OSMITROL 10% IN WATER IN PLASTIC CONTAINER
Clinical safety rating
cautionComprehensive 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. |
| Molecular Weight | 182.17 |
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 | Mannitol is a category C drug. There are no adequate and well-controlled studies in pregnant women. Use only if potential benefit justifies potential risk to the fetus. Mannitol may cause fluid and electrolyte disturbances that could affect the fetus. |
| 2nd trimester | Same as T1: Category C, use only if clearly needed. Monitor maternal fluid and electrolyte balance closely. |
| 3rd trimester | Same as T1: Category C. Avoid use near term as mannitol may cause polyhydramnios or fetal fluid imbalance. Use only if clearly indicated. |
Clinical note
Comprehensive clinical and safety monograph for OSMITROL 10% IN WATER IN PLASTIC CONTAINER (OSMITROL 10% IN WATER IN PLASTIC CONTAINER).
| Placental transfer | Mannitol crosses the placenta. Studies show that mannitol equilibrates between maternal and fetal compartments, reaching similar concentrations in fetal plasma and amniotic fluid. |
| Breastfeeding | Mannitol is excreted into human breast milk in small amounts. The molecular weight (182.17 Da) suggests limited excretion. However, due to potential for osmotic diuresis and electrolyte disturbances in the infant, caution is advised. Use only when clearly indicated and monitor infant for signs of dehydration or electrolyte imbalance. |
| Lactation Rating | L3: Moderately Safe |
| 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. |
| 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. |
■ FDA Black Box Warning
Not approved for use in patients with severe renal impairment, anuria, or intracranial hemorrhage with active bleeding.
| Serious Effects |
Anuria due to severe renal diseaseSevere pulmonary congestion or edemaActive intracranial bleeding (except during craniotomy)Severe dehydrationProgressive renal failure after starting mannitol therapyHypersensitivity to mannitol or any component of the formulation
| 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. |
| Food/Dietary | No specific food interactions. Maintain adequate hydration as directed. Avoid excessive salt intake to minimize fluid retention. |
| Clinical Pearls | Osmítrol 10% is a hyperosmotic agent used to reduce intracranial pressure and cerebral edema. Administer via IV infusion using an in-line filter to prevent particulate embolism. Monitor serum osmolarity and sodium levels; discontinue if osmolarity exceeds 320 mOsm/L. Ensure adequate hydration to avoid hypovolemia. Use with caution in patients with renal impairment, congestive heart failure, or pulmonary congestion. Crystallization may occur at low temperatures; warm to redissolve crystals before use. |
| Patient Advice | This medication is given intravenously to reduce swelling in the brain. · You may experience a headache, nausea, or increased thirst during infusion. · Report any signs of allergic reaction (rash, itching, difficulty breathing) immediately. · You will be monitored with blood tests to check kidney function and electrolyte levels. · Avoid rapid position changes to prevent dizziness due to fluid shifts. · Do not stop this medication abruptly; follow your healthcare provider's instructions. |
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