FDA records indicate that there are no current recalls for this drug.
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Mannitol 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 mannitol and the resultant osmotic diuresis may significantly affect cardiopulmonary and renal dynamics.
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 preservative.
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
5% Mannitol is indicated for use as a urologic irrigation fluid for transurethral prostatic resection and other transurethral surgical procedures.
History
There is currently no drug history available for this drug.
Other Information
Each 100 mL contains:
Mannitol USP 5 g
Water for Injection USP qs
pH: 5.5 (4.5–7.0)
Calculated Osmolarity: 275 mOsmol/liter
The formula of the active ingredient is:
Ingredient | Molecular Formula | Molecular Weight |
---|---|---|
Mannitol USP | ![]() |
182.17 |
5% Mannitol Irrigation is a prediluted, sterile, nonpyrogenic aqueous solution suitable for urologic irrigation. The solution is approximately isotonic.
Mannitol USP is chemically designated D-mannitol (C6H14O6). Mannitol is a hexitol naturally occurring in fruits and vegetables and is produced commercially by the reduction of glucose.
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.
Sources
Mannitol Irrigant Manufacturers
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B. Braun Medical Inc.
Mannitol Irrigant | B. Braun Medical Inc.
As required for urologic irrigation.
5% Mannitol Irrigation should be administered only by the appropriate transurethraI urologic instrumentation.
Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.
Solutions should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permits.
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