Potassium Chloride in Dextrose
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- Potassium Chloride in Dextrose
- Generic name
- DEXTROSE MONOHYDRATE AND POTASSIUM CHLORIDE INJECTION, SOLUTION
- Manufacturer
- ICU Medical Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 02d694b5-3600-4d55-bd5c-924abaec5315
- SPL ID
- f342a90d-8637-42b9-add5-e6875e700d3b
- Version
- 10
- Effective date
- 2025-10-30
- Source export date
- 2026-09-28
- Source partition
- 10
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:07:03
| Harmonized routes |
|---|
| INTRAVENOUS |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | NDA | 018371 | derived:openfda.application_number |
| application number | NDA018371 | openfda.application_number | |
| brand name | Potassium Chloride in Dextrose | openfda.brand_name | |
| generic name | DEXTROSE MONOHYDRATE AND POTASSIUM CHLORIDE INJECTION, SOLUTION | openfda.generic_name | |
| manufacturer name | ICU Medical Inc. | openfda.manufacturer_name | |
| ndc | package | 0990-7905-09 | openfda.package_ndc |
| ndc | product | 0990-7905 | openfda.product_ndc |
| ndc11 | package | 00990790509 | derived:openfda.package_ndc |
| rxcui | 309783 | openfda.rxcui | |
| spl id | f342a90d-8637-42b9-add5-e6875e700d3b | id | |
| spl set id | 02d694b5-3600-4d55-bd5c-924abaec5315 | set_id | |
| unii | 660YQ98I10 | openfda.unii | |
| unii | LX22YL083G | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Solutions which contain potassium ions 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. To avoid potassium intoxication, do not infuse these solutions rapidly. In patients with severe renal insufficiency or adrenal insufficiency, administration of potassium chloride may cause potassium intoxication. In patients with diminished renal function, administration of solutions containing potassium ions may result in potassium retention. The intravenous administration of this solution 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 concentration of administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Reactions which may occur because of the solutions or technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary. Nausea, vomiting, abdominal pain and diarrhea have been reported with potassium therapy. The signs and symptoms of potassium intoxication include paresthesias of the extremities, flaccid paralysis, listlessness, mental confusion, weakness and heaviness of the legs, hypotension, cardiac arrhythmias, heart block, electrocardiographic abnormalities such as disappearance of P waves, spreading and slurring of the QRS complex with development of a biphasic curve and cardiac arrest. Potassium-containing solutions are intrinsically irritating to tissues. Therefore, extreme care should be taken to avoid perivascular infiltration. Local tissue necrosis and subsequent sloughing may result if extravasation occurs. Chemical phlebitis and venospasm have also been reported. Should perivascular infiltration occur, I.V. administration at that site should be discontinued at once. Local infiltration of the affected area with procaine hydrochloride, 1%, to which hyaluronidase may be added, will often reduce venospasm and dilute the potassium remaining in the tissues locally. Local application of heat may also be helpful.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.