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| Product NDC Code | 63323-139 | ||||
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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, SOLUTION | ||||
| RxCUI drug identifier | 1807580 | ||||
| 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 In the event of over hydration or solute overload, reevaluate the patient and institute appropriate corrective measures. (See WARNINGS and PRECAUTIONS .)
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 None known.
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 (CI — ) 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, 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. 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 reestablish normal serum sodium concentration. Chloride (CI — ) 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 (CI — ) 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 Sodium chloride injection 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 Sodium Chloride Injection, USP is a sterile, nonpyrogenic, concentrated solution for intravenous administration ONLY AFTER DILUTION to replenish electrolytes. The preparation contains 2.5 mEq/mL (14.6%) sodium chloride, in Water for Injection. The solution contains no bacteriostat, antimicrobial agent or added buffer; pH of the solution ranges from 4.5 to 7.0. Each mL contains: Sodium chloride 146 mg; Water for Injection q.s. pH may have been adjusted with hydrochloric acid. The osmolar concentration of the 2.5 mEq/mL solution is 5 mOsmol/mL. Sodium chloride is chemically designated NaCI, a white crystalline compound freely soluble in water.
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 Sodium chloride injection 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. All or part of the contents of one or more additive containers may be added to an intravenous solution container. Concentrations of up to 5% sodium chloride have been administered. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. (See PRECAUTIONS .)
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 Sodium Chloride Injection, USP is indicated for parenteral restoration of sodium ion in patients with restricted oral intake. Sodium replacement is specifically indicated in patients with hyponatremia or low salt syndrome. Sodium chloride injection may also be added to compatible carbohydrate solutions such as dextrose in water to provide electrolytes.
Spl product data elements
Usually a list of ingredients in a drug product.Sodium Chloride SODIUM CHLORIDE HYDROCHLORIC ACID SODIUM CHLORIDE SODIUM CATION CHLORIDE ION
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 - Sodium Chloride 40 mL Vial Label NDC 63323-139-40 13940 Sodium Chloride Injection, USP Concentrated 14.6% (2.5 mEq/mL) For IV Use Only After Dilution Rx only 40 mL Single Dose Vial 13940-vial
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.14.6% (2.5 mEq/mL) CONCENTRATED SOLUTIONS FOR USE ONLY AFTER DILUTION WITH COMPATIBLE IV FLUIDS TO CORRECT SODIUM DEFICIENCY WHEN ORAL REPLACEMENT IS NOT FEASIBLE.
45873E Revised: June 2008 logo
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 Sodium Chloride Injection, USP is available in flip-top glass vials. Product No. NDC No. % NaCl Na + mEq/mL Cl - mEq/mL mOsmol/ mL Fill Volume mL 13920 63323-139-20 14.6 2.5 2.5 5 20 13940 63323-139-40 14.6 2.5 2.5 5 40 These vials are Single Dose Vials; packaged 25 vials per tray. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not permit to freeze.
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Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS Do not use unless the solution is clear and seal is intact. Discard unused portion. Sodium chloride injection must be diluted before infusion to avoid a sudden increase in the level of plasma sodium. Too rapid administration should be avoided. Special caution should be used in administering sodium containing solutions to patients with severe renal impairment, cirrhosis of the liver, cardiac failure, 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. Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions, to patients receiving corticosteroids or corticotropin. Pregnancy Teratogenic Effects: Pregnancy Category C— Animal reproduction studies have not been conducted with sodium chloride. 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.
Pregnancy Teratogenic Effects: Pregnancy Category C— Animal reproduction studies have not been conducted with sodium chloride. 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.
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 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. 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.
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