Potassium Chloride In Dextrose And Sodium Chloride label

Potassium Chloride In Dextrose And Sodium Chloride

Potassium Chloride In Dextrose And Sodium Chloride Recall

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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.

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FDA Safety Alerts

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

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Manufacturer Warnings

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

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FDA Labeling Changes

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

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Uses

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

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History

There is currently no drug history available for this drug.

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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.

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Potassium Chloride In Dextrose And Sodium Chloride Recall
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Potassium Chloride In Dextrose And Sodium Chloride Manufacturers

  • Baxter Healthcare Corporation
    Potassium Chloride In Dextrose And Sodium Chloride | Baxter Healthcare Corporation
    No Recall

    Potassium Chloride In Dextrose And Sodium Chloride | Baxter Healthcare Corporation

    Potassium Chloride In Dextrose And Sodium Chloride | Baxter Healthcare Corporation

    As directed by a physician. Dosage is dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations.

    Parenteral drug products should be inspected visually for particulate matter anddiscoloration prior to administration whenever solution and container permit. Do not administer unless solution is clear and seal is intact. Use of a final filter is recommended during administration of all parenteral solutions, where possible.

    All injections in AVIVA plastic containers are intended for intravenous administration using sterile equipment.

    Additives may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Do not store solutions containing additives.

  • B. Braun Medical Inc.
    Potassium Chloride In Dextrose And Sodium Chloride | B. Braun Medical Inc.
    No Recall

    Potassium Chloride In Dextrose And Sodium Chloride | B. Braun Medical Inc.

    Potassium Chloride In Dextrose And Sodium Chloride | B. Braun Medical Inc.

    These solutions are for intravenous use only.

    Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy.

    When a hypertonic solution is to be administered peripherally, it should be slowly infused through a small bore needle, placed well within the lumen of a large vein to minimize venous irritation. Carefully avoid infiltration.

    Usually, up to 40 mEq of potassium per liter daily is sufficient to replace normal loss in adults. Typical infusion rates should not exceed 10 mEq per hour or 120 mEq per day. Pediatric patients may require 2 to 3 mEq per kg of body weight daily. See WARNINGS and PRECAUTIONS for pediatric use.

    Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.

    Dextrose may be administered to normal individuals at a rate of 0.5 g/kg/hour without producing glycosuria. At the maximum infusion rate of 0.8 g/kg/hour, approximately 95% of the dextrose is retained.

    Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

    Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

  • Hospira, Inc.
    Potassium Chloride In Dextrose And Sodium Chloride | Hospira, Inc.
    No Recall

    Potassium Chloride In Dextrose And Sodium Chloride | Hospira, Inc.

    Potassium Chloride In Dextrose And Sodium Chloride | Hospira, Inc.

    These solutions should be administered only by intravenous infusion and as directed by the physician. The dose and rate of injection are dependent upon the age, weight and clinical condition of the patient. If the serum potassium level is greater than 2.5 mEq/liter, potassium should be given at a rate not to exceed 10 mEq/hour in a concentration less than 30 mEq/liter. Somewhat faster rates and greater concentrations (usually up to 40 mEq/liter) of potassium may be indicated in patients with more severe potassium deficiency. The total 24-hour dose should not generally exceed 200 mEq of potassium.

    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.

    Drug Interactions

    Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.

    Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

  • Baxter Healthcare Corporation
    Potassium Chloride In Dextrose And Sodium Chloride | Baxter Healthcare Corporation
    No Recall

    Potassium Chloride In Dextrose And Sodium Chloride | Baxter Healthcare Corporation

    Potassium Chloride In Dextrose And Sodium Chloride | Baxter Healthcare Corporation

    As directed by a physician. Dosage is dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations.

    Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Use of a final filter is recommended during administration of all parenteral solutions, where possible.

    All injections in VIAFLEX Plus plastic containers are intended for intravenous administration using sterile equipment.

    The dosage selection 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. Frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants. The infusion rate and volume depends on the age, weight, clinical and metabolic conditions of the patient, concomitant therapy and should be determined by the consulting physician experienced in pediatric intravenous fluid therapy.

    Additives may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Do not store solutions containing additives.

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