3% Sorbitol Urologic Irrigating
Solution in UROMATIC Plastic Container
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,
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
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
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
Not for injection.
Not for use in patients with documented or
suspected fructose intolerance.
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,
metabolism of absorbed sorbitol may occur in patients with diabetes
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
status, especially of the patient with cardiac disease, should be
carefully observed before and during transurethral resection of the
prostate when using 3% Sorbitol Urologic Irrigating Solution, because
the quantity of fluid absorbed into the systemic circulation by opened
prostatic veins may produce significant expansion of the intravascular
fluid and lead to fulminating congestive heart failure.
Shift of sodium
free intracellular fluid into the extracellular compartment, following
systemic absorption may lower serum concentration and aggravate
Excessive loss of
water and electrolytes may lead to serious imbalances. With continuous
administration of solution, loss of water may occur in excess of
electrolytes, producing hypernatremia.
Sustained diuresis that results from transurethral irrigation with sorbitol irrigating
solutions may obscure and intensify inadequate hydration or hypovolemia.
Pregnancy category C.
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. 3% Sorbitol
Urologic Irrigating Solution should be given to
a pregnant woman only if clearly
effectiveness in pediatric patients have not been
studies of Irrigation Solutions did not include sufficient
numbers of subjects aged 65 and over to determine whether they
respond differently from other younger subjects. Other reported
clinical experience has not identified differences in responses
between the elderly and younger patients.
administer unless the solution is clear and the seal is
Life threatening adverse reactions with
intravenous sorbitol infusions have been reported in patients with
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.
reactions occur, discontinue the irrigant and reevaluate the clinical
status of the patient.
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.
DOSAGE AND ADMINISTRATION
The volume of
solution needed will vary with the nature and duration of the urologic
If desired, warm in
overwrap to near body temperature in a water bath or oven heated to not
more than 45°C.
products should be inspected visually for particulate matter and
discoloration prior to administration whenever solution and container
Urologic Irrigating Solution in UROMATIC plastic containers is available
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
DIRECTIONS FOR USE
Tear overwrap down
side at slit and remove solution container. Some opacity of the plastic
due to moisture absorption during the sterilization process may be
observed. This is normal and does not affect the solution quality or
safety. The opacity will diminish gradually. Check for minute leaks by
squeezing bag firmly. If leaks are found, discard solution as sterility
may be impaired.
Suspend container using hanger hole.
Remove protector from outlet port.
Attach irrigation set. Refer to complete directions accompanying
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Printed in USA
Rev. August 2004
and PL 146 are trademarks of Baxter International Inc.