Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1583
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rdfs:label |
Sorbitol-Mannitol (Irrigant)
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dailymed-instance:dosage |
Sorbitol-Mannitol Irrigation should be administered only
by transurethral instillation with appropriate urologic instrumentation. A
disposable administration set should be used. The total volume of solution
used for irrigation is solely at the discretion of the surgeon. Height
of container(s) above the operating table in excess of 60 cm (approx. 2 ft)
has been reported to increase intravascular absorption of the irrigating fluid. Parenteral
drug products should be inspected visually for particulate matter and discoloration
prior to administration, whenever container and solution permit. See PRECAUTIONS.
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dailymed-instance:descripti... |
Sorbitol-Mannitol Irrigation is a sterile, nonpyrogenic,
hypotonic, aqueous solution for urologic nonelectrolyte irrigation during
transurethral surgical procedures. Each 100 mL contains sorbitol 2.70 g and
mannitol 0.54 g in water for injection. The solution is nonelectrolytic and
hypotonic (178 mOsmol/liter calc.); pH 5.2 (4.0 to 7.0). The
solution contains no bacteriostat, antimicrobial agent or added buffer and
is intended only for use as a single-dose irrigation. When smaller volumes
are required the unused portion should be discarded. Sorbitol-Mannitol
Irrigation is a nonelectrolyte urologic irrigant. Sorbitol,
NF is chemically designated D-glucitol (CHO),
white powder, granules or flakes very soluble in water. It has the following
structural formula: Mannitol, USP is chemically designated
D-mannitol (CHO), white crystalline powder
or free-flowing granules, freely soluble in water. It has the following structural
formula: Water for Injection, USP is chemically
designated H0. The flexible plastic container
is fabricated from a specially formulated polyvinylchloride. Water can permeate
from inside the container into the overwrap but not in amounts sufficient
to affect the solution significantly. The semi-rigid
container is fabricated from a specially formulated polyolefin. It is a copolymer
of ethylene and propylene. The container requires no vapor barrier to maintain
the proper drug concentration. Solutions in contact
with the plastic container may leach out certain chemical components from
the plastic in very small amounts; however, biological testing was supportive
of the safety of the plastic container materials. Exposure
to temperatures above 25��C/77��F during transport and storage will
lead to minor losses in moisture content. Higher temperatures lead to greater
losses. It is unlikely that these minor losses will lead to clinically significant
changes within the expiration period.
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dailymed-instance:clinicalP... |
Sorbitol and mannitol are hexitols and are nonelectrolytes.
A solution of these constituents in water is therefore nonconductive and suitable
for urologic irrigation during electrosurgical procedures. A 3% (approx.)
total concentration of sorbitol-mannitol contains sufficient solute to minimize
the risk of intravascular hemolysis which can occur from absorption of plain
water through open prostatic veins during transurethral resection (TUR). Any
solution that is absorbed intravascularly during transurethral prostatic or
bladder surgery, although variable in amount depending primarily on the extent
of surgery, will be excreted by the kidney. When absorbed intravascularly,
sorbitol and mannitol act as osmotic diuretics. Intravascular
absorption of sorbitol has been shown to produce elevations of serum lactate
after TUR above preoperative values owing to sorbitol's favored metabolism
to lactate from pyruvate. Increased lactate levels were not sufficient to
produce evidence of metabolic acidosis. Mannitol is only slightly metabolized
and rapidly excreted by the kidney.
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dailymed-instance:activeIng... | |
dailymed-instance:contraind... |
NOT FOR INJECTION BY USUAL PARENTERAL ROUTES. Do
not use in patients with anuria.
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dailymed-instance:supply |
Sorbitol-Mannitol Irrigation is supplied in single-dose 3000
mL flexible irrigation container (List No. 7981). Exposure
of pharmaceutical products to heat should be minimized. Avoid excessive heat.
Protect from freezing. It is recommended that the product be stored at room
temperature (25��C/77��F). HOSPIRA, INC., LAKE FOREST,
IL 60045 USA
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dailymed-instance:activeMoi... | |
dailymed-instance:inactiveI... | |
dailymed-instance:precautio... |
Cardiovascular status, especially of the patient with cardiac
disease, should be carefully observed before and during transurethral resection
of the prostate when using Sorbitol-Mannitol Irrigation, because the quantity
of fluid absorbed into the systemic circulation by opened prostatic veins
may produce significant expansion of the extracellular fluid and lead to fulminating
congestive heart failure. Shift of sodium-free intracellular
fluid into the extracellular compartment following systemic absorption of
solution may lower serum sodium concentration and aggravate pre-existing hyponatremia. Excessive
loss of water and electrolytes may lead to serious imbalances. With continuous
irrigation, loss of water may occur in excess of electrolytes, producing hypernatremia. Sustained
diuresis that results from transurethral irrigation with Sorbitol-Mannitol
Irrigation may obscure and intensify inadequate hydration or hypovolemia. Aseptic
technique is essential for the use of sterile solutions for irrigation. The
administration set should be attached promptly. Unused portions should be
discarded and a fresh container of appropriate size used for the start-up
of each cycle or repeat procedure. Do not administer
unless solution is clear, seal is intact and container is undamaged. Discard
unused portion.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility:: Studies with Sorbitol-Mannitol Irrigation have not been performed
to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.<br/>Nursing Mothers:: Caution should be exercised when Sorbitol-Mannitol Irrigation
is administered to a nursing woman.<br/>Pregnancy:: Teratogenic Effects. Pregnancy Category C. Animal reproduction studies
have not been conducted with Sorbitol-Mannitol Irrigation. It is also not
known whether Sorbitol-Mannitol Irrigation can cause fetal harm when administered
to a pregnant woman or can affect reproduction capacity. Sorbitol-Mannitol
Irrigation should be given to a pregnant woman only if clearly needed.<br/>Pediatric Use:: The safety and effectiveness of Sorbitol-Mannitol Irrigation
have not been established. Its limited use in pediatric patients has been
inadequate to fully define proper dosage and limitations for use.
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dailymed-instance:overdosag... |
In the event of dehydration, fluid or solute overload, discontinue
the irrigation, evaluate the patient and institute corrective measures as
indicated. See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS.
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dailymed-instance:genericMe... |
Sorbitol and Mannitol
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dailymed-instance:fullName |
Sorbitol-Mannitol (Irrigant)
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dailymed-instance:adverseRe... |
Adverse reactions may result from intravascular absorption
of sorbitol and mannitol. The literature reports occasional adverse reactions
from intravenous sorbitol-mannitol infusions. Consequences of absorption of
urologic irrigating solutions include fluid and electrolyte disturbances such
as acidosis, electrolyte loss, marked diuresis, urinary retention, edema,
dryness of mouth, thirst and dehydration; cardiovascular disorders such as
hypotension, tachycardia, angina-like pains; pulmonary disorders such as pulmonary
congestion; and other general reactions such as blurred vision, convulsions,
nausea, vomiting, diarrhea, rhinitis, chills, vertigo, backache and urticaria.
Allergic reactions from sorbitol-mannitol have also been reported. Should
any adverse reaction occur, discontinue the irrigant, evaluate the patient,
institute appropriate therapeutic countermeasures and save the remainder of
the fluid for examination if deemed necessary.
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dailymed-instance:warning |
FOR UROLOGIC IRRIGATION ONLY. 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-mannitol
irrigant must be regarded as a systemic drug. Absorption of large amounts
of fluids containing sorbitol-mannitol and the osmotic diuresis it produces
may significantly alter cardiopulmonary and renal dynamics. Hyperglycemia
from metabolism of sorbitol may occur in patients with diabetes mellitus. Hyperlactatemia
from metabolism of sorbitol may potentially produce a significant lactic acidemia
in metabolically compromised patients. 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 irrigation solution since it contains no preservatives.
Do not heat over 66��C (150��F).
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dailymed-instance:indicatio... |
Sorbitol-Mannitol Irrigation is indicated for use as a urologic
irrigating fluid during transurethral prostatic resection and other transurethral
surgical procedures.
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dailymed-instance:represent... | |
dailymed-instance:routeOfAd... | |
dailymed-instance:name |
Sorbitol-Mannitol
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