECGs. ( 5.2 ) • Hyperglycemia or Hyperosmolar Hyperglycemic State : Monitor blood glucose and administer insulin as needed. ( 5.3 , 8.4 ) • Hyponatremia, Hypernatremia and Hyperchloremia : Avoid in patients with or at risk for hypo-/hypernatremia. If use cannot be avoided, monitor serum sodium concentrations. 4 CONTRAINDICATIONS Potassium Chloride in Dextrose and Sodium Chloride Injection is contraindicated in patients with: • known hypersensitivity to potassium chloride, dextrose and/or sodium chloride [see Warnings and Precautions 5.1) ] • clinically significant hyperkalemia [see Warnings and Precautions (5.2) ] • clinically significant hyperglycemia [see Warnings and Precautions (5.3) ] • Known hype...
Pregnancy
8.1 Pregnancy Risk Summary Appropriate administration of Potassium Chloride in Dextrose Sodium Chloride Injection during pregnancy is not expected to cause adverse developmental outcomes, including congenital malformations. Animal reproduction studies have not been conducted with Potassium Chloride in Dextrose 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 Potassium Chloride in Dextrose and Sodium Chloride Injection, are clear solutions in 500 mL and 1000 mL single-dose, flexible containers available as follows: Code Size (mL) NDC mEq Potassium Product Name 2B1614 2B1613 1000 500 0338-0663-04 0338-0663-03 20 mEq/L 10 mEq/L Potassium Chloride in 5% Dextrose and 0.2% Sodium Chloride Injection, USP 2B1473 500 0338-0...
Frequently Asked Questions
What is Potassium Chloride, Dextrose Monohydrate And Sodium Chloride used for?▼
1 INDICATIONS AND USAGE Potassium Chloride in Dextrose and Sodium Chloride Injection is indicated as a source of water, electrolytes and calories. Potassium Chloride in Dextrose and Sodium Chloride Injection is indicated as a source of water, electrolytes and calories. ( 1 )
What are the side effects of Potassium Chloride, Dextrose Monohydrate And Sodium Chloride?▼
6 ADVERSE REACTIONS The following adverse reactions associated with the use of Potassium Chloride in Dextrose and 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 Potassium Chloride, Dextrose Monohydrate And Sodium Chloride during pregnancy?▼
8.1 Pregnancy Risk Summary Appropriate administration of Potassium Chloride in Dextrose Sodium Chloride Injection during pregnancy is not expected to cause adverse developmental outcomes, including congenital malformations. Animal reproduction studies have not been conducted with Potassium Chloride in Dextrose 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 Potassium Chloride, Dextrose Monohydrate And Sodium Chloride?▼
5 WARNINGS AND PRECAUTIONS • Hypersensitivity Reactions : monitor for signs and symptoms and discontinue infusion if reactions occur. ( 5.1 ) • Hyperkalemia : May result in cardiac arrhythmias. Avoid use in patients with, or at risk for, hyperkalemia. If use cannot be avoided, use a product with a low amount of potassium chloride, infuse slowly and monitor serum potassium concentrations and ECGs. ( 5.2 ) • Hyperglycemia or Hyperosmolar Hyperglycemic State : Monitor blood glucose and administer insulin as needed. ( 5.3 , 8.4 ) • Hyponatremia, Hypernatremia and Hyperchloremia : Avoid in patients with or at risk for hypo-/hypernatremia. If use cannot be avoided, monitor serum sodium concentrations. 4 CONTRAINDICATIONS Potassium Chloride in Dextrose and Sodium Chloride Injection is contraindicated in patients with: • known hypersensitivity to potassium chloride, dextrose and/or sodium chloride [see Warnings and Precautions 5.1) ] • clinically significant hyperkalemia [see Warnings and Precautions (5.2) ] • clinically significant hyperglycemia [see Warnings and Precautions (5.3) ] • Known hype...
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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.