Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1036
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Sodium Chloride (Injection, Solution)
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The dose is dependent upon the age, weight and clinical
condition of the patient. 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 and container permit. See PRECAUTIONS.
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| dailymed-instance:descripti... |
0.9% Sodium Chloride Injection, USP is sterile and
nonpyrogenic. It is a parenteral solution containing sodium chloride
in water for injection intended for intravenous administration. Each 100 mL of 0.9% Sodium Chloride Injection, USP contains
900 mg sodium chloride in water for injection. Electrolytes per 1000
mL: sodium (Na) 154 mEq; chloride (Cl) 154 mEq. The osmolarity is 308 mOsmol/L (calc.). The pH is 5.6 (4.5 to 7.0). This solution contains
no bacteriostat, antimicrobial agent or added buffer and is intended
only as a single-dose injection. When smaller doses are required,
the unused portion should be discarded. 0.9%
Sodium Chloride Injection, USP is a parenteral fluid and electrolyte
replenisher. 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 clear multilayer plastic film (FC97). 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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When administered intravenously, these solutions
provide a source of water and electrolytes. Solutions which provide combinations of hypotonic or isotonic concentrations
of sodium chloride are suitable for parenteral maintenance or replacement
of water and electrolyte requirements. Isotonic
concentrations of sodium chloride are suitable for parenteral replacement
of chloride losses that exceed or equal the sodium loss. Hypotonic
concentrations of sodium chloride are suited for parenteral maintenance
of water requirements when only small quantities of salt are desired.
A hypertonic concentration of sodium chloride may be used to repair
severe salt depletion syndrome. 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 requirements range
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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None known.
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| dailymed-instance:supply |
0.9% Sodium Chloride Injection, USP is supplied in
single-dose flexible plastic containers as follows: Store at 20 to 25��C (68 to 77��F). [See
USP Controlled Room Temperature.] Protect from freezing. Covered by one or more of the following US patents: 4,368,765,
4,344,472. May, 2006 HOSPIRA, INC., LAKE
FOREST, IL 60045 USA
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| dailymed-instance:precautio... |
Clinical evaluation and periodic laboratory determinations
are necessary to monitor changes in fluid balance, electrolyte concentrations
and acid-base balance during prolonged parenteral therapy or whenever
the condition of the patient warrants such evaluation. Caution must be exercised in the administration of parenteral
fluids, especially those containing sodium ions to patients receiving
corticosteroids or corticotropin. Do not administer
unless solution is clear and container is undamaged. Discard unused
portion.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility:: Studies have not been performed with Sodium Chloride
Injection, USP to evaluate the potential for carcinogenesis, mutagenesis
or impairment of fertility.<br/>Pregnancy:: Teratogenic Effects Pregnancy Category
C. Animal reproduction studies have not been conducted with
sodium chloride. It is also not known whether sodium chloride can
cause fetal harm when administered to a pregnant woman or can affect
reproduction capacity. Sodium chloride should be given to a pregnant
woman only if clearly needed.<br/>Nursing Mothers:: Caution should be exercised when Sodium Chloride
Injection, USP is administered to a nursing woman.<br/>Pediatric Use:: The safety and effectiveness in the pediatric population
are based on the similarity of the clinical conditions of the pediatric
and adult populations. In neonates or very small infants the volume
of fluid may affect fluid and electrolyte balance.<br/>Geriatric Use:: Clinical studies of 0.9% Sodium Chloride Injection,
USP did not include sufficient numbers of subjects aged 65 and over
to determine whether they 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, usually starting
at the low end of the dosing range, 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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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 (Injection, Solution)
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| dailymed-instance:adverseRe... |
Reactions which may occur because of the solution
or the technique of administration include febrile response, infection
at the site of injection, venous thrombosis or phlebitis extending
from the site of injection, extravasation and hypervolemia. If an adverse reaction does occur, discontinue the infusion,
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 |
Solutions containing sodium ions should be used with
great care, if at all, in patients with congestive heart failure,
severe renal insufficiency and in clinical states in which there exists
edema with sodium retention. Excessive administration
of potassium-free solutions may result in significant hypokalemia. In patients with diminished renal function, administration
of solutions containing sodium ions may result in sodium retention. The intravenous administration of these solutions 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.
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Intravenous solutions containing sodium chloride
are indicated for parenteral replenishment of fluid and sodium chloride
as required by the clinical condition of the patient.
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| dailymed-instance:name |
Sodium Chloride
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