Dutifully Restore Natural Bowel Rhythm with Duphalac
Duphalac
Duphalac (lactulose) is a first-line, osmotic laxative of choice for healthcare professionals managing constipation and hepatic encephalopathy. As a synthetic disaccharide, it works through a unique, non-systemic mechanism of action, drawing water into the colon to soften stool and promote peristalsis. Its efficacy and well-established safety profile make it a cornerstone in both acute and chronic therapeutic regimens for patients of all ages, from infants to the elderly. This expert-oriented guide details the pharmacological characteristics, clinical applications, and essential prescribing information for this essential medication.
Features
- Active Pharmaceutical Ingredient: Lactulose (a synthetic disaccharide sugar).
- Pharmacotherapeutic Group: Osmotic laxative, Ammonia detoxicant.
- Available Formulations: Oral solution and syrup, typically at a concentration of 3.35g/5ml or 667mg/ml.
- Mechanism of Action: Functions as an osmotic agent in the colon; is metabolized by colonic flora to low molecular weight acids.
- Onset of Action: Full effect may take up to 24-48 hours to manifest.
- Prescription Status: Available both as a prescription and over-the-counter (OTC) in many regions, depending on strength and local regulations.
Benefits
- Effectively induces gentle, predictable bowel movements by softening stool and increasing fecal bulk, mimicking natural physiology.
- Reduces blood ammonia levels in patients with hepatic encephalopathy by acidifying colonic contents and trapping ammonium ions.
- Exhibits a high safety margin, making it suitable for long-term management of chronic constipation without causing tolerance or dependency.
- Suitable for a wide demographic range, including pregnant women, nursing mothers, children, and the elderly, under medical guidance.
- Non-systemic in its primary action; minimally absorbed in the small intestine, with activity localized primarily to the colon.
- Helps restore and maintain a healthy balance of colonic flora by promoting the growth of beneficial bacteria like lactobacilli and bifidobacteria.
Common use
Duphalac is primarily indicated for the treatment of constipation. It is used to restore and maintain regular bowel habits in cases of occasional or chronic constipation. Its second major indication is for the prevention and treatment of portal-systemic encephalopathy (hepatic encephalopathy), a serious complication of liver disease characterized by the buildup of toxins like ammonia in the bloodstream. It is also frequently used for bowel preparation before certain diagnostic procedures, such as colonoscopy, when combined with other agents, and for managing constipation in specific patient populations, including post-operative patients and those on constipating medications like opioids.
Dosage and direction
Dosage must be individualized based on the indication and patient response. It is typically administered orally, once daily, preferably at the same time each day (e.g., with breakfast).
- Constipation (Adults & Adolescents): The usual starting dose is 15-30 ml (10-20g of lactulose) daily. The dose may be adjusted to produce one or two soft stools per day. Maintenance dose is typically 10-25 ml (6.7-16.7g) daily.
- Constipation (Children): For infants and children, the dose is weight-based. A common regimen is 2.5-10 ml (1.67-6.7g) per day. Dosing in children should be strictly supervised by a physician.
- Hepatic Encephalopathy (Adults): The initial dose is typically much higher, such as 30-50 ml (20-33g) three to four times daily. The dose is then adjusted to produce 2-3 soft stools daily. The goal is to achieve a pH of below 5.5 in the stool.
- Administration: Can be taken undiluted or diluted in water, juice, or milk. Adequate fluid intake (6-8 glasses per day) is recommended during therapy to enhance effectiveness.
Precautions
- Electrolyte Monitoring: Long-term use, especially in high doses, should be monitored for potential imbalances in electrolytes, particularly potassium.
- Underlying Conditions: Use with caution in patients with diabetes mellitus due to its sugar content, though minimal amounts are absorbed. Caution is also advised in patients with lactose intolerance.
- Abdominal Complaints: If unexplained abdominal pain, nausea, or vomiting develops or persists, discontinue use and investigate the cause.
- Elderly and Debilitated Patients: These populations may be more susceptible to electrolyte imbalance; monitor accordingly.
- Pregnancy and Lactation: Duphalac is considered safe for use during pregnancy and breastfeeding, as its systemic absorption is negligible. However, a physician should be consulted before use.
Contraindications
Duphalac is contraindicated in patients with:
- Known hypersensitivity to lactulose or any of the excipients in the formulation.
- Galactosaemia, a rare genetic metabolic disorder.
- Conditions where a reduction in colonic pH is undesirable.
- Intestinal obstruction, acute abdominal pain, or undiagnosed abdominal symptoms such as nausea and vomiting, which could be signs of a more serious condition.
Possible side effect
Duphalac is generally well-tolerated. Side effects are primarily gastrointestinal and dose-dependent, often subsiding with continued use or dose adjustment.
- Very Common (>1/10): Flatulence, abdominal distension, and discomfort.
- Common (1/10 to 1/100): Nausea, vomiting, diarrhea, and abdominal cramps.
- Uncommon (1/100 to 1/1000): Electrolyte imbalance (e.g., hypokalaemia) due to diarrhea, particularly with prolonged high-dose therapy.
- Excessive diarrhea can lead to dehydration and hypovolaemia.
Drug interaction
- Non-systemic Mechanism: Due to its minimal absorption, Duphalac has a very low potential for pharmacokinetic drug interactions.
- Antacids: Concomitant use with non-absorbable antacids (e.g., containing aluminum or magnesium hydroxide) may reduce the colonic acidifying effect of Duphalac and should be avoided, particularly in the treatment of hepatic encephalopathy.
- Other Laxatives: The concurrent use of other laxatives is not generally recommended unless directed by a physician, as it may increase the risk of diarrhea and electrolyte disturbances.
- Colon pH: Its action of lowering colonic pH could theoretically affect the release profile of other drugs formulated for pH-dependent release (e.g., mesalazine); monitoring is advised.
Missed dose
- If a dose is missed, it should be taken as soon as it is remembered.
- However, if it is almost time for the next scheduled dose, the missed dose should be skipped.
- Do not take a double dose to make up for a missed one.
Overdose
- Manifestations: Overdose will result in severe diarrhea and abdominal cramps.
- Management: Treatment is supportive and should focus on the correction of excessive fluid and electrolyte losses through appropriate hydration and electrolyte replacement. Discontinuation of the medication is necessary until symptoms resolve.
Storage
- Store below 25°C (77°F). Do not freeze.
- Keep the bottle tightly closed to protect from light and moisture.
- Keep out of the sight and reach of children.
- Do not use after the expiration date printed on the packaging.
Disclaimer
This information is for educational and informational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or before starting any new treatment. Never disregard professional medical advice or delay in seeking it because of something you have read here.
Reviews
- Gastroenterologist, 15 years experience: “Duphalac remains a reliable and predictable first-step agent for chronic idiopathic constipation. Its safety profile is excellent for long-term use, which is a significant advantage over stimulant laxatives. I find it particularly valuable for elderly patients.”
- Hepatology Nurse Specialist: “In our hepatic unit, it’s a cornerstone therapy for managing encephalopathy. Titrating the dose to achieve 2-3 soft stools is effective for most patients in reducing ammonia levels and improving cognitive symptoms.”
- General Practitioner: “I frequently recommend it for pregnant patients suffering from constipation. Its non-systemic action and long history of safe use provide significant peace of mind for both me and my patients.”
- Patient (Long-term user for chronic constipation): “It took a few days to start working effectively, but it provides gentle and consistent relief without any cramps or urgency, which was a problem with other products I’ve tried. It has greatly improved my quality of life.”