Laxitol

Approved and Clinically Accepted Uses:

• Chronic Constipation:
  – Used for the treatment of chronic idiopathic or functional constipation in adults and children.
  – Safe and effective for long-term management when other laxatives are ineffective or poorly tolerated.
• Hepatic Encephalopathy (HE):
  – Used to reduce blood ammonia levels in patients with hepatic encephalopathy.
  – Helps prevent and manage neurocognitive complications associated with liver dysfunction.
• Post-Operative or Drug-Induced Constipation (Off-label):
  – Sometimes used in patients with constipation caused by opioids, surgery, or prolonged immobilization.

Route: Oral
Formulations: Powder for solution, granules, or syrup

Adults – Constipation:

• Initial dose: 10–20 g once daily, preferably with breakfast
• Maintenance dose: 10–20 g/day adjusted based on bowel response
• Maximum dose: Up to 40 g/day in divided doses (under supervision)

Children – Constipation:

• 1–6 years: 2.5–5 g once daily
• 6–12 years: 5–10 g once daily
• >12 years: Same as adults
• Mix with water, juice, or soft food

Adults – Hepatic Encephalopathy:

• Initial dose: 30–60 g/day in 2–3 divided doses
• Titrated to produce: 2–3 soft stools per day

Elderly:

• Same as adult dosing; monitor hydration and electrolytes

Renal Impairment:

• No adjustment required; not systemically absorbed

Hepatic Impairment:

• No specific adjustment, but close monitoring recommended

Administration Instructions:

• Dissolve the powder fully in water or another fluid before ingestion
• Take with meals to improve tolerability

Lactitol is a non-absorbable disaccharide that acts as an osmotic laxative. It passes unchanged through the small intestine and is metabolized by colonic bacteria into low-molecular-weight organic acids such as lactic acid and acetic acid. These acids lower the pH in the colon, increase osmotic pressure, and promote water retention in the bowel lumen, which softens stools and stimulates peristalsis. In hepatic encephalopathy, the acidification of the colon traps ammonia as ammonium, reducing systemic ammonia absorption and alleviating neurotoxic effects.

• Absorption: Minimal systemic absorption; acts locally in the colon
• Distribution: Not systemically distributed
• Metabolism: Fermented by colonic bacteria into short-chain fatty acids and gases (e.g., H₂, CO₂, CH₄)
• Excretion: Excreted as fermentation products via feces
• Onset of Action: 6–24 hours after administration
• Bioavailability: Not systemically bioavailable
• Half-life: Not applicable
• Active Metabolites: None with systemic activity

• Pregnancy:
  – Not assigned an FDA pregnancy category.
  – Considered safe for occasional or chronic use under medical supervision.
  – No known teratogenic or embryotoxic effects.
• Lactation:
  – Safe during breastfeeding.
  – Minimal to no excretion into breast milk.
  – No adverse effects expected in breastfed infants.
• Caution:
  – Use the lowest effective dose.
  – Monitor for maternal dehydration or electrolyte imbalance.

• Primary Class: Osmotic Laxative
• Sub-Class: Non-absorbable disaccharide laxative

• Known hypersensitivity to lactitol or formulation components
• Intestinal obstruction or perforation
• Patients with galactosemia
• Requirement for a low-galactose diet
• Severe dehydration with electrolyte imbalance

• Use with caution in:
  – Patients with diabetes (contains sugar alcohol)
  – Individuals with lactose intolerance
  – Those at risk of electrolyte imbalance or dehydration
  – Children and elderly patients (monitor stool consistency and hydration)
• Monitoring:
  – Electrolytes and hydration status during prolonged use
  – Adjust dose if diarrhea or cramping occurs
• Discontinue and consult a physician if:
  – Severe abdominal pain, vomiting, or rectal bleeding develops

Gastrointestinal:

• Flatulence
• Bloating
• Mild abdominal cramping
• Nausea
• Diarrhea (dose-related)

Metabolic:

• Electrolyte imbalance (with prolonged or excessive use)

Hypersensitivity (Rare):

• Rash
• Pruritus
• Anaphylaxis (extremely rare)

Onset & Severity:

• Most GI effects occur within the first few days of use
• Side effects are generally mild and reversible with dose adjustment

• Antibiotics (e.g., neomycin):
  – May reduce lactitol’s efficacy by altering gut microbiota
• Other laxatives or enemas:
  – Increased risk of fluid or electrolyte loss
• Drugs with narrow absorption windows (e.g., digoxin):
  – Absorption may be affected due to altered GI transit time
• Alcohol:
  – May worsen dehydration risk during laxative use

Enzyme Systems:
– Not metabolized by CYP450 enzymes; minimal risk of hepatic drug interactions

• Constipation Guidelines:
  – Recognized in several international guidelines as a well-tolerated alternative to lactulose with improved taste and similar efficacy.
• Hepatic Encephalopathy Management:
  – Included as an alternative to lactulose in the treatment of hepatic encephalopathy for reducing ammonia levels.
• Pediatric Use:
  – Increasing use supported by evidence of safety and efficacy in children with functional constipation.

• Temperature: Store below 25°C
• Humidity: Keep in a dry place
• Light Protection: Store in original packaging; protect from direct sunlight
• Handling Instructions:
  – Keep container tightly closed
  – Do not use after expiry
  – Shake oral suspension well before use
• Reconstitution:
  – Dissolve powder immediately before use
  – Do not store prepared solution for later use
• Refrigeration: Not required unless specified by manufacturer