OSMITROL 10% IN WATER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for OSMITROL 10% IN WATER (OSMITROL 10% IN WATER).
Osmotic diuretic that increases plasma osmolality, drawing water from intracellular spaces into extracellular fluid and increasing renal blood flow, thereby enhancing water excretion.
| Metabolism | Primarily excreted unchanged in urine; minimal hepatic metabolism. |
| Excretion | Renal: >90% excreted unchanged by glomerular filtration with minimal tubular reabsorption. Negligible biliary/fecal elimination. |
| Half-life | Terminal elimination half-life is approximately 0.25–1.5 hours in patients with normal renal function, prolonged in renal impairment. |
| Protein binding | Negligible (<1%); mannitol does not bind significantly to plasma proteins. |
| Volume of Distribution | Approximately 0.5–0.7 L/kg; distributes primarily in extracellular fluid, excluded from intracellular space and does not cross blood-brain barrier under normal conditions. |
| Bioavailability | Intravenous: 100% bioavailability. Not administered via other routes; oral bioavailability is poor (~17%) due to limited gastrointestinal absorption. |
| Onset of Action | Intravenous: Diuresis begins within 1–3 hours after infusion. Reduction of intracranial pressure occurs within 15 minutes, maximal effect at 60–90 minutes. |
| Duration of Action | Diuresis persists for 6–8 hours post-infusion. Reduction of intracranial pressure lasts approximately 3–6 hours, with rebound effect possible after cessation. |
0.25-2 g/kg intravenously over 30-60 minutes, repeated every 6-12 hours as needed. Maximum dose: 2 g/kg per dose or 200 g daily.
| Dosage form | INJECTABLE |
| Renal impairment | Contraindicated in anuria or severe renal impairment (GFR < 10 mL/min). For GFR 10-50 mL/min: reduce dose by 50% and monitor serum osmolality. For GFR > 50 mL/min: no adjustment needed. |
| Liver impairment | No specific adjustment for Child-Pugh classes; use with caution in severe hepatic impairment due to risk of fluid overload. |
| Pediatric use | 0.25-1 g/kg intravenously over 30-60 minutes, repeated every 6-12 hours. Maximum 2 g/kg per dose. |
| Geriatric use | Start at lower end of dosing range (0.25-0.5 g/kg) due to age-related decline in renal function; monitor serum electrolytes and osmolality closely. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for OSMITROL 10% IN WATER (OSMITROL 10% IN WATER).
| Breastfeeding | Not known if mannitol is excreted in human breast milk. Due to its molecular weight and water solubility, excretion is possible but likely low. Use with caution; consider risk-benefit. M/P ratio: not available. |
| Teratogenic Risk | Osmotic diuretics like mannitol cross the placenta. First trimester: limited human data, but animal studies show no consistent teratogenicity. Second and third trimesters: may cause fetal fluid and electrolyte disturbances, including hyponatremia and dehydration. Caution advised; avoid for prolonged use or high doses. Fetal monitoring recommended. |
■ FDA Black Box Warning
None
| Serious Effects |
["Anuria due to severe renal disease","Severe pulmonary congestion or pulmonary edema","Active intracranial bleeding (except during craniotomy)","Severe dehydration","Hypersensitivity to mannitol"]
| Precautions | ["May cause fluid and electrolyte imbalances","Risk of pulmonary congestion or edema in patients with impaired cardiac function","Monitor renal function and serum electrolytes","Avoid extravasation due to risk of local tissue damage"] |
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| Fetal Monitoring | Monitor maternal electrolytes (sodium, potassium, chloride), serum osmolality, fluid balance, urine output, and renal function. Fetal monitoring includes heart rate and ultrasound for signs of fluid or electrolyte imbalance. |
| Fertility Effects | No specific studies on fertility in humans. In animals, intravenous mannitol at high doses may cause ovarian or testicular effects, but clinical relevance unknown. Not expected to impair fertility at therapeutic doses. |