Sorbitol-Mannitol

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Sorbitol-Mannitol
Generic name
SORBITOL AND MANNITOL
Manufacturer
ICU Medical Inc.
Product type
HUMAN PRESCRIPTION DRUG
SPL set ID
5b44e248-4b7b-4777-954a-921c7b309944
SPL ID
fba5680c-d4e6-461a-95e3-25edd33ba39c
Version
8
Effective date
2025-10-30
Source export date
2026-09-28
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:28:16
Harmonized routes table
Harmonized routes
URETHRAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

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).

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS Adverse reactions may result from intravascular absorption of sorbitol and mannitol. The literature reports occasional adverse reactions from intravenous sorbitol-mannitol infusions. Consequences of absorption of urologic irrigating solutions include fluid and electrolyte disturbances such as acidosis, electrolyte loss, marked diuresis, urinary retention, edema, dryness of mouth, thirst and dehydration; cardiovascular disorders such as hypotension, tachycardia, angina-like pains; pulmonary disorders such as pulmonary congestion; and other general reactions such as blurred vision, convulsions, nausea, vomiting, diarrhea, rhinitis, chills, vertigo, backache and urticaria. Allergic reactions from sorbitol-mannitol have also been reported. Should any adverse reaction occur, discontinue the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.