Sorbitol (irrigation)

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# Overview
Sorbitol (irrigation) is a bladder irrigant that is FDA approved for the procedure of transurethral irrigation.   Common adverse reactions include acidosis, electrolyte loss, marked diuresis, urinary retention, edema, dryness of mouth, thirst, and dehydration.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)
- 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.
- 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 45C.
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Sorbitol (irrigation) in adult patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Sorbitol (irrigation) in adult patients.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Sorbitol (irrigation) in pediatric patients.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Sorbitol (irrigation) in pediatric patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Sorbitol (irrigation) in pediatric patients.

# Contraindications
- Anuria.

# Warnings
- 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.
- 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.

### Precautions
- The cardiovascular status, especially of the patient with cardiac disease, should be carefully observed before and during transurethral resection of the prostate when using 3% Sorbitol Urologic Irrigating Solution, because the quantity of fluid absorbed into the systemic circulation by opened prostatic veins may produce significant expansion of the intravascular fluid and lead to fulminating congestive heart failure.
- Shift of sodium free intracellular fluid into the extracellular compartment, following systemic absorption may lower serum concentration and aggravate preexisting hyponatremia.
- Excessive loss of water and electrolytes may lead to serious imbalances. With continuous administration of solution, loss of water may occur in excess of electrolytes, producing hypernatremia.
- Sustained diuresis that results from transurethral irrigation with sorbitol irrigating solutions may obscure and intensify inadequate hydration or hypovolemia.

# Adverse Reactions

## Clinical Trials Experience
- 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.

## Postmarketing 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.

# Drug Interactions
There is limited information regarding Sorbitol (irrigation) Drug Interactions in the drug label.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA): C
- 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.
Pregnancy Category (AUS): 
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Sorbitol (irrigation) in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Sorbitol (irrigation) during labor and delivery.

### Nursing Mothers
There is no FDA guidance on the use of Sorbitol (irrigation) with respect to nursing mothers.

### Pediatric Use
- Safety and effectiveness in pediatric patients have not been established

### Geriatic Use
- Clinical studies of Irrigation Solutions did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from other younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
- Do not administer unless the solution is clear and the seal is intact.

### Gender
There is no FDA guidance on the use of Sorbitol (irrigation) with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Sorbitol (irrigation) with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Sorbitol (irrigation) in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Sorbitol (irrigation) in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Sorbitol (irrigation) in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Sorbitol (irrigation) in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Irrigant

### Monitoring
There is limited information regarding Monitoring of Sorbitol (irrigation) in the drug label.

# IV Compatibility
There is limited information regarding IV Compatibility of Sorbitol (irrigation) in the drug label.

# Overdosage
There is limited information regarding Chronic Overdose of Sorbitol (irrigation) in the drug label.

# Pharmacology
There is limited information regarding Sorbitol (irrigation) Pharmacology in the drug label.

## Mechanism of Action
- 3% Sorbitol Urologic Irrigating Solution is useful as an irrigating fluid for the urinary bladder because the sorbitol solution is nonhemolytic, electrically nonconductive, and provides a high degree of visibility for urologic procedures requiring endoscopy. During transurethral surgical procedures, the solution acts as a lavage for removing blood and tissue fragments. It is also useful as an irrigating fluid to maintain the patency of an indwelling catheter in the immediate postoperative period. If absorbed either intravascularly or extravascularly during transurethral resections, the sorbitol will be either metabolized to carbon dioxide and water via the fructose pathway, or excreted by a normally functioning kidney.

## Structure
- 3% Sorbitol Urologic Irrigating Solution is a sterile, nonpyrogenic, nonhemolytic, electrically nonconductive solution in a single dose UROMATIC Plastic Container for use as a urologic irrigating solution. Each liter contains 30 g Sorbitol in Water for Injection. pH 5.0 (4.5 to 6.5). Osmolarity 165 mOsmol/L (calc.). No antimicrobial agent has been added.
- Sorbitol is a reduced form of dextrose and is designated chemically as D-Glucitol,
- The UROMATIC plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.

## Pharmacodynamics
There is limited information regarding Pharmacodynamics of Sorbitol (irrigation) in the drug label.

## Pharmacokinetics
There is limited information regarding Pharmacokinetics of Sorbitol (irrigation) in the drug label.

## Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Sorbitol (irrigation) in the drug label.

# Clinical Studies
There is limited information regarding Clinical Studies of Sorbitol (irrigation) in the drug label.

# How Supplied
- 3% Sorbitol Urologic Irrigating Solution in UROMATIC plastic containers is available as follows:
- Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25C); brief exposure up to 40C does not adversely affect the product.

## Storage
There is limited information regarding Sorbitol (irrigation) Storage in the drug label.

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
There is limited information regarding Patient Counseling Information of Sorbitol (irrigation) in the drug label.

# Precautions with Alcohol
- Alcohol-Sorbitol (irrigation) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
There is limited information regarding Sorbitol (irrigation) Brand Names in the drug label.

# Look-Alike Drug Names
There is limited information regarding Sorbitol (irrigation) Look-Alike Drug Names in the drug label.

# Drug Shortage Status

# Price