Solutions for urologic irrigation must be used with caution in patients with severe cardiopulmonary or renal dysfunction.
Since irrigating fluids used during transurethral prostatectomy have been demonstrated to enter the systemic circulation in relatively large volumes, any irrigation solution must be regarded as a systemic drug.
Absorption of large amounts of fluids containing sorbitol and the resultant osmotic diuresis may significantly affect cardiopulmonary and renal dynamics.
Hyperglycemia from metabolism of sorbitol may occur in patients with diabetes mellitus.
Hyperlactatemia from metabolism of sorbitol may potentially produce a significant lactic acidemia in metabolically compromised patients.
3.3% Sorbitol Irrigation must be used with caution in patients unable to metabolize sorbitol rapidly enough to avoid the development of hyperosmolar states.
Do not warm above 150°F (66°C).
After opening container, its contents should be used promptly to minimize the possibility of bacterial growth or pyrogen formation. Discard unused portion of irrigating solution since it contains no preservatives.
Sorbitol is chemically designated D-glucitol (C6H14O6).
Sorbitol, an isomer of mannitol, is a hexitol naturally occurring in many fruits, and is produced commercially by the reduction of glucose.
3.3% Sorbitol Irrigation is a prediluted, sterile, nonpyrogenic aqueous solution suitable for urologic irrigation. The solution is slightly hypotonic.
The solution contains no antimicrobial or bacteriostatic agents or added buffers.
The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert.
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.