Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2077
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Sodium Chloride (Irrigant)
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dailymed-instance:dosage |
The dose is dependent upon the capacity or surface
area of the structure to be irrigated and the nature of the procedure.
When used as a diluent or vehicle for other drugs, the manufacturer's
recommendations should be followed. Drug Interactions Additives may be incompatible. Consult with pharmacist, if available.
When introducing additives, use aseptic technique, mix thoroughly
and do not store. Parenteral drug products should
be inspected visually for particulate matter and discoloration prior
to administration, whenever solution container permits. See PRECAUTIONS.
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dailymed-instance:descripti... |
These products are sterile, nonpyrogenic solutions
of electrolytes in water for injection intended only for sterile irrigation,
washing, rinsing and dilution purposes. Each
100 mL of 0.45% Sodium Chloride Irrigation, USP contains: Sodium chloride
450 mg; pH 5.6 (4.5 to 7.0). The solution is hypotonic (154 mOsmol/liter,
CALC.) and has the following electrolyte content (mEq/liter): Na77; Cl77. Each
100 mL of 0.9% Sodium Chloride Irrigation, USP contains: Sodium chloride
900 mg; pH 5.6 (4.5 to 7.0). May contain sodium hydroxide and/or
hydrochloric acid for pH adjustment. The solution is isotonic (308
mOsmol/liter, CALC.) and has the following electrolyte content (mEq/liter):
Na154; Cl154. These irrigations contain no bacteriostat, antimicrobial agent or
added buffer and are intended only for use as single-dose or short
procedure irrigation. When smaller volumes are required the unused
portion should be discarded. Each of these irrigations
may be classified as a sterile irrigant, wash, rinse, diluent and
pharmaceutical vehicle. Sodium Chloride, USP
is chemically designated NaCl, a white crystalline powder freely soluble
in water. Water for Injection, USP is chemically
designated HO. 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... |
Each of these irrigation solutions exert a mechanical
cleansing action for sterile irrigation of body cavities, tissues
or wounds, indwelling urethral catheters and surgical drainage tubes
and for washing, rinsing or soaking surgical dressings, instruments
and laboratory specimens. Each also serves as a diluent or vehicle
for drugs used for irrigation or other pharmaceutical preparations. 0.45% Sodium Chloride Irrigation, USP provides a hypotonic
half-strength saline irrigation identical in composition with 0.45%
Sodium Chloride Injection, USP. 0.9% Sodium
Chloride Irrigation, USP provides an isotonic saline irrigation identical
in composition with 0.9% Sodium Chloride Injection, USP (normal saline). 0.9% Sodium Chloride Irrigation, USP is considered generally
compatible with living tissues and organs; 0.45% Sodium Chloride Irrigation,
USP may be used alone or combined with appropriate additives when
0.9% sodium chloride is considered too irritating for wounds or other
altered structures. Sodium chloride in water
dissociates to provide sodium (Na) and chloride (Cl) ions. Sodium (Na) is the principal
cation of the extracellular fluid and plays a large part in the therapy
of fluid and electrolyte disturbances. Chloride (Cl) has an integral role in buffering action when oxygen and carbon
dioxide exchange occurs in the red blood cells. The distribution and
excretion of sodium (Na) and chloride (Cl) are largely under the control of the kidney which maintains a balance
between intake and output. Water is an essential
constituent of all body tissues and accounts for approximately 70%
of total body weight. Average normal adult daily requirement ranges
from two to three liters (1.0 to 1.5 liters each for insensible
water loss by perspiration and urine production). Water balance is maintained by various regulatory mechanisms. Water
distribution depends primarily on the concentration of electrolytes
in the body compartments and sodium (Na) plays a major
role in maintaining physiologic equilibrium.
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dailymed-instance:activeIng... | |
dailymed-instance:contraind... |
NOT FOR INJECTION BY USUAL PARENTERAL ROUTES. An electrolyte solution should not be used for irrigation
during electrosurgical procedures.
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dailymed-instance:supply |
0.45% Sodium Chloride Irrigation, USP: 0.9% Sodium Chloride Irrigation, USP: Store at 20 to 25��C (68 to 77��F). [See
USP Controlled Room Temperature.] Protect from freezing. March, 2007
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dailymed-instance:activeMoi... | |
dailymed-instance:inactiveI... | |
dailymed-instance:precautio... |
Do not use for irrigation that may result in absorption
into the blood. Caution should be observed when
a hypotonic solution is used for continuous irrigation or allowed
to���dwell���inside body cavities because of possible
absorption into the blood stream and the production of intravascular
hemolysis and circulatory overload. Aseptic
technique is essential with the use of sterile solutions for irrigation
of body cavities, wounds and urethral catheters or for wetting dressings
that come in contact with body tissues. When
used as a���pour���irrigation, no part of the contents
should be allowed to contact the surface below the outer protected
thread area of the semi-rigid wide mouth container. The flexible container
is designed for use with nonvented irrigation sets. When used for
irrigation via irrigation equipment, 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. For repeated irrigations of urethral catheters,
a separate container should be used for each patient. 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 Sodium Chloride Irrigation, USP have
not been performed to evaluate carcinogenic potential, mutagenic potential,
or effects on fertility.<br/>Nursing Mothers:: Caution should be exercised when Sodium Chloride
Irrigation, USP is administered to a nursing woman.<br/>Pregnancy:: Teratogenic Effects. Pregnancy Category
C. Animal reproduction studies have not been conducted with
Sodium Chloride Irrigation, USP. It is also not known whether Sodium
Chloride Irrigation, USP can cause fetal harm when administered to
a pregnant woman or can affect reproduction capacity. Sodium Chloride
Irrigation, USP should be given to a pregnant woman only if clearly
needed.<br/>Pediatric Use:: Safety and effectiveness of Sodium Chloride irrigation
solution in pediatric patients have not been established by adequate
and well-controlled trials. However, the use of Sodium Chloride irrigation
solution in the pediatric population is referenced in the medical
literature. The Warnings, Precautions, and Adverse Reactions identified
in the label should be observed in the pediatric population.<br/>Geriatric Use:: An evaluation of current literature revealed no clinical
experience identifying differences in response between elderly and
younger patients. This drug is known to
be substantially secreted by the kidney, and the risk of toxic reactions
to this drug may be greater in patients with impaired renal function.
Because elderly patients are more likely to have decreased renal function,
care should be taken in dose selection, and it may be useful to monitor
renal function.
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dailymed-instance:overdosag... |
In the event of overhydration or solute overload,
re-evaluate the patient and institute appropriate corrective measures.
See WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS.
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dailymed-instance:genericMe... |
Sodium Chloride
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dailymed-instance:fullName |
Sodium Chloride (Irrigant)
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dailymed-instance:adverseRe... |
Possible adverse effects arising from the irrigation
of body cavities, tissues, or indwelling catheters and tubes are usually
avoidable when proper procedures are followed. Displaced catheters
or drainage tubes can lead to irrigation or infiltration of unintended
structures or cavities. Excessive volume or pressure during irrigation
of closed cavities may cause undue distension or disruption of tissues.
Accidental contamination from careless technique may transmit infection. 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 IRRIGATION ONLY. NOT FOR INJECTION. Entry of a hypotonic solution into the circulation may
cause hemolysis. Irrigating fluids have been
demonstrated to enter the systemic circulation in relatively large
volumes; thus each of these irrigations must be regarded as a systemic
drug. Absorption of large amounts can cause fluid and/or solute overloading
resulting in dilution of serum electrolyte concentrations, overhydration,
congested states or pulmonary edema. The risk
of dilutional states is inversely proportional to the electrolyte
concentrations of administered parenteral solutions. The risk of solute
overload causing congested states with peripheral and pulmonary edema
is directly proportional to the electrolyte concentrations of such
solutions. Do not heat container over 66��C
(150��F).
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dailymed-instance:indicatio... |
Each of these solutions is indicated for all general
irrigation, washing, rinsing and dilution purposes which permit use
of a sterile, nonpyrogenic electrolyte solution.
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dailymed-instance:routeOfAd... | |
dailymed-instance:name |
Sodium Chloride
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