Sorbitol

Indications

INDICATIONS AND 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 and administration (summary)

DOSAGE AND 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.

Contraindications

CONTRAINDICATIONS Anuria.

Warnings and 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.

Pregnancy

Pregnancy Teratogenic Effects Animal reproduction studies have not been conducted with 3% Sorbitol Urologic Irrigating Solution. It is not known whether 3% Sorbitol Urologic Irrigating Solution can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.

Storage and supply

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).

Source: Sorbitol (Sorbitol) — US FDA prescribing information, 2019-12-31, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.