FDA label a118e555-eb33-4ff2-965c-4966603425f0
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
- SPL set ID
- a7b4d5bf-472b-4f7d-b8c5-363eda02dfad
- SPL ID
- a118e555-eb33-4ff2-965c-4966603425f0
- Version
- 6
- Effective date
- 2016-12-01
- Source export date
- 2026-10-12
- Source partition
- 13
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 03:03:19
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 |
|---|---|---|---|
| spl id | a118e555-eb33-4ff2-965c-4966603425f0 | id | |
| spl set id | a7b4d5bf-472b-4f7d-b8c5-363eda02dfad | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Dextrose solutions I.V. can cause fluid or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema. Hypertonic dextrose solutions, even when given intravenously, have a tendency to cause venous thrombosis. Proper technique for intravenous injection should therefore be employed to avoid vein damage. For example: It is suggested that a needle of the smallest practicable bore be used; that the injection be made as slowly as conditions permit; that the bevel of the inserted needle be kept as far away as possible from the wall of the vein (usually the superior vena cava or other equally large vein); blood flow in the punctured vein be increased by the application of heat to that extremity; that the solution itself be warmed to body temperature, or at least to room temperature, before use; and that the tourniquet be removed as soon as the needle is in the vein and before any solution is injected. Dextrose-containing solutions should be used with caution in patients with subclinical or overt diabetes mellitus or carbohydrate intolerance. Rapid administration of hypertonic solutions may produce significant hyperglycemia or hyperosmolar syndrome, especially in patients with chronic uremia or carbohydrate intolerance.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS A number of serious reactions have been reported following the intravenous injection of dextrose, which can be attributed to the solution or error in technique. These include: febrile response; infection at the injection site; tissue necrosis; venous thrombosis or phlebitis extending from the site of injection; extravasation; hypovolemia; hypervolemia; dehydration; mental confusion or unconsciousness. It has been claimed that dextrose may produce allergic reactions in corn-sensitive persons, but this allegation has been refuted. The largest available peripheral vein and a well placed small bore needle should be used. Thrombophlebitis may result from the use of hypertonic solutions via the intravenous route of administration. Rapid infusion (e.g., 50 to 100 g over three minutes, as in an intravenous glucose tolerance test) may occasionally cause a generalized flush. This subsides within ten minutes. Significant hyperglycemia, hyperosmolar syndrome and glycosuria may occur with too rapid administration of hypertonic solutions (See WARNINGS ). They are more likely to cause irritation and should therefore be administered into larger central veins. The administration of dextrose without an adequate provision of certain B vitamins, which form the coenzyme systems in its metabolism, will exhaust tissue stores of these factors, leading to deficiency states. Similarly, the utilization of glucose will cause the intracellular movement of potassium, so that provisions for replacement of this element during periods of dextrose administration may require consideration under certain conditions. The level of blood sugar appears to be one factor in governing the rate of production of certain hormones; hyperglycemia invokes an outpouring of insulin; hypoglycemia causes release of epinephrine and through this latter mechanism, the pituitary-adrenal cortex is stimulated. From the anterior pituitary and adrenal cortex, the anti-insulin factors which tend to restore the blood sugar to normal are liberated.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.