SORBITOL 3% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for SORBITOL 3% IN PLASTIC CONTAINER (SORBITOL 3% IN PLASTIC CONTAINER).
Sorbitol is a sugar alcohol that acts as an osmotic diuretic. When administered intravenously, it increases plasma osmolality, drawing water from extravascular spaces into the intravascular compartment, thereby reducing intracranial pressure and cerebral edema. It is also used as a hyperosmotic laxative via oral administration, drawing water into the colon to stimulate bowel movements.
| Metabolism | Sorbitol is metabolized primarily in the liver to fructose via sorbitol dehydrogenase, and to a lesser extent in other tissues. It is also partially excreted unchanged in urine. |
| Excretion | Sorbitol is primarily excreted renally as metabolites (fructose and glucose) and unchanged drug; approximately 50-70% is recovered in urine over 24 hours, with less than 10% eliminated in feces. |
| Half-life | Terminal elimination half-life is approximately 1.5-2 hours in patients with normal renal function; prolonged in renal impairment (up to 6 hours in anuria). |
| Protein binding | Not significantly bound to plasma proteins (<5%). |
| Volume of Distribution | Approximately 0.3-0.5 L/kg, indicating distribution primarily in extracellular fluid. |
| Bioavailability | Oral bioavailability is low (approximately 30%) due to extensive hepatic metabolism to fructose; intravenous bioavailability is 100%. |
| Onset of Action | Intravenous: onset of osmotic diuresis within 15-30 minutes; oral: onset of cathartic effect within 0.5-1 hour. |
| Duration of Action | Intravenous: duration of diuresis is 2-4 hours; oral: cathartic effect lasts 1-3 hours. |
30 mL of 3% solution (0.9 g) administered intravenously over 30-60 minutes, typically as a single dose.
| Dosage form | SOLUTION |
| Renal impairment | Contraindicated in anuria and severe renal impairment (GFR <30 mL/min). No dose adjustment needed for mild-to-moderate renal impairment; monitor renal function and serum electrolytes. |
| Liver impairment | No specific dosage adjustments recommended for hepatic impairment. Use with caution in severe liver disease due to potential for fluid and electrolyte disturbances. |
| Pediatric use | 0.5-1 g/kg (16-33 mL/kg of 3% solution) intravenously over 30-60 minutes, repeated if needed based on serum sodium and clinical response. |
| Geriatric use | Use with caution; monitor renal function, fluid balance, and serum sodium closely due to higher risk of volume overload and electrolyte disturbances. No specific dose reduction required. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for SORBITOL 3% IN PLASTIC CONTAINER (SORBITOL 3% IN PLASTIC CONTAINER).
| Breastfeeding | Sorbitol is not expected to be excreted into breast milk in significant amounts due to negligible systemic absorption. No M/P ratio has been established. It is considered compatible with breastfeeding, but monitor infant for loose stools or gastrointestinal disturbances. |
| Teratogenic Risk | Sorbitol 3% is a hyperosmotic laxative with minimal systemic absorption. No teratogenic effects have been reported in animal studies or human case series. The FDA assigns it pregnancy category C; however, limited systemic exposure suggests minimal fetal risk across all trimesters when used as directed. Caution is advised in third trimester due to potential for maternal fluid/electrolyte shifts. |
■ FDA Black Box Warning
Sorbitol 3% in plastic container is not associated with a boxed warning.
| Serious Effects |
Anuria due to severe renal disease, severe dehydration, pulmonary edema, active intracranial bleeding (except during craniotomy), known hypersensitivity to sorbitol or any component of the formulation.
| Precautions | Use with caution in patients with renal impairment, heart failure, or conditions where fluid overload is a concern. Monitor serum electrolytes, osmolality, and renal function. May cause fluid and electrolyte imbalances, including hypernatremia and hypokalemia. Rapid administration can induce vasodilation and hypotension. Use in patients with known sorbitol or fructose intolerance may cause adverse effects. |
Loading safety data…
| Fetal Monitoring | No specific fetal monitoring is required. In prolonged use or in patients with renal impairment, monitor maternal serum electrolytes (sodium, potassium) and hydration status, as sorbitol can cause osmotic diarrhea leading to dehydration or electrolyte imbalance. |
| Fertility Effects | No known adverse effects on human fertility. Animal studies have not reported impaired fertility. The lack of systemic absorption minimizes any potential impact on reproductive function. |