Sorbitol

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.

Anuria.

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.

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. 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. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric 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.

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.

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.

Safety and effectiveness in pediatric patients have not been established.

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.