Sorbitol

INDICATIONS AND USAGE 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.

DOSAGE AND ADMINISTRATION 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 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.

CONTRAINDICATIONS Anuria.

ADVERSE REACTIONS 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.

CLINICAL PHARMACOLOGY 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.