Balanced salt solution is an isotonic solution indicated for use as irrigating solution of the eyes, ears, nose, and throat during a variety of surgical procedures. It is indicated for use as an extraocular and intraocular irrigating solution during ocular surgical procedures involving perfusion of the eye with an expected maximum duration of less than 60 minutes. It is a physiological irrigating solution, and it is isotonic to ocular tissue and contains electrolytes required for normal cellular metabolic functions.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Topical Administration
Other Topical Formulations
Topical Irrigation
18 mL bottle
-The LuerLok adapter is designed to accept a needle or other device with reciprocal fitting.
-For external irrigation, attachment of any device may not be necessary.
-To use the container in an aseptic field, remove the backing material to expose the container of the balanced salt solution.
-Aseptically transfer the container out of the plastic tray and remove the protective cap with a brisk twist to reveal the adapter.
-Attach needle or appropriate attachment by pushing it firmly onto the adapter and twisting into place.
-Before use, test the assembly to ensure proper function.
-Storage: For single patient use only; discard unused portion as the solution contains no preservatives.
200 mL, 250 mL, and 500 mL bottles
-Use an administration set equipped with an air inlet device in the plastic spike end since the container does not have an airway tube.
-Follow directions of the particular administration set to be used.
-Flip off plastic cap from the aluminum seal assembly or remove the aluminum tab.
-Using aseptic technique, it is recommended to insert the spike through the larger circular, indented area of the rubber plug.
-Before irrigating, invert the bottle and allow solution to flow entire length of tubing so air is purged from the tubing.
-Storage: For single patient use only; discard unused portion as the solution contains no preservatives.
Ophthalmic Administration
Ocular Irrigation
BSS Plus
-Supplied in 2 packages for reconstitution immediately prior to use:
--500 mL bag containing 480 mL (Part 1)
-20 mL glass vial (Part 2)
-Use aseptic technique.
-Remove Part 1 (480 mL bag) from the clear overwrap and remove the blue flip-off seal from Part 2 (20 mL vial). Clean the stoppers on both parts with sterile alcohol wipes.
-Peel open and remove the supplied dual-spike transfer device from its packaging. Remove the protector from the white plastic piercing pin of the dual-spike transfer device.
-Grasp the device from behind the flange and insert the white plastic piercing pin into the upright rubber stopper of Part 2 (20 mL vial).
-Remove the guard from the filter needle. While grasping the vial in the palm of the hand, use the thumb and index finger to hold the plastic flange against the top of the vial.
-Hold the vial in the upright position, incline and immediately insert the transfer device into the center of the rubber stopper of Part 1 (480 mL bag). DO NOT invert part 2 (20 mL vial) before or during spiking of Part 1 (480 mL bag) until ready to initiate transfer.
-Invert the vial to initiate transfer of Part 2 into Part 1. If transfer does not occur immediately, gently manipulate the bag to initiate transfer. NOTE: An excess amount of Part 2 is provided in each vial; a non-transferred solution residual of approximately 0.3 mL is expected to remain in the vial.
-Immediately remove the vial (with spike attached) from Part 1, and discard the vial.
-Alternative Transfer Method:
--The contents of Part 2 (20 mL vial) may be aspirated with an 18-gauge cannula attached to a 20 mL syringe.
-The contents of the 20 mL syringe are then transferred into Part 1 (480 mL bag).
-Place a sterile safety cap over the rubber stopper of Part 1 if the solution is not going to be used immediately. Mix the solution gently until uniform. Record the patient's name and the date and time of reconstitution.
-Storage: Solution must be used within 6 hours of reconstitution. Do not use unless the product is clear, seal is intact, and the container is undamaged. Do not use if product is discolored or contains precipitates.
Bullous keratopathy may result when abnormal corneal endothelium is irrigated or subjected to any other trauma. There have been reports of corneal opacification or corneal edema after ocular surgery in which balanced salt solution was used as an irrigating solution. Post-operative inflammatory reactions as well as incidents of corneal decompensation have also been reported. As in all surgical procedures, take care to minimize trauma to the cornea and other ocular tissues. Discontinue use of balanced salt solution if any adverse reaction occurs, institute appropriate care, and save the remaining fluid for analysis.
Balanced salt solution is for irrigation only. It is not to be used for parenteral administration, including intravenous administration.
Use intraocular irrigating solutions which are isoosmotic with normal aqueous fluids with caution in patients with diabetes mellitus undergoing vitrectomy since intraoperative lens changes have been observed.
Use balanced salt solution during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women.
Use caution when balanced salt solution is administered to a breast-feeding woman. There have been no controlled studies addressing the safety of balanced salt solution in lactating women.
For use as irrigating solution of eyes, ears, nose, and throat during a variety of surgical procedures, including ocular surgery:
Irrigation dosage:
Adults: Use for irrigation according to the standard format for the surgical procedure.
Maximum Dosage Limits:
-Adults
No maximum dosage information is available.
-Geriatric
No maximum dosage information is available.
-Adolescents
Safety and efficacy have not been established.
-Children
Safety and efficacy have not been established.
-Infants
Safety and efficacy have not been established.
-Neonates
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
*non-FDA-approved indication
There are no drug interactions associated with Balanced Salt Solution, BSS products.
Balanced salt solution is administered as an irrigating solution for eyes, ears, nose, and throat. The solution is isotonic to ocular tissue and contains electrolytes required for normal cellular metabolic functions.
Balanced salt solution is administered as an irrigating solution for eyes, ears, nose, and throat. The pH is 7, and the osmolality is 300 mOsm/kg.
Affected cytochrome P450 isoenzymes and drug transporters: none