Drug Class: Osmotic Laxative | Ammonia Reducing Agent | Form: Oral Syrup | Prescription Status: Prescription Only (Rx) — DRAP Registered
What is Duphalac Syrup 120ml?
Duphalac Syrup contains Lactulose — a synthetic disaccharide sugar that is not digested or absorbed by the human gut — making it unique among laxatives in that it acts entirely within the colon without entering the bloodstream. Lactulose works as an osmotic laxative — drawing water into the large intestine to soften stools, increase stool bulk, and stimulate bowel movement — providing gentle, effective relief from constipation (قبض) without the harsh cramping or dependency associated with stimulant laxatives. Beyond its use as a laxative, Lactulose has a clinically distinct and important second indication — hepatic encephalopathy — where its ability to acidify the colon and reduce ammonia production and absorption makes it a cornerstone treatment for the confusion, disorientation, and altered consciousness caused by liver failure-related ammonia accumulation in the brain. Duphalac Syrup is suitable for adults, children, and infants — making it one of the most versatile and safely used laxative preparations across all age groups.
What is Duphalac Syrup Used For?
- Constipation — relief of acute and chronic constipation in adults, children, and infants when dietary measures are insufficient (قبض)
- Hepatic encephalopathy — reduction of blood ammonia levels and management of confusion, disorientation, and altered consciousness caused by liver failure-related ammonia accumulation (جگر کی بیماری میں دماغی خرابی)
- Prevention of hepatic encephalopathy — long-term maintenance therapy to prevent recurrence of hepatic encephalopathy episodes in patients with chronic liver disease
- Chronic constipation in elderly — particularly valuable in elderly patients where stimulant laxatives carry greater risk of electrolyte disturbance and dependency
- Haemorrhoid-related constipation — softening stools to reduce straining and pain during defecation in patients with haemorrhoids or anal fissures (بواسیر)
- Post-operative constipation — gentle bowel regulation following abdominal or anorectal surgery where straining must be avoided
How Does Duphalac Syrup Work?
Osmotic Laxative Mechanism: Lactulose is a synthetic sugar composed of fructose and galactose — neither of which can be digested or absorbed by human small intestinal enzymes. When Lactulose reaches the large intestine undigested, it is fermented by colonic bacteria into short-chain fatty acids — primarily lactic acid, acetic acid, and formic acid — and small amounts of carbon dioxide and hydrogen gas. These organic acids lower the pH of the colonic contents and exert a powerful osmotic effect — drawing water from the surrounding tissues and bloodstream into the lumen of the colon. The resulting increase in colonic water content softens the stool, increases stool bulk, stimulates peristaltic movement of the bowel, and makes defecation easier and more comfortable — typically producing a bowel movement within 24 to 48 hours of the first dose.
Ammonia-Reducing Mechanism in Hepatic Encephalopathy: In patients with liver failure, the liver's ability to convert ammonia — produced by gut bacteria from dietary protein and urea — into urea for excretion is severely impaired. Ammonia accumulates in the bloodstream and crosses the blood-brain barrier — causing the progressive confusion, disorientation, drowsiness, and coma of hepatic encephalopathy. Lactulose addresses this through two complementary mechanisms in the colon. First, the acidification of colonic contents by Lactulose-derived organic acids converts ammonia (NH3) — a freely membrane-permeable form — into ammonium ions (NH4+) which cannot cross the colonic mucosa into the bloodstream — trapping ammonia in the colon for excretion in stool. Second, the osmotic laxative effect of Lactulose accelerates colonic transit — reducing the time available for ammonia to be absorbed and simultaneously increasing the frequency of stool in which trapped ammonium is eliminated.
Dosage and Administration
⚠️ Always take exactly as prescribed by your doctor. Adjust the dose to achieve 2 to 3 soft stools per day for constipation. For hepatic encephalopathy, doses are significantly higher and must be medically supervised.
| Indication | Usual Starting Dose | Frequency | Maintenance |
|---|---|---|---|
| Constipation — Adults | 15–30mL | Once or twice daily | Adjust to 2–3 soft stools daily |
| Constipation — Children 7–14 years | 15mL | Once daily | Adjust to response |
| Constipation — Children 1–6 years | 5–10mL | Once daily | Adjust to response |
| Constipation — Infants under 1 year | 2.5–5mL | Once daily | Under medical supervision |
| Hepatic encephalopathy — Initial | 30–45mL | Three times daily | Adjust to 2–3 soft stools daily |
| Hepatic encephalopathy — Maintenance | 15–30mL | Three times daily | Under specialist supervision |
Critical Dosing Rules:
- For constipation, the correct dose is the lowest amount that produces 2 to 3 comfortable soft stools per day — doses that produce watery diarrhoea are too high and must be reduced
- For hepatic encephalopathy, much higher doses are required than for constipation — always under strict specialist supervision with regular blood ammonia monitoring
- The full laxative effect of Lactulose typically develops over 24 to 48 hours — do not increase the dose before this period has elapsed as premature dose escalation causes excessive diarrhoea
- Maintain excellent hydration — drink at least 6 to 8 glasses of water daily; osmotic laxatives draw fluid into the bowel and adequate fluid intake prevents dehydration
- Lactulose contains significant amounts of galactose and lactose — patients with galactosaemia or lactose intolerance must not use Duphalac without specialist advice
- Long-term use for chronic constipation is acceptable but should be reviewed periodically by your doctor — lifestyle and dietary measures should be optimised alongside Lactulose treatment
How to Take:
- Measure the dose carefully using the measuring cup provided or a calibrated measuring spoon
- May be taken undiluted or mixed with water, fruit juice, or milk to improve palatability — the sweet taste can be diluted if preferred
- Take at the same time each day — morning dosing with breakfast is preferred for most patients
- For hepatic encephalopathy, divide doses evenly throughout the day as prescribed
- If a dose is missed, take it as soon as remembered the same day — skip if it is the next day; never double the dose
Active Ingredients
| Ingredient | Strength per 5mL |
|---|---|
| Lactulose | 3.35g |
Who Should NOT Take Duphalac Syrup?
Do not take if you:
- Are allergic to Lactulose or any ingredient in the syrup
- Have galactosaemia — Lactulose contains galactose which cannot be safely metabolised in this rare hereditary condition
- Have intestinal obstruction — osmotic laxatives are contraindicated when a physical blockage prevents normal bowel transit
- Have acute inflammatory bowel conditions requiring surgical assessment — abdominal pain of unknown cause must be investigated before using any laxative
Always consult your doctor before taking Duphalac if you have:
- Diabetes (ذیابیطس) — Lactulose contains small amounts of galactose and lactose; monitor blood sugar with regular use particularly at higher hepatic encephalopathy doses
- Lactose intolerance — Duphalac contains lactose; use only after medical assessment
- Inflammatory bowel disease (Crohn's disease or ulcerative colitis) — use with caution under medical supervision
- Liver disease (جگر کی بیماری) — for hepatic encephalopathy use only under specialist supervision with regular monitoring
- Kidney disease (گردے کی بیماری) — electrolyte monitoring required with prolonged use
- Are elderly — more susceptible to electrolyte disturbances from prolonged osmotic laxative use
- Are pregnant — Lactulose is generally considered safe in pregnancy as it is not absorbed; consult your doctor
- Are breastfeeding — Lactulose is not absorbed and does not pass into breast milk
Side Effects
Common Side Effects:
- Flatulence and bloating — most common particularly in the first few days of treatment; caused by colonic bacterial fermentation of Lactulose producing gas; usually improves as gut bacteria adapt
- Nausea — mild and usually temporary; reduced by diluting syrup with water or juice
- Abdominal cramping — mild colicky discomfort from increased bowel activity; dose reduction usually resolves this
- Diarrhoea — sign of too high a dose; reduce dose until 2 to 3 comfortable soft stools are produced daily
- Sweet taste or palatability concerns — the sweetness of Lactulose can be reduced by mixing with water or unsweetened juice
Serious Side Effects — Stop Taking and Seek Medical Help Immediately:
- Severe dehydration — extreme thirst, very dark urine, dizziness, or collapse — from excessive fluid loss with very high doses or prolonged use without adequate fluid intake (طبی ہنگامی صورتحال)
- Severe electrolyte disturbances — muscle cramps, extreme weakness, irregular heartbeat, or confusion — prolonged high-dose Lactulose causes loss of sodium, potassium, and other electrolytes through excessive diarrhoea; requires immediate blood electrolyte assessment
- Hypokalaemia (dangerously low potassium) — muscle weakness, dangerous cardiac arrhythmia — from prolonged excessive diarrhoea; particularly serious in patients on Digoxin
- Severe hypernatraemia (dangerously high sodium) — confusion, extreme thirst, neurological symptoms — from dehydration in elderly or immobile patients unable to replace fluid losses
- Severe allergic reaction — swelling of face, lips, tongue or throat, difficulty breathing, widespread rash (یہ طبی ہنگامی صورتحال ہے)
- Worsening abdominal pain — persistent or severe abdominal pain developing during Lactulose treatment may indicate an underlying surgical condition requiring urgent evaluation; stop and seek medical assessment
Drug Interactions
| Medicine / Substance | Possible Interaction |
|---|---|
| Antacids (e.g., Aluminium / Magnesium hydroxide) | May reduce the colonic acidification effect of Lactulose — potentially reducing its effectiveness in hepatic encephalopathy; avoid combining or separate timing |
| Neomycin / other non-absorbable antibiotics | Combined use with Lactulose in hepatic encephalopathy reduces colonic bacteria needed to ferment Lactulose — may reduce Lactulose effectiveness; however this combination is sometimes used short-term under specialist supervision |
| Digoxin | Lactulose-induced hypokalaemia from excessive diarrhoea increases Digoxin toxicity risk — monitor potassium levels and Digoxin levels closely; maintain adequate potassium intake |
| Diuretics (e.g., Furosemide, Hydrochlorothiazide) | Additive potassium loss — hypokalaemia risk increases significantly with combined use; monitor electrolytes regularly |
| Antidiabetic medicines (e.g., Insulin, Metformin) | Lactulose contains small amounts of galactose and lactose — monitor blood sugar with regular use particularly at hepatic encephalopathy doses |
| Warfarin / anticoagulants | Altered bowel transit from Lactulose can affect Vitamin K absorption — may alter anticoagulant effect; monitor INR during prolonged use |
| Other laxatives | Additive laxative effect — excessive diarrhoea, dehydration, and electrolyte disturbance risk; avoid combining laxatives without medical advice |
| Alcohol (شراب) | Worsens liver disease — counterproductive in hepatic encephalopathy; avoid completely during treatment for liver-related conditions |
Storage Instructions
- Store below 25°C in a cool, dry place
- Do not refrigerate — cold temperatures can cause crystallisation of Lactulose
- Keep the bottle tightly closed after every use
- Protect from direct sunlight and excessive heat
- Keep out of reach of children (بچوں کی پہنچ سے دور رکھیں)
- Do not use after the expiry date printed on the bottle
- Do not use if the syrup has changed colour or shows signs of crystallisation
Frequently Asked Questions (FAQs)
Q: How long does Duphalac Syrup take to work for constipation? Lactulose typically produces its first bowel movement within 24 to 48 hours of the initial dose — do not increase the dose before this period has elapsed as the delayed onset is normal and premature dose escalation causes excessive diarrhoea and abdominal cramps.
Q: Can Duphalac Syrup be used long-term for chronic constipation? Yes — Lactulose is one of the safest laxatives for long-term use as it is not absorbed and does not cause the dependency associated with stimulant laxatives; however long-term use should be reviewed periodically by your doctor and accompanied by optimisation of dietary fibre and fluid intake.
Q: Why is Duphalac used in liver disease at much higher doses than for constipation? In hepatic encephalopathy, the goal is not just regular bowel movements but aggressive colonic acidification and accelerated transit to trap and eliminate ammonia — requiring significantly higher Lactulose doses of 30 to 45mL three times daily; this use must always be medically supervised with regular blood ammonia and electrolyte monitoring.
Q: Can Duphalac Syrup be given to infants and young children? Yes — Lactulose is one of the few laxatives considered safe for use in infants and young children; however dosing in infants under 1 year must always be under paediatric medical supervision as even small electrolyte disturbances carry greater clinical significance in very young patients.
Medical Disclaimer: This information is for general awareness only and does not replace advice from your doctor or pharmacist. Always adjust the dose of Duphalac to achieve 2 to 3 comfortable soft stools daily — not watery diarrhoea. Maintain excellent hydration throughout treatment. For hepatic encephalopathy use, regular specialist supervision and blood monitoring are essential.
