Sorbitol and mannitol

FDA label, ICU Medical Inc., urethral, effective 2025-10-30. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Osmotic Diuretic

Dosing in kidney impairment

CONTRAINDICATIONS NOT FOR INJECTION BY USUAL PARENTERAL ROUTES. Do not use in patients with anuria. 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.

Preparation and administration

DOSAGE AND ADMINISTRATION Sorbitol-Mannitol Irrigation should be administered only by transurethral instillation with appropriate urologic instrumentation. A disposable administration set should be used. The total volume of solution used for irrigation is solely at the discretion of the surgeon. Height of container(s) above the operating table in excess of 60 cm (approx. 2 ft) has been reported to increase intravascular absorption of the irrigating fluid.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever container and solution permit. (See PRECAUTIONS .)

Contraindications

CONTRAINDICATIONS NOT FOR INJECTION BY USUAL PARENTERAL ROUTES. Do not use in patients with anuria.

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

LiverTox has no chapter for sorbitol and mannitol. Check the label's hepatic warnings.

Pregnancy and lactation

Pregnancy

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.

Lactation

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.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

Supply and cost

Drug shortage status

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Recalls (last 24 months)

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Therapeutic equivalence (Orange Book)

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