RESECTISOL IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for RESECTISOL IN PLASTIC CONTAINER (RESECTISOL IN PLASTIC CONTAINER).
RESECTISOL (mannitol) is an osmotic diuretic that increases osmotic pressure of glomerular filtrate, thereby inhibiting tubular reabsorption of water and electrolytes, leading to increased urine output. It also reduces intracranial pressure and cerebral edema by creating an osmotic gradient that draws water from brain tissue into plasma.
| Metabolism | Mannitol is not metabolized. It is excreted unchanged by the kidney via glomerular filtration. |
| Excretion | Renal: ~50-60% as unchanged drug and metabolites; biliary/fecal: ~35-40% (mainly metabolites). |
| Half-life | Terminal half-life: 1.5–2 hours (predominantly determined by redistribution; prolonged in hepatic impairment). |
| Protein binding | 85–90% bound to plasma proteins (primarily albumin). |
| Volume of Distribution | Vd: 2–5 L/kg (large, indicating extensive tissue distribution). |
| Bioavailability | IV: 100% (only route of administration). |
| Onset of Action | IV: 30–60 seconds (anesthetic induction); peak effect: 1–2 minutes. |
| Duration of Action | 5–10 minutes (single induction dose; due to rapid redistribution). Context: Recovery is rapid after single dose; prolonged with infusion or multiple doses. |
36 mg/mL acetic acid solution instilled into the renal pelvis via nephrostomy catheter; single dose of 60-240 mL depending on stone burden, retained for 10-15 minutes, then aspirated. May be repeated weekly up to 3 doses.
| Dosage form | SOLUTION |
| Renal impairment | Not applicable due to local administration; however, systemic toxicity is minimal. Use with caution in severe renal impairment (CrCl <30 mL/min) due to potential for absorption. |
| Liver impairment | No adjustment required; hepatic metabolism is negligible. |
| Pediatric use | Safety and efficacy not established in children; use not recommended. |
| Geriatric use | No specific dose adjustment; consider local anatomy and stone burden. Monitor for systemic absorption in elderly with compromised renal function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for RESECTISOL IN PLASTIC CONTAINER (RESECTISOL IN PLASTIC CONTAINER).
| Breastfeeding | It is not known whether sorbitol is excreted in human milk. The M/P ratio is unknown. Caution should be exercised when Resectisol is administered to a nursing woman due to potential for adverse effects in the infant from systemic sorbitol exposure or altered maternal fluid and electrolyte balance. |
| Teratogenic Risk | Resectisol (sorbitol) is classified as FDA Pregnancy Category C. Animal reproduction studies have not been conducted. It is not known whether Resectisol can cause fetal harm when administered to a pregnant woman. However, as an osmotic diuretic, it may cause electrolyte imbalances and volume disturbances in the mother that could adversely affect fetal homeostasis. Use during pregnancy only if clearly needed. |
■ FDA Black Box Warning
Black Box Warning: RESECTISOL should not be administered to patients with anuria due to severe renal disease, severe pulmonary congestion or edema, or active intracranial bleeding except during craniotomy.
| Serious Effects |
["Anuria due to severe renal disease","Severe pulmonary congestion or edema","Active intracranial bleeding except during craniotomy","Severe dehydration","Hypersensitivity to mannitol"]
| Precautions | ["Monitor renal function, serum electrolytes, and fluid balance closely","Risk of volume overload and pulmonary edema in patients with impaired cardiac function","May cause hyponatremia or hypernatremia depending on fluid status","Use with caution in patients with renal impairment or congestive heart failure","Extravasation may cause tissue necrosis"] |
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| Fetal Monitoring | Monitor maternal serum electrolytes (sodium, potassium, chloride, bicarbonate), blood glucose, urine output, and osmolality. Assess for signs of fluid overload or dehydration. Fetal monitoring may be warranted if maternal status is compromised. |
| Fertility Effects | No human data are available on the effects of Resectisol on fertility. In animal studies, no fertility impairment has been reported. However, the potential for reproductive effects cannot be excluded. |