Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/4229
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rdf:type | |
rdfs:label |
Physiosol (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 vehicle for other drugs, the manufacturer's recommendations should
be followed. 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... |
PhysioSol is a sterile, nonpyrogenic solution
of electrolytes in water for injection intended only for sterile irrigation,
washing and rinsing purposes. Each 100 mL of PhysioSol Irrigation
contains sodium chloride 526 mg, sodium acetate 222 mg, sodium gluconate
502 mg, potassium chloride 37 mg, magnesium chloride hexahydrate 30 mg.
The pH is 6.0 (5.0 to 6.5) adjusted with hydrochloric acid. The solution is
isotonic (294 mOsmol/liter, calc.) and has the following electrolyte
content (mEq/liter): Na140, K5, Mg3,
Cl98, HCO50 alternates
(27 as acetate and 23 as gluconate). It contains no
bacteriostat, antimicrobial agent or added buffer (except for pH adjustment)
and is intended only for use as single-dose or short procedure irrigation.
When smaller volumes are required the unused portion should be discarded. PhysioSol may
be classified as a sterile irrigant, wash, rinse and pharmaceutical vehicle. Magnesium
Chloride, USP is chemically designated magnesium chloride hexahydrate (MgCl���6
HO), colorless, odorless flakes or crystals very soluble in water. Potassium
Chloride, USP is chemically designated KCl, a white granular powder freely
soluble in water. Sodium Chloride, USP is chemically
designated NaCl, a white crystalline powder freely soluble in water. Sodium
Acetate, USP is chemically designated sodium acetate (CHONa),
colorless crystals or white crystalline powder or flakes very soluble in water.
It has the following structural formula: Sodium
gluconate is chemically designated CHNaO,
the normal sodium salt of gluconic acid soluble in water. It has the following
structural formula: Water for Injection, USP is chemically
designated H0. 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 concentrations. 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... |
PhysioSol Irrigation exerts 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.
It also serves as a vehicle for drugs used for irrigation or other pharmaceutical
preparations. PhysioSol provides an
isotonic calcium-free balanced electrolyte irrigation with the same ionic
composition as Normosol-R, a multiple electrolyte solution
for I.V. replacement of acute extracellular fluid losses. PhysioSol Irrigation
is considered generally compatible with living tissues and organs. Magnesium
chloride in water dissociates to provide magnesium (Mg) and chloride
(Cl) ions. Magnesium is the second most plentiful cation
of the intracellular fluids. It is an important cofactor for enzymatic reactions
and plays an important role in neurochemical transmission and muscular excitability.
Normal plasma concentration ranges from 1.5 to 2.5 or 3.0 mEq/liter. Magnesium
is excreted solely by the kidney at a rate proportional to the plasma concentration
and glomerular filtration. Potassium chloride in water
dissociates to provide potassium (K) and chloride (Cl)
ions. Potassium is the chief cation of body cells (160 mEq/liter of intracellular
water). It is found in low concentration in plasma and extracellular fluids
(3.5 to 5.0 mEq/liter in a healthy adult). Potassium plays an important role
in electrolyte balance. Normally about 80 to 90% of
the potassium intake is excreted in the urine; the remainder in the stools
and to a small extent, in the perspiration. The kidney does not conserve potassium
well so that during fasting or in patients on a potassium free diet, potassium
loss from the body continues resulting in potassium depletion. 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. Sodium
acetate provides sodium (Na) and acetate (CHCOO)
ions, the latter anion (a source of hydrogen ion acceptors) serving as an
alternate source of bicarbonate (HCO) by metabolic
conversion in the liver. This has been shown to proceed readily even in the
presence of severe liver disease. Thus, acetate anion exerts a mild systemic
antiacidotic action that may be advantageous during fluid and electrolyte
replacement therapy. Sodium gluconate provides sodium
(Na) and gluconate (CHO)
ions. Although gluconate is a theoretical alternate metabolic source of bicarbonate
(HCO) anion, a significant antiacidotic (alkalizing)
action has not been established. Thus, the gluconate anion serves primarily
to complete the cation-anion balance of the solutions. 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 |
PhysioSol Irrigation is supplied in single-dose
250, 500 and 1000 mL semi-rigid irrigation containers (List No. 6141). 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). HOSPIRA, INC., LAKE FOREST,
IL 60045 USA
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dailymed-instance:activeMoi... | |
dailymed-instance:inactiveI... | |
dailymed-instance:precautio... |
Caution should be observed when a 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 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. When used for irrigation via irrigation
equipment, the administration set should be attached promptly. Unused portions
should be discarded and a fresh container ofappropriate 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/>Drug Interactions: Additives may be incompatible. Consult with pharmacist, if
available. When introducing additives, use aseptic technique, mix thoroughly
and do not store.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility:: Studies with PhysioSol Irrigation have not
been performed to evaluate carcinogenic potential, mutagenic potential, or
effects on fertility.<br/>Nursing Mothers:: Caution should be exercised when PhysioSol Irrigation
is administered to a nursing woman.<br/>Pregnancy:: Teratogenic Effects: Pregnancy
Category C: Animal reproduction studies have not been conducted
with PhysioSol Irrigation. It is also not known whether PhysioSol Irrigation
can cause fetal harm when administered to a pregnant woman or can affect reproduction
capacity. PhysioSol Irrigation should be given to a pregnant
woman only if clearly needed.<br/>Pediatric Use:: The safety and effectiveness of PhysioSol Irrigation
pH 7.4 have not been established. Its limited use in pediatric patients has
been inadequate to fully define proper dosage and limitations for use.<br/>Geriatric Use:: Clinical studies of PhysioSol Irrigation
have not been performed to determine whether patients over 65 years respond
differently from younger subjects. Other reported clinical experience has
not identified differences in responses between elderly and younger patients.
In general, dose selection for an elderly patient should be cautious, reflecting
the greater frequency of decreased hepatic, renal, or cardiac function, and
of concomitant disease or other drug therapy. This drug
is known to be substantially excreted 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, sodium acetate, sodium gluconate, potassium chloride and magnesium chloride
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dailymed-instance:fullName |
Physiosol (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. Irrigating
fluids have been demonstrated to enter the systemic circulation in relatively
large volumes, thus, those 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 over 66��C
(150��F).
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dailymed-instance:indicatio... |
PhysioSol is indicated for all general irrigation,
washing and rinsing purposes which permit use of a sterile, nonpyrogenic electrolyte
solution.
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dailymed-instance:represent... | |
dailymed-instance:routeOfAd... | |
dailymed-instance:name |
Physiosol
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