Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2992
Predicate | Object |
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rdf:type | |
rdfs:label |
Sorbitol (Irrigant)
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dailymed-instance:dosage |
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.
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dailymed-instance:descripti... |
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 invery 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.
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dailymed-instance:clinicalP... |
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.
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dailymed-instance:activeIng... | |
dailymed-instance:contraind... |
Anuria.
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dailymed-instance:supply |
3% Sorbitol
Urologic Irrigating Solution in UROMATIC plastic containers is available
as follows: 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.
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dailymed-instance:activeMoi... | |
dailymed-instance:inactiveI... | |
dailymed-instance:precautio... |
The cardiovascular
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 ofthe 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
preexisting hyponatremia. 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.<br/>Pregnancy:<br/>Teratogenic
Effects:<br/>Pediatric Use: Safety and
effectiveness in pediatric patients have not been
established.<br/>Geriatric Use: Clinical
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. Do not
administer unless the solution is clear and the seal is
intact.
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dailymed-instance:genericMe... |
Sorbitol
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dailymed-instance:fullName |
Sorbitol (Irrigant)
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dailymed-instance:adverseRe... |
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.<br/>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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dailymed-instance:warning |
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 managementis 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.
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dailymed-instance:indicatio... |
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.
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dailymed-instance:represent... | |
dailymed-instance:routeOfAd... | |
dailymed-instance:name |
Sorbitol
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