Product Elements:
Sodium chloride sodium chloride water sodium chloride chloride ion
Drug Interactions:
Drug interactions caution must be exercised in the administration of sodium chloride injection, usp to patients receiving corticosteroids or corticotropin. carcinogenesis, mutagenesis, impairment of fertility studies have not been performed with sodium chloride injection, usp to evaluate the potential for carcinogenesis, mutagenesis or impairment of fertility. pregnancy: teratogenic effects pregnancy category c animal reproduction studies have not been conducted with sodium chloride injection, usp. it is also not known whether sodium chloride injection, usp can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. sodium chloride injection, usp should be given to a pregnant woman only if clearly needed. labor and delivery studies have not been conducted to evaluate the effects of sodium chloride injection, usp on labor and delivery. caution should be exercised when administering this drug during labor and delivery. nursing mothers it is not known w
Read more...hether this drug is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when sodium chloride injection, usp is administered to a nursing mother. pediatric use the use of sodium chloride injection, usp in pediatric patients is based on clinical practice. plasma electrolyte concentrations should be closely monitored in the pediatric population as this population may have impaired ability to regulate fluids and electrolytes. the infusion of hypotonic fluids (0.45% sodium chloride injection, usp) together with the non-osmotic secretion of adh may result in hyponatremia in patients with acute volume depletion. hyponatremia can lead to headache, nausea, seizures, lethargy, coma, cerebral edema and death, therefore acute symptomatic hyponatremic encephalopathy is considered a medical emergency. geriatric use clinical studies of sodium chloride injection, usp did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses 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 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. do not administer unless solution is clear and container is undamaged. discard unused portion.
Indications and Usage:
Indications and usage intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient.
Warnings:
Warnings sodium chloride injection, usp 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. the intravenous administration of sodium chloride injection, usp can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. the risk of dilutive states is inversely proportional to the electrolyte concentration of the injections. the risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injections. in patients with diminished renal function, administration of sodium chloride injection, usp may result in sodium retention.
Dosage and Administration:
Dose and administration the dose is dependent upon the age, weight and clinical condition of the patient. additives may be incompatible. consult with pharmacist, if available. when introducing additives, use aseptic technique, mix thoroughly and do not store. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. (see precautions .)
Contraindications:
Contraindications none known.
Adverse Reactions:
Adverse reactions reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. 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. in addition to the above listed adverse reactions hyponatremia has been reported for 0.45% sodium chloride injection, usp (see pediatric use section).
Drug Interactions:
Drug interactions caution must be exercised in the administration of sodium chloride injection, usp to patients receiving corticosteroids or corticotropin. carcinogenesis, mutagenesis, impairment of fertility studies have not been performed with sodium chloride injection, usp to evaluate the potential for carcinogenesis, mutagenesis or impairment of fertility. pregnancy: teratogenic effects pregnancy category c animal reproduction studies have not been conducted with sodium chloride injection, usp. it is also not known whether sodium chloride injection, usp can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. sodium chloride injection, usp should be given to a pregnant woman only if clearly needed. labor and delivery studies have not been conducted to evaluate the effects of sodium chloride injection, usp on labor and delivery. caution should be exercised when administering this drug during labor and delivery. nursing mothers it is not known w
Read more...hether this drug is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when sodium chloride injection, usp is administered to a nursing mother. pediatric use the use of sodium chloride injection, usp in pediatric patients is based on clinical practice. plasma electrolyte concentrations should be closely monitored in the pediatric population as this population may have impaired ability to regulate fluids and electrolytes. the infusion of hypotonic fluids (0.45% sodium chloride injection, usp) together with the non-osmotic secretion of adh may result in hyponatremia in patients with acute volume depletion. hyponatremia can lead to headache, nausea, seizures, lethargy, coma, cerebral edema and death, therefore acute symptomatic hyponatremic encephalopathy is considered a medical emergency. geriatric use clinical studies of sodium chloride injection, usp did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses 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 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. do not administer unless solution is clear and container is undamaged. discard unused portion.
Overdosage:
Overdosage in the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. (see warnings , precautions , and adverse reactions .)
Description:
Description
Clinical Pharmacology:
Clinical pharmacology when administered intravenously, these solutions provide a source of water and electrolytes. solutions which provide combinations of hypotonic or isotonic concentrations of sodium chloride are suitable for parenteral maintenance or replacement of water and electrolyte requirements. isotonic concentrations of sodium chloride are suitable for parenteral replacement of chloride losses that exceed or equal the sodium loss. hypotonic concentrations of sodium chloride are suited for parenteral maintenance of water requirements when only small quantities of salt are desired. a hypertonic concentration of sodium chloride may be used to repair severe salt depletion syndrome. sodium chloride in water dissociates to provide sodium (na+) and chloride (clâ) ions. sodium (na+) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. chloride (clâ) has an integral role in buffering action when oxyge
Read more...n and carbon dioxide exchange occurs in the red blood cells. the distribution and excretion of sodium (na+) and chloride (clâ) are largely under the control of the kidney which maintains a balance between intake and output. water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. average normal adult daily requirements range from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production). water balance is maintained by various regulatory mechanisms. water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (na+) plays a major role in maintaining physiologic equilibrium.
How Supplied:
How supplied 0.9% sodium chloride injection, usp is supplied in the following dosage forms: ndc 51662-1522-1 0.9% sodium chloride injection, usp, 500ml bag hf acquisition co llc, dba healthfirst mukilteo, wa 98275 also supplied in the following manufacture supplied dosage forms sodium chloride injection, usp is supplied in single-dose flexible plastic containers in various sizes and concentrations as shown in the accompanying table. * manufactured by icu medical, inc., lake forest, illinois, 60045, usa â manufactured for icu medical, inc., lake forest, illinois, 60045, usa icu medical is transitioning ndc codes from "0409" to "0990" labeler code. both ndc codes are expected to be in the market for a period of time. store at 20 to 25°c (68 to 77°f). [see usp controlled room temperature.] protect from freezing. revised: 1/2018 en-4686 how supplied
Package Label Principal Display Panel:
Principal display panel - serialized label ndc 51662-1522-1 serialized
Principal display panel - ndc 0990-7983-55 front label front label
Principal display panel - ndc 0990-7983-55 rear label rear label