POTASSIUM CHLORIDE IN DEXTROSE

POTASSIUM CHLORIDE IN DEXTROSE is an FDA-registered drug product whose active ingredient is DEXTROSE AND POTASSIUM CHLORIDE. It is labelled by B. Braun Medical Inc. taken by intravenous and marketed as a human prescription drug product. Identifiers on file: NDC 0264-7625, application NDA019699, label effective 20200731. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing DEXTROSE AND POTASSIUM CHLORIDE are most often described in connection with: potassium chloride, dextrose injection, indicated source, electrolytes calories. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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

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 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 Remove plastic protector from sterile set port at bottom of container. 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 Prepare medication site. Using syringe with 18-22 gauge needle, puncture medication port and inner diaphragm and inject. Squeeze and tap ports while ports are upright and mix solution and medication thoroughly. 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 Close clamp on the set. Prepare medication site. Using syringe with 18-22 gauge needle of appropriate length (at least 5/8 inch), puncture resealable medication port and inner diaphragm and inject. Remove container from IV pole and/or turn the container so the ports are in an upright position. Evacuate both ports by tapping and squeezing them while container ports are in the upright position. Mix solution and medication thoroughly. 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. 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

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)] known hypersensitivity to potassium chloride and/or dextrose ( 5.1) clinically significant hyperkalemia (5.2) clinically significant hyperglycemia (5.3)

6 ADVERSE REACTIONS The following adverse reactions associated with the use of Potassium Chloride in Dextrose Injection were identified in post marketing 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: including anaphylaxis and chills [see Warnings and Precautions (5.1)] Hyperkalemia, including cardiac arrest, as a manifestation [see Warnings and Precautions (5.2)] Hyponatremia and hyponatremic encephalopathy [see Warnings and Precautions (5.4)] Hypokalemia [see Warnings and Precautions (5.5)] Hypervolemia [see Warnings and Precautions (5.6)] Injection site reactions: infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation, infusion site rash, infusion site pain, infusion site vesicles, infusion site pruritus, pyrexia and chills Adverse reactions include electrolyte imbalances, hyperglycemia, and hypervolemia and injection site reactions. To report SUSPECTED ADVERSE REACTIONS, contact B. Braun Medical Inc. at 1-866-854-6851 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

4 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is POTASSIUM CHLORIDE IN DEXTROSE used for?
1 INDICATIONS AND USAGE Potassium Chloride in Dextrose Injection is indicated as a source of electrolytes, calories, and water for hydration. Potassium Chloride in Dextrose Injection is indicated as a source of electrolytes, calories, and water for hydration.

Who makes POTASSIUM CHLORIDE IN DEXTROSE?
B. Braun Medical Inc. is the labeler of record for POTASSIUM CHLORIDE IN DEXTROSE.

What form does POTASSIUM CHLORIDE IN DEXTROSE come in?
administered by intravenous. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is POTASSIUM CHLORIDE IN DEXTROSE prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has POTASSIUM CHLORIDE IN DEXTROSE been recalled?
4 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.