TIS-U-SOL IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TIS-U-SOL IN PLASTIC CONTAINER (TIS-U-SOL IN PLASTIC CONTAINER).
TIS-U-SOL is a balanced isotonic solution for irrigation and flushing during surgical procedures. It does not have a pharmacological mechanism of action as it is not systemically absorbed. It maintains physiologic osmolarity and electrolyte balance in the irrigated field.
| Metabolism | Not metabolized; eliminated from the body via excretion from the irrigated site. |
| Excretion | Renal: 100% (as electrolytes). Biliary/Fecal: negligible. |
| Half-life | Not applicable (electrolyte solution; components distribute and are excreted with endogenous pools). |
| Protein binding | 0% (electrolytes are unbound in plasma). |
| Volume of Distribution | Sodium: ~0.45 L/kg (extracellular fluid); Chloride: ~0.25 L/kg (extracellular); others distribute according to fluid compartments. |
| Bioavailability | Intravenous: 100%. |
| Onset of Action | Intravenous: Immediate upon infusion. |
| Duration of Action | Duration depends on infusion rate and renal function; continuous infusion required to maintain effect. |
Not applicable; TIS-U-SOL is an irrigation solution for intra-operative use. No systemic dosing.
| Dosage form | SOLUTION |
| Renal impairment | No adjustment required as solution is used topically and not absorbed systemically. |
| Liver impairment | No adjustment required as solution is used topically and not absorbed systemically. |
| Pediatric use | Not applicable; use as surgical irrigation with no systemic absorption. |
| Geriatric use | No specific considerations; use same as adult for irrigation. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for TIS-U-SOL IN PLASTIC CONTAINER (TIS-U-SOL IN PLASTIC CONTAINER).
| Breastfeeding | TIS-U-SOL is not systemically absorbed when used for irrigation; thus, exposure to breastfed infants is negligible. For intravenous administration, the components (electrolytes, water) are normal body constituents and not expected to cause adverse effects in the infant. No M/P ratio is available as it is not a drug per se. |
| Teratogenic Risk | TIS-U-SOL is a balanced electrolyte solution used for irrigation, absorption, and intravenous administration. No teratogenic effects have been observed in animal studies; however, use during pregnancy should be based on clinical need with caution, especially during the first trimester due to lack of human data. No specific fetal risks are documented for the solution itself, but underlying maternal conditions treated may pose risks. |
■ FDA Black Box Warning
None
| Serious Effects |
["Hypersensitivity to any component of the solution"]
| Precautions | ["For irrigation only, not for intravenous administration","Do not use if solution is discolored or contains particles","Use only if container is intact","Do not warm above 66°C (150°F) to avoid container damage","Avoid contamination during use"] |
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| Fetal Monitoring | When used intravenously, monitor maternal serum electrolytes, fluid balance, renal function, and signs of fluid overload (e.g., edema, pulmonary congestion). Fetal monitoring includes heart rate and growth via ultrasound if maternal fluid imbalance or electrolyte disturbances develop. |
| Fertility Effects | No known effects on fertility from TIS-U-SOL. It is a physiologic solution without hormonal or gametotoxic properties. |