B-Sol

Approved Indication:

• Extraocular and intraocular irrigation during ocular surgical procedures involving perfusion of the eye, with maximum duration of less than 60 minutes (FDA Access Data)

Clinically Accepted Additional Uses:

• Irrigation of ear, nose, throat, or ocular surfaces in ENT and ophthalmic microsurgery when physiological irrigants are required (olikla.cz)
• Cell culture and laboratory tissue preparation as a physiological buffered salt medium for maintaining pH, osmotic pressure, and cell viability (eCFR)

Route of Administration:

• Topical irrigation only (external or intraocular)
• Not for intravenous or intramuscular use (FDA Access Data)

Ophthalmic (Surgical) Use:

• Use aseptic techniques: disinfect stopper, spike container, purge air from tubing (DailyMed)
• Perfusion should not exceed 60 minutes (FDA Access Data)
• Single‑patient use only; discard after opening (FDA Access Data)

Laboratory Use:

• Volume and exposure time depend on experimental requirements
• Used at ambient temperature according to laboratory protocol

BSS is an isotonic electrolyte solution containing sodium, potassium, calcium, magnesium, acetate, and citrate at physiologic pH (~7.0–7.5) and osmolality (~300 mOsm/kg). It mimics the ionic composition of aqueous humor, maintaining cellular hydration, corneal endothelial integrity, and osmotic balance during ocular irrigation. It provides a stable environment for cells and tissues during surgical or laboratory procedures, without pharmacologic activity (medtigo.com, Wikipedia).

• Absorption & Distribution: Not systemically absorbed; remains local to irrigation site
• Metabolism & Excretion: Not applicable (no systemic uptake)
• Onset of Action: Immediate upon contact
• Bioavailability & Half‑Life: Not relevant for topical use

• Pregnancy: Not systemically administered; no systemic exposure expected. Minimal risk during ophthalmic use.
• Lactation: Not relevant; no transfer into breast milk occurs via topical intraocular irrigation.

• Primary Class: Ophthalmic Irrigating Solution
• Subclass: Balanced Salt Solution matching physiological aqueous humor

• Not for injection or intravenous infusion; intended strictly for topical irrigation (FDA Access Data, FDA Report)
• Do not use if container is damaged, seal broken, overwrap compromised, or solution is discolored or has precipitate (FDA Access Data)
• Single-patient use only; reuse is contraindicated (FDA Access Data, DailyMed)

• Strictly not for injection; misuse may lead to fluid overload or electrolyte imbalance (FDA Access Data, FDA Report)
• Use under aseptic conditions only
• Use with caution in diabetic patients undergoing vitrectomy, as intraoperative lens changes or corneal effects have been reported (DailyMed)
• Do not add supplements or medications unless compatibility is verified—additives may cause corneal decompensation (FDA Access Data)

• Corneal swelling or edema, including bullous keratopathy, especially if corneal endothelium is traumatized or in diabetic eyes (DailyMed)
• Postoperative inflammation, corneal clouding, or decompensation have been reported rarely (DailyMed)

• No drug‑drug, drug‑food, or alcohol interactions, as BSS is not systemically absorbed
• Additives are not recommended unless compatibly demonstrated; mixing with unapproved substances may damage ocular tissues (Drugs.com)

• Regulatory emphasis on single‑patient containers, no preservative, and maximum irrigation duration of 60 minutes (FDA Access Data)
• BSS PLUS variant includes bicarbonate, dextrose, glutathione; used for longer intraocular procedures like vitrectomy, with improved retinal support and endothelial preservation (FDA Access Data)
• No recent changes in core composition or new systemic safety warnings have emerged

• Temperature: Store at 20 °C to 25 °C (68 °F to 77 °F); excursions permitted to 15 °C–30 °C (59 °F–86 °F) (MedLibrary.org)
• Humidity & Light: Store in original overwrap to protect from light and humidity
• Freezing: Do not freeze
• Handling: Use only if overwrap intact, container clear, seal unbroken; follow aseptic technique. Discard unused portion immediately after opening; do not reuse container (MedLibrary.org)