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| Product NDC Code | 0264-9375 | ||||
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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 | 1807637 | ||||
| Application Number | NDA019635 | ||||
| Labeler Name | B. Braun Medical Inc. | ||||
| 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 In the event of a fluid or solute overload during parenteral therapy, reevaluate the patient’s condition and institute appropriate corrective treatment.
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 Reactions which may occur because of the solution, added drugs or the technique of reconstitution or administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. Carefully review the prescribing information for the diluted drug. The physician should also be alert to the possibility of adverse reactions to drug additives. Prescribing information for drug additives to be administered in this manner should be consulted. Symptoms may result from an excess or deficit of one or more of the ions present in the solution; therefore, frequent monitoring of electrolyte levels is essential. Hypernatremia may be associated with edema and exacerbation of congestive heart failure due to the retention of water, resulting in an expanded extracellular fluid volume. If infused in large amounts, chloride ions may cause a loss of bicarbonate ions, resulting in an acidifying effect. 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.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.CLINICAL PHARMACOLOGY 0.9% Sodium Chloride Injection USP provides electrolytes and is a source of water for hydration. It is capable of inducing diuresis depending on the clinical condition of the patient. Sodium, the major cation of the extracellular fluid, functions primarily in the control of water distribution, fluid balance, and osmotic pressure of body fluids. Sodium is also associated with chloride and bicarbonate in the regulation of the acid-base equilibrium of body fluid. Chloride, the major extracellular anion, closely follows the metabolism of sodium, and changes in the acid-base balance of the body are reflected by changes in the chloride concentration.
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 This solution is contraindicated where the administration of sodium or chloride could be clinically detrimental.
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 Each 1 mL of 0.9% Sodium Chloride Injection USP contains: Sodium Chloride USP 9 mg Water for Injection USP qs pH: 5.6 (4.5-7.0) Calculated Osmolarity: 0.308 mOsmol/mL pH adjusted with Hydrochloric Acid NF Concentration of Electrolytes (mEq/liter): Sodium 154 Chloride 154 0.9% Sodium Chloride Injection USP is sterile, nonpyrogenic, isotonic and contains no bacteriostatic or antimicrobial agents. The formula of the active ingredient is: Ingredient Molecular Formula Molecular Weight Sodium Chloride USP NaCI 58.44 Not made with natural rubber latex, PVC or DEHP.
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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 This solution is for intravenous use only. Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy. In the average adult, daily requirements of sodium and chloride are met by the infusion of one liter of 0.9% sodium chloride (154 mEq each of sodium and chloride). There is no specific pediatric dose. The dose is dependent on weight, clinical condition and laboratory results. Follow recommendations of appropriate pediatric reference text. (See PRECAUTIONS, Pediatric Use . ) Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient. 0.9% Sodium Chloride Injection USP may also be administered intravascularly as a priming fluid in hemodialysis procedures. When Sodium Chloride Injections USP are used as diluents for infusion of compatible drug additives, refer to dosage and administration information accompanying additive drugs. Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
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 pharmaceutic aid and diluent for the infusion of compatible drug additives. Refer to prescribing information accompanying additive drugs.
Spl product data elements
Usually a list of ingredients in a drug product.Sodium Chloride Sodium Chloride SODIUM CHLORIDE SODIUM CATION CHLORIDE ION
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.Carcinogenesis, Mutagenesis, Impairment of Fertility Studies with 0.9% Sodium Chloride Injection USP have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.
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.PRINCIPAL DISPLAY PANEL NDC 0264-9375-88 0.9% Sodium Chloride Injection USP 10 mL Single-dose ampoule. Discard unused portion. Calc. Osmolarity: 0.308 mOsmol/mL For dilution of medication. For intravenous use. Use only if solution is clear. PRESERVATIVE-FREE Protect from freezing. Store at room temperature (25°C). Rx only Manufactured for: B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA Produced in Germany, API from Denmark. LD-521-A-4 LOT EXP 10 mL Ampoule Bottle 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.A4800327-2 Package Insert Rx only Manufactured for: B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA Produced in Germany. API from Denmark. Manufactured by: Solupharm Pharmazeutische Erzeugnisse GmbH
Instructions for use
Information about safe handling and use of the drug product.Directions for Use of Ampoule To open ampoules, using gauze, place thumb and forefinger on color line, break at constriction. NOTE: Before use, perform the following checks: Inspect each container. Read the label. Ensure solution is the one ordered and is within the expiration date. Invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter. Any container which is suspect should not be used. Use only if solution is clear and container and seals are intact.
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 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 this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when 0.9% 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 Safety and effectiveness of sodium chloride injections in pediatric patients have not been established by adequate and well controlled trials, however, the use of electrolyte solutions in the pediatric population is referenced in the medical literature. The warnings, precautions and adverse reactions identified in the label copy should be observed in the pediatric population.
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 Teratogenic Effects Pregnancy Category C. Animal reproduction studies have not been conducted with 0.9% Sodium Chloride Injection USP. It is also not known whether 0.9% Sodium Chloride Injection USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 0.9% Sodium Chloride Injection USP 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 0.9% Sodium Chloride Injection USP is supplied sterile and nonpyrogenic in glass ampoule container. NDC Size 0264-9375-88 10 mL Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product. Revised: May 2018 Directions for Use of Ampoule To open ampoules, using gauze, place thumb and forefinger on color line, break at constriction. NOTE: Before use, perform the following checks: Inspect each container. Read the label. Ensure solution is the one ordered and is within the expiration date. Invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter. Any container which is suspect should not be used. Use only if solution is clear and container and seals are intact.
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General precautions
Information about any special care to be exercised for safe and effective use of the drug.General 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. Significant deviations from normal concentrations may require tailoring of the electrolyte pattern, in these or alternative solutions. Since Sodium Chloride Injection does not contain antimicrobial agents and is intended for single use, any unused amount must be discarded immediately following withdrawal of any portion of the contents of the ampoule. Do not open ampoule until it is to be used. This solution should be used with care in patients with hypervolemia, renal insufficiency, urinary tract obstruction, or impending or frank cardiac decompensation. Consult the manufactures instructions for choice of vehicle, appropriate dilution or volume for dissolving the drug to be injected, including the route and rate of injection. Extraordinary electrolyte losses such as may occur during protracted nasogastric suction, vomiting, diarrhea or gastrointestinal fistula drainage may necessitate additional electrolyte supplementation. Additional essential electrolytes, minerals and vitamins should be supplied as needed. Sodium-containing solutions should be administered with caution to patients receiving corticosteroids or corticotropin, or to other salt-retaining patients. Care should be exercised in administering solutions containing sodium to patients with renal or cardiovascular insufficiency, with or without congestive heart failure, particularly if they are postoperative or elderly. Infusion of more than one liter of isotonic (0.9%) sodium chloride per day may supply more sodium and chloride than normally found in serum, and can exceed normal tolerance, resulting in hypernatremia; this may also cause a loss of bicarbonate ions, resulting in an acidifying effect. To minimize the risk of possible incompatibilities arising from mixing this solution with other additives that may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration and periodically during administration. If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. This solution is intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours. Use only if solution is clear and container and glass ampoule is intact.
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS General 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. Significant deviations from normal concentrations may require tailoring of the electrolyte pattern, in these or alternative solutions. Since Sodium Chloride Injection does not contain antimicrobial agents and is intended for single use, any unused amount must be discarded immediately following withdrawal of any portion of the contents of the ampoule. Do not open ampoule until it is to be used. This solution should be used with care in patients with hypervolemia, renal insufficiency, urinary tract obstruction, or impending or frank cardiac decompensation. Consult the manufactures instructions for choice of vehicle, appropriate dilution or volume for dissolving the drug to be injected, including the route and rate of injection. Extraordinary electrolyte losses such as may occur during protracted nasogastric suction, vomiting, diarrhea or gastrointestinal fistula drainage may necessitate additional electrolyte supplementation. Additional essential electrolytes, minerals and vitamins should be supplied as needed. Sodium-containing solutions should be administered with caution to patients receiving corticosteroids or corticotropin, or to other salt-retaining patients. Care should be exercised in administering solutions containing sodium to patients with renal or cardiovascular insufficiency, with or without congestive heart failure, particularly if they are postoperative or elderly. Infusion of more than one liter of isotonic (0.9%) sodium chloride per day may supply more sodium and chloride than normally found in serum, and can exceed normal tolerance, resulting in hypernatremia; this may also cause a loss of bicarbonate ions, resulting in an acidifying effect. To minimize the risk of possible incompatibilities arising from mixing this solution with other additives that may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration and periodically during administration. If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. This solution is intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours. Use only if solution is clear and container and glass ampoule is intact. Carcinogenesis, Mutagenesis, Impairment of Fertility Studies with 0.9% Sodium Chloride Injection USP have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility. Pregnancy Teratogenic Effects Pregnancy Category C. Animal reproduction studies have not been conducted with 0.9% Sodium Chloride Injection USP. It is also not known whether 0.9% Sodium Chloride Injection USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 0.9% Sodium Chloride Injection USP should be given to a pregnant woman only if clearly needed. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when 0.9% Sodium Chloride Injection USP is administered to a nursing woman. Pediatric Use Safety and effectiveness of sodium chloride injections in pediatric patients have not been established by adequate and well controlled trials, however, the use of electrolyte solutions in the pediatric population is referenced in the medical literature. The warnings, precautions and adverse reactions identified in the label copy should be observed in the pediatric 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 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 The administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentration. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration. 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 is sodium retention with edema. In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention. Infusion of isotonic (0.9%) sodium chloride during or immediately after surgery may result in excessive sodium retention. Use the patient’s circulatory system status as a guide.
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