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Sodium Chloride for Irrigation
Overview
What is Sodium Chloride for Irrigation?
Each 100 mL contains:
Sodium Chloride USP 0.9 g; Water for Injection USP qs
pH adjusted with Hydrochloric Acid NF
pH: 5.75 (4.50-7.00)
Calculated Osmolarity: 308 mOsmol/liter
Concentration of Electrolytes (mEq/liter): Sodium 154; Chloride 154
0.9% Sodium Chloride Irrigation USP is sterile, nonpyrogenic, isotonic and contains no bacteriostatic or antimicrobial agents.
The formula of the active ingredient is:
The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.
Not made with natural rubber latex, PVC or DEHP.
What does Sodium Chloride for Irrigation look like?
What are the available doses of Sodium Chloride for Irrigation?
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What should I talk to my health care provider before I take Sodium Chloride for Irrigation?
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How should I use Sodium Chloride for Irrigation?
0.9% Sodium Chloride Irrigation USP is indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of a sterile, nonpyrogenic electrolyte solution.
As required for irrigation.
When used as a diluent, or vehicle for other drugs, the drug manufacturer's recommendations should be followed.
Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.
Solutions should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permits.
What interacts with Sodium Chloride for Irrigation?
0.9% Sodium Chloride Irrigation USP is not for injection by usual parenteral routes.
An electrolyte solution should not be used for irrigation during electrosurgical procedures.
What are the warnings of Sodium Chloride for Irrigation?
Aluminum-containing preparations (e.g., antacids, phosphate binders) should not be administered chronically with paricalcitol, as increased blood levels of aluminum and aluminum bone toxicity may occur.
FOR IRRIGATION ONLY. NOT FOR INJECTION.
Irrigating fluids have been demonstrated to enter the systemic circulation in relatively large volumes; thus, irrigation solutions must be regarded as systemic drugs. Absorption of large amounts 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 concentrations of the administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration.
Do not warm above 150°F (66°C).
After opening container, its contents should be used promptly to minimize the possibility of bacterial growth or pyrogen formation.
Discard unused portion of irrigating solution since it contains no preservatives.
What are the precautions of Sodium Chloride for Irrigation?
General
Use aseptic technique when preparing and administering sterile irrigation solutions.
Use only if solution is clear and container and seal are intact.
Do not use for irrigation that may result in absorption of large amounts of fluid into the blood.
Caution should be observed when the solution is used for continuous irrigation or allowed to ‘‘dwell” inside body cavities because of possible absorption into the blood stream and the production of circulatory overload.
When used for irrigation via appropriate irrigation equipment, the administration set should be attached promptly. Unused portions should be discarded and a fresh container of appropriate size used for the start up of each cycle or repeat procedure. For repeated irrigations of urethral catheters, a separate container should be used for each patient.
Laboratory Tests
Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance after prolonged irrigation, when fluid absorption is suspected, or whenever the condition of the patient warrants such evaluation.
Drug Interactions
Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic technique. Mix thoroughly. Do not store.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Studies with 0.9% Sodium Chloride Irrigation USP have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.
Pregnancy
Pregnancy Category C
Animal reproduction studies have not been conducted with 0.9% Sodium Chloride Irrigation USP. It is also not known whether 0.9% Sodium Chloride Irrigation USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 0.9% Sodium Chloride Irrigation USP should be given to a pregnant woman only if clearly needed.
Labor and Delivery
Safety and effectiveness of 0.9% Sodium Chloride Irrigation USP during labor and delivery have not been established. Caution should be exercised, and the fluid balance, glucose and electrolyte concentrations, and acid-base balance, of both mother and fetus should be evaluated periodically or whenever warranted by the condition of the patient or fetus.
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 Irrigation USP is administered to a nursing woman.
Pediatric Use
The safety and effectiveness of 0.9% Sodium Chloride Irrigation USP in pediatric patients have not been established. Its limited use in pediatric patients has been inadequate to fully define proper dosage and limitations for use.
Geriatric Use
Clinical studies of 0.9% Sodium Chloride Irrigation USP did not include a sufficient number of patients age 65 years and over to determine whether they respond differently from younger subjects. 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. Frequent laboratory determinations and clinical evaluations are recommended to monitor changes in blood glucose, electrolyte concentrations, and renal function.
What are the side effects of Sodium Chloride for Irrigation?
Possible adverse effects arising from the irrigation of body cavities, tissues, or indwelling catheters and tubes can be minimized when proper procedures are followed. Displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. Excessive volume or pressure during irrigation of closed cavities may cause undue distension or disruption of tissues. Accidental contamination from careless technique may transmit infection.
If an adverse reaction does occur, discontinue administration of the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.
What should I look out for while using Sodium Chloride for Irrigation?
0.9% Sodium Chloride Irrigation USP is not for injection by usual parenteral routes.
An electrolyte solution should not be used for irrigation during electrosurgical procedures.
FOR IRRIGATION ONLY. NOT FOR INJECTION.
Irrigating fluids have been demonstrated to enter the systemic circulation in relatively large volumes; thus, irrigation solutions must be regarded as systemic drugs. Absorption of large amounts 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 concentrations of the administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration.
Do not warm above 150°F (66°C).
After opening container, its contents should be used promptly to minimize the possibility of bacterial growth or pyrogen formation.
Discard unused portion of irrigating solution since it contains no preservatives.
What might happen if I take too much Sodium Chloride for Irrigation?
In the event of overhydration or solute overload, reevaluate the patient’s condition, and institute appropriate corrective treatment. Intravascular volume overload may respond to hemodialysis. See and
How should I store and handle Sodium Chloride for Irrigation?
Storage ConditionsStore refrigerated between 2° and 8°C (36° and 46°F). Upon removal from refrigeration to room temperature storage conditions (25°C / 77°F), use Rocuronium Bromide Injection within 60 days. Use opened vials of Rocuronium Bromide Injection within 30 days. Do not freeze.Storage ConditionsStore refrigerated between 2° and 8°C (36° and 46°F). Upon removal from refrigeration to room temperature storage conditions (25°C / 77°F), use Rocuronium Bromide Injection within 60 days. Use opened vials of Rocuronium Bromide Injection within 30 days. Do not freeze.Storage ConditionsStore refrigerated between 2° and 8°C (36° and 46°F). Upon removal from refrigeration to room temperature storage conditions (25°C / 77°F), use Rocuronium Bromide Injection within 60 days. Use opened vials of Rocuronium Bromide Injection within 30 days. Do not freeze.0.9% Sodium Chloride Irrigation USP is supplied sterile and nonpyrogenic in single-dose 2000 mL and 3000 mL plastic containers packaged 4 per case.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.Do not warm above 150°F (66°C).0.9% Sodium Chloride Irrigation USP is supplied sterile and nonpyrogenic in single-dose 2000 mL and 3000 mL plastic containers packaged 4 per case.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.Do not warm above 150°F (66°C).0.9% Sodium Chloride Irrigation USP is supplied sterile and nonpyrogenic in single-dose 2000 mL and 3000 mL plastic containers packaged 4 per case.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.Do not warm above 150°F (66°C).
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
0.9% Sodium Chloride Irrigation USP is utilized for a variety of clinical indications such as sterile irrigation of body cavities, tissues or wounds, indwelling urethral catheters, surgical drainage tubes, and for washing, rinsing or soaking surgical dressings, instruments and laboratory specimens. It also serves as a diluent or vehicle for drugs used for irrigation or other pharmaceutical preparations.
0.9% Sodium Chloride Irrigation USP provides an isotonic saline irrigation identical in composition with 0.9% Sodium Chloride Injection USP (normal saline).
Physiological irrigation solutions are considered generally compatible with living tissues and organs.
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.
Non-Clinical Toxicology
0.9% Sodium Chloride Irrigation USP is not for injection by usual parenteral routes.An electrolyte solution should not be used for irrigation during electrosurgical procedures.
FOR IRRIGATION ONLY. NOT FOR INJECTION.
Irrigating fluids have been demonstrated to enter the systemic circulation in relatively large volumes; thus, irrigation solutions must be regarded as systemic drugs. Absorption of large amounts 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 concentrations of the administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration.
Do not warm above 150°F (66°C).
After opening container, its contents should be used promptly to minimize the possibility of bacterial growth or pyrogen formation.
Discard unused portion of irrigating solution since it contains no preservatives.
Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic technique. Mix thoroughly. Do not store.
Use aseptic technique when preparing and administering sterile irrigation solutions.
Use only if solution is clear and container and seal are intact.
Do not use for irrigation that may result in absorption of large amounts of fluid into the blood.
Caution should be observed when the solution is used for continuous irrigation or allowed to ‘‘dwell” inside body cavities because of possible absorption into the blood stream and the production of circulatory overload.
When used for irrigation via appropriate irrigation equipment, the administration set should be attached promptly. Unused portions should be discarded and a fresh container of appropriate size used for the start up of each cycle or repeat procedure. For repeated irrigations of urethral catheters, a separate container should be used for each patient.
Possible adverse effects arising from the irrigation of body cavities, tissues, or indwelling catheters and tubes can be minimized when proper procedures are followed. Displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. Excessive volume or pressure during irrigation of closed cavities may cause undue distension or disruption of tissues. Accidental contamination from careless technique may transmit infection.
If an adverse reaction does occur, discontinue administration of the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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