FDA
Sorbitol 3% in Plastic Container
The FDA lists this product in 2 strengths and forms.
Indications
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
Anuria.
Warnings and precautions
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.
Pregnancy and breastfeeding
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.



