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| Product NDC Code | 0338-0160 | ||||
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| Drug Name | Sodium chloride |
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| Type | Generic | ||||
| Pharm Class | Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC] |
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| Active Ingredients |
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| Route | INTRAVENOUS | ||||
| Dosage Form | INJECTION | ||||
| RxCUI drug identifier | 1807548, 1807631, 1807632 |
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| Application Number | NDA020178 | ||||
| Labeler Name | Baxter Healthcare Corporation | ||||
| Packages |
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Overdosage of sodium chloride
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.OVERDOSAGE Excessive administration of: • 0.9% Sodium Chloride Injection, USP can cause hypernatremia. • 0.9% 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).
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.ADVERSE REACTIONS Post-Marketing Adverse Reactions The following adverse reactions have been identified during postapproval use of 0.9% 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 0.9% Sodium Chloride Injection, USP and include the following: Hypersensitivity reactions: hypersensitivity/infusion reactions, including hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus. General disorders and administration site conditions: infusion site reactions, such as infusion site erythema, injection site streaking, burning sensation, and infusion site urticaria. Metabolism and nutrition disorders: hypernatremia, hyperchloremic metabolic acidosis, and hyponatremia, which may be symptomatic. Nervous System Disorders: Hyponatremic encephalopathy. 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.
sodium chloride Drug Interactions
Information about and practical guidance on preventing clinically significant drug/drug and drug/food interactions that may occur in people taking the drug.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 Sodium Chloride Injection, USP. Monitor serum may result in increased lithium concentrations during concomitant use. Renal sodium and lithium clearance may be increased during administration of Sodium Chloride Injection, USP. Monitor serum lithium concentrations during concomitant use. Other Drugs that Increase the Risk of Hyponatremia Administration of 0.9% Sodium Chloride Injection, USP in patients treated concomitantly with medications associated with hyponatremia may increase the risk of developing hyponatremia. Avoid use of 0.9% 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.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.CLINICAL PHARMACOLOGY Sodium Chloride Injection, USP has value as a source of water and electrolytes. It is capable of inducing diuresis depending on the clinical condition of the patient.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.CONTRAINDICATIONS None known.
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.DESCRIPTION 0.9% Sodium Chloride Injection, USP in the Mini-Bag Plus Container System is a sterile, nonpyrogenic solution for intravenous administration after admixture with a single dose powdered or liquid (up to 10 mL) drug vial. It contains no antimicrobial agents. The nominal pH is 5.0 (4.5 to 7.0). Each 100 mL contains 900 mg of Sodium Chloride, USP (NaCl). The osmolarity is 308 mOsmol/L (calculated). Hydrochloric Acid, NF or Sodium Hydroxide, NF may be added for pH adjustment. It contains 154 mEq/L sodium and 154 mEq/L chloride. The Mini-Bag Plus Container is a standard diluent container with an integral drug vial adaptor. It allows for drug admixture after connection to a single dose powdered or liquid (up to 10 mL) drug vial having a 13mm or 20mm closure . A breakaway seal in the tube between the vial adaptor and the container is broken to allow transfer of the diluent into the vial and reconstitution of the drug. The Mini-Bag Plus product mechanically prohibits the transfer of contaminants into and out of the system during and after docking, minimizing environmental and personal exposure. The reconstituted drug is then transferred from the vial into the container diluent and mixed to result in an admixture for delivery to the patient. The VIAFLEX Plastic Container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). 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. 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 chemical components from the plastic in very small amounts. However, biological testing was supportive of the safety of the plastic container materials.
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DOSAGE AND ADMINISTRATION Important Administration Instructions • 0.9 % 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. • 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. 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 healthcare provider experienced in intravenous fluid therapy.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.INDICATIONS AND USAGE 0.9% Sodium Chloride Injection, USP is indicated as a source of water and electrolytes and may also be used as diluent for reconstitution of a powdered or liquid (up to 10 mL) drug product packaged in a vial with a 13mm or 20mm closure.
Spl product data elements
Usually a list of ingredients in a drug product.SODIUM CHLORIDE sodium chloride SODIUM CHLORIDE SODIUM CATION CHLORIDE ION WATER SODIUM CHLORIDE sodium chloride SODIUM CHLORIDE SODIUM CATION CHLORIDE ION WATER SODIUM CHLORIDE sodium chloride SODIUM CHLORIDE SODIUM CATION CHLORIDE ION WATER SODIUM CHLORIDE sodium chloride SODIUM CHLORIDE SODIUM CATION CHLORIDE ION WATER
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PACKAGE/LABEL PRINCIPAL DISPLAY PANEL BREAK SEAL AND MIX BEFORE USE EZPB0038LF NDC 0338-0160-01 50 mL 0.9% Sodium Chloride Injection USP MINI-BAG Plus Single Dose Container FOR USE WITH 13mm VIAL 1 Symbol 13 mm VIAL Each 50 mL contains 450 mg Sodium Chloride USP mEq/50 mL Sodium 8 Chloride 8 Sterile See prescribing information Additive compatibility consult pharmacist For intravenous use Store at Room Temperature (25°C) Avoid Excessive Heat Rx Only Baxter Logo Baxter Healthcare Corporation Deerfield, IL 60015 USA Made in Ireland CB-35-05-005 (1) Bar Code (01)00303380160013 Lot Exp BREAK SEAL AND MIX BEFORE USE EZPB0042LF NDC 0338-0164-01 50 mL 0.9% Sodium Chloride Injection USP MINI-BAG PLUS SINGLE DOSE CONTAINER FOR USE WITH 20mm VIAL 1 Symbol 20 mm VIAL Each 50 mL contains 450 mg Sodium Chloride USP mEq/50 mL Sodium 8 Chloride 8 Sterile See prescribing information Additive compatibility consult pharmacist For intravenous use Store at Room Temperature (25°C) Avoid Excessive Heat Rx Only Baxter Logo Baxter Healthcare Corporation Deerfield, IL 60015 USA Made in Ireland CB-35-05-006 (1) Bar Code (01)00303380164011 LOT EXP BREAK SEAL AND MIX BEFORE USE EZPB0039LF NDC 0338-0162-01 1000 mL 0.9% Sodium Chloride Injection USP MINI-BAG PLUS SINGLE DOSE CONTAINER FOR USE WITH 13mm VIAL 1 Symbol 13 mm VIAL Each 100 mL contains 900 mg Sodium Chloride USP mEq/100 mL Sodium 15 Chloride 15 Sterile See prescribing information Additive compatibility consult pharmacist For intravenous use Store at Room Temperature (25°C) Avoid Excessive Heat Rx Only Baxter Logo Baxter Healthcare Corporation Deerfield, IL 60015 USA Made in Ireland CB-35-05-007 (1) Bar Code (01)00303380162017 LOT EXP BREAK SEAL AND MIX BEFORE USE EZPB0043LF NDC 0338-0166-01 1000 mL 0.9% Sodium Chloride Injection USP MINI-BAG PLUS SINGLE DOSE CONTAINER FOR USE WITH 20mm VIAL 1 Symbol 20 mm VIAL Each 100 mL contains 900 mg Sodium Chloride USP mEq/100 mL Sodium 15 Chloride 15 Sterile See prescribing information Additive compatibility consult pharmacist For intravenous use Store at Room Temperature (25°C) Avoid Excessive Heat Rx Only Baxter Logo Baxter Healthcare Corporation Deerfield, IL 60015 USA Made in Ireland CB-35-05-008 (1) Bar Code (01)00303380166015 LOT EXP Representative container lbl CB3505005 0338-0160-01 Representative container CB3505006 0338-0164-01 Representative container lbl CB3505007 NDC 0338-0162-01 Representative container lbl CB3505008 0338-0166-01
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.DIRECTIONS FOR USE 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. Prior to use, check that the vial adaptor cover is intact. Check the solution container for minute leaks by squeezing inner bag firmly. If leaks are found or if the vial adaptor cover is not intact, discard product as sterility may be impaired. To Assemble and Reconstitute See diagram for detailed instructions. Mini-Bag Plus Container Directions Only For Single Dose Powdered or Liquid (up to 10 mL) Drug Vials with 13mm or 20mm Closures Use Aseptic Technique Assembly 1-3 Reconstitution 4-6.jpg List 7 - 11
Manufactured by, Packed by, Distributed by: Baxter Healthcare Corporation Deerfield, IL 60015 USA Baxter, Mini-Bag Plus and Viaflex are trademarks of Baxter International Inc. CB-30-02-787 Rev. December 2022
Geriatric use
Information about any limitations on any geriatric indications, needs for specific monitoring, hazards associated with use of the drug in the geriatric population.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.
Nursing mothers
Information about excretion of the drug in human milk and effects on the nursing infant, including pertinent adverse effects observed in animal offspring.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
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.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.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)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 during pregnancy only if the potential benefit justifies the potential risk to the fetus.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.HOW SUPPLIED 0.9% Sodium Chloride Injection, USP is a sterile solution supplied in Mini-Bag Plus Containers. The product is available as single packs (1 unit per overpouch). Table 1 lists single pack presentation compatible with vials with a 13 mm closure, and Table 2 lists single pack presentation compatible with vials with a 20 mm closure. Table 1. Presentations of 0.9% Sodium Chloride Injection Compatible with Vials with a 13 mm Closure Product Description Size Vial Adaptor Size Configuration Code NDC 0.9% Sodium Chloride Injection, USP 50 mL 13 mm single pack EZPB0038LF O338-0160-01 100 mL 13 mm single pack EZPB0039LF 0338-0162-01 Table 2. Presentations of 0.9% Sodium Chloride Injection Compatible with Vials with a 20 mm Closure Product Description Size Vial Adaptor Size Configuration Code NDC 0.9% Sodium Chloride Injection, USP 50 mL 20 mm single pack EZPB0042LF O338-0164-01 100 mL 20 mm single pack EZPB0043LF 0338-0166-01 Minimize exposure of 0.9% Sodium Chloride Injection to heat. Avoid excessive heat. Store at room temperature (25°C (77°F)).
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS Patients with Severe Renal Impairment Administration of 0.9%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 Sodium Chloride Injection, USP. Monitor serum may result in increased lithium concentrations during concomitant use. Renal sodium and lithium clearance may be increased during administration of Sodium Chloride Injection, USP. Monitor serum lithium concentrations during concomitant use. Other Drugs that Increase the Risk of Hyponatremia Administration of 0.9% Sodium Chloride Injection, USP in patients treated concomitantly with medications associated with hyponatremia may increase the risk of developing hyponatremia. Avoid use of 0.9% 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 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.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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. 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 distrurbance 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, fluid balance, electrolyte concentrations, and acid base balance, as needed and especially during prolonged use. Hyponatremia 0.9% 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, in 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 0.9% 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 0.9% 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. For use only with a single dose powdered or liquid (up to 10 mL) drug vial with a 13mm or 20mm closure. Do not administer unless drug is completely dissolved and drug vial is empty. Do not remove drug vial at any time prior to or during administration.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API