pharmacopeia

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Acid-Base Activity; Electrolyte Activity.

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
  • Dec 9, 1970NDANDA016677Baxter Hlthcare
  • Dec 9, 1970NDANDA016678Baxter Hlthcare
  • Mar 22, 1971NDANDA016697Baxter Hlthcare
  • Feb 24, 1972NDANDA016366Otsuka Icu Medcl
  • Dec 31, 1974NDANDA017427Baxter Hlthcare
  • Aug 13, 1975NDANDA017586Otsuka Icu Medcl
  • Aug 13, 1975NDANDA017606Otsuka Icu Medcl
  • Aug 13, 1975NDANDA017607Otsuka Icu Medcl

FDA shortages

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Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Sodium Chloride 0.9%, Injection, 100 mL ADD-Vantage® Flexible Container (NDC 0409-7101-67)To be discontinued
    Sponsor: Hospira, Inc., a Pfizer Company
    Updated
  • Sodium Chloride 0.9%, Injection, 250 mL ADD-Vantage® Flexible Container (NDC 0409-7101-02)To be discontinued
    Sponsor: Hospira, Inc., a Pfizer Company
    Updated
  • Sodium Chloride 0.9%, Injection, 50 mL ADD-Vantage® Flexible Container (NDC 0409-7101-66)To be discontinued
    Sponsor: Hospira, Inc., a Pfizer Company
    Updated

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.
264,805 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 Ineffective17,5066.6%
  2. 2Off Label Use17,1036.5%
  3. 3Fatigue14,0035.3%
  4. 4Nausea13,6045.1%
  5. 5Death13,2625.0%
  6. 6Dyspnoea12,6734.8%
  7. 7Diarrhoea11,4684.3%
  8. 8Headache11,1754.2%
  9. 9Vomiting10,9804.1%
  10. 10Pyrexia10,8344.1%
  11. 11Pain10,2933.9%
  12. 12Seizure9,9863.8%
  13. 13Pneumonia9,5563.6%
  14. 14Rash8,0983.1%
  15. 15Dizziness8,0813.1%

Literature

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Recent PubMed references pinned to Sodium Chloride 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 20,920 ClinicalTrials.gov registrations naming Sodium Chloride as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Sodium Chloride work?
Mechanism-of-action classes: Acid-Base Activity; Electrolyte Activity.
What is Sodium Chloride used for?
According to FDA labeling, Sodium Chloride 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 class of drug is Sodium Chloride?
Sodium Chloride is classified as Electrolyte solutions, Salt solutions, Sodium, Acid-Base Activity, Electrolyte Activity, Alveolar Surface Tension Reduction, Decreased Respiratory Secretion Viscosity, Increased Intravascular Volume.
What are the brand names for Sodium Chloride?
Sodium Chloride is marketed under brand names including Altamist, Aminosyn 3.5 % M, Sulfite Free, Aminosyn 8.5 % with Electrolytes, Sulfite-Free, Aminosyn II 8.5 % with Electrolytes, Sulfite-Free, Ayr Saline Nasal, BSS Ophthalmic Solution, Broncho Saline, Cleanoz Saline.
What are the contraindications for Sodium Chloride?
Sodium Chloride 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-chloride 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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