Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/28
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Sodium Chloride (Injection, Solution, Concentrate)
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| dailymed-instance:dosage |
14.6% Sodium Chloride Injection, USP Additive Solution is
administered intravenously only after addition
to a larger volume of fluid. The dose, dilution
and rate of injection are dependent upon the individual needs of each patient. All
or part of the contents of one or more additive containers may be added to
an intravenous solution container. Concentrations of up to 5% sodium chloride
have been administered. 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... |
14.6% Sodium Chloride Injection, USP Additive Solution is
a sterile, nonpyrogenic, concentrated solution for intravenous administration
ONLY AFTER DILUTION to replenish electrolytes. The preparations contain either
2.92 or 5.84 g of sodium chloride (50 or 100 mEq each of Naand
Cl) in Water for Injection, USP. The solution contains
no bacteriostat, antimicrobial agent or added buffer; pH 4.8 (4.5 to 7.0).
May contain hydrochloric acid for pH adjustment. The osmolar concentration
is 5 mOsmol/mL (calc.); specific gravity is 1.10. Sodium
Chloride, USP is chemically designated NaCl, a white crystalline compound
freely soluble in water. The semi-rigid material used
for the plastic vials is fabricated from a specially formulated polyolefin.
It is a copolymer of ethylene and propylene. The safety of the plastic has
been confirmed by tests in animals according to USP biological standards for
plastic containers. The container requires no vapor barrier to maintain the
proper drug concentration.
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| dailymed-instance:clinicalP... |
Sodium chloride in water dissociates to provide sodium (Na)
and chloride (Cl) ions. These ions are normal constituents
of the body fluids (principally extracellular) and are essential for maintaining
electrolyte balance. Sodium is the principal cation
of extracellular fluid. It comprises more than 90% of the total cations at
its normal plasma concentration of approximately 142 mEq/liter. While the
sodium ion can diffuse across cell membranes, intracellular sodium is maintained
at a much lower concentration than extracellular sodium through the expenditure
of energy by the cell (so called���sodium cation pump���).
Loss of intracellular potassium ion is usually accompanied by an increase
in intracellular sodium ion. When serum sodium concentration
is low, the secretion of antidiuretic hormone (ADH) by the pituitary is inhibited,
thereby preventing water reabsorption by the distal renal tubules. On the
other hand, adrenal secretion of aldosterone increases renal tubular reabsorption
of sodium in an effort to re-establish normal serum sodium concentration. 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.
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| dailymed-instance:activeIng... | |
| dailymed-instance:contraind... |
14.6% Sodium Chloride Injection, USP Additive Solution is
contraindicated in patients with hypernatremia or fluid retention.
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| dailymed-instance:supply |
14.6% Sodium Chloride Injection, USP Additive Solution is
supplied as the following single-dose units: Store at controlled room temperature 15��to 30��C
(59��to 86��F) [See USP.] HOSPIRA, INC., LAKE FOREST,
IL 60045 USA
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| dailymed-instance:activeMoi... | |
| dailymed-instance:inactiveI... | |
| dailymed-instance:precautio... |
14.6% Sodium Chloride Injection, USP Additive Solution must
be diluted before infusion to avoid a sudden increase in the level of plasma
sodium. Too rapid administration should be avoided. Special
caution should be used in administering sodium containing solutions to patients
with severe renal impairment, cirrhosis of the liver, cardiac failure, or
other edematous or sodium-retaining states. 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 use unless the solution is clear and seal is intact. Discard unused portion.<br/>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/>Geriatric Use: An evaluation of current literature revealed no clinical
experience identifying differences in response 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.<br/>Pediatric Use: The safety and effectiveness of 14.6% Sodium Chloride Injection,
USP Additive Solution have not been established. Its limited use in pediatric
patients has been inadequate to fully define proper dosage and limitations
for use.
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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 and
PRECAUTIONS.
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| dailymed-instance:genericMe... |
Sodium Chloride
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| dailymed-instance:fullName |
Sodium Chloride (Injection, Solution, Concentrate)
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| dailymed-instance:adverseRe... |
Sodium overload can occur with intravenous infusion of excessive
amounts of sodium-containing solutions. See WARNINGS and PRECAUTIONS.
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| dailymed-instance:warning |
14.6% Sodium Chloride Injection, USP is hypertonic and must
be diluted prior to administration. Inadvertent direct injection or absorption
of concentrated sodium chloride solution may give rise to sudden hypernatremia
and such complications as cardiovascular shock, central nervous system disorders,
extensive hemolysis, cortical necrosis of the kidneys and severe local tissue
necrosis (if administered extravascularly). 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. In
patients with diminished renal function, administration of solutions containing
sodium may result in sodium retention. The intravenous
administration of this solution (after appropriate dilution) can cause fluid
and/or solute overload resulting in dilution of other serum electrolyte concentrations,
overhydration, congested states or pulmonary edema. Excessive
administration of potassium free solutions may result in significant hypokalemia. WARNING:
This product contains aluminum that may be toxic. Aluminum may reach toxic
levels with prolonged parenteral administration if kidney function is impaired.
Premature neonates are particularly at risk because their kidneys are immature,
and they require large amounts of calcium and phosphate solutions, which contain
aluminum. Research indicates that patients with impaired
kidney function, including premature neonates, who receive parenteral levels
of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels
associated with central nervous system and bone toxicity. Tissue loading may
occur at even lower rates of administration.
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| dailymed-instance:indicatio... |
14.6% Sodium Chloride Injection, USP Additive Solution is
indicated for parenteral restoration of sodium ion in patients with restricted
oral intake. Sodium replacement is specifically indicated in patients with
hyponatremia or low salt syndrome. 14.6% Sodium Chloride Additive Solution
may also be added to compatible carbohydrate solutions such as dextrose in
water to provide electrolytes.
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| dailymed-instance:name |
Sodium Chloride
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