LACTULOSE AUG PHARMA 3.35 GM / 5 ML ( LACTULOSE ) ORAL SOLUTION 320 ML

Generic Name:

Lactulose

Pharmacological Class:

Osmotic laxative / Ammonia detoxicant

Strength and Formulation:

• Each 5 mL contains Lactulose 3.35 g
• Oral solution or syrup form

Mechanism of Action:

• Lactulose is a synthetic disaccharide (galactose + fructose) that is not absorbed in the small intestine.
• In the colon, it is metabolized by bacterial flora to low–molecular-weight organic acids (lactic, acetic, formic acids).
• These acids increase osmotic pressure in the colon, causing water retention → softens stool and stimulates peristalsis.
• In hepatic encephalopathy, the acidic environment converts ammonia (NH₃) into ammonium (NH₄⁺), reducing its absorption and systemic toxicity.

Therapeutic Indications:

1. Chronic constipation
2. Hepatic encephalopathy (prevention and treatment)
3. Bowel regulation after surgery or prolonged immobilization
4. Prevention of straining in patients with hemorrhoids or post-anorectal surgery

Dosage & Administration:

Constipation:

• Adults: 15–30 mL daily (may start with 15 mL twice daily, adjust to effect)
• Children (7–14 years): 15 mL daily
• Children (1–6 years): 5–10 mL daily
• Infants (<1 year): up to 5 mL daily

Adjust dose individually to produce 2–3 soft stools per day.

Hepatic Encephalopathy

• Adults: Initial 30–45 mL 3–4 times daily, then adjust to maintain 2–3 soft stools/day.
• Pediatric use: As directed by a physician.

Onset of Action:

• Usually 24–48 hours after first dose for constipation.

Adverse Effects:

Precautions & Warnings:

• Use with caution in diabetic patients (contains galactose and lactose).
• Avoid prolonged use without medical advice.
• Monitor electrolytes in long-term therapy or high doses.
• Contraindicated in:
  • Galactosemia
  • Intestinal obstruction
  • Hypersensitivity to Lactulose

Drug Interactions:

• Antacids or antibiotics (e.g., neomycin) may reduce the acidifying effect of Lactulose in the colon.
• Electrolyte imbalance may occur with concomitant diuretic use.

Pregnancy & Lactation:

• Safe to use; not systemically absorbed.
• No teratogenic or fetal effects reported.

Storage:

• Store below 25°C.
• Do not freeze.
• Keep tightly closed and away from light.

Patient Counseling:

• May be taken with or without food.
• Drink plenty of water during treatment.
• Effects may take 1–2 days to appear.
• Report persistent diarrhea or abdominal pain.

References:

1. British National Formulary (BNF), 2025 Edition.
2. AHFS Drug Information, American Society of Health-System Pharmacists.
3. WHO Model List of Essential Medicines, 2023.
4. Schumann C. Clinical Nutrition Supplement, 2002 — Mechanisms and safety of lactulose.

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