POTASSIUM CHLORIDE IN DEXTROSE

POTASSIUM CHLORIDE IN DEXTROSE- dextrose and potassium chloride solution
B. Braun Medical Inc.

1 INDICATIONS AND USAGE

Potassium Chloride in Dextrose Injection is indicated as a source of electrolytes, calories, and water for hydration.

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

  • Potassium Chloride in Dextrose Injection is only for intravenous infusion [see Warnings and Precautions (5.2)].
  • For patients receiving Potassium Chloride in Dextrose Injection at greater than maintenance rates, frequent monitoring of serum potassium concentrations and serial electrocardiograms (ECGs) are recommended.
  • The osmolarity of Potassium Chloride in Dextrose Injection is 295 mOsmol/L (calc). Peripheral administration is generally acceptable; however; consider central vein administration if there is peripheral vein irritation, phlebitis, and/or associated pain.
  • Do not administer Potassium Chloride in Dextrose Injection simultaneously with blood products through the same administration set because of the possibility of pseudo agglutination or hemolysis.
  • To prevent air embolism, use a non-vented infusion set or close the vent on a vented set, avoid multiple connections, do not connect flexible containers in series, fully evacuate residual gas in the container prior to administration, do not pressurize the flexible container to increase flow rates, and if administration is controlled by a pumping device, turn off pump before the container runs dry.
  • Prior to infusion, visually inspect the solution for particulate matter. The solution should be clear and there should be no precipitates. Do not administer unless solution is clear and container is undamaged.
  • Use of a final filter is recommended during administration of parenteral solutions, where possible.

2.2 Recommended Dosage

The infusion rate and volume depends on the age, weight, clinical and metabolic conditions of the patient and concomitant therapy. Electrolyte supplementation may be indicated according to the clinical needs of the patient.

The administration rate should be governed, especially for premature infants with low birth weight, during the first few days of therapy, by the patient’s tolerance to dextrose. Increase the infusion rate gradually as indicated by frequent monitoring of blood glucose concentrations [see Warnings and Precautions (5.1), Use in Specific Populations (8.4)].

2.3 Instructions for Use

To Open

  • Tear overwrap down at notch and remove solution container.
  • Visually inspect the container. The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Evaluate the following:
  • Read the label. Ensure solution is the one ordered and is within the expiration date.
  • If the outlet port protector is damaged, detached or not present, discard container.
  • Invert the container and check to ensure the solution is clear and there is no haze or particulate matter. Discard if there is a color change and/or the appearance of precipitates, insoluble complexes or crystals.
  • Check for minute leaks by squeezing solution container firmly. If leaks are found, discard solution as sterility may be impaired.
  • If supplemental medication is desired, follow directions below before preparing for administration.

Preparation for Administration

  1. Remove plastic protector from sterile set port at bottom of container.
  2. Attach administration set. Refer to complete directions accompanying set.

To Add Medication

  • Additives may be incompatible. Complete information is not available. Do not use additives known or determined to be incompatible.
  • Before adding a substance or medication, verify that it is soluble and/or stable in Potassium Chloride in Dextrose Injection and that the pH range of Potassium Chloride in Dextrose Injection is appropriate.
  • Consult with pharmacist, if available. If, in the informed judgment of the healthcare provider, it is deemed advisable to introduce additives, use aseptic technique.

To Add Medication Before Solution Administration

  1. Prepare medication site.
  2. Using syringe with 18-22 gauge needle, puncture medication port and inner diaphragm and inject.
  3. Squeeze and tap ports while ports are upright and mix solution and medication thoroughly.
  4. After addition, check to ensure the solution is clear and there are no precipitates. Discard if there is a color change and/or the appearance of precipitates, insoluble complexes or crystals.

To Add Medication During Solution Administration

  1. Close clamp on the set.
  2. Prepare medication site.
  3. Using syringe with 18-22 gauge needle of appropriate length (at least 5/8 inch), puncture resealable medication port and inner diaphragm and inject.
  4. Remove container from IV pole and/or turn the container so the ports are in an upright position.
  5. Evacuate both ports by tapping and squeezing them while container ports are in the upright position.
  6. Mix solution and medication thoroughly.
  7. After addition, check to ensure the solution is clear and there are no precipitates. Discard if there is a color change and/or the appearance of precipitates, insoluble complexes or crystals, do not use.
  8. Return container to in use position and continue administration.

Storage

  • Use promptly; do not store solutions containing additives.
  • Single-dose container.
  • Discard any unused portion

3 DOSAGE FORMS AND STRENGTHS

Potassium Chloride in 5% Dextrose Injection USP is supplied sterile and nonpyrogenic in 1000 mL single-dose, flexible container.

4 CONTRAINDICATIONS

Potassium Chloride in Dextrose Injection is contraindicated in patients with:

  • known hypersensitivity to potassium chloride and/or dextrose [see Warnings and Precautions 5.1)]
  • clinically significant hyperkalemia [see Warnings and Precautions (5.2)]
  • clinically significant hyperglycemia [see Warnings and Precautions (5.3)]

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Reactions

Hypersensitivity and infusion reactions, including anaphylaxis, have been reported with Potassium Chloride in Dextrose Injection [see Adverse Reactions (6)]. Stop the infusion immediately if signs or symptoms of a hypersensitivity or infusion reaction develops [see Contraindications (4)]. Appropriate therapeutic countermeasures must be instituted as clinically indicated.

5.2 Hyperkalemia

Potassium-containing solutions, including Potassium Chloride in Dextrose Injection may increase the risk of hyperkalemia. Hyperkalemia can be asymptomatic and manifest only by increased serum potassium concentrations and/or characteristic electrocardiographic (ECG) changes. Cardiac arrhythmias, some fatal, can develop at any time during hyperkalemia.

To avoid life threatening hyperkalemia, do not administer Potassium Chloride in Dextrose Injection as an intravenous push (i.e., intravenous injection manually with a syringe connected to the intravenous access, without quantitative infusion device [see Dosage and Administration (2.1)].

Patients at increased risk of developing hyperkalemia and cardiac arrhythmias include those:

  • with severe renal impairment, acute dehydration, extensive tissue injury or burns, and certain cardiac disorders such as congestive heart failure or AV block (especially if they receive digoxin).
  • with hyperosmolality, acidosis, or undergoing correction of alkalsis (conditions associated with a shift of potassium from intracellular to extracellular space).
  • treated concurrently or recently with agents or products that can cause or increase the risk of hyperkalemia [see Drug Interactions (7.1)].

Avoid use of Potassium Chloride in 5% Dextrose Injection 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.

5.3 Hyperglycemia and Hyperosmolar Hyperglycemic State

The use of dextrose infusions in patients with impaired glucose tolerance (such as diabetes mellitus, renal impairment, or in the presence of sepsis, trauma, or shock) may worsen hyperglycemia. Administration of dextrose at a rate exceeding the patient’s utilization rate may lead to hyperglycemia, coma, and death.

Hyperglycemia is associated with an increase in serum osmolality, resulting in osmotic diuresis, dehydration and electrolyte losses [see Warnings and Precautions (5.6)]. Patients with underlying central nervous system disease and renal impairment who receive dextrose infusions, may be at greater risk of developing hyperosmolar hyperglycemic state.

Monitor blood glucose concentrations and treat hyperglycemia to maintain concentrations within normal limits while administering Potassium Chloride in Dextrose Injection. Insulin may be administered or adjusted to maintain optimal blood glucose concentrations.

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