K-Y Jelly

Approved Indications:

• Osmotic laxative for the relief of occasional constipation.
• Management of increased intracranial pressure (ICP) and cerebral edema.
• Reduction of intraocular pressure in acute glaucoma.
• Component of parenteral nutrition solutions for energy supply.
• Used in ophthalmic preparations as a lubricant and osmotic agent.

Clinically Accepted Off-Label Uses:

• Management of mild dehydration in combination solutions.
• Adjunct in reducing cerebral ischemia.
• Used as a vehicle in various pharmaceutical formulations.

Adults:

• For constipation (rectal): 1 adult suppository (approximately 2-3 g) rectally as needed.
• For increased ICP or glaucoma (oral): 1–1.5 g/kg body weight as a single dose, diluted in juice or water.

Pediatric:

• Constipation: 1 pediatric suppository (approximately 1 g) rectally as needed.
• Oral solutions for ICP/glaucoma should be under strict medical supervision.

Elderly:

• Same as adults; monitor for dehydration and electrolyte imbalance.

Special Populations:

• Renal impairment: Use with caution; monitor serum osmolality and electrolytes.
• Hepatic impairment: No specific adjustment, but hydration should be maintained.

Administration:

• Rectal: Insert suppository high into the rectum.
• Oral: Dilute glycerol solution in juice/water to minimize GI discomfort.
• Parenteral (nutrition): Administer as per individualized caloric needs.

Glycerol acts as an osmotic agent, drawing water into the intestinal lumen when administered rectally, which softens stool and stimulates bowel evacuation. Orally, it increases plasma osmolality, leading to dehydration of tissues, including ocular fluids and cerebrospinal fluid, thereby reducing intraocular and intracranial pressure. It also serves as a metabolic substrate, being converted to glucose in the liver via gluconeogenesis.

• Absorption: Rapidly absorbed from the GI tract after oral administration.
• Distribution: Widely distributed in body fluids and tissues.
• Metabolism: Metabolized primarily in the liver to glucose and glycogen.
• Excretion: Small amounts excreted unchanged in urine; major portion metabolized.
• Onset of action: Laxative effect in 15–60 minutes (rectal).
• Half-life: Approximately 30–45 minutes for systemic clearance.

• Pregnancy: Considered relatively safe when used occasionally as a laxative; systemic use should be evaluated for risk-benefit ratio.
• Lactation: Minimal excretion into breast milk; unlikely to harm the infant. Use short-term only and under supervision.
• Data: Limited human studies; caution is advised for prolonged use.

• Primary Class: Osmotic laxative.
• Additional Roles: Osmotic diuretic (oral for ICP/IOP), metabolic substrate in parenteral nutrition.

• Known hypersensitivity to glycerol or formulation components.
• Severe dehydration.
• Anuria or severe renal impairment (for systemic use).
• Gastrointestinal obstruction.

• Use with caution in patients with diabetes mellitus (due to conversion to glucose).
• Monitor electrolytes during prolonged use.
• Risk of dehydration in elderly or pediatric patients.
• Avoid excessive or chronic use as a laxative to prevent dependence.

Common:

• Mild abdominal discomfort or cramping.
• Rectal irritation (with suppository use).
• Mild diarrhea.

Serious/Rare:

• Hyperosmolar dehydration (with systemic use).
• Electrolyte imbalance.
• Headache, dizziness (with large oral doses).

Timing: Rectal effect within 15–60 min; systemic effects within 30–90 min.

• Drug-Drug: Minimal systemic interaction risk with rectal use; oral/systemic glycerol may enhance diuretic effect of other osmotic agents.
• Drug-Food: No significant interactions.
• Drug-Alcohol: No clinically relevant interactions reported.
• Enzyme Involvement: Not significantly metabolized by CYP450 enzymes.

• No major changes in FDA or EMA guidelines in recent years.
• Still classified as a safe and effective osmotic laxative and osmotic agent for IOP/ICP reduction.
• Increasing preference for glycerol as a component in artificial tear formulations for dry eye management.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from excessive heat and moisture.
• Do not freeze suppositories or solutions.
• Keep container tightly closed when not in use.
• For parenteral solutions, follow aseptic handling and storage as per manufacturer’s instructions.