pharmacopeia

Sodium

US-FDASourced from openFDA
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Indications

Sourced from openFDA
  • This sterile, nonpyrogenic electrolyte solution is indicated for all general irrigation, washing, rinsing and dilution purposes including blood cell washing (when used in conjunction with automated intraoperative blood salvaging equipment).

Contraindications

Sourced from openFDA
  • NOT FOR INJECTION BY USUAL PARENTERAL ROUTES. An electrolyte solution should not be used for irrigation during electrosurgical procedures.contraindicated

Dosage & administration

Sourced from openFDA

The dose is dependent upon the capacity or surface area of the structure to be irrigated and the nature of the procedure. When used as a diluent or vehicle for other drugs, the manufacturer's recommendations should be followed. For use in cell washing, the manufacturer's recommendations for blood salvaging and red cell processing should be followed. Drug Interactions Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution container permits. See PRECAUTIONS .

Warnings & precautions

Sourced from openFDA

FOR IRRIGATION ONLY. NOT FOR INJECTION. Entry of a hypotonic solution into the circulation may cause hemolysis. Irrigating fluids have been demonstrated to enter the systemic circulation in relatively large volumes; thus, each of these irrigations must be regarded as a systemic drug. Absorption of large amounts 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 concentrations 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. Do not heat over 66° C (150° F).

Adverse reactions

Sourced from openFDA

Possible adverse effects arising from the irrigation of body cavities, tissues, cells or indwelling catheters and tubes are usually avoidable when proper procedures are followed. Displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. Excessive volume or pressure during irrigation of closed cavities may cause undue distension or disruption of tissues. Accidental contamination from careless technique may transmit infection. Should any adverse reaction occur, discontinue the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

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
  • May 8, 1956NDANDA010379King Pharms
  • Mar 22, 1972NDANDA017037Hikma
  • Aug 13, 1975NDANDA017586Otsuka Icu Medcl
  • Apr 12, 1977NDANDA017799Otsuka Icu Medcl
  • Sep 27, 1978NDANDA017512Vantive Us Hlthcare
  • Feb 2, 1979NDANDA018016Baxter Hlthcare
  • May 10, 1983NDANDA018892Hospira
  • Jul 13, 1984NDANDA019011Azurity

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.
2,099,558 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. 1Drug Ineffective209,32010.0%
  2. 2Off Label Use114,7085.5%
  3. 3Fatigue113,5545.4%
  4. 4Nausea112,1365.3%
  5. 5Pain101,0114.8%
  6. 6Headache87,3254.2%
  7. 7Dyspnoea85,8524.1%
  8. 8Diarrhoea85,3274.1%
  9. 9Arthralgia81,9373.9%
  10. 10Vomiting71,1333.4%
  11. 11Dizziness66,2393.2%
  12. 12Rash60,7332.9%
  13. 13Pyrexia59,9582.9%
  14. 14Malaise59,1532.8%
  15. 15Pneumonia58,9232.8%

Literature

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Recent PubMed references pinned to Sodium 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 12,637 ClinicalTrials.gov registrations naming Sodium as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

What is Sodium used for?
According to FDA labeling, Sodium carries indications including: This sterile, nonpyrogenic electrolyte solution is indicated for all general irrigation, washing, rinsing and dilution purposes including blood cell washing (when used in conjunction with automated intraoperative blood salvaging equipment).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What are the contraindications for Sodium?
Sodium labeling lists contraindications including: NOT FOR INJECTION BY USUAL PARENTERAL ROUTES. An electrolyte solution should not be used for irrigation during electrosurgical procedures.. Always consult the full prescribing information and a clinician.
Note. Data for sodium 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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