Potassium Chloride In Dextrose And Sodium Chloride

Potassium Chloride In Dextrose And Sodium Chloride

Potassium Chloride In Dextrose And Sodium Chloride Recall

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Questions & Answers

Side Effects & Adverse Reactions

Potassium Chloride in 5% Dextrose and Sodium Chloride Injection, USP 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.

Potassium Chloride in 5% Dextrose and Sodium Chloride Injection, USP should be used with great care, if at all, in patients with hyperkalemia, severe renal failure, and in conditions in which potassium retention is present.

Injections containing carbohydrates with low electrolyte concentration should not be administered simultaneously with blood through the same administration set because of the possibility of pseudoagglutination or hemolysis. The container label for these injections bears the statement: Do not administer simultaneously with blood.

The intravenous administration of Potassium Chloride in 5% Dextrose and Sodium Chloride Injection, USP 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 the injection. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injection.

In patients with diminished renal function, administration of Potassium Chloride in 5% Dextrose and Sodium Chloride Injection, USP may result in sodium or potassium retention.

In very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolality and possible intracerebral hemorrhage.

Potassium salts should never be administered by IV push.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Potassium Chloride in 5% Dextrose and Sodium Chloride Injection, USP is indicated as a source of water, electrolytes and calories.

History

There is currently no drug history available for this drug.

Other Information

Potassium Chloride in 5% 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.

*
Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions (> 600 mOsmol/L) may cause vein damage.
Table 1
Composition
(g/L)
Ionic Concentration(mEq/L)

Size (mL) **Dextrose Hydrous, USP Sodium Chloride, USP (NaCl) Potassium Chloride, USP (KCl) *Osmolarity (mOsmol/L)(calc.) pH
nominal
(range)
Sodium Potassium Chloride Caloric Content (kCal/L)
Potassium Chloride in 5% Dextrose and 0.2% Sodium Chloride Injection, USP
mEq Potassium
10 mEq 1000 50 2 0.75 341 4.5
(3.5 to 6.5)
34 10 44 170
20 mEq
10 mEq
1000
500
50 2 1.5 361 4.5
(3.5 to 6.5)
34 20 54 170
30 mEq 1000 50 2 2.24 381 4.5
(3.5 to 6.5)
34 30 64 170
40 mEq 1000 50 2 3 401 4.5
(3.5 to 6.5)
34 40 74 170
Potassium Chloride in 5% Dextrose and 0.33% Sodium Chloride Injection, USP
mEq Potassium
20 mEq
10 mEq
1000
500
50 3.3 1.5 405 4.5
(3.5 to 6.5)
56 20 76 170
30 mEq 1000 50 3.3 2.24 425 4.5
(3.5 to 6.5)
56 30 86 170
40 mEq 1000 50 3.3 3 446 4.5
(3.5 to 6.5)
56 40 96 170
Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP
mEq Potassium
10 mEq 1000 50 4.5 0.75 426 4.5
(3.5 to 6.5)
77 10 87 170
20 mEq
10 mEq
1000
500
50 4.5 1.5 447 4.5
(3.5 to 6.5)
77 20 97 170
30 mEq 1000 50 4.5 2.24 466 4.5
(3.5 to 6.5)
77 30 107 170
40 mEq 1000 50 4.5 3 487 4.5
(3.5 to 6.5)
77 40 117 170
Potassium Chloride in 5% Dextrose and 0.9% Sodium Chloride Injection, USP
mEq Potassium
20 mEq 1000 50 9 1.5 601 4.5
(3.5 to 6.5)
154 20 174 170
40 mEq 1000 50 9 3 641 4.5
(3.5 to 6.5)
154 40 194 170
Image from Drug Label Content

The flexible container is made with non-latex plastic materials specially designed for a wide range of parenteral drugs including those requiring delivery in containers made of polyolefins or polypropylene. For example, the AVIVA container system is compatible with and appropriate for use in the admixture and administration of paclitaxel. In addition, the AVIVA container system is compatible with and appropriate for use in the admixture and administration of all drugs deemed compatible with existing polyvinyl chloride container systems. The solution contact materials do not contain PVC, DEHP, or other plasticizers.

The suitability of the container materials has been established through biological evaluations, which have shown the container passes Class VI U.S. Pharmacopeia (USP) testing for plastic containers. These tests confirm the biological safety of the container system.

The flexible container is a closed system, and air is prefilled in the container to facilitate drainage. The container does not require entry of external air during administration.

The container has two ports: one is the administration outlet port for attachment of an intravenous administration set and the other port has a medication site for addition of supplemental medication (See Directions for Use). The primary function of the overwrap is to protect the container from the physical environment.

Potassium Chloride In Dextrose And Sodium Chloride Manufacturers


  • Baxter Healthcare Corporation
    Potassium Chloride In Dextrose And Sodium Chloride (Dextrose Monohydrate, Sodium Chloride And Potassium Chloride) Injection, Solution [Baxter Healthcare Corporation]
  • B. Braun Medical Inc.
    Potassium Chloride In Dextrose And Sodium Chloride (Dextrose, Sodium Chloride, And Potassium Chloride) Injection [B. Braun Medical Inc.]
  • Hospira, Inc.
    Potassium Chloride In Dextrose And Sodium Chloride (Dextrose Monohydrate, Sodium Chloride, And Potassium Chloride) Injection, Solution [Hospira, Inc.]
  • Baxter Healthcare Corporation
    Potassium Chloride In Dextrose And Sodium Chloride (Potassium Chloride, Dextrose Monohydrate And Sodium Chloride) Injection, Solution [Baxter Healthcare Corporation]

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