pharmacopeia

Sodium Gluconate

US-FDASourced from openFDA
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Indications

Sourced from openFDA
  • Normosol-R pH 7.4 is indicated for replacement of acute extracellular fluid volume losses in surgery, trauma, burns or shock. Normosol-R pH 7.4 also can be used as an adjunct to restore a decrease in circulatory volume in patients with moderate blood loss.

Contraindications

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  • None known.contraindicated

Dosage & administration

Sourced from openFDA

Normosol-R pH 7.4 is administered by intravenous infusion. It may also be administered subcutaneously. The amount to be infused is based on replacement of losses of extracellular fluid volume in the individual patient. Up to three times the volume of estimated blood loss during and after surgery can be given to correct circulatory volume when there is only a moderate loss of blood. Parenteral drug products should be inspected visually for particulate matter or discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS. INSTRUCTIONS FOR USE To Open Tear outer wrap at notch and remove solution 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. If supplemental medication is desired, follow directions below before preparing for administration. To Add Medication Prepare additive port. Using aseptic technique and an additive delivery needle of appropriate length, puncture resealable additive port at target area, inner diaphragm and inject. Withdraw needle after injecting medication. The additive port may be protected by covering with an additive cap. Mix container contents thoroughly. To Administer Attach administration set per manufacturer’s instructions. Regulate rate of administration per institutional policy. WARNING: DO NOT USE FLEXIBLE CONTAINER IN SERIES CONNECTIONS.

Warnings & precautions

Sourced from openFDA

Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention. Solutions which contain potassium 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. In patients with diminished renal function, administration of solutions containing sodium or potassium ions may result in sodium or potassium retention. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function during fluid replacement with Normosol-R. Solutions containing acetate or gluconate ions should be used with great care in patients with metabolic or respiratory alkalosis. Acetate or gluconate should be administered with great care in those conditions in which there is an increased level or an impaired utilization of these ions, such as severe hepatic insufficiency. 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. Elderly patients may be at increased risk for the development of fluid overloading and dilutional hyponatremia following Normosol-R administration. The risk of dilutional states is inversely proportional to the electrolyte concentrations of administered parenteral solutions.

Adverse reactions

Sourced from openFDA

Reactions which may occur because of the solution or the 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.

Use in specific populations

Sourced from openFDA

Pregnancy Category C. Animal reproduction studies have not been conducted with Normosol-R pH 7.4. It is also not known whether this solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This solution should be given to a pregnant woman only if clearly needed.

Overdosage

Sourced from openFDA

In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS.

Approval history

Sourced from openFDA
  • Aug 13, 1975NDANDA017586Otsuka Icu Medcl
  • Aug 13, 1975NDANDA017609Otsuka Icu Medcl
  • Feb 2, 1979NDANDA017378Baxter Hlthcare
  • Jun 8, 1984NDANDA019024B Braun
  • Sep 29, 1989NDANDA019711B Braun
  • Sep 29, 1989NDANDA019696B Braun
  • Jun 8, 2022ANDAANDA215371Fresenius Kabi Usa
  • Jun 29, 2022ANDAANDA215370Fresenius Kabi Usa

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
114 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Atrial Fibrillation1412%
  2. 2Bradycardia108.8%
  3. 3Acute Kidney Injury97.9%
  4. 4Respiratory Failure87.0%
  5. 5Emotional Distress76.1%
  6. 6Pain76.1%
  7. 7Pyrexia76.1%
  8. 8Renal Failure76.1%
  9. 9Sepsis76.1%
  10. 10Anxiety65.3%
  11. 11Injury65.3%
  12. 12Constipation54.4%
  13. 13Death54.4%
  14. 14Metabolic Acidosis54.4%
  15. 15Tachypnoea54.4%

Literature

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Recent PubMed references pinned to Sodium Gluconate as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 615 ClinicalTrials.gov registrations naming Sodium Gluconate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

What is Sodium Gluconate used for?
According to FDA labeling, Sodium Gluconate carries indications including: Normosol-R pH 7.4 is indicated for replacement of acute extracellular fluid volume losses in surgery, trauma, burns or shock. Normosol-R pH 7.4 also can be used as an adjunct to restore a decrease in circulatory volume in patients with moderate blood loss.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What are the brand names for Sodium Gluconate?
Sodium Gluconate is marketed under brand names including Isolyte S, Isolyte S in 5 % Dextrose, Normosol-R, Normosol-R in 5 % Dextrose, Nutrilyte, Physiolyte, Physiosol, Plasma-lyte 148.
What are the contraindications for Sodium Gluconate?
Sodium Gluconate labeling lists contraindications including: None known.. Always consult the full prescribing information and a clinician.
Note. Data for sodium-gluconate is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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