Get your patient on Sorbitol - Mannitol - Sorbitol And Mannitol irrigant (Sorbitol And Mannitol)

Sorbitol-Mannitol Irrigation is indicated for use as a urologic irrigating fluid during transurethral prostatic resection and other transurethral surgical procedures.

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 .)

NOT FOR INJECTION BY USUAL PARENTERAL ROUTES.

Do not use in patients with anuria.

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.

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 (C ₆ H ₁₄ O ₆ ), white powder, granules or flakes very soluble in water. It has the following structural formula:

Mannitol, USP is chemically designated D-mannitol (C ₆ H ₁₄ O ₆ ), white crystalline powder or free-flowing granules, freely soluble in water. It has the following structural formula:

Water for Injection, USP is chemically designated H ₂ 0.000000000000000e+00

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.

Sorbitol and mannitol are hexitols and are nonelectrolytes. A solution of these constituents in water is therefore nonconductive and suitable for urologic irrigation during electrosurgical procedures. A 3% (approx.) total concentration of sorbitol-mannitol contains sufficient solute to minimize the risk of intravascular hemolysis which can occur from absorption of plain water through open prostatic veins during transurethral resection (TUR). Any solution that is absorbed intravascularly during transurethral prostatic or bladder surgery, although variable in amount depending primarily on the extent of surgery, will be excreted by the kidney. When absorbed intravascularly, sorbitol and mannitol act as osmotic diuretics.

Intravascular absorption of sorbitol has been shown to produce elevations of serum lactate after TUR above preoperative values owing to sorbitol's favored metabolism to lactate from pyruvate. Increased lactate levels were not sufficient to produce evidence of metabolic acidosis. Mannitol is only slightly metabolized and rapidly excreted by the kidney.

Sorbitol-Mannitol Irrigation is supplied in single-dose 3000 mL flexible irrigation container
(NDC No. 0409-7981-08 / 0990-7981-08).

ICU Medical is transitioning NDC codes from the "0409" to a "0990" labeler code. Both NDC codes are expected to be in the market for a period of time.

Store at 20 to 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.] Protect from freezing.

Revised: July, 2018

EN-4664

ICU Medical, Inc., Lake Forest, Illinois, 60045, USA