Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/145
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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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Sodium Chloride Injection, USP solutions are sterile
and nonpyrogenic. They are parenteral solutions containing various
concentrations of sodium chloride in water for injection intended
for intravenous administration. For 0.45%
Sodium Chloride Injection, USP, each 100 mL contains 450 mg sodium
chloride in water for injection. Electrolytes per 1000 mL: sodium
77 mEq; chloride 77 mEq. The osmolarity is 154 mOsmol/L (calc.). For 0.9% Sodium Chloride Injection, USP, each 100
mL contains 900 mg sodium chloride in water for injection. Electrolytes
per 1000 mL: sodium 154 mEq; chloride 154 mEq. The osmolarity is
308 mOsmol/L (calc.). The pH for both concentrations
in the 100 mL and smaller containers is 6.0; for the 250 mL and larger
containers, the pH is 5.6. The pH range is 4.5 to 7.0 for all containers. The solutions contain no bacteriostat, antimicrobial
agent or added buffer and each is intended only as a single-dose injection.
When smaller doses are required the unused portion should be discarded. The solutions are parenteral fluid and electrolyte
replenishers. 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. 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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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 concentrationof 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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Sodium Chloride Injection, USP is supplied in single-dose
flexible plastic containers in various sizes and concentrations as
shown in the accompanying Table. 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. November, 2005 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.
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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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Sodium Chloride
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Sodium Chloride (Injection, Solution)
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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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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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Sodium Chloride
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