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Mannitol (B. Braun Medical Inc.)

Available Formats

Dosage Form Package Information Links
IRRIGANT 4 CONTAINER in 1 CASE (0264-2303-70) > 4000 mL in 1 CONTAINER Label Information
IRRIGANT 8 CONTAINER in 1 CASE (0264-2303-50) > 2000 mL in 1 CONTAINER Label Information

Complete Mannitol Information


    Package Insert

    PICâ„¢ (Plastic Irrigation Containers)

    Nonelectrolyte Irrigating Fluid for Transurethral
    Surgical Procedures.

    For Urologic Irrigation Only.

    Not for Injection.


    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  Chemical Structure  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 PICâ„¢ Container is PVC-free and DEHP-free.


    In humans, mannitol is confined to the extracellular space and is only slightly metabolized. It is rapidly excreted in the urine. When mannitol is absorbed intravascularly, it produces osmotic diuresis and will be excreted by the kidneys.

    Mannitol is nonelectrolytic and is, therefore, nonconductive, making it suitable for urologic irrigation during electrosurgical procedures.

    5% Mannitol is a nonhemolytic irrigating solution.


    5% Mannitol is indicated for use as a urologic irrigation fluid for transurethral prostatic resection and other transurethral surgical procedures.


    5% Mannitol is not for injection. It is contraindicated in patients with anuria.



    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.



    Use aseptic technique when preparing and administering sterile irrigation solutions.

    Use only if solution is clear and container and seal are intact.

    Cardiovascular status, especially in patients with cardiac disease, should be carefully determined before and during transurethral resection of the prostate when using 5% Mannitol as an irrigant. The fluid absorbed into the systemic circulation via severed prostatic veins may produce significant extracellular fluid expansion and lead to fulminating congestive heart failure.

    Shift of sodium-free intracellular fluid into the extracellular compartment following systemic absorption of 5% Mannitol may lower serum sodium concentration and aggravate pre-existing hyponatremia.

    Excessive loss of water and electrolytes may lead to serious imbalances. Continuous administration of 5% Mannitol may cause loss of water in excess of electrolytes and produce hypernatremia.

    Sustained diuresis from transurethral irrigation with 5% Mannitol may obscure and intensify inadequate hydration or hypovolemia.

    When used for irrigation via appropriate irrigation equipment, the administration set should be attached promptly. Unused portions should be discarded and a fresh container of appropriate size used for the start up of each cycle or repeat procedure. For repeated irrigations of urethral catheters, a separate container should be used for each patient.

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    Studies with 5% Mannitol Irrigation have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.


    Teratogenic Effects

    Pregnancy Category C

    Animal reproduction studies have not been conducted with 5% Mannitol Irrigation. It is also not known whether 5% Mannitol Irrigation can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 5% Mannitol Irrigation should be given to a pregnant woman only if clearly needed.

    Nursing Mothers

    Caution should be exercised when 5% Mannitol Irrigation is administered to a nursing woman.

    Pediatric Use

    Safety and effectiveness in pediatric patients have not been established.

    Geriatric Use

    Clinical studies of 5% Mannitol Irrigation did not include a sufficient number of patients age 65 years and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

    This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. See WARNINGS.


    Occasional adverse reactions to intravenous mannitol infusions have been reported. These include fluid and electrolyte disturbances, such as acidosis, electrolyte loss, marked diuresis, urinary retention, edema, dryness of the mouth, thirst and dehydration, cardiovascular/pulmonary disorders such as pulmonary congestion, hypotension, tachycardia, angina-like pain, and thrombophlebitis, and other general reactions such as blurred vision, convulsions, nausea, vomiting, rhinitis, chills, vertigo, backache, and urticaria.

    If an adverse reaction does occur, discontinue administration of the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination, if deemed necessary.


    In the event of dehydration or fluid or solute overload, discontinue the irrigant, evaluate the patient and institute appropriate corrective treatment. See WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS.


    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.


    5% Mannitol Irrigation is supplied sterile and nonpyrogenic in PICâ„¢ (Plastic Irrigation Containers). The 2000 mL containers are packaged 8 per case and the 4000 mL containers are packaged 4 per case.

    NDC Cat. No. Size
     5% Mannitol Irrigation
    (Canada DIN 01963953)
     0264-2303-50  R6515-01  2000 mL
     0264-2303-70  R6517  4000 mL

    Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.

    Do not warm above 150°F (66°C).


    Rx only

    Revised: March 2009

    PIC is a trademark of B. Braun Medical Inc.

  • Directions for Use of PICâ„¢ (Plastic Irrigation Containers)

    Not for injection.

    Aseptic technique is required.

    1. Caution – Before use, perform the following checks:
                 (a) Read the label. Ensure solution is the one ordered and is within the expiration date.

                 (b) Invert container and inspect the solution in good light for cloudiness, haze, or particulate 
                      matter; check the container for leakage or damage. Any container which is suspect
                      should not be used.

    Use only if solution is clear and container and seal are intact.

    Single dose container.

    2. Outer Closure Removal – Grasp the container with one hand and turn the breakaway ring 
        counterclockwise with the other hand until slight resistance is felt. Then, twisting the 
        container in the opposite direction, turn the breakaway ring sharply until the entire outer
        cap is loose and can be lifted off.
    Figure 1

    3. Connect the administration set through the sterile port according to set instructions or 
        remove screw cap and pour.
    Figure 2

    4. Do not warm above 150°F to assure minimal bottle distortion. Keep bottles upright.


    B. Braun Medical Inc.
    Irvine, CA 92614-5895 USA
    Made in USA

    In Canada, distributed by:
    B. Braun Medical Inc.
    Scarborough, Ontario M1H 2W4



    5% Mannitol Irrigation

    For Urologic Irrigation

    REF R6515-01
    NDC 0264-2303-50
    DIN 01963953

    2000 mL


    Each 100 mL contains:
    Mannitol USP 5 g
    Water for Injection USP qs

    pH: 5.5 (4.5-7.0)
    Calc. Osmolarity: 275 mOsmol/liter

    Not for Injection: Use only if
    solution is clear and container
    and seal are intact.

    Sterile, nonpyrogenic.
    Single dose container.

    Warning: Do not warm above
    150°F (66°C).

    Recommended Storage:
    Room temperature (25°C).
    Avoid excessive heat.
    Protect from freezing.
    See Package Insert.

    Rx only

    PVC-free and DEHP-free

    B. Braun Medical Inc.
    Irvine, CA 92614-5895 USA
    Made in USA

    In Canada, distributed by:
    B. Braun Medical Inc.
    Scarborough, Ontario M1H 2W4


    Principal Display Panel - 2000 mL Label

    mannitol irrigant
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0264-2303
    Route of Administration IRRIGATION
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0264-2303-50 8 in 1 CASE
    1 2000 mL in 1 CONTAINER
    2 NDC:0264-2303-70 4 in 1 CASE
    2 4000 mL in 1 CONTAINER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA016772 02/10/1978
    Labeler - B. Braun Medical Inc. (002397347)