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| Product NDC Code | 63323-095 | ||||
|---|---|---|---|---|---|
| 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, SOLUTION, CONCENTRATE | ||||
| RxCUI drug identifier | 313016 | ||||
| Application Number | ANDA212070 | ||||
| Labeler Name | Fresenius Kabi USA, LLC | ||||
| 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 23.4% Sodium Chloride Injection, USP may result in electrolyte imbalance with water retention, edema, loss of potassium and aggravation of an existing acidosis. See WARNINGS .
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 To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Sodium overload can occur with intravenous infusion of excessive amounts of sodium containing solutions. See WARNINGS and PRECAUTIONS .
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.CLINICAL PHARMACOLOGY 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/L. While the sodium ion can diffuse across cell membranes, the 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. Sodium is the principal ion that determines osmotic pressure of interstitial fluids and the degree of tissue hydration. 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.
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 23.4% Sodium Chloride Injection, USP Additive Solution is contraindicated in patients with hypernatremia or fluid retention.
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 23.4% Sodium Chloride Injection, USP Additive Solution is a sterile, nonpyrogenic, concentrated solution for intravenous administration ONLY AFTER DILUTION to replenish electrolytes. The preparations contain 23.4 g of sodium chloride (400 mEq each of Na+ and Cl - ) in Water for Injection, USP. The solution contains no bacteriostat, antimicrobial agent or added buffer. The additive may contain sodium hydroxide and/or hydrochloric acid for pH adjustment. The pH is 5.0 (4.5 to 7.0). The specific gravity is 1.15, and the osmolarity is 8008 mOsmol/L (calc). Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluble in water. The molecular weight is 58.44 g/mol. The Pharmacy Bulk Package is a sterile dosage form which contains multiple single doses for preparation of admixtures for intravenous infusion (see DOSAGE AND ADMINISTRATION ).
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 23.4% 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. In solutions for total parenteral nutrition (TPN), 120 mEq of sodium/day (range: 75-180 mEq/day) is the recommended adult dosage, whereas the recommended dosage is 3-4 mEq/kg/day for preterm infants. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard unused portion. Additives may be incompatible with the fluid dispensed from this container. Consult with pharmacist, if available. When admixing, use aseptic technique, mix thoroughly and do not store. Directions for Proper Use of Pharmacy Bulk Package Use Aseptic Technique During use, container must be stored and all manipulations performed in an appropriate laminar flow hood. To hang the bottle use plastic hanger. Remove fliptop cap from vial and cleanse closure with antiseptic. Insert suitable sterile dispensing set or transfer device and suspend unit in a laminar flow hood. The closure should be entered only once and after initial entry, the withdrawal of container contents should be completed promptly in one continuous operation. Should this not be possible, a maximum time of 4 hours from initial closure puncture is permitted to complete fluid transfer operations; i.e., discard container no later than 4 hours after initial closure puncture. Sequentially dispense aliquots of 23.4% Sodium Chloride Injection, USP into intravenous containers using appropriate transfer device. During fluid transfer operations, the Pharmacy Bulk Package should be maintained under the storage conditions recommended in the labeling. Inspect solution after admixing. Discard if the solution is discolored or particulates are observed.
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 23.4% Sodium Chloride Injection, USP is indicated for use as an electrolyte replenisher in parenteral fluid therapy. It serves as an additive for total parenteral nutrition (TPN) and as an additive for carbohydrate containing I.V. fluids.
Spl product data elements
Usually a list of ingredients in a drug product.Sodium Chloride Sodium Chloride SODIUM CHLORIDE SODIUM CATION CHLORIDE ION HYDROCHLORIC ACID WATER SODIUM HYDROXIDE
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 – 23.4% Sodium Chloride Injection, USP Vial Label NDC 63323-095-02 918961 23.4% SODIUM CHLORIDE INJECTION, USP 400 mEq/100 mL (4 mEq/mL) CONCENTRATE CAUTION: MUST BE DILUTED FOR INTRAVENOUS USE* PHARMACY BULK PACKAGE- Not for Direct Infusion Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – 23.4% Sodium Chloride Injection, USP Vial Label
PACKAGE LABEL - PRINCIPAL DISPLAY – 23.4% Sodium Chloride Injection, USP Tray Label NDC 63323-095-61 918961 23.4% SODIUM CHLORIDE INJECTION, USP 400 mEq/100 mL (4 mEq/mL) CONCENTRATE CAUTION: MUST BE DILUTED FOR INTRAVENOUS USE* PHARMACY BULK PACKAGE- Not for Direct Infusion Rx only 20 x 100 mL Vials PACKAGE LABEL - PRINCIPAL DISPLAY – 23.4% Sodium Chloride Injection, USP Tray Label
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.451722 /Issued: November 2021 Maxivial ® Rx only 23.4% Sodium Chloride Injection, USP 400 mEq (4 mEq/mL) Additive Solution Plastic Fliptop Vials PHARMACY BULK PACKAGE- Not For Direct Infusion CONCENTRATE CAUTION: MUST BE DILUTED FOR I.V. USE Concentrated Solution - For use only after dilution with compatible intravenous fluids to correct sodium deficiency when oral replacement is not feasible. Fresenius Kabi Logo
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 − 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.
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 23.4% Sodium Chloride Injection, USP is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when sodium chloride 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 − Safety and effectiveness of 23.4% Sodium Chloride Injection, USP have not been established in pediatric patients. Its limited use in pediatric patients has been inadequate to fully define proper dosage and limitations for use.
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 − Animal reproduction studies have not been conducted with 23.4% Sodium Chloride Injection, USP. 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.
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 23.4% Sodium Chloride Injection, USP (4 mEq/mL) is supplied as follows: Product Code Unit of Sale Strength/Concentration Each 918961 NDC 63323-095-61 Unit of 20 400 mEq/100 mL (4 mEq/mL) NDC 63323-095-02 100 mL fill in a 100 mL Plastic Fliptop Vial Pharmacy Bulk Package Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Preservative Free. The container closure is not made with natural rubber latex. Lake Zurich, IL 60047 www.fresenius-kabi.com/us 451722 /Issued: November 2021 Fresenius Kabi Logo
| 918961 | NDC 63323-095-61 Unit of 20 | 400 mEq/100 mL (4 mEq/mL) | NDC 63323-095-02 100 mL fill in a 100 mL Plastic Fliptop Vial Pharmacy Bulk Package |
General precautions
Information about any special care to be exercised for safe and effective use of the drug.General − Excessive amounts of sodium chloride by any route may cause hypokalemia and acidosis. Excessive amounts by the parenteral route may precipitate congestive heart failure and acute pulmonary edema, especially in patients with cardiovascular disease and in patients receiving corticosteroids or corticotropin or drugs that may give rise to sodium retention. Special caution should be used in administering sodium-containing solutions to patients with severe renal impairment, cirrhosis of the liver 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. Do not use unless the solution is clear and seal is intact.
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS General − Excessive amounts of sodium chloride by any route may cause hypokalemia and acidosis. Excessive amounts by the parenteral route may precipitate congestive heart failure and acute pulmonary edema, especially in patients with cardiovascular disease and in patients receiving corticosteroids or corticotropin or drugs that may give rise to sodium retention. Special caution should be used in administering sodium-containing solutions to patients with severe renal impairment, cirrhosis of the liver 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. Do not use unless the solution is clear and seal is intact. Pregnancy − Animal reproduction studies have not been conducted with 23.4% Sodium Chloride Injection, USP. 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. Nursing Mothers − It is not known whether 23.4% Sodium Chloride Injection, USP is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when sodium chloride is administered to a nursing woman. Pediatric Use − Safety and effectiveness of 23.4% Sodium Chloride Injection, USP have not been established in pediatric patients. Its limited use in pediatric patients has been inadequate to fully define proper dosage and limitations for use. 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.
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 23.4% 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, specifically osmotic demyelination syndrome, 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 overloading 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.
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