SORBITOL irrigant

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SORBITOL (UNII: 506T60A25R) (SORBITOL - UNII:506T60A25R)

Available from:

Baxter Healthcare Corporation

INN (International Name):

SORBITOL

Composition:

SORBITOL 30.00 g in 1000.00 mL

Administration route:

IRRIGATION

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

3% Sorbitol Urologic Irrigating Solution is indicated for use as a urologic irrigating fluid with endoscopic instruments during transurethral procedures requiring distension, irrigation, and lavage of the urinary bladder. It may be used for lavage of an indwelling catheter to maintain patency. Anuria.

Product summary:

3% Sorbitol Urologic Irrigating Solution in UROMATIC plastic containers is available as follows: 2B7357 3000mL NDC 0338-0295-47 Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C); brief exposure up to 40°C does not adversely affect the product.

Authorization status:

New Drug Application

Summary of Product characteristics

SORBITOL- SORBITOL IRRIGANT
BAXTER HEALTHCARE CORPORATION
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3% SORBITOL UROLOGIC IRRIGATING SOLUTION
IN UROMATIC PLASTIC CONTAINER
DESCRIPTION
3% Sorbitol Urologic Irrigating Solution is a sterile, nonpyrogenic,
nonhemolytic, electrically
nonconductive solution in a single dose UROMATIC Plastic Container for
use as a urologic irrigating
solution. Each liter contains 30 g Sorbitol in Water for Injection. pH
5.0 (4.5 to 6.5). Osmolarity 165
mOsmol/L (calc.). No antimicrobial agent has been added.
Sorbitol is a reduced form of dextrose and is designated chemically as
D-Glucitol,
The UROMATIC plastic container is fabricated from a specially
formulated polyvinyl chloride (PL
146 plastic). The amount of water that can permeate from inside the
container into the overwrap is
insufficient to affect the solution significantly. Solutions in
contact with the plastic container can leach
out certain of its chemical components in very small amounts within
the expiration period, e.g., di-2-
ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the
safety of the plastic has been
confirmed in tests in animals according to USP biological tests for
plastic containers as well as by
tissue culture toxicity studies.
CLINICAL PHARMACOLOGY
3% Sorbitol Urologic Irrigating Solution is useful as an irrigating
fluid for the urinary bladder because
the sorbitol solution is nonhemolytic, electrically nonconductive, and
provides a high degree of
visibility for urologic procedures requiring endoscopy. During
transurethral surgical procedures, the
solution acts as a lavage for removing blood and tissue fragments. It
is also useful as an irrigating fluid
to maintain the patency of an indwelling catheter in the immediate
postoperative period. If absorbed
either intravascularly or extravascularly during transurethral
resections, the sorbitol will be either
metabolized to carbon dioxide and water via the fructose pathway, or
excreted by a normally functioning
kidney.
INDICATIONS AND USAGE
3% Sorbitol Urologic Irrigating Solution i