pharmacopeia

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Physiochemical Activity.

Indications

Sourced from openFDA
  • 3% Sorbitol Urologic Irrigating Solution is indicated for use as a urologic irrigating fluid with endoscopic instruments during transurethral procedures requiring distension, irrigation, and lavage of the urinary bladder. It may be used for lavage of an indwelling catheter to maintain patency.

Contraindications

Sourced from openFDA
  • Anuria.contraindicated

Dosage & administration

Sourced from openFDA

The volume of solution needed will vary with the nature and duration of the urologic procedure. If desired, warm in overwrap to near body temperature in a water bath or oven heated to not more than 45°C. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Warnings & precautions

Sourced from openFDA

Not for injection. Not for use in patients with documented or suspected fructose intolerance. Solutions for urologic irrigation must be used with caution in patients with severe cardiopulmonary or renal dysfunction. Irrigating fluids used during transurethral prostatectomy have been demonstrated to enter the systemic circulation in relatively large volumes; thus sorbitol irrigating solution must be regarded as a systemic drug. Absorption of large amounts of fluids containing sorbitol may significantly alter cardiopulmonary and renal dynamics. Appropriate patient monitoring should be maintained due to the possibility of fluid overload. Should fluid overload occur, intensive fluid and electrolyte management is necessary. Monitoring of fluid and electrolyte levels beyond the acute phase may be considered due to the possibility of delayed fluid absorption. (See ADVERSE REACTIONS, Post-Marketing Experience) Hyperglycemia from metabolism of absorbed sorbitol may occur in patients with diabetes mellitus. The contents of an opened container should be used promptly to minimize the possibility of bacterial growth or pyrogen formation. Discard the unused portion of irrigating solution since no antimicrobial agent has been added.

Adverse reactions

Sourced from openFDA

Life threatening adverse reactions with intravenous sorbitol infusions have been reported in patients with fructose intolerance. The literature reports occasional adverse reactions for intravenous sorbitol infusions. These include disturbances such as acidosis, electrolyte loss, marked diuresis, urinary retention, edema, dryness of mouth and thirst, and dehydration; cardiovascular/pulmonary disorders such as pulmonary congestion, hypotension, tachycardia, angina-like pains, and other general reactions such as blurred vision, convulsions, nausea, vomiting, diarrhea, rhinitis, chills, vertigo, and backache. Allergic reactions reported to occur from sorbitol include urticaria. Should adverse reactions occur, discontinue the irrigant and reevaluate the clinical status of the patient. Post-Marketing Experience Following off-label use of 3% Sorbitol Urologic Irrigating Solution for hysteroscopic procedures in women, life-threatening adverse events related to fluid overload have been reported.

Use in specific populations

Sourced from openFDA

Pregnancy Teratogenic Effects Animal reproduction studies have not been conducted with 3% Sorbitol Urologic Irrigating Solution. It is not known whether 3% Sorbitol Urologic Irrigating Solution can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. 3% Sorbitol Urologic Irrigating Solution should be given to a pregnant woman only if clearly needed.

Approval history

Sourced from openFDA
  • Feb 22, 1980NDANDA018316Otsuka Icu Medcl
  • May 30, 1980NDANDA017863Baxter Hlthcare

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.
590 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. 1Vomiting437.3%
  2. 2Nausea416.9%
  3. 3Diarrhoea406.8%
  4. 4Acute Kidney Injury366.1%
  5. 5Fatigue355.9%
  6. 6Pain355.9%
  7. 7Constipation335.6%
  8. 8Chronic Kidney Disease325.4%
  9. 9Fall325.4%
  10. 10Asthenia315.3%
  11. 11Renal Failure294.9%
  12. 12Hypotension284.7%
  13. 13Pneumonia274.6%
  14. 14Dizziness264.4%
  15. 15Dyspnoea264.4%

Literature

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Recent PubMed references pinned to Sorbitol 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 202 ClinicalTrials.gov registrations naming Sorbitol as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Sorbitol work?
Mechanism-of-action class: Physiochemical Activity.
What is Sorbitol used for?
According to FDA labeling, Sorbitol carries indications including: 3% Sorbitol Urologic Irrigating Solution is indicated for use as a urologic irrigating fluid with endoscopic instruments during transurethral procedures requiring distension, irrigation, and lavage of the urinary bladder. It may be used for lavage of an indwelling catheter to maintain patency.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Sorbitol?
Sorbitol is classified as Enemas, Osmotically acting laxatives, Other irrigating solutions, Tests for bile duct patency, Physiochemical Activity, Stimulation Small Intestine Fluid/Electrolyte Absorption.
What are the contraindications for Sorbitol?
Sorbitol labeling lists contraindications including: Anuria.. Always consult the full prescribing information and a clinician.
Note. Data for sorbitol 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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