Potassium Chloride in Dextrose and Sodium Chloride

Potassium Chloride in Dextrose and Sodium Chloride is an FDA-registered drug product whose active ingredient is POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE. It is labelled by Baxter Healthcare Company taken by intravenous and marketed as a human prescription drug product. Identifiers on file: NDC 0338-0603, application NDA018629, label effective 20190221. 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 POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE are most often described in connection with: potassium chloride, injection indicated, source water. 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 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 )

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. • Do not administer Potassium Chloride in Dextrose and Sodium Chloride Injection simultaneously with blood products through the same administration set because of the possibility of pseudoagglutination 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 choice of the specific potassium chloride, sodium chloride, and dextrose concentrations, 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 • Do not remove container from overwrap until ready to use. • Tear overwrap down side at slit and remove solution container. • Visually inspect the container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Evaluate the following: o If the outlet port protector is damaged, detached, or not present, discard container. o 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. o Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard container. Preparation for Administration 1. Suspend container from eyelet support. 2. Remove protector from outlet port at bottom of container. 3. 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. • Consult with pharmacist, if available. If, in the informed judgment of the healthcare provider, it is deemed advisable to introduce additives, use aseptic technique. • When introducing additives, consult the instructions for use of the medication to be added and other relevant literature. • Before adding a substance or medication, verify that it is soluble and/or stable in Potassium Chloride in Dextrose and Sodium Chloride Injection and that the pH range of Potassium Chloride in Dextrose and Sodium Chloride Injection is appropriate. To Add Medication Before Solution Administration 1. Prepare medication site. 2. Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject. 3. Mix solution and medication thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix 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 19 to 22 gauge needle, puncture resealable medication port and inject. 4. Remove container from IV pole and/or turn to an upright position. 5. Evacuate both ports by squeezing them while container is 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. Storage • Use promptly; do not store solutions containing additives. • Single-dose container. • Discard any unused portion.

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 hypersensitivity to potassium chloride, dextrose, or sodium chloride ( 4 , 5.1 ) • Clinically significant hyperkalemia ( 4 , 5.2 ) • Clinically significant hyperglycemia ( 4 , 5.3 )

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) ]. • Metabolism and Nutrition Disorders : hyperkalemia [see Warnings and Precautions (5.2) ], hyperglycemia and hyperosmolar hyperglycemic state [see Warnings and Precautions (5.3) ], hyponatremia and hyponatremic encephalopathy [see Warnings and Precautions (5.4) ], fluid overload [see Warnings and Precautions (5.6) ] and refeeding syndrome [see Warnings and Precautions (5.2) ]. Hypernatremia and hyperchloremia acidosis [see Warnings and Precautions (5.5) ] have been observed in solutions containing 0.9% sodium chloride. • Cardiac Disorder : cardiac arrest as a manifestation of rapid intravenous administration and/or of hyperkalemia [see Warnings and Precautions (5.2) ]. • Infusion Site Reactions : injection site vesicles, extravasation, venous thrombosis or phlebitis, infusion site pain. Adverse reactions include electrolyte imbalances, hyperglycemia, and hypervolemia and injection site reactions. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

What is Potassium Chloride in Dextrose 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 )

Who makes Potassium Chloride in Dextrose and Sodium Chloride?
Baxter Healthcare Company is the labeler of record for Potassium Chloride in Dextrose and Sodium Chloride.

What form does Potassium Chloride in Dextrose and Sodium Chloride 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 and Sodium Chloride 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 and Sodium Chloride been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

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.