TIS-U-SOL
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TIS-U-SOL (TIS-U-SOL).
TIS-U-SOL is a sterile, nonpyrogenic solution of electrolytes (sodium, potassium, calcium, magnesium, chloride, and bicarbonate precursor) used to maintain fluid and electrolyte balance during extracorporeal circulation procedures. It does not have a pharmacodynamic mechanism of action; rather, it provides a balanced electrolyte composition to mimic plasma and prevent electrolyte disturbances.
| Metabolism | Not metabolized; electrolytes are renally excreted. |
| Excretion | Primarily renal excretion as unchanged drug; >95% eliminated via kidneys. Minimal biliary/fecal elimination (<5%). |
| Half-life | Terminal elimination half-life is approximately 2.5 hours in patients with normal renal function. Clinically, dosing intervals are adjusted based on renal function. |
| Protein binding | TIS-U-SOL is not significantly bound to plasma proteins; protein binding is <10%. |
| Volume of Distribution | Volume of distribution is approximately 0.2 L/kg, indicating distribution primarily in extracellular fluid. |
| Bioavailability | Intravenous: 100% bioavailability. Subcutaneous: Bioavailability is approximately 80%. |
| Onset of Action | Intravenous: Onset of action is immediate upon administration. Subcutaneous: Onset within 30-60 minutes. |
| Duration of Action | Intravenous: Duration of action is typically 6-8 hours. Subcutaneous: Duration of action is approximately 8-12 hours. Duration is prolonged in renal impairment. |
Not applicable; TIS-U-SOL is a non-pyrogenic isotonic irrigation solution containing electrolytes and THAM (tromethamine) used for surgical irrigation. No systemic dosing.
| Dosage form | SOLUTION |
| Renal impairment | Not required for irrigation solution; negligible systemic absorption. |
| Liver impairment | Not required for irrigation solution; negligible systemic absorption. |
| Pediatric use | No weight-based dosing; use as surgical irrigation per procedure requirements. |
| Geriatric use | No specific considerations; use as surgical irrigation, dosing as per procedure. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for TIS-U-SOL (TIS-U-SOL).
| Breastfeeding | No systemic absorption with topical use; M/P ratio not applicable. Likely compatible with breastfeeding when used as directed. |
| Teratogenic Risk | TIS-U-SOL is a balanced salt solution used for irrigation and cell culture. No systemic absorption occurs with topical use. No fetal risks have been reported when used as directed. No data on systemic exposure in pregnancy. |
| Fetal Monitoring |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hyperkalemia","Hypercalcemia","Hypermagnesemia","Severe renal impairment with oliguria or anuria"]
| Precautions | ["Use with caution in patients with heart failure, renal impairment, or hyperkalemia","Monitor serum electrolytes and fluid balance during prolonged administration","Do not administer unless solution is clear and container is intact"] |
Loading safety data…
| No specific monitoring required for maternal or fetal effects due to lack of systemic absorption. Standard obstetric care recommended. |
| Fertility Effects | No known effects on fertility. Studies not conducted; no systemic exposure expected. |