PLEGISOL IN PLASTIC CONTAINER
Clinical safety rating
cautionComprehensive 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. |
| Molecular Weight | 310.86 |
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 | Plegisol is a cardioplegic solution used intraoperatively; systemic exposure is minimal. No adequate human studies; animal data lacking. Theoretical risk of electrolyte disturbances. Use only if clearly needed. |
| 2nd trimester | Same as T1; minimal systemic absorption. Consider risks vs benefits during cardiac surgery. |
| 3rd trimester | Same as T1; potential for fetal effects from maternal electrolyte shifts or hypotension, but unlikely with single exposure. |
Clinical note
Comprehensive clinical and safety monograph for PLEGISOL IN PLASTIC CONTAINER (PLEGISOL IN PLASTIC CONTAINER).
| Placental transfer | Negligible due to intraoperative, localized administration; molecular weight and charge limit transfer. No specific studies. |
| Breastfeeding | Intraoperative use; systemic levels negligible. No data on excretion into breast milk. Consider interruption of breastfeeding for 24 hours post-procedure due to general anesthesia and surgical stress, not Plegisol itself. |
| Lactation Rating | L1 (Safe) |
| 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. |
| Fertility Effects | No known direct effect on fertility due to local, intraoperative use. |
■ FDA Black Box Warning
None.
| Serious Effects |
Hypersensitivity to any componentHyperkalemiaHypercalcemiaSevere metabolic acidosis
| 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. |
| Food/Dietary | No specific food interactions; Plegisol is administered intraoperatively and directly into the heart. However, patients should follow preoperative fasting guidelines as directed by the surgical team. |
| Clinical Pearls | Plegisol is a cardioplegic solution used to induce cardiac arrest during open-heart surgery. It is typically administered via the aortic root or coronary ostia after aortic cross-clamping. The solution is cold (4-8°C) to reduce myocardial metabolism and protect against ischemia. Monitor for electrolyte imbalances, especially potassium and magnesium, as Plegisol contains high potassium (16 mEq/L) and magnesium (32 mEq/L). Do not administer intravenously; it is for cardiac perfusion only. Avoid overdistension of the heart; monitor intraventricular pressure. Use within 24 hours of opening the container. |
| Patient Advice | This medication is given during heart surgery to stop your heart temporarily so the surgeon can operate. · You will be under general anesthesia and will not feel anything during administration. · After surgery, your heart will be restarted with a warm blood solution. · Possible side effects include temporary changes in heart rhythm, electrolyte imbalances, or low blood pressure. · Tell your doctor if you have a history of kidney problems or electrolyte disorders. · You may need blood tests to monitor your potassium and magnesium levels. |
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