OSMITROL 15% IN WATER IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for OSMITROL 15% IN WATER IN PLASTIC CONTAINER (OSMITROL 15% IN WATER IN PLASTIC CONTAINER).
Osmotically active agent that increases plasma osmolality, drawing water from intracellular and interstitial spaces into the vascular compartment, thereby reducing cerebral edema and intraocular pressure.
| Metabolism | Minimal metabolism; excreted unchanged in urine via glomerular filtration. |
| Excretion | Renal: >90% unchanged by glomerular filtration; minimal tubular reabsorption or secretion. <10% metabolized in liver (negligible). |
| Half-life | Terminal half-life: 0.25–1.5 hours (15–90 minutes) in normal renal function; prolonged to 24–36 hours in anuria or severe renal impairment. |
| Protein binding | 0% (mannitol is not bound to plasma proteins). |
| Volume of Distribution | 0.5–0.7 L/kg (distributes primarily in extracellular fluid; does not enter cells). |
| Bioavailability | Intravenous: 100%. Oral: <10% (poorly absorbed; negligible systemic availability). |
| Onset of Action | Intravenous: 30–60 minutes (diuresis begins within 1–3 hours post-infusion). |
| Duration of Action | Intravenous: 6–8 hours (diuresis continues for 4–6 hours after infusion ends; osmotic effect persists while drug remains in extracellular space). |
1.5-2 g/kg intravenous infusion over 30-60 minutes every 6-8 hours as needed for reduction of intracranial pressure or cerebral edema.
| Dosage form | INJECTABLE |
| Renal impairment | Contraindicated in anuria or severe renal impairment (GFR < 20 mL/min). For GFR 20-50 mL/min, reduce dose by 50% and monitor serum osmolality and renal function. |
| Liver impairment | No specific Child-Pugh based dosage adjustments; use with caution in severe hepatic impairment due to risk of volume overload and electrolyte disturbances. |
| Pediatric use | 0.25-1 g/kg intravenous infusion over 30-60 minutes every 6-8 hours, titrated to clinical effect. Maximum dose 2 g/kg per 24 hours. |
| Geriatric use | Start at lower end of dosing range (0.5-1 g/kg) due to increased risk of volume overload, renal impairment, and electrolyte imbalances; monitor renal function and serum osmolality closely. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for OSMITROL 15% IN WATER IN PLASTIC CONTAINER (OSMITROL 15% IN WATER IN PLASTIC CONTAINER).
| Breastfeeding | Excretion in human milk unknown; consider risk of infant electrolyte imbalance. M/P ratio not determined. |
| Teratogenic Risk | No adequate and well-controlled studies in pregnant women. Animal reproduction studies not conducted. Osmotic diuretics cross placenta and may cause electrolyte disturbances in fetus. Use only if clearly needed; risk not quantifiable per trimester. |
| Fetal Monitoring |
■ FDA Black Box Warning
Do not administer to patients with anuria due to severe renal disease, pulmonary congestion, or active intracranial bleeding except during craniotomy.
| Serious Effects |
["Anuria due to severe renal disease","Pulmonary congestion or edema","Active intracranial bleeding (except during craniotomy)","Severe dehydration","Hypersensitivity to mannitol"]
| Precautions | May cause circulatory overload, heart failure, pulmonary edema; monitor serum electrolytes, renal function, and fluid balance; avoid extravasation. |
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| Monitor maternal serum electrolytes, osmolality, urine output, and fluid balance. Fetal assessment (ultrasound) if prolonged use. |
| Fertility Effects | No human data; animal studies not available. Potential for menstrual cycle disruption due to osmotic effects. |