Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED 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.; PRINCIPAL DISPLAY PANEL - PACKAGING LABELING Container Label Container Label LOT EXP 3000 mL 2B7357 NDC 0338-0295-47 NOT FOR INJECTION 3% Sorbitol Urologic Irrigating Solution EACH 100 mL CONTAINS 3 g SORBITOL NO ANTIMICROBIAL AGENT HAS BEEN ADDED pH 5.0 (4.5 TO 6.5) HYPOTONIC OSMOLARITY 165 mOsmol/L (CALC) STERILE NONPYROGENIC SINGLE DOSE CONTAINER DO NOT USE UNLESS SOLUTION IS CLEAR DISCARD UNUSED PORTION HYPOTONIC SOLUTION FOR BLADDER IRRIGATION IN CONNECTION WITH CYSTOSCOPIC EXAMINATION AND UROLOGICAL SURGICAL PROCEDURES SEE DIRECTION SHEET CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND RX ONLY STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25°C) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT UROMATIC CONTAINER PL 146 PLASTIC BAXTER UROMATIC AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INC Baxter Logo BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA MADE IN USA FOR PRODUCT INFORMATION 1-800-933-0303 Sorbitol Representative Container Label
- HOW SUPPLIED 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.
- PRINCIPAL DISPLAY PANEL - PACKAGING LABELING Container Label Container Label LOT EXP 3000 mL 2B7357 NDC 0338-0295-47 NOT FOR INJECTION 3% Sorbitol Urologic Irrigating Solution EACH 100 mL CONTAINS 3 g SORBITOL NO ANTIMICROBIAL AGENT HAS BEEN ADDED pH 5.0 (4.5 TO 6.5) HYPOTONIC OSMOLARITY 165 mOsmol/L (CALC) STERILE NONPYROGENIC SINGLE DOSE CONTAINER DO NOT USE UNLESS SOLUTION IS CLEAR DISCARD UNUSED PORTION HYPOTONIC SOLUTION FOR BLADDER IRRIGATION IN CONNECTION WITH CYSTOSCOPIC EXAMINATION AND UROLOGICAL SURGICAL PROCEDURES SEE DIRECTION SHEET CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND RX ONLY STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25°C) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT UROMATIC CONTAINER PL 146 PLASTIC BAXTER UROMATIC AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INC Baxter Logo BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA MADE IN USA FOR PRODUCT INFORMATION 1-800-933-0303 Sorbitol Representative Container Label
Overview
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. Sorbitol Structural Formula
Indications & Usage
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.
Dosage & Administration
The volume of solution needed will vary with the nature and duration of the urologic procedure. If desired, warm in overwrap to near body temperature in a water bath or oven heated to not more than 45°C. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Warnings & Precautions
WARNINGS Not for injection. Not for use in patients with documented or suspected fructose intolerance. 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 irrigating solution must be regarded as a systemic drug. Absorption of large amounts of fluids containing sorbitol may significantly alter cardiopulmonary and renal dynamics. Appropriate patient monitoring should be maintained due to the possibility of fluid overload. Should fluid overload occur, intensive fluid and electrolyte management is necessary. Monitoring of fluid and electrolyte levels beyond the acute phase may be considered due to the possibility of delayed fluid absorption. (See ADVERSE REACTIONS, Post-Marketing Experience) Hyperglycemia from metabolism of absorbed sorbitol may occur in patients with diabetes mellitus. 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 irrigating solution since no antimicrobial agent has been added.
Contraindications
Anuria.
Adverse Reactions
Life threatening adverse reactions with intravenous sorbitol infusions have been reported in patients with fructose intolerance. The literature reports occasional adverse reactions for intravenous sorbitol infusions. These include disturbances such as acidosis, electrolyte loss, marked diuresis, urinary retention, edema, dryness of mouth and thirst, and dehydration; cardiovascular/pulmonary disorders such as pulmonary congestion, hypotension, tachycardia, angina-like pains, and other general reactions such as blurred vision, convulsions, nausea, vomiting, diarrhea, rhinitis, chills, vertigo, and backache. Allergic reactions reported to occur from sorbitol include urticaria. Should adverse reactions occur, discontinue the irrigant and reevaluate the clinical status of the patient. Post-Marketing Experience Following off-label use of 3% Sorbitol Urologic Irrigating Solution for hysteroscopic procedures in women, life-threatening adverse events related to fluid overload have been reported.
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