Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1288
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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. 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. 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' Irrigation pH 7.4 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 pH 7.4 contains sodium chloride, 526 mg; sodium acetate,
anhydrous 222 mg; sodium gluconate, 502 mg; potassium chloride, 37 mg; magnesium
chloride hexahydrate 30 mg. May contain HCl and/or NaOH for pH adjustment.
pH 7.4 (6.5 to 7.6). 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
Irrigation pH 7.4 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 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 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. Solutions inside the plastic container
also can leach out certain of its chemical components in very small amounts
before the expiration period is attained. However, the safety of the plastic
has been confirmed by tests in animals according to USP biological standards
for plastic containers.
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dailymed-instance:clinicalP... |
PhysioSol Irrigation pH 7.4 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 vehiclefor drugs used for irrigation or other pharmaceutical
preparations. PhysioSol Irrigation pH 7.4 is useful
as an irrigant of body joints because the pH and electrolyte composition of
the solution approximates that of synovial fluid. Additionally, it provides
a transparent fluid medium with optical properties suitable for good visualization
of the interior joint surface during endoscopic examination. During arthroscopic
surgical procedures, the solution acts as a lavage for removing blood, tissue
fragments and bone fragments. PhysioSol Irrigation pH
7.4 provides an isotonic calcium-free balanced electrolyte irrigation with
the same ionic composition as Normosol'-R, pH 7.4, a multiple electrolyte
solution for I.V. replacement of acute extracellular fluid losses. PhysioSol
Irrigation pH 7.4 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. An electrolyte solution
should not be used for irrigation during electrosurgical procedures.
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dailymed-instance:supply |
PhysioSol Irrigation pH 7.4 is supplied in a single-dose
1000 mL flexible irrigation container (List No. 7012). Exposure
of pharmaceutical products to heat should be minimized. Store at 20 to 25��C
(68 to 77��F). [See USP Controlled Room Temperature.] Revised:
January, 2005 ��Hospira 2005 EN-0820 Printed in
USA HOSPIRA, INC., LAKE
FOREST, IL 60045 USA
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dailymed-instance:activeMoi... | |
dailymed-instance:inactiveI... | |
dailymed-instance:precautio... |
Do not administer unless solution is clear and container
is undamaged. Discard unused portion. 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 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.<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/>Pregnancy Category C.: Animal reproduction studies have not been conducted with
this solution. It is also not known whether it can cause fetal harm when administered
to a pregnant woman or can affect reproduction capacity. It 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 anhydrous, 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 container
over 66��C (150��F).
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dailymed-instance:indicatio... |
PhysioSol Irrigation pH 7.4 is indicated for all general
irrigation, washing and rinsing purposes which permit use of a sterile, nonpyrogenic
electrolyte solution. PhysioSol Irrigation pH 7.4 is
also indicated for use as an arthroscopic irrigating fluid with endoscopic
instruments during arthroscopic procedures requiring distention and irrigation
of the knee, shoulder, elbow or other bone joints. This solution is not indicated
for use with electrosurgical instruments.
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dailymed-instance:name |
Physiosol
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