OSMITROL 20% IN WATER IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for OSMITROL 20% IN WATER IN PLASTIC CONTAINER (OSMITROL 20% IN WATER IN PLASTIC CONTAINER).
Osmotic diuretic that increases plasma osmolality, drawing water from intracellular spaces into extracellular fluid and increasing renal tubular osmotic pressure, thereby inhibiting water reabsorption and promoting diuresis.
| Metabolism | Not significantly metabolized; excreted unchanged by the kidneys via glomerular filtration. |
| Excretion | Primarily renal (90-100% unchanged) via glomerular filtration; <3% metabolized in liver; minimal biliary/fecal excretion. |
| Half-life | Terminal elimination half-life is 0.25–1.5 hours in normal renal function; prolonged to 4–6 hours with anuria or oliguria. Clinically, osmotic diuresis lasts as long as urine output sustains concentration. |
| Protein binding | Approximately 0%; no significant protein binding. |
| Volume of Distribution | 0.3–0.6 L/kg; distributes primarily in extracellular fluid, limited intracellular penetration. Higher Vd in edema states. |
| Bioavailability | Intravenous: 100% (only route of administration); oral bioavailability is negligible due to poor absorption and osmotic diarrhea. |
| Onset of Action | Intravenous: diuresis occurs within 1–3 hours of infusion; reduction of intracranial pressure begins within 15–45 minutes. |
| Duration of Action | Diuresis lasts 1–3 hours post-infusion; reduction of cerebral edema persists for 3–8 hours, depending on dose and renal function. Repeated doses may be needed. |
0.25-1 g/kg intravenously over 30-60 minutes, repeated every 6-12 hours if needed.
| Dosage form | INJECTABLE |
| Renal impairment | Contraindicated in anuria; for oliguria, monitor urine output closely; no specific GFR-based dose adjustment established, but use with caution in renal impairment. |
| Liver impairment | No specific Child-Pugh based adjustment; use with caution in hepatic failure. |
| Pediatric use | 0.25-1 g/kg intravenously over 30-60 minutes, repeat every 4-6 hours as needed; maximum 2 g/kg/day. |
| Geriatric use | Start at lower end of dosing range (0.25 g/kg) due to decreased renal function; monitor electrolytes and renal function closely. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for OSMITROL 20% IN WATER IN PLASTIC CONTAINER (OSMITROL 20% IN WATER IN PLASTIC CONTAINER).
| Breastfeeding | Excretion in human milk unknown. Avoid breastfeeding during administration due to potential for adverse effects in infant (e.g., electrolyte imbalance, dehydration). M/P ratio is not available. |
| Teratogenic Risk | Pregnancy Category C. Animal reproduction studies have not been conducted. Osmotic diuretics may cause maternal dehydration and electrolyte imbalances. Inadequate human data across all trimesters; potential fetal harm if maternal hypovolemia or severe electrolyte disturbances occur. Use only if clearly needed. |
■ FDA Black Box Warning
May cause osmotic nephrosis and acute renal failure, especially with doses >200 g or in patients with pre-existing renal disease.
| 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 serum electrolytes, osmolarity, and renal function","Avoid extravasation as it may cause tissue necrosis","Use with caution in patients with cardiac or pulmonary congestion","May precipitate heart failure due to volume expansion"] |
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| Fetal Monitoring | Monitor maternal urine output, serum electrolytes (sodium, potassium, chloride, bicarbonate), osmolality, and fluid balance. Assess for signs of dehydration or hypervolemia. Fetal monitoring for heart rate abnormalities if used during labor. |
| Fertility Effects | No data on effects on fertility. Osmotic diuretics may cause reversible electrolyte disturbances that could theoretically impair reproductive function, but no specific studies exist. |