Sapotor

Glycerin (also known as Glycerol) is approved and commonly used for the following indications:

Approved Indications

• Osmotic laxative for temporary relief of occasional constipation.
• Hyperosmotic agent for reducing elevated intraocular pressure in:
• Acute glaucoma (including angle-closure glaucoma)
• Pre- and post-ocular surgery to decrease intraocular pressure.
• Lubricant and humectant in topical, oral, and ophthalmic preparations for:
• Dry skin conditions (eczema, dermatitis)
• Dry mouth (xerostomia)
• Dry eye syndrome.

Off-label / Clinically Accepted Uses

• Cough syrups as a soothing agent for throat irritation.
• Moisturizing agent in pharmaceutical and cosmetic formulations.
• Adjuvant in wound care to maintain moisture balance.

Adults

• As laxative (rectal suppository):
• Glycerin suppository 2–3 g (pediatric), 3–5 g (adult), administered rectally once daily as needed.
• As oral hyperosmotic agent for glaucoma:
• Dose: 1–1.5 g/kg body weight diluted in fruit juice, given orally as a single dose 30–60 minutes before surgery or during acute IOP crisis.

Pediatric

• Laxative (rectal):
• 1–1.5 g for infants and children, administered once daily as needed.

Elderly

• Same as adult dosing; monitor for dehydration and electrolyte imbalance.

Special Populations

• Renal impairment: Use with caution; monitor fluid/electrolyte status.
• Hepatic impairment: No specific dose adjustment required, but caution advised.

Administration

• Oral: Dilute in fruit juice to improve taste; give on an empty stomach for maximum effect.
• Rectal: Insert suppository gently into the rectum; effect occurs within 15–30 minutes.
• Ophthalmic: Follow specific product instructions for intraocular use under supervision.

Glycerin acts as an osmotic agent. When administered orally, it increases plasma osmolarity, drawing water out of tissues, including the aqueous humor, thereby reducing intraocular pressure. As a rectal laxative, glycerin exerts a hyperosmotic effect in the colon, drawing water into the rectum and stimulating bowel evacuation by softening stools and promoting peristalsis. Topically, it works as a humectant, attracting and retaining moisture in the stratum corneum, improving hydration of the skin or mucous membranes.

• Absorption: Well absorbed orally; minimal absorption from rectal route.
• Distribution: Widely distributed in body fluids and tissues.
• Metabolism: Primarily metabolized in the liver via glycerol kinase pathway to glucose and glycogen or oxidized to CO₂ and water.
• Half-life: Approximately 30–45 minutes after oral administration.
• Excretion: Metabolites excreted in urine; minimal unchanged drug excreted.

• Pregnancy: Considered relatively safe when used short-term; minimal systemic toxicity. Avoid prolonged or high-dose use unless clearly indicated.
• Lactation: Excretion into breast milk is minimal; generally regarded as safe. Use under medical guidance.

• Primary Class: Osmotic agent.
• Subclasses:
• Laxative (rectal)
• Hyperosmotic agent (systemic)
• Humectant/moisturizer (topical)

• Known hypersensitivity to glycerin.
• Severe dehydration or anuria (when used systemically).
• Active rectal bleeding or bowel obstruction (for rectal formulations).

• Use with caution in patients with diabetes (due to conversion to glucose).
• Monitor for electrolyte imbalance with prolonged use.
• Rectal irritation may occur with suppository use.
• Do not use as a chronic laxative; may cause dependence.

Common

• Rectal: Mild irritation, abdominal cramps.
• Oral: Nausea, vomiting, headache, thirst.

Rare/Serious

• Hyperglycemia in diabetic patients.
• Severe dehydration or electrolyte imbalance with excessive systemic use.

• Oral glycerin may alter absorption of other oral medications if taken simultaneously.
• No major CYP450 interactions reported.
• Avoid concurrent use with strong dehydrating agents without monitoring.

• Clinical guidelines emphasize short-term use for constipation relief and controlled dosing for intraocular pressure management.
• No recent major regulatory changes noted in FDA, EMA, or WHO guidance.

• Store at controlled room temperature (15–30°C).
• Protect from excessive heat and moisture.
• Do not freeze.
• Keep in tightly closed container; discard if discolored or contaminated.