SODIUM CHLORIDE injection, solution
Sodium Chloride by
Drug Labeling and Warnings
Sodium Chloride by is a Prescription medication manufactured, distributed, or labeled by Baxter Healthcare Corporation, Baxter, S.A. de C.V., Baxter Healthcare S.A., Bieffe Medital SA. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
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DESCRIPTION
Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents. The nominal pH is 5.0 (4.5 to 7.0). Composition, osmolarity, and ionic concentration are shown below:
0.45% Sodium Chloride Injection, USP contains 4.5 g/L Sodium Chloride, USP (NaCl) and is hypotonic with an osmolarity of 154 mOsmol/L (calc). It contains 77 mEq/L sodium and 77 mEq/L chloride.
0.9% Sodium Chloride Injection, USP contains 9 g/L Sodium Chloride, USP (NaCl) with an osmolarity of 308 mOsmol/L (calc). It contains 154 mEq/L sodium and 154 mEq/L chloride.
The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2- ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.
- CLINICAL PHARMACOLOGY
- INDICATIONS AND USAGE
- CONTRAINDICATIONS
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WARNINGS
Hypersensitivity
Hypersensitivity and infusion reactions, including hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus have been reported with 0.9% Sodium Chloride Injection, USP and may occur with 0.45% Sodium Chloride Injection, USP.
Stop the infusion immediately if signs or symptoms of a hypersensitivity reaction develop, such as tachycardia, chest pain, dyspnea and flushing. Appropriate therapeutic countermeasures must be instituted as clinically indicated.
Electrolyte Imbalances
Fluid Overload
Depending on the volume and rate of infusion, and the patient’s underlying clinical condition, the intravenous administration of Sodium Chloride Injection, USP can cause fluid disturbances such as overhydration/hypervolemia and congested states, including pulmonary congestion and edema.
Avoid 0.9% Sodium Chloride Injection, USP in patients with or at risk for fluid and/or solute overloading. If use cannot be avoided, monitor fluid balance, electrolyte concentrations, and acid base balance, as needed and especially during prolonged use.
Hyponatremia
Sodium Chloride Injection, USP may cause hyponatremia. Hyponatremia can lead to acute hyponatremic encephalopathy characterized by headache, nausea, seizures, lethargy, and vomiting. Patients with brain edema are at particular risk of severe, irreversible and life-threatening brain injury.
The risk of hospital-acquired hyponatremia is increased in patients with cardiac or pulmonary failure, and in patients with non-osmotic vasopressin release (including SIADH) treated with high volume of Sodium Chloride Injection, USP.
The risk for hyponatremia is increased in pediatric patients, elderly patients, postoperative patients, those with psychogenic polydipsia, and in patients treated with medications that increase the risk of hyponatremia (such as diuretics, certain antiepileptic and psychotropic medications). See DRUG INTERACTIONS.
Patients at increased risk for developing complications of hyponatremia such as hyponatremic encephalopathy, include pediatric patients, women (in particular pre-menopausal women), patients with hypoxemia, and patients with underlying central nervous system disease. Avoid Sodium Chloride Injection, USP in patients with or at risk for hyponatremia. If use cannot be avoided, monitor serum sodium concentrations.
Rapid correction of hyponatremia is potentially dangerous with risk of serious neurologic complications. Brain adaptations reducing risk of cerebral edema make the brain vulnerable to injury when chronic hyponatremia is too rapidly corrected, which is known as osmotic demyelination syndrome (ODS). To avoid complications, monitor serum sodium and chloride concentrations, fluid status, acid-base balance, and signs of neurologic complications.
Hypernatremia
Hypernatremia may occur with Sodium Chloride Injection, USP. Conditions that may increase the risk of hypernatremia, fluid overload and edema (central and peripheral), include patients with: primary hyperaldosteronism; secondary hyperaldosteronism
associated with, for example, hypertension, congestive heart failure, liver disease (including cirrhosis), renal disease (including renal artery stenosis, nephrosclerosis); and pre-eclampsia.
Certain medications, such as corticosteroids or corticotropin, may also increase risk of sodium and fluid retention, see DRUG INTERACTIONS.
Avoid Sodium Chloride Injection, USP in patients with, or at risk for, hypernatremia. If use cannot be avoided, monitor serum sodium concentrations.
Rapid correction of hypernatremia is potentially dangerous with risk of serious neurologic complications. Excessively rapid correction of hypernatremia is also associated with a risk for serious neurologic complications such as osmotic demyelination syndrome (ODS) with risk of seizures and cerebral edema.
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PRECAUTIONS
Patients with Severe Renal Impairment
Administration of Sodium Chloride Injection, USP in patients with or at risk of severe renal impairment, may result in hypernatremia and/or fluid overload (see WARNINGS). Avoid Sodium Chloride Injection, USP in patients with severe renal impairment or conditions that may cause sodium and/or potassium retention, fluid overload, or edema. If use cannot be avoided, monitor patients with severe renal impairment for development of these adverse reactions.
Drug Interactions
Other Products that Affect Fluid and/or Electrolyte Balance
Administration of Sodium Chloride Injection, USP to patients treated concomitantly with drugs associated with sodium and fluid retention may increase the risk of hypernatremia and volume overload. Avoid use of Sodium Chloride Injection, USP in patients receiving such products, such as corticosteroids or corticotropin. If use cannot be avoided, monitor serum electrolytes, fluid balance and acid-base balance.
Lithium
Renal sodium and lithium clearance may be decreased during administration of 0.45% Sodium Chloride Injection, USP. Monitor serum lithium concentrations during concomitant use.
Renal sodium and lithium clearance may be increased during administration of 0.9% Sodium Chloride Injection, USP. Monitor serum lithium concentrations during concomitant use.
Other Drugs that Increase the Risk of Hyponatremia
Administration of Sodium Chloride Injection, USP in patients treated concomitantly with medications associated with hyponatremia may increase the risk of developing hyponatremia.
Avoid use of Sodium Chloride Injection, USP in patients receiving products, such as diuretics, and certain antiepileptic and psychotropic medications. Drugs that increase the vasopressin effect reduce renal electrolyte free water excretion and may also increase the risk of hyponatremia following treatment with intravenous fluids. If use cannot be avoided, monitor serum sodium concentrations.
Pregnancy
There are no adequate and well controlled studies with Sodium Chloride Injection, USP in pregnant women and animal reproduction studies have not been conducted with this drug. Therefore, it is not known whether Sodium Chloride Injection, USP can cause fetal harm when administered to a pregnant woman. Sodium Chloride Injection, USP should be given to a during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers
It is not known whether this drug is present in human milk. Because many drugs are present in human milk, caution should be exercised when Sodium Chloride Injection, USP is administered to a nursing woman.
Pediatric Use
The use of Sodium Chloride Injection, USP in pediatric patients is based on clinical practice. (See DOSAGE AND ADMINISTRATION).
Closely monitor plasma electrolyte concentrations in pediatric patients who may have impaired ability to regulate fluids and electrolytes. In very low birth weight infants, excessive or rapid administration of Sodium Chloride Injection, USP may result in increased serum osmolality and risk of intracerebral hemorrhage.
Children (including neonates and older children) are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy.
Geriatric Use
Geriatric patients are at increased risk of developing electrolyte imbalances. Sodium Chloride Injection, USP 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. Therefore, 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. Consider monitoring renal function in elderly patients.
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ADVERSE REACTIONS
Post-Marketing Adverse Reactions
The following adverse reactions have been identified during post approval use of Sodium Chloride Injection, USP. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following adverse reactions have been reported in the post-marketing experience during use of Sodium Chloride Injection, USP and include the following:
General disorders and administration site conditions: Infusion site erythema, injection site streaking, burning sensation, and infusion site urticaria
Hypersensitivity reactions: Hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus.
Metabolism and nutrition disorders: Hypernatremia*, hyponatremia, hyperchloremic metabolic acidosis.
Nervous System Disorders: Hyponatremic encephalopathy
* Adverse reaction of hyponatremia is only related to 0.9% Sodium Chloride Injection, USP
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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OVERDOSAGE
Excessive administration of:
- 0.45% Sodium Chloride Injection, USP can cause hyponatremia and hypernatremia. Both hypo- and hypernatremia can lead to CNS manifestations, including seizures, coma, cerebral edema and death.
- 0.9% Sodium Chloride Injection, USP can cause hypernatremia.
- Sodium Chloride Injection, USP can cause fluid overload (which can lead to pulmonary and/or peripheral edema). See WARNINGS and ADVERSE REACTIONS.
When assessing an overdose, any additives in the solution must also be considered. The effects of an overdose may require immediate medical attention and treatment.
Interventions include discontinuation of Sodium Chloride Injection, USP administration, dose reduction, and other measures as indicated for the specific clinical constellation (e.g., monitoring of fluid balance, electrolyte concentrations and acid base balance).
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DOSAGE AND ADMINISTRATION
Important Administration Instructions
- Sodium Chloride Injection, USP is intended for intravenous administration using sterile equipment.
- Do not connect flexible plastic containers in series in order to avoid air embolism due to possible residual air contained in the primary container.
- Set the vent to the closed position on a vented intravenous administration set to prevent air embolism.
- Use a dedicated line without any connections to avoid air embolism.
- Do not pressurize intravenous solutions contained in flexible plastic containers to increase flow rates in order to avoid air embolism due to incomplete evacuation of residual air in the container.
- Prior to infusion, visually inspect the solution for particulate matter and discoloration. The solution should be clear and there should be no precipitates. Do not administer unless solution is clear, and container is undamaged.
- Do not mix or administer 0.45% Sodium Chloride Injection, USP through the same administration set with whole blood or cellular blood components
Dosing Information
The choice of product, dosage, volume, rate, and duration of administration is dependent upon the age, weight and clinical condition of the patient and concomitant therapy, and administration should be determined by a physician experienced in intravenous fluid therapy.
Introduction of Additives
Additives may be incompatible.
Evaluate all additions to the plastic container for compatibility and stability of the resulting preparation. Consult with a pharmacist, if available.
If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. After addition, if there is a discoloration and/or the appearance of precipitates, insoluble complexes or crystals, do not use. Do not store solutions containing additives. Discard any unused portion.
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HOW SUPPLIED
The available sizes of each injection in VIAFLEX plastic containers are shown below:
Code
Size (mL)
NDC
Product Name
2B1313
500
0338-0043-03
0.45% Sodium Chloride Injection, USP
2B1314
1000
0338-0043-04
2B1300
25 Quad Pack
0338-0049-10
0.9% Sodium Chloride Injection, USP
50
2B1306
Single pack
0338-0049-41
2B1301
Quad pack
0338-0049-11
2B1308
Multi pack
0338-0049-31
100
2B1307
Single pack
0338-0049-48
2B1302
Quad pack
0338-0049-18
2B1309
Multi pack
0338-0049-38
2B1321
150
0338-0049-01
2B1322
250
0338-0049-02
2B1323
500
0338-0049-03
2B1324
1000
0338-0049-04
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C/77°F); brief exposure up to 40°C/104°F does not adversely affect the product.
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DIRECTIONS FOR USE OF VIAFLEX PLASTIC CONTAINER
For Information on Risk of Air Embolism – see DOSAGE AND ADMINISTRATION.
To Open
Tear overwrap down side at slit and remove solution container. Visually inspect the container. If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. 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. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow directions below.
Preparation for Administration
- 1. Suspend container from eyelet support.
- 2. Remove protector from outlet port at bottom of container.
- 3. Attach administration set. Refer to complete directions accompanying set.
To add medication before solution administration
- 1. Prepare medication site.
- 2. Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
- 3. Mix solution and medication thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly.
To add medication during solution administration
- 1. Close clamp on the set.
- 2. Prepare medication site.
- 3. Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
- 4. Remove container from IV pole and/or turn to an upright position.
- 5. Evacuate both ports by squeezing them while container is in the upright position.
- 6. Mix solution and medication thoroughly.
- 7. Return container to in-use position and continue administration.
- SPL UNCLASSIFIED SECTION
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PACKAGE LABELING - PRINCIPAL DISPLAY PANEL
LOT
EXP2B1302
NDC: 0338-0049-180.9% Sodium Chloride Injection USP
100 mL
Single dose container
Each 100 mL contains
900 mg Sodium Chloride USP
pH 5.0 (4.5 to 7.0) mEq/100 mL
Sodium 15 Chloride 15 Osmolarity
308 mOsmol/L (calc) Sterile
Nonpyrogenic Read package insert
for full information Additives may
be incompatible Dosage
Intravenously as directed by a
physician Cautions Must not be used
in series connections Do not use
unless solution is clear Rx Only
VIAFLEX container
PL 146
Baxter VIAFLEX and PL 146 are trademarks of
Baxter International IncBaxter
Baxter Healthcare Corporation
Deerfiled IL 60015 USA
Made in USALot: PXX
QTY: 96-100 mLExp: XX XX
Code: 2B1302
NDC: 0338-0049-180.9% SODIUM CHLORIDE INJ USP
(17) XXXX00 (10) PXX
(01) 50303380049184
LOT EXP
281313
NDC0338-0043-03
0.45°/o Sodium Chloride
Injection USP500ml
EACH 100 mL CONTAINS 450 rng SODIUM CHLORIDE USP
pH 5.0 (4. 5 TO 7.0) mEq/L SODIUM 77 CHLORIDE 77
HYPOTONIC OSMOLARITY 154 mQsmol/L (CALC) STERILE
NONPYROGENIC SINGLE DOSE CONTAINER ADDITIVES MAY BE INCOMPATIBLE CONSULT WITH PHARMACIST IF AVAILABLE
WHEN INTRODUCING ADDITIVES USE ASEPTIC TECHNIQUE MIX
THOROUGHLY DO NOT STORE DOSAGE INTRAVENOUSLY AS
DIRECTED BY A PHYSICIAN SEE DIRECTIONS CAUTIONS
SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT
STERILITY DISCARD IF LEAKS ARE FOUND MUST NOT BE USED
IN SERIES CONNECTIONS Do NOT USE UNLESS SOLUTION IS
CLEAR Rx ONLY STORE UNIT IN MOISTURE BARRIER
OVERWRAP AT ROOM TEMPERATURE (25°C/77°F) UNTIL READY
TO USE AVOID EXCESSIVE HEAT SEE INSERTVIAFLEX CONTAINER Pl 146 PLASTIC
BAXTER VIAFLEX AND PL 146 ARE TRADEMARKS OF
BAXTER INTERNATIONAL INCFOR PRODUCT INFORMATION 1-800-933-0303
Baxter Logo
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USAMADE IN USA
07-25-34-139
2B1313Q 24-500 ML
VIAFLEX® CONTAINER
0.45% SODIUM CHLORIDE
INJECTION, USPEXP
XXXXX
SECONDARY BAR CODE
(17) YYMMOO (10) XXXXX
LOT
XXXXX
PRIMARY BAR CODE
(01) 50303380043038
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INGREDIENTS AND APPEARANCE
SODIUM CHLORIDE
sodium chloride injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 0338-0049 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 9 g in 1000 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0338-0049-01 150 mL in 1 BAG; Type 0: Not a Combination Product 12/09/1970 2 NDC: 0338-0049-02 250 mL in 1 BAG; Type 0: Not a Combination Product 12/09/1970 3 NDC: 0338-0049-03 500 mL in 1 BAG; Type 0: Not a Combination Product 12/09/1970 4 NDC: 0338-0049-04 1000 mL in 1 BAG; Type 0: Not a Combination Product 12/09/1970 5 NDC: 0338-0049-10 4 in 1 PACKAGE 12/09/1970 5 25 mL in 1 BAG; Type 0: Not a Combination Product 6 NDC: 0338-0049-41 1 in 1 PACKAGE 12/09/1970 6 50 mL in 1 BAG; Type 0: Not a Combination Product 7 NDC: 0338-0049-11 4 in 1 PACKAGE 12/09/1970 7 50 mL in 1 BAG; Type 0: Not a Combination Product 8 NDC: 0338-0049-31 16 in 1 PACKAGE 12/09/1970 8 50 mL in 1 BAG; Type 0: Not a Combination Product 9 NDC: 0338-0049-48 1 in 1 PACKAGE 12/09/1970 9 100 mL in 1 BAG; Type 0: Not a Combination Product 10 NDC: 0338-0049-18 4 in 1 PACKAGE 12/09/1970 10 100 mL in 1 BAG; Type 0: Not a Combination Product 11 NDC: 0338-0049-38 16 in 1 PACKAGE 12/09/1970 11 100 mL in 1 BAG; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA016677 12/09/1970 SODIUM CHLORIDE
sodium chloride injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 0338-0043 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 4.5 g in 1000 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0338-0043-03 500 mL in 1 BAG; Type 0: Not a Combination Product 02/02/1979 2 NDC: 0338-0043-04 1000 mL in 1 BAG; Type 0: Not a Combination Product 02/02/1979 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA018016 02/02/1979 Labeler - Baxter Healthcare Corporation (005083209) Establishment Name Address ID/FEI Business Operations Baxter Healthcare Corporation 059140764 ANALYSIS(0338-0043, 0338-0049) , LABEL(0338-0043, 0338-0049) , MANUFACTURE(0338-0043, 0338-0049) , PACK(0338-0043, 0338-0049) , STERILIZE(0338-0043, 0338-0049) Establishment Name Address ID/FEI Business Operations Baxter Healthcare Corporation 189326168 ANALYSIS(0338-0049, 0338-0043) , LABEL(0338-0049, 0338-0043) , MANUFACTURE(0338-0049, 0338-0043) , PACK(0338-0049, 0338-0043) , STERILIZE(0338-0049, 0338-0043) Establishment Name Address ID/FEI Business Operations Baxter, S.A. de C.V. 810432484 ANALYSIS(0338-0049) , LABEL(0338-0049) , MANUFACTURE(0338-0049) , PACK(0338-0049) , STERILIZE(0338-0049) Establishment Name Address ID/FEI Business Operations Baxter Healthcare Corporation 194684502 ANALYSIS(0338-0043, 0338-0049) Establishment Name Address ID/FEI Business Operations Baxter Healthcare Corporation 091171389 ANALYSIS(0338-0049) , MANUFACTURE(0338-0049) , LABEL(0338-0049) , PACK(0338-0049) , STERILIZE(0338-0049) Establishment Name Address ID/FEI Business Operations Baxter Healthcare S.A. 988899845 ANALYSIS(0338-0049) , LABEL(0338-0049) , MANUFACTURE(0338-0049) , PACK(0338-0049) , STERILIZE(0338-0049) Establishment Name Address ID/FEI Business Operations Bieffe Medital SA 464755693 ANALYSIS(0338-0049) , LABEL(0338-0049) , MANUFACTURE(0338-0049) , PACK(0338-0049) , STERILIZE(0338-0049)
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