Sorbitol-mannitol
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Questions & Answers
Side Effects & Adverse Reactions
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).
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
Sorbitol-Mannitol Irrigation is indicated for use as a urologic irrigating fluid during transurethral prostatic resection and other transurethral surgical procedures.
History
There is currently no drug history available for this drug.
Other Information
Sorbitol-Mannitol Irrigation is a sterile, nonpyrogenic, hypotonic, aqueous solution for urologic nonelectrolyte irrigation during transurethral surgical procedures. Each 100 mL contains sorbitol 2.70 g and mannitol 0.54 g in water for injection. The solution is nonelectrolytic and hypotonic (178 mOsmol/liter calc.); pH 5.2 (4.0 to 7.0).
The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose irrigation. When smaller volumes are required the unused portion should be discarded.
Sorbitol-Mannitol Irrigation is a nonelectrolyte urologic irrigant.
Sorbitol, NF is chemically designated D-glucitol (C6H14O6), white powder, granules or flakes very soluble in water. It has the following structural formula:
Mannitol, USP is chemically designated D-mannitol (C6H14O6), white crystalline powder or free-flowing granules, freely soluble in water. It has the following structural formula:
Water for Injection, USP is chemically designated H20.
The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly.
The semi-rigid container is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The container requires no vapor barrier to maintain the proper drug concentration.
Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials.
Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.
Sources
Sorbitol-mannitol Manufacturers
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Hospira, Inc.
![Sorbitol-mannitol (Sorbitol And Mannitol) Irrigant [Hospira, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Sorbitol-mannitol | Hospira, Inc.
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.)
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