Sorbitol-Mannitol

Sorbitol-Mannitol Irrigation is indicated for use as a urologic irrigating fluid during transurethral prostatic resection and other transurethral surgical procedures.

FOR UROLOGIC IRRIGATION ONLY.

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-Mannitol irrigant must be regarded as a systemic drug. Absorption of large amounts of fluids containing Sorbitol-Mannitol and the osmotic diuresis it produces may significantly alter 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.

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 irrigation solution since it contains no preservatives. Do not heat over 66°C (150°F).

Cardiovascular status, especially of the patient with cardiac disease, should be carefully observed before and during transurethral resection of the prostate when using Sorbitol-Mannitol Irrigation, because the quantity of fluid absorbed into the systemic circulation by opened prostatic veins may produce significant expansion of the extracellular fluid and lead to fulminating congestive heart failure.

Shift of sodium-free intracellular fluid into the extracellular compartment following systemic absorption of solution may lower serum sodium concentration and aggravate pre-existing hyponatremia.

Excessive loss of water and electrolytes may lead to serious imbalances. With continuous irrigation, loss of water may occur in excess of electrolytes, producing hypernatremia.

Sustained diuresis that results from transurethral irrigation with Sorbitol-Mannitol Irrigation may obscure and intensify inadequate hydration or hypovolemia.

Aseptic technique is essential for the use of sterile solutions for irrigation. The administration set should be attached promptly. Unused portions should be discarded and a fresh container of appropriate size used for the start-up of each cycle or repeat procedure.

Do not administer unless solution is clear, seal is intact and container is undamaged. Discard unused portion.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies with Sorbitol-Mannitol Irrigation have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

Nursing Mothers: Caution should be exercised when Sorbitol-Mannitol Irrigation is administered to a nursing woman.

Pregnancy: Teratogenic Effects.

Pregnancy Category C. Animal reproduction studies have not been conducted with Sorbitol-Mannitol Irrigation. It is also not known whether Sorbitol-Mannitol Irrigation can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sorbitol-Mannitol Irrigation should be given to a pregnant woman only if clearly needed.

Pediatric Use: The safety and effectiveness of Sorbitol-Mannitol Irrigation have not been established. Its limited use in pediatric patients has been inadequate to fully define proper dosage and limitations for use.

In the event of dehydration, fluid or solute overload, discontinue the irrigation, evaluate the patient and institute corrective measures as indicated. (See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS.)

2
HDPE

TO OPEN TEAR AT NOTCH

DO NOT REMOVE FROM OVERWRAP UNTIL READY FOR USE. AFTER REMOVING
THE OVERWRAP, CHECK FOR MINUTE LEAKS BY SQUEEZING CONTAINER FIRMLY.
IF LEAKS ARE FOUND, DISCARD SOLUTION AS STERILITY MAY BE IMPAIRED.
RECOMMENDED STORAGE: ROOM TEMPERATURE (25°C). AVOID EXCESSIVE
HEAT. PROTECT FROM FREEZING. SEE INSERT.
98-4321-R14-3/98