OSMITROL 20% IN WATER IN PLASTIC CONTAINER
Clinical safety rating
cautionComprehensive 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. |
| Molecular Weight | 182.17 |
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 | Contraindicated in first trimester due to risk of fetal hypernatremia and dehydration. |
| 2nd trimester | Use only if clearly needed; may cause maternal fluid shifts affecting placental perfusion. |
| 3rd trimester | Avoid; may induce maternal hypervolemia and electrolyte disturbances in neonate. |
Clinical note
Comprehensive clinical and safety monograph for OSMITROL 20% IN WATER IN PLASTIC CONTAINER (OSMITROL 20% IN WATER IN PLASTIC CONTAINER).
| Placental transfer | Osmotically active; crosses placenta to some extent, causing fetal shifting of water and electrolytes. |
| Breastfeeding | Not recommended during breastfeeding; excretion in milk unknown but potential for infant hypernatremia and diuresis. |
| Lactation Rating | L5 |
| 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. |
| 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. |
■ 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 |
Severe renal impairment (anuria)Pulmonary edemaActive intracranial bleedingHypersensitivity to mannitolSevere dehydration
| 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 |
| Food/Dietary | No specific food interactions. Maintain adequate hydration as directed. Patients with electrolyte imbalances may require dietary modifications (e.g., sodium or potassium adjustments) based on serum levels. Avoid excessive fluid intake unless instructed, as it may counteract the osmotic effect. |
| Clinical Pearls | Osmotrol 20% (mannitol) is a hyperosmotic agent used to reduce intracranial pressure (ICP) and cerebral edema. Administer via IV infusion using an in-line filter (pore size ≤5 microns) to prevent mannitol crystals from entering the circulation. Monitor serum osmolality closely; target <320 mOsm/L to avoid acute kidney injury. Rapid administration can cause transient hypervolemia, which may precipitate heart failure in susceptible patients. Onset of action typically within 15–30 minutes for ICP reduction. Extravasation risk: mannitol causes venous irritation; stop infusion immediately if pain or swelling occurs. |
| Patient Advice | This medication is given through a vein to reduce swelling in the brain or to promote urine output. · Report any burning, pain, or redness at the IV site immediately. · You may experience increased thirst or a dry mouth during treatment. · Kidney function and blood levels will be monitored regularly while receiving this medication. · If you have a history of heart failure or kidney problems, inform your healthcare provider. · Do not drive or operate machinery if you feel dizzy or faint. · Tell your doctor about all other medications you are taking, especially diuretics or medications that affect kidney function. |
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