SORBITOL 3.3% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for SORBITOL 3.3% IN PLASTIC CONTAINER (SORBITOL 3.3% IN PLASTIC CONTAINER).
Sorbitol is a sugar alcohol that acts as an osmotic diuretic. It increases the osmolarity of the glomerular filtrate, which inhibits renal tubular reabsorption of water and electrolytes, thereby promoting diuresis. Additionally, it reduces intracranial pressure by creating an osmotic gradient that draws water from brain tissue into the cerebrospinal fluid and bloodstream.
| Metabolism | Sorbitol is primarily metabolized in the liver to fructose via sorbitol dehydrogenase, and then fructose is metabolized via glycolysis. A small fraction is converted to glucose. |
| Excretion | Renal excretion of unchanged sorbitol; >90% eliminated via kidneys within 24 hours. Minor biliary/fecal elimination (<5%). |
| Half-life | 1.5–2.5 hours in normal renal function; prolonged in renal impairment (up to 20–30 hours in oliguric states). |
| Protein binding | Negligible (<5%); does not significantly bind to plasma proteins. |
| Volume of Distribution | 0.2–0.4 L/kg; distributes primarily in extracellular fluid, minimal intracellular penetration. |
| Bioavailability | Oral: 20–30% (due to colonic metabolism and excretion); intravenous: 100%. |
| Onset of Action | Intravenous: within 15–30 minutes for diuresis; oral: 30–60 minutes for cathartic effect. |
| Duration of Action | Intravenous diuresis: 2–4 hours; oral catharsis: 3–6 hours. Effects may be prolonged in renal insufficiency. |
Intravenous infusion: 100-200 mL of a 3.3% solution (3.3-6.6 g sorbitol) over 15-30 minutes, typically used as an osmotic diuretic or for bowel preparation; frequency depends on indication, e.g., once for diagnostic procedures or up to 4 times daily for bowel evacuation.
| Dosage form | SOLUTION |
| Renal impairment | eGFR <10 mL/min: contraindicated (risk of accumulation and osmotic nephrosis); eGFR 10-30 mL/min: reduce dose by 50% and monitor serum osmolality and renal function; eGFR >30 mL/min: no adjustment necessary. |
| Liver impairment | Child-Pugh class C: avoid due to risk of lactic acidosis and volume overload; Child-Pugh class A and B: no specific dose adjustment, but monitor for ascites and electrolyte imbalance. |
| Pediatric use | Children: 2-6 mL/kg of 3.3% solution intravenously over 30 minutes, not to exceed 200 mL per dose; may repeat based on tolerance and response, maximum 5 doses per 24 hours. |
| Geriatric use | Start with lower end of adult dose (100-150 mL) due to age-related reduction in renal function and increased risk of electrolyte disturbances; monitor serum electrolytes, osmolality, and fluid balance closely. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for SORBITOL 3.3% IN PLASTIC CONTAINER (SORBITOL 3.3% IN PLASTIC CONTAINER).
| Breastfeeding | Sorbitol is minimally absorbed systemically; therefore, excretion into breast milk is negligible. The M/P ratio is unknown but likely very low. It is considered compatible with breastfeeding. Use with caution due to potential laxative effect on the infant if large doses are consumed. |
| Teratogenic Risk | Sorbitol 3.3% is a hyperosmotic laxative. Animal studies have not been conducted; no well-controlled human studies exist. Systemic absorption is minimal after oral or rectal administration, so teratogenic risk is considered low across all trimesters. However, prolonged use may cause electrolyte imbalances which could theoretically affect fetal development. No specific malformation patterns reported. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Anuria due to severe renal disease","Severe dehydration","Hypersensitivity to sorbitol","Pulmonary edema or congestive heart failure","Known fructose intolerance"]
| Precautions | ["May cause fluid and electrolyte disturbances, including hyponatremia or hypernatremia","Risk of volume overload in patients with renal or cardiac impairment","Extravasation can cause tissue necrosis","May precipitate seizures in patients with renal failure","Monitor serum osmolality, electrolytes, and renal function"] |
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| Fetal Monitoring | Maternal monitoring: vital signs, serum electrolytes (especially sodium and potassium) with prolonged use or if vomiting/diarrhea occur, fluid intake/output. Fetal monitoring: not routinely required; assess for fetal wellbeing if maternal electrolyte disturbances develop. |
| Fertility Effects | No known adverse effects on human fertility. Animal studies are lacking, but given minimal systemic absorption, significant reproductive impact is unlikely. |