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Sodium Chloride

Pronunciation

Class: Replacement Preparations
VA Class: TN400
Molecular Formula: NaCl
CAS Number: 7647-14-5
Brands: Dey-Pak

Introduction

Source of essential sodium and chloride ions.a g l

Uses for Sodium Chloride

Hydration

Maintenance or replacement of sodium chloride and water for hydration.a b c d e l

Prevention of muscle cramps and heat prostration secondary to fluid loss from excessive perspiration during exposure to high temperatures.a

Electrolyte Balance

Prevention or treatment of deficiencies of sodium and chloride ions (e.g., caused by excessive diuresis or excessive salt restriction).a g h

Extracellular fluid replacement (isotonic [0.9%] sodium chloride injection).a e

Management of metabolic alkalosis in the presence of fluid loss and mild sodium depletion (0.9% sodium chloride injection).a e

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Management of severe sodium chloride depletion (e.g., presence of heart failure, renal impairment, during surgery, postoperatively) when rapid electrolyte restoration is essential (hypertonic [3 or 5%] sodium chloride injection).a l

Management of hyponatremia and hypochloremia resulting from administration of sodium-free fluids during fluid and electrolyte therapy (3 or 5% sodium chloride injection).a l

Management of extreme dilution of extracellular fluid following excessive water intake (e.g., resulting from multiple enemas or perfusion of irrigating solutions into open venous sinuses during transurethral prostatic resections) (3 or 5% sodium chloride injection).a l

Emergency treatment of severe sodium chloride depletion resulting from excessive sweating, vomiting, diarrhea, and other conditions (3 or 5% sodium chloride injection).a l

In general, isotonic sodium chloride solutions are used for parenteral replacement of chloride losses equal to or exceeding sodium losses;e h hypotonic sodium chloride solutions are used for parenteral maintenance of hydration requirements when only small quantities of salt are desired;e hypertonic sodium chloride solutions are used for repletion in severe salt depletion syndrome.l

Hyperosmolar Diabetes

Management of hyperosmolar diabetes (hypotonic [0.45%] sodium chloride injection).a e

Assessment of Renal Function

Assessment of renal function status (0.45% sodium chloride injection).a e

Priming Agent

Priming fluid for hemodialysis procedures (0.9% sodium chloride injection).a e

Initiate and terminate blood transfusions without hemolyzing RBCs (0.9% isotonic sodium chloride injection).e

Diluent

Pharmaceutical aid, diluent, and delivery system for the infusion of compatible drug additives.a b e f

Measurement of Cardiac Oputput

Measurement of cardiac output by the thermodilution method (0.9% sodium chloride injection as Thermoject system).j

Respiratory and Tracheal Uses

Inhalation via nebulization, dilution of compatible drugs for nebulization, and tracheal lavage and irrigation (0.9% sodium chloride inhalation solution).a

Cystic Fibrosis

An inhalation for cystic fibrosis patients to produce a sustained acceleration of mucus clearance and improve lung function (7% sodium chloride solution).o p

Sodium Chloride Dosage and Administration

General

  • Frequent laboratory determinations and clinical evaluation of the patient are essential during therapy, especially during prolonged therapy, to monitor changes in fluid, electrolytes, and acid-base balance.a b c d e g h l

  • Sterile inhalation solutions of sodium chloride are commercially available in single-dose containers for inhalation via nebulization, for dilution of compatible drugs for nebulization, and for tracheal lavage and irrigation, and in metered-dose aerosols for dilution of compatible drugs for nebulization.a

Administration

Administer orally, by IV infusion, intravascularly as a priming fluid, or as an oral inhalation via nebulization.a b c e g h l o p

Administer thermodilution solution only via thermodilution catheter; do not administer by any other route.j

Bacteriostatic sodium chloride injection is not for inhalation.f

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer 3 and 5% solutions via a large peripheral vein with a well-placed small-bore needle; use care to avoid infiltration.a l

Administer 14.6 and 23.4% sodium chloride injections only after dilution.g h

Some manufacturers recommend use of a final filter.c

Discard unused portion of solutions that are preservative free or intended for single use only.d h j l

Dilution

Prior to IV administration, dilute 14.6 and 23.4% sodium chloride injections (2.5 or 4 mEq/mL each of sodium and chloride) with a compatible IV solution.a g h Dilution amount is determined by the individual needs of the patient.g Sodium chloride concentrations of ≤5% sodium chloride have been administered.g

Sodium chloride 23.4% injection: Divide the required amount of mEqs of sodium chloride by 4 to calculate the volume (mL) of sodium chloride.h Withdraw this amount and transfer to the parenteral solution (e.g., 5% dextrose injection).h

When diluting additive drugs, consult prescribing information accompanying additives.b e (See Compatibility under Stability.)

Rate of Administration

Sodium chloride 3 or 5% infusion: Administer the solution slowly;l maximum 100 mL/hour.a l

Intravascular Administration

Administer intravascularly as a priming fluid in hemodialysis procedures.e

Injection via Thermodilution Catheter

For measurement of cardiac output, administer 0.9% sodium chloride injection (in Thermoject system) iced or at room temperature via a thermodilution catheter.j

Consult prescribing information for complete administration information.j

Dosage

Determine dosage based on the age, weight, clinical condition, and fluid, electrolyte, and acid-base balance of the patient.a b c d e f g h l

Normal physiologic osmolarity range is approximately 280–310 mOsm/L.c Administration of substantially hypertonic solutions (≥600 mOsm/L) may cause vein damage.c

Table 1. Ionic Concentration and Osmolarity of Sodium Chloride 0.45–5% Injectionsabcdejl

Sodium Chloride Injection Solution

Sodium and Chloride Content (mEq/L of each)

Estimated Calculated Osmolarity (mOsm/L)

0.45% Sodium chloride injection (hypotonic solution)

77

154

0.9% Sodium chloride injection (normal saline)

154

308

3% Sodium chloride injection (hypertonic solution)

513

1025

5% Sodium chloride injection (hypertonic solution)

855

1710

Must be diluted prior to administration.g h

Table 2. Ionic Concentration and Osmolarity of Sodium Chloride Additive Solutionsagh

Sodium Chloride Additive Solution

Sodium and Chloride Content (mEq/mL of each)

Estimated Calculated Osmolarity (mOsm/L)

14.6% Sodium chloride injection

2.5

5000

23.4% Sodium chloride injection

4

8000

Pediatric Patients

Bacteriostatic sodium chloride injection is contraindicated in neonates.f (See Benzyl Alcohol Toxicity and see Pediatric Use under Cautions.)

Usual Dosage
IV

Children: Determine dosage based on the patient's weight, clinical condition, and laboratory tests.d e l

Adults

Usual Dosage
Oral

1–2 g given 3 times daily.a

IV

Usual adult sodium and chloride requirements met by 1 L of 0.9% sodium chloride injection daily;a e alternatively, 1–2 L of 0.45% sodium chloride injection daily.a

3 or 5% sodium chloride injection: Initially, 100 mL infused slowly over a 1-hour period.a l

Determine the need for additional dose(s) based on serum electrolyte concentrations, including chloride and bicarbonate.a l

Sodium Chloride Deficiencies
Additive in Parenteral Fluid
IV

Sodium chloride 14.6 and 23.4% additive solutions: Dosage is determined by the patient's individual needs.g h

Measurement of Cardiac Output
IV

0.9% (Thermoject) solution: 1–10 mL as required.j Use the smallest volume necessary to produce an adequate curve.j

Prescribing Limits

Adults

Usual Dosage
IV

3 or 5% sodium chloride injection: Maximum 100 mL given over a 1-hour period.a l Maximum 400 mL in 24 hours.l

Special Populations

Hepatic Impairment

Select dosage with extreme caution in cirrhosis.a (See Hepatic Impairment under Cautions.)

Renal Impairment

Select dosage with extreme caution in diminished renal function or severe renal insufficiency; monitor sodium concentrations.a b c d e g l (See Renal Impairment under Cautions.)

Geriatric Patients

Select dosage with caution, usually initiating at the lower end of the usual range, because of age-related decreases in hepatic, renal, and/or cardiac function and of concomitant disease or drug therapy.c e l (See Geriatric Use under Cautions.)

Cautions for Sodium Chloride

Contraindications

  • When administration of sodium or chloride could be clinically detrimental.a b e l

  • Bacteriostatic sodium chloride injection: Contraindicated in neonates.f (See Pediatric Use under Cautions.)

  • 3 and 5% sodium chloride injections: Presence of increased, normal, or only slightly decreased serum electrolyte concentrations.a l

  • Thermoject 0.9% injection: Not for injection by the usual parenteral routes of infusion, including infusion through IV administration sets.j

  • 14.6% sodium chloride injection: Hypernatremia or fluid retention.g

Warnings/Precautions

Warnings

Surgical and Postsurgical Use

Avoid use during and immediately following surgery, unless factors producing salt depletion are present.h Because of renal retention of salt during surgery, administration of additional electrolyte may result in fluid retention, edema, and circulatory overload.h Monitor for signs of postoperative salt intolerance (e.g., cellular dehydration, weakness, disorientation, anorexia, nausea, distention, deep respiration, oliguria, increased BUN).h

Sodium Content

See ionic concentration and osmolarity tables under Dosage and Administration for specific sodium content information.

Risk of sodium retention; use caution when administering solutions containing sodium to patients with hypervolemia, urinary tract obstruction, impending or frank cardiac decompensation, or renal or cardiovascular insufficiency (with or without CHF); to geriatric patients; or in clinical states with sodium retention with edema.b c d e f g l (See Specific Populations under Cautions.)

Aluminum Content

Some preparations contain aluminum; may reach toxic levels with prolonged parenteral administration if kidney function is impaired, including in premature neonates.g h If such patients receive parenteral aluminum in amounts of >4–5 mcg/kg daily, aluminum may accumulate to levels associated with CNS and bone toxicity.g h Tissue loading may occur at even lower rates of administration.g h (See Pediatric Use under Cautions.)

Infusion Site Reactions

Infusion site and other reactions (e.g., fever, infection at the site of injection, venous thrombosis, hypervolemia, extravasation, phlebitis extending from the site of injection) possible.a b c d e f j l May occur because of the solution (e.g., contamination) or administration technique.a b c e f j l

Symptoms may result from excess or deficit of 1 or more ions in the solution; monitor electrolyte concentrations frequently.b e l (See Electrolyte Disturbances under Cautions.)

3 and 5% sodium chloride injections are strongly hypertonic; may cause local pain or venous irritation or damage.c l (See IV Administration under Dosage and Administration.)

If adverse effects occur, discontinue infusion; evaluate patient and institute appropriate therapeutic measures; save remainder of fluid for examination, if necessary.a b c d e f j l

Fluid and/or Solute Overload

Possible fluid and/or solute overload following IV administration resulting in dilution of serum electrolytes, overhydration, congestive conditions, or pulmonary edema.a d e g h l

Infuse 3 and 5% solutions slowly with constant observation of patient to avoid pulmonary edema.l

Risk of dilutional conditions is inversely proportional to the electrolyte concentration administered.a d e Risk of solute overload and resultant congestive conditions with peripheral and/or pulmonary edema is directly proportional to the electrolyte concentration administered.a d e

Major Toxicities

Benzyl Alcohol Toxicity

Risk of benzyl alcohol toxicity in neonates with use of preparations containing benzyl alcohol.a f (See Pediatric Use under Cautions.)

General Precautions

Electrolyte Disturbances

As patient's condition warrants and during prolonged therapy, evaluate changes in fluid balance, electrolyte concentrations, and acid-base balance, both clinically and via laboratory determinations.a b c d e f g l May require additional electrolyte supplements or other appropriate therapy.a b e

Possible hypokalemia with excessive or prolonged administration of potassium-free solutions.a f g h

Possible hypernatremia with excessive IV administration of sodium chloride.a l Hypernatremia may be associated with edema and exacerbation of CHF secondary to the retention of water.b l

Risk of sudden hypernatremia and complications (e.g., cardiovascular shock, CNS disorders, extensive hemolysis, cortical necrosis of the kidneys) from inadvertent direct injection or absorption of a concentrated sodium chloride solution.h Dilute hypertonic solutions prior to administration.h (See Dilution under Dosage and Administration.)

If infused in large amounts, chloride ions may cause a loss of bicarbonate ions, resulting in an acidifying effect.a e h l

Patients with substantial electrolyte losses (e.g., resulting from protracted nasogastric suctioning, vomiting, diarrhea, or GI fistula drainage) may require additional electrolyte supplementation.a e l

Specific Populations

Pregnancy

Category C.b c d e f g h j l

Lactation

Not known if sodium chloride is distributed into human milk.c e h j Caution if used in nursing women.b c d e h j l

Pediatric Use

Safety and efficacy of sodium chloride injection not established; however, the use of sodium chloride solutions in pediatric patients is referenced in medical literature.b c e h

Use with caution in neonates and small infants; the volume of fluid may affect fluid and electrolyte balance.d j l

Some preparations contain aluminum, which may be toxic in premature neonates and in individuals with impaired kidney function.g h Premature neonates are at particular risk because of immature kidneys and because they require large amounts of calcium and phosphate solutions, which contain aluminum.g h (See Aluminum Content under Cautions.)

Bacteriostatic sodium chloride injection containing benzyl alcohol as a preservative (antimicrobial agent) should not be used for diluting or reconstituting drugs for administration in neonates, nor to flush intravascular catheters in neonates.a f

Large amounts of benzyl alcohol (i.e., 100–400 mg/kg daily) have been associated with toxicity in neonates.a q s t u v w Several deaths have been reported in neonates weighing <2.5 kg in whom bacteriostatic sodium chloride for injection containing 0.9% benzyl alcohol was used for flushing IV catheters; some of these neonates received additional benzyl alcohol when bacteriostatic sodium chloride injection was used to dilute or reconstitute drugs.a

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.b c e Substantially eliminated by the kidneys; monitor renal function since geriatric patients are more likely to have decreased renal function.b c e (See Geriatric Patients under Dosage and Administration and also see Sodium Content under Cautions.)

Hepatic Impairment

Use with extreme caution, if at all, in patients with liver cirrhosis.a g

Renal Impairment

Use with extreme caution, if at all, in patients with severe renal insufficiency.a b c d e g l Risk of sodium retention in patients with diminished renal function.c d e g l Monitor renal function.b c (See Renal Impairment under Dosage and Administration and also see Sodium Content under Cautions.)

Interactions for Sodium Chloride

Specific Drugs

Drug

Interaction

Comments

Corticosteroids

Possible risk of sodium retention h

Use with cautiona b c d e f g h l

Corticotropin

Possible risk of sodium retention h

Use with cautiona b c d e f g h l

Sodium Chloride Pharmacokinetics

Distribution

Extent

Not known whether sodium chloride is distributed into milk.c e j

Elimination

Elimination Route

Substantially excreted by the kidneys.b c d f g h l

Special Populations

Renal insufficiency may cause sodium retention.b c e g l (See Special Populations under Dosage and Administration and see Sodium Content and also Specific Populations under Cautions.)

Stability

Storage

Parenteral

Bacteriostatic Injection

0.9% injection: 15–30°C.f

Injection

Generally at room temperature (20–25°C),b c d e g h j l although some containers can be frozen.b Consult manufacturer's labeling for specific storage instructions.

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution Compatibility (for Sodium Chloride 14.6 and 23.4%)HID

Compatible

Dextran 6% in dextrose 5%

Dextran 6% in sodium chloride 0.9%

Dextrose–Ringer’s injection combinations

Dextrose–Ringer’s injection, lactated, combinations

Dextrose–saline combinations

Dextrose 2½, 5, or 10% in water

Fructose 10% in sodium chloride 0.9%

Fructose 10% in water

Invert sugar 5 and 10% in sodium chloride 0.9%

Invert sugar 5 and 10% in water

Ionosol products

Ringer’s injection

Ringer’s injection, lactated

Sodium chloride 0.45 or 0.9%

Sodium lactate (1/6) M

Variable

Fat emulsion 10%, IV

Drug Compatibility
Admixture Compatibility (for Sodium Chloride 3%)HID

Compatible

Potassium chloride

When bacteriostatic sodium chloride injection is used as a diluent, consider the compatibility of the antimicrobial agent(s) contained in the bacteriostatic sodium chloride injection and the particular drug that is to be dissolved or diluted.a f

Actions

  • 0.9% sodium chloride solution (i.e., isotonic) closely approximates the composition of the extracellular fluid of the body.a

  • Required for the regulation of acid-base balance equilibrium.a e g l

  • Sodium, the principal extracellular fluid cation, controls water distribution, fluid balance, and the osmotic pressure of body fluids.a d e f g h l

  • Chloride, the major extracellular anion, reflects changes in the acid-base balance of the bodya e h l and has a buffering action when oxygen and carbon dioxide exchange occurs in RBCs.d f g

  • Can induce diuresis depending on the volume administered and the clinical condition of the patient.a c e l

Advice to Patients

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.b

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.b

  • Importance of informing patients of other important precautionary information.b (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Sodium Chloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral Inhalation

Aerosol, sterile, for dilution of oral inhalation solutions

0.9%*

Solution, for nebulization

0.45%*

0.9%*

Dey-Pak Sodium Chloride Solution

Dey

Dey-Vial Sodium Chloride Solution

Dey

Sodium Chloride Inhalation Solution

Nephron

3%

Dey-Pak Sodium Chloride Solution

Dey

10%

Dey-Pak Sodium Chloride Solution

Dey

Parenteral

Injection

0.45%*

0.45% Sodium Chloride Injection

Baxter, Braun, Hospira

0.9%*

0.9% Sodium Chloride Injection

Baxter, Braun, Hospira

0.9% Sodium Chloride Injection in Thermoject System (with Thermoject injector and empty vial for temperature probe)

Hospira

3%*

3% Sodium Chloride Injection Hypertonic

Baxter, Braun

5%*

5% Sodium Chloride Injection Hypertonic

Baxter, Braun, Hospira

Injection, for preparation of IV admixtures

2.5 mEq of Na+/mL and Cl-/mL*

2.5 mEq of Na+/mL and Cl-/mL pharmacy bulk package

Sodium Chloride Additive Solution

Abraxis, APP, Hospira

4 mEq of Na+/mL and Cl-/mL*

4 mEq of Na+/mL and Cl-/mL pharmacy bulk package

Sodium Chloride Injection Concentrate MaxiVial

Abraxis

Sodium chloride is also commercially available in combination with dextrose, dextran or hetastarch, invert sugar, and potassium chloride for IV administration.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Bacteriostatic Sodium Chloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection

0.9% (with benzyl alcohol or parabens)*

Bacteriostatic Sodium Chloride Injection (with 0.9% benzyl alcohol or parabens)

American Regent, Hospira

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Sodium Chloride Bacteriostatic 0.9% Solution (HOSPIRA): 10/$28.99 or 30/$67.97

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions July 1, 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

a. AHFS Drug Information 2008. McEvoy GK, ed. Sodium chloride. Bethesda, MD: American Society of Health-System Pharmacists; 2008:2737-8.

b. B. Braun Medical Inc. Sodium chloride 0.9% injection prescribing information. Irvine, CA; 2006 Apr.

c. Baxter. Sodium chloride 3% and 5% injection, USP prescribing information. Deerfield, IL; undated.

d. Hospira. Sodium chloride 0.45% and 0.9% injection, USP prescribing information. Lake Forest, IL; 2005 Nov.

e. B.Braun Medical Inc. Sodium chloride 0.45% and 0.9% injection prescribing information. Irvine, CA; 2003 Oct.

f. American Regent, Inc. Bacteriostatic sodium chloride 0.9% injection, USP prescribing information. Shirley, NY; 2003 Sept.

g. American Pharmaceutical Partners. Sodium chloride 14.6% injection, USP prescribing information. Schaumburg, IL; 2006 Jan.

h. Abraxis Pharmaceutical Partners. Sodium chloride 23.4% injection, USP prescribing information. Schaumburg, IL; 2006 May.

j. Hospira. Thermoject 0.9% sodium chloride injection prescribing information. Lake Forest, IL; 2005 Jun.

l. B.Braun Medical Inc. Sodium chloride 3% and 5% injection prescribing information. Irvine, CA; 2002 Jun.

o. Donaldson SH, Bennett WD, Zeman KL, et. al,. Mucus clearance and lung function in cystic fibrosis with hypertonic saline. N Engl J Med. 2006 Jan 19;354(3):241-50.

p. Elkins MR, Robinson M, Rose BR A Controlled trial of long-term inhaled hypertonic saline in patients with cystic fibrosis. N Engl J Med. 2006 Jan 19; 354(3):229-40.

q. American Academy of Pediatrics Committee on Fetus and Newborn and Committee on Drugs. Benzyl alcohol: toxic agent in neonatal units. Pediatrics. 1983; 72:356 8. [IDIS 175725] [PubMed 6889041]

s. Anon. Benzyl alcohol may be toxic to newborns. FDA Drug Bull. 1982; 12(2):10 11.

t. Centers for Disease Control. Neonatal deaths associated with use of benzyl alcohol. MMWR. 1982; 31:290 1. [IDIS 150868] [PubMed 6810084]

u. Gershanik J, Boecler B, Ensley H et al. The gasping syndrome and benzyl alcohol poisoning. N Engl J Med. 1982; 307:1384 8. [IDIS 160823] [PubMed 7133084]

v. Menon PA, Thach BT, Smith CH et al. Benzyl alcohol toxicity in a neonatal intensive care unit: incidence, symptomatology, and mortality. Am J Perinatol. 1984; 1:288 92. [PubMed 6440575]

w. Anderson CW, Ng KJ, Andresen B et al. Benzyl alcohol poisoning in a premature newborn infant. Am J Obstet Gynecol. 1984; 148:344 6. [IDIS 181207] [PubMed 6695984]

HID. Trissel LA. Handbook on injectable drugs. 14th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2007:1490-2.

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