PLEGISOL IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for PLEGISOL IN PLASTIC CONTAINER (PLEGISOL IN PLASTIC CONTAINER).
PLEGISOL is an extracellular-type crystalloid cardioplegic solution used for myocardial protection during cardiac surgery. Its mechanism involves inducing rapid cardiac arrest by high potassium concentration (depolarizing arrest), reducing myocardial oxygen demand, and providing buffering capacity via tromethamine to maintain pH. The solution also contains magnesium to stabilize membranes and mannitol as an osmotic agent to reduce edema.
| Metabolism | PLEGISOL components are not extensively metabolized. Potassium and magnesium are excreted renally; mannitol is minimally metabolized and excreted primarily in urine; tromethamine is excreted renally and metabolized via the liver to a minor extent. |
| Excretion | Plegisol is an extracellular cardioplegic solution; its components (electrolytes and calcium) are not metabolized. Elimination of infused volume occurs primarily via renal excretion (approx. 95%) as unchanged water and electrolytes; minor biliary/fecal elimination (<5%) accounts for negligible electrolyte loss. |
| Half-life | Not applicable; Plegisol is not a systemically active drug. Its cardioplegic effect is immediate upon perfusion into coronary arteries and dissipates upon reperfusion. The solution's components have endogenous half-lives (e.g., potassium: 1-1.5 h in plasma), but this is not clinically relevant for the product. |
| Protein binding | Negligible; Plegisol is a crystalloid solution; its ions (Na+, K+, Ca2+, Mg2+, Cl-, HCO3-) are not significantly bound to plasma proteins (<10% binding for each, primarily albumin for calcium). |
| Volume of Distribution | Not applicable; Plegisol is administered directly into the coronary vasculature and does not distribute systemically. The infused volume distributes within the extracellular fluid space (approx. 0.2 L/kg), but this is irrelevant to its cardioplegic use. |
| Bioavailability | 100% via direct intracoronary administration (the only route used). No systemic bioavailability data exist as it is not given intravenously or orally. |
| Onset of Action | Immediate (seconds to 1 minute) after direct coronary artery perfusion during cardiopulmonary bypass; induces rapid diastolic arrest of the heart. |
| Duration of Action | Duration of cardioplegia is dose- and temperature-dependent; single dose typically provides myocardial protection for 60–90 minutes (at 4°C); repeated doses every 20–30 minutes are required for prolonged procedures. |
Administered as an intraperitoneal infusion for organ preservation. Typical adult dose: 2.5-3.0 liters for kidney, 2.5-3.0 liters for liver, 3.0-4.0 liters for pancreas, single dose prior to procurement.
| Dosage form | SOLUTION |
| Renal impairment | Not applicable; single-use perfusate not intended for systemic circulation. No renal dose adjustment required. |
| Liver impairment | Not applicable; single-use perfusate not intended for systemic circulation. No hepatic dose adjustment required. |
| Pediatric use | Pediatric dosing not established; use based on organ size and institutional protocols. Typically 100-200 mL/kg for donor organ perfusion. |
| Geriatric use | No specific geriatric adjustment; dosing per organ preservation protocol regardless of age. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for PLEGISOL IN PLASTIC CONTAINER (PLEGISOL IN PLASTIC CONTAINER).
| Breastfeeding | Not systemically absorbed; no risk to breastfeeding infant. M/P ratio not applicable. |
| Teratogenic Risk | Plegisol, an electrolyte solution for cardioplegia, is not systemically administered; direct fetal exposure is negligible. No teratogenic effects reported in first, second, or third trimesters. |
| Fetal Monitoring | Standard monitoring during cardiac surgery with cardiopulmonary bypass, including fetal heart rate monitoring if applicable. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to any component.","Significant renal failure (unless dialysis is available).","Pre-existing severe hyperkalemia.","Pre-existing severe metabolic alkalosis."]
| Precautions | ["Hyperkalemia: Risk of severe hyperkalemia in patients with renal impairment.","Hypokalemia: May cause rebound hypokalemia after reperfusion.","Hypomagnesemia: Electrolyte disturbances may occur.","Renal Impairment: Use with caution in patients with compromised renal function; monitor electrolytes.","Acid-Base Disturbances: Tromethamine may cause transient hypoglycemia and respiratory depression.","Mannitol: Risk of osmotic diuresis and volume depletion."] |
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| Fertility Effects | No known direct effect on fertility due to local, intraoperative use. |