OSMITROL 10% IN WATER IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for OSMITROL 10% IN WATER IN PLASTIC CONTAINER (OSMITROL 10% IN WATER IN PLASTIC CONTAINER).
Increases plasma osmolality, drawing water from tissues into the bloodstream, thereby reducing intracranial pressure and cerebral edema.
| Metabolism | Primarily excreted unchanged by the kidneys; not metabolized. |
| Excretion | Primarily renal; >90% excreted unchanged in urine via glomerular filtration; <5% biliary/fecal. |
| Half-life | Terminal half-life approximately 1.5 hours in normal renal function; prolonged in renal impairment (up to 36 hours in anuria). |
| Protein binding | Negligible (<10%); does not significantly bind to plasma proteins. |
| Volume of Distribution | Vd ~0.5 L/kg; distributes primarily in extracellular fluid, excluding cells. |
| Bioavailability | Not applicable (administered intravenously only); bioavailability is 100% by IV route. |
| Onset of Action | Intravenous: Diuresis occurs within 1 hour; reduction of intracranial pressure within 15 minutes. |
| Duration of Action | Diuresis lasts 6-8 hours; intracranial pressure reduction persists 3-6 hours. |
Initial: 0.25–1 g/kg (25–100 mL of 10% solution) IV over 30–60 minutes. May repeat every 6–12 hours if needed. Typical adult dose: 50–100 g IV. Maximum: 2 g/kg per dose.
| Dosage form | INJECTABLE |
| Renal impairment | Contraindicated in anuria or severe renal impairment (GFR <10 mL/min). In patients with GFR 10–50 mL/min, reduce dose by 50% and monitor serum osmolarity and urine output. Do not use if oliguria persists after test dose (0.2 g/kg IV over 3–5 minutes). |
| Liver impairment | No specific Child-Pugh based adjustment. Use with caution in severe hepatic impairment due to potential for fluid overload and electrolyte disturbances. Monitor serum electrolytes and hepatic function. |
| Pediatric use | Oliguria: Test dose 0.2 g/kg (2 mL/kg of 10% solution) IV over 3–5 minutes. If urine output >40 mL/hr, maintenance dose: 0.25–1 g/kg (2.5–10 mL/kg) IV over 30–60 minutes every 6–12 hours. Maximum: 2 g/kg per dose. Reduce intracranial pressure: 0.25–1 g/kg IV over 30–60 minutes. |
| Geriatric use | Start at lower end of dosing range (0.25 g/kg) due to age-related decline in renal function. Monitor renal function, serum osmolarity, electrolytes (especially sodium and potassium), and fluid balance closely. Avoid use if GFR <50 mL/min unless benefit outweighs risk. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for OSMITROL 10% IN WATER IN PLASTIC CONTAINER (OSMITROL 10% IN WATER IN PLASTIC CONTAINER).
| Breastfeeding | It is not known whether mannitol is excreted in human breast milk. No M/P ratio is available. Caution should be exercised when administered to a nursing woman. Consider the developmental and health benefits of breastfeeding alongside the mother's clinical need for the drug. |
| Teratogenic Risk | Osmitrol 10% (mannitol) is a hyperosmolar agent. There are no adequate and well-controlled studies in pregnant women. Animal studies have not been conducted. In first trimester, use only if clearly needed. In second and third trimesters, mannitol can cross the placenta and may cause fetal dehydration, electrolyte disturbances, and osmotic shifts. Risk cannot be excluded. |
■ FDA Black Box Warning
Not approved for use in patients with severe renal impairment, anuria, or intracranial hemorrhage with active bleeding.
| Serious Effects |
Anuria, severe renal impairment, pulmonary congestion, active intracranial hemorrhage, severe dehydration, known hypersensitivity to mannitol.
| Precautions | Monitor renal function, fluid and electrolyte balance, and serum osmolality. Use caution in patients with cardiac or pulmonary congestion, and administer via a filter to prevent crystallization. |
Loading safety data…
| Fetal Monitoring | Monitor maternal fluid balance, urine output (goal ≥30-50 mL/hr), serum electrolytes (sodium, potassium, chloride), and serum osmolality. Fetal monitoring may include heart rate monitoring and assessment of amniotic fluid volume via ultrasound due to potential for maternal-fetal osmotic shifts. |
| Fertility Effects | No specific studies on fertility effects. Mannitol is a diuretic; chronic use may impact fluid and electrolyte homeostasis, which could theoretically affect reproductive function. No evidence of direct gonadal toxicity. |