Get your patient on Sodium Chloride - Sodium Chloride injection (Sodium Chloride)
Sodium Chloride - Sodium Chloride injection prescribing information
INDICATIONS AND USAGE
Sodium Chloride Injection, USP is indicated as a source of water and electrolytes.
0.9% Sodium Chloride Injection, USP is also indicated for use as a priming solution in hemodialysis procedures.
DOSAGE AND ADMINISTRATION
Important Administration Instructions
- Sodium Chloride Injection, USP is intended for intravenous administration using sterile equipment.
- Do not connect flexible plastic containers in series in order to avoid air embolism due to possible residual air contained in the primary container.
- Set the vent to the closed position on a vented intravenous administration set to prevent air embolism.
- Use a dedicated line without any connections to avoid air embolism.
- Do not pressurize intravenous solutions contained in flexible plastic containers to increase flow rates in order to avoid air embolism due to incomplete evacuation of residual air in the container.
- Prior to infusion, visually inspect the solution for particulate matter and discoloration.
- The solution should be clear and there should be no precipitates. Do not administer unless solution is clear, and container is undamaged.
Dosing Information The choice of product, dosage, volume, rate, and duration of administration is dependent upon the age, weight and clinical condition of the patient and concomitant therapy, and administration should be determined by a physician experienced in intravenous fluid therapy. Introduction of Additives Additives may be incompatible.
Evaluate all additions to the plastic container for compatibility and stability of the resulting preparation. Consult with a pharmacist, if available.
If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. After addition, if there is a discoloration and/or the appearance of precipitates, insoluble complexes or crystals, do not use. Do not store solutions containing additives. Discard any unused portion.
CONTRAINDICATIONS
None known.
ADVERSE REACTIONS
Post-Marketing Adverse Reactions
The following adverse reactions have been identified during postapproval use of Sodium Chloride Injection, USP. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following adverse reactions have been reported in the post-marketing experience during use of Sodium Chloride Injection, USP and include the following:
General disorders and administration site conditions : Infusion site erythema, injection site streaking, burning sensation, and infusion site urticaria
Hypersensitivity reactions : Hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus.
Metabolism and nutrition disorders : Hypernatremia•, hyponatremia, hyperchloremic metabolic acidosis.
Nervous System Disorders : Hyponatremic encephalopathy
•Adverse reaction of hyponatremia is only related to 0.9% Sodium Chloride Injection, USP. 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.
Drug Interactions
Other Products that Affect Fluid and/or Electrolyte Balance Administration of Sodium Chloride Injection, USP to patients treated concomitantly with drugs associated with sodium and fluid retention may increase the risk of hypernatremia and volume overload. Avoid use of Sodium Chloride Injection, USP in patients receiving such products, such as corticosteroids or corticotropin. If use cannot be avoided, monitor serum electrolytes, fluid balance and acid-base balance.
Lithium
Renal sodium and lithium clearance may be decreased during administration of 0.45% Sodium Chloride Injection, USP. Monitor serum lithium concentrations during concomitant use.
Renal sodium and lithium clearance may be increased during administration of 0.9% Sodium Chloride Injection, USP. Monitor serum lithium concentrations during concomitant use.
Other Drugs that Increase the Risk of Hyponatremia Administration of Sodium Chloride Injection, USP in patients treated concomitantly with medications associated with hyponatremia may increase the risk of developing hyponatremia.
Avoid use of Sodium Chloride Injection, USP in patients receiving products, such as diuretics, and certain antiepileptic and psychotropic medications. Drugs that increase the vasopressin effect reduce renal electrolyte free water excretion and may also increase the risk of hyponatremia following treatment with intravenous fluids. If use cannot be avoided, monitor serum sodium concentrations.
DESCRIPTION
Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents. The nominal pH is 5.6 (4.5 to 7.0). Composition, osmolarity, and ionic concentration are shown below:
0.9% Sodium Chloride Injection, USP contains 9 g/L Sodium Chloride, USP (NaCl) with an osmolarity of 308 mOsmol/L (calc). It contains 154 mEq/L sodium and 154 mEq/L chloride.
The plastic container is not made with PVC or DEHP.
The plastic container is made of polypropylene formulated and developed for parenteral drugs. The suitability of the plastic container has been established through biological evaluations, which have shown the container passes Class VI testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests confirm the biological safety of the container closure system.
The container has two ports, one is for the intravenous administration set and the other is a medication addition site. Refer to the Directions for Use of the container to properly identify the ports.
No vapor barrier is necessary.
CLINICAL PHARMACOLOGY
Sodium Chloride Injection, USP has value as a source of water and electrolytes. It is capable of inducing diuresis depending on the clinical condition of the patient.
HOW SUPPLIED
The available sizes of 0.9% Sodium Chloride Injection, USP are shown below: NDC 0487-4301-05 - 50 mL, 64 units per shipper NDC 0487-4301-10 - 100 mL, 64 units per shipper NDC 0487-4301-25 - 250 mL, 35 units per shipper NDC 0487-4301-50 - 500 mL, 18 units per shipper Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25° C/ 77° F); brief exposure up to 40° C/ 104°F does not adversely affect the product.
DIRECTIONS FOR USE
For Information on Risk of Air Embolism - see DOSAGE AND ADMINISTRATION .
Inspection Before Preparation for Administration
Visually inspect the container. If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. Check for minute leaks by squeezing bag firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow directions below. Check solution for clarity and absence of foreign matter. If solution is not clear or contains foreign matter, discard the solution.
Preparation for Administration
- Suspend container from eyelet support.
- Remove plastic protector from outlet port at bottom of container.
- Grip the small wing on the neck of the port with one hand.
- Grip the large wing on the cap with the other hand and twist.
- The cap will pop off. 3. Attach administration set. Refer to complete directions accompanying set.
To Add Medication
Additives may be incompatible.
To add medication before solution administration
- Remove additive port closure: hold container below additive port and grasp cap between thumb and forefinger then flip cap upward. Swab exposed additive port using aseptic technique.
- Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
- Mix solution and medication thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly.
To add medication during solution administration
- Close clamp on the set.
- Prepare medication site.
- Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
- Remove container from IV pole and/or turn to an upright position.
- Evacuate both ports by squeezing them while container is in the upright position.
- Mix solution and medication thoroughly.
- Return container to in-use position and continue administration.
