Sorbitol Irrigant

Sorbitol Irrigant

Sorbitol Irrigant Recall

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Questions & Answers

Side Effects & Adverse Reactions

FOR UROLOGIC IRRIGATION ONLY. NOT FOR INJECTION.

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.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

3.3% Sorbitol Irrigation is indicated for use as a urologic irrigation fluid.

History

There is currently no drug history available for this drug.

Other Information

Each 100 mL contains:
Sorbitol (from Sorbitol Solution USP) 3.3 g
Water for Injection USP qs

pH: 5.3 (5.0–7.0)
Calculated Osmolarity: 185 mOsmol/liter, hypotonic

The formula of the active ingredient is:

Ingredient Molecular Formula Molecular Weight
Sorbitol Chemical Structure 182.17

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 PIC Container is PVC-free and DEHP-free.

Sorbitol Irrigant Manufacturers


  • B. Braun Medical Inc.
    Sorbitol Irrigant [B. Braun Medical Inc.]
  • Baxter Healthcare Corporation
    Sorbitol Irrigant [Baxter Healthcare Corporation]

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