SORBITOL and MANNITOL

FDA Drug Profile — Sorbitol-Mannitol

Drug Details

Generic Name
SORBITOL and MANNITOL
Brand Names
Sorbitol-Mannitol
Application Number
NDA018316
Sponsor
ICU Medical Inc.
NDC Codes
1
Dosage Forms
IRRIGANT
Routes
URETHRAL
Active Ingredients
MANNITOL, SORBITOL

Indications and Usage

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

Warnings

WARNINGS 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).