Дуфалак

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Дуфалак

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Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Дуфалак

Property Description
Active ingredient Lactulose (Single-component)
Form Oral solution or powder for oral solution
Pharmacological class Osmotic Laxative, Ammonium Detoxicant
Common use Relief of chronic constipation, Hepatic Encephalopathy
Origin Synthetic disaccharide (derived from lactose)

The Defining Component: What is Дуфалак (Lactulose)?

Дуфалак is a pharmaceutical preparation whose single active component is the generic substance Lactulose, a synthetic disaccharide composed of galactose and fructose. This molecule is designed for oral administration and remains non-absorbed by the human small intestine, allowing it to exert its therapeutic effects locally within the colon rather than circulating systemically. Unlike most conventional sugars, Lactulose's unique structure specifically permits its use as a medicinal agent; it is a single-component formulation with an established profile.

Pharmacological Classification and General Action

The drug holds a dual classification as both an Osmotic Laxative and an Ammonium Detoxicant. Its pharmacological mechanism relies on osmotic activity, where the unabsorbed Lactulose draws water into the colon, promoting a gentler action compared to stimulant alternatives. Lactulose works by being broken down by colonic bacteria into organic acids, which is a key process that facilitates both stool softening and, separately, the removal of specific toxins.

Understanding the Therapeutic Scope

The general therapeutic benefits of Дуфалак involve improving bowel function and reducing specific toxins associated with severe liver conditions. Its use is directed at the symptomatic relief of chronic constipation across patient populations, and it is utilized as a therapeutic agent for the management of hepatic encephalopathy (HE). This dual purpose makes it a treatment for certain neurocognitive complications arising from liver disease, where the substance’s action is pivotal in controlling the ammonia load.

Regulatory References

  1. Osmotic Laxative
  2. Ammonium Detoxicant
  3. MedlinePlus Drug Information

What side effects are possible with Дуфалак?

Possible Side Effects and Safety Information

The officially documented adverse reactions for Lactulose (Дуфалак) primarily involve the gastrointestinal system and are classified by frequency in regulatory documents. These effects are generally due to the substance’s action within the colon and its subsequent fermentation.

Official Adverse Reaction Categories

The frequency classification based on official labeling indicates that Diarrhoea is a Very Common effect, meaning it occurs in more than 1 in 10 patients. Common reactions (1 to 10 in 100 patients) include Flatulence, Abdominal pain, Nausea, and Vomiting. These gastrointestinal effects, particularly flatulence and cramps, may be observed during the first few days of treatment but are often described as transient.

Serious Adverse Reactions and Safety Constraints

The most serious risk documented in regulatory texts is Electrolyte Imbalance (classified as Uncommon). Severe or persistent diarrhoea caused by excessive use may lead to clinically significant shifts in blood chemistry, such as Hypokalemia (low potassium) and Hypernatremia (high sodium). For patients, particularly the elderly or debilitated, receiving treatment for more than six months, periodic control of serum electrolytes is formally indicated.

Regarding specific restrictions, the medication is contraindicated for individuals with Galactosemia or those with actual or suspected Gastrointestinal Obstruction. Caution is also specified for its use in diabetic patients due to the presence of unabsorbed sugars.

Overdose and Emergency Response

Overdose and when to seek help

This information is strictly based on documented overdose findings and emergency requirements published in governmental regulatory sources.

Overdose from excessive intake of Lactulose is primarily characterized by severe gastrointestinal hyperactivity. The officially documented manifestations include pronounced diarrhea, abdominal pain, and abdominal cramps. The principal severe outcome is not the immediate manifestation but the subsequent fluid and electrolyte loss, which can lead to serious disturbances like hypokalemia (low potassium) and hypernatremia (high sodium).

Overdose Action Required Regulatory Instruction (Strictly Label-Based)
Immediate Management Cessation of treatment or dose reduction is the first step. Treatment should be symptomatic and supportive, often requiring the correction of electrolyte disturbances and fluid loss.
When to Seek Urgent Help Seek immediate medical attention if too much is used. Contact emergency services straight away if severe diarrhea or vomiting persists for more than a couple of days and is accompanied by signs like an irregular heartbeat or muscle cramps (indicators of severe electrolyte imbalance).

Management procedures include periodic control of electrolytes following excessive dosage. A specific antidote is not known. For patients with advanced liver disease, a specific risk noted in regulatory labeling is the exacerbation of hepatic encephalopathy following an overdose.

Therapeutic Uses of Дуфалак

What Дуфалак Treats: Main Uses and Benefits

The medication is generally applied across two distinct therapeutic domains, covering the symptomatic relief of persistent bowel issues and the relevant application for conditions associated with systemic imbalance stemming from severe liver disease.


Relief for Persistent Chronic Constipation

This medicine is commonly used to help with symptoms that interfere with daily functioning due to chronic constipation. It is relevant in conditions characterized by periods of heightened symptoms, such as straining, infrequent evacuation, and the passage of hard, difficult stools. It supports the patient during difficult episodes by easing distress and contributes to improved comfort, supporting more manageable bowel functioning, and assisting with maintaining functional stability.

Management of Neurocognitive Symptoms in Liver Disease

The second important application is for conditions associated with acute or disruptive episodes, specifically Hepatic Encephalopathy (HE), which involves neurocognitive symptoms like confusion, disorientation, and personality changes. Applied across domains where additional symptomatic support is needed, it helps address symptom clusters that may become intense or disruptive. This use provides support that helps ease the overall symptom burden and assists with maintaining functional stability for patients with advanced liver disease.


Quick Fact: Relief for Gastrointestinal and Neurocognitive Strain The dual function of this medication supports patients dealing with chronic difficulties in bowel evacuation, and, separately, those managing the systemic symptoms of severe liver failure.

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

The eligibility for using Дуфалак (Lactulose) is defined by regulatory agencies based on gastrointestinal integrity, metabolic status, and age, reflecting its non-systemic mechanism of action.

Populations for Whom Use is Contraindicated

The medicine must not be used by patients with a history of Galactosaemia or those requiring a low-galactose diet. It is also contraindicated in patients with a confirmed or suspected gastrointestinal obstruction (other than normal constipation), perforation, or risk of perforation, or those with painful abdominal syndromes of undetermined cause. Use is prohibited in cases of known hypersensitivity to the active substance or its excipients.

Age and Condition-Based Restrictions

Classification Eligibility Rule Condition
Pediatric Use Use is exceptional and requires medical supervision. Safety and efficacy for Hepatic Encephalopathy are not established in children (newborn to 18 years). Children/Infants
Pregnancy/Lactation Use is permitted as no effects are anticipated due to negligible systemic absorption. Pregnant/Breastfeeding
Metabolic Risk Use with caution in patients with Diabetes Mellitus due to the presence of trace sugars, particularly with high-dose regimens. Diabetes Mellitus
Organ Function No special dosage recommendations exist for elderly patients or those with renal or hepatic insufficiency. Elderly/Impaired Function

What should I know about interactions with other medicines?

The interaction profile for Lactulose is determined by its local action in the colon, as no systemic pharmacokinetic interactions (including those involving CYP enzymes or drug transporters) are documented due to its negligible absorption.

The most significant interactions are pharmacodynamic and physicochemical. Co-administration with potassium-depleting agents such as thiazide diuretics, corticosteroids, or the antifungal amphotericin B may increase the risk of potassium loss. This hypokalemia risk is regulatory relevant, as resultant potassium deficiency can enhance the effects of co-administered cardiac glycosides.

Physicochemical interactions arise from the drug’s colonic pH lowering. Non-absorbable antacids or other alkalis may inhibit this desired pH drop, potentially antagonizing the therapeutic effect, especially in the management of Hepatic Encephalopathy (HE). Conversely, the pH change may also alter the dissolution of medications, potentially inactivating drugs that rely on a higher colonic pH for release.

Official restrictions exist for certain conditions: the use of other laxatives must be avoided during HE treatment, as this combination prevents proper individualization of the Lactulose dose. Furthermore, official labeling mandates periodic serum electrolyte measurement for elderly or debilitated patients receiving continuous therapy beyond six months.

Mechanism of Action

Microbiota-Driven Fermentation and Osmosis

The mechanism of action begins in the colon where the drug acts as a substrate for resident saccharolytic bacteria, such as Bifidobacteria. These bacteria initiate the process by using enzymes to ferment the drug into short-chain fatty acids (SCFAs). The resulting high concentration of soluble molecules drives osmotic activity, which draws water from the body into the bowel lumen. This influx of water increases the hydration and volume of the colonic contents.


Luminal Acidification and Ion Trapping

The production of SCFAs leads to a significant reduction in the colonic pH (acidification). This chemical change supports the ion-trapping of highly absorbable ammonia ( NH3) by converting it into the non-absorbable ammonium ion ( NH4^+). The resulting ionized form is retained within the lumen, preventing its movement into the portal circulation and facilitating its excretion with the feces.


Modulation of Gastrointestinal Peristalsis

The combined effect of increased fluid volume and the localized presence of the chemical irritants (SCFAs) acts on the intestinal smooth muscle. This dual stimulus modulates peristaltic activity and influences the transit rate of contents through the large intestine.

Dosage and Administration Information

How to Use Duphalac (Lactulose Oral Solution)

The following details the administration and dosing for Duphalac.

Administration Method and Preparation

Duphalac is an Oral Solution (liquid) that must be swallowed. It can be taken either undiluted or mixed with liquids such as water or fruit juice immediately prior to consumption. The dosage should be swallowed promptly and not held in the mouth. When using the solution from a bottle, a provided measuring cup or spoon must be used to ensure the accuracy of the dose.

Official Dosing and Frequency

For constipation, the daily dose is typically taken as a single dose, preferably during breakfast. Dosing requires an initial phase followed by a maintenance phase, adjusted based on the patient's response.

Population Starting Dose (Daily) Maintenance Dose (Daily)
Adults & Adolescents 15 ml - 45 ml 15 ml - 30 ml
Children (7-14 years) 15 ml 10 ml - 15 ml
Children (1-6 years) 5 ml - 10 ml 5 ml - 10 ml
Infants (under 1 year) Up to 5 ml Up to 5 ml

For the treatment of Hepatic Encephalopathy (HE), the adult starting dose is 30 ml - 45 ml, administered three to four times daily. The dose is adjusted to produce 2 to 3 soft stools per day.

Procedural Notes

Treatment requires several days (often 2–3 days) before the full therapeutic effect is observed. Patients must ensure adequate fluid intake (1.5 to 2 litres) daily throughout the course of administration. If a dose is missed, it should be skipped, and the next dose taken at the usual time; do not double the dose to compensate.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Дуфалак (Lactulose)


Evidence for Use in Chronic Constipation

Research exploring the use of Lactulose for chronic constipation has relied primarily on Randomized Controlled Trials (RCTs). These trials were typically short-term, lasting a few weeks, and focused on outcomes related to physical discomfort and daily functioning. Specifically, studies examined how symptoms change over time by monitoring the frequency of spontaneous bowel movements per week, changes in stool consistency (using standardized scales), and patient-reported outcomes describing perceived discomfort such as straining.

The findings from these short-term studies describe patterns observed in the observed populations, generally indicating that research highlights changes measured during the study period related to recorded bowel movement frequency. Studies also reported patterns in which participant's stools were measured as softer on standardized scales. The evidence contributes to the broader evidence landscape for chronic constipation relief.

Evidence for Use in Hepatic Encephalopathy (HE)

For the management of neurocognitive symptoms associated with severe liver disease, Lactulose was studied extensively in Randomized Controlled Trials (RCTs) and systematic reviews. This research focused on conditions associated with acute or disruptive episodes, where symptoms may vary in intensity. Studies explored outcomes describing episodic or acute changes by monitoring changes in the grade of Hepatic Encephalopathy severity (neurological status scores) and systemic imbalance by monitoring the biomarker blood ammonia. Research also examined the use of Lactulose in prevention protocols, monitoring rates of HE recurrence in patients with underlying liver disease.

The research base for this use is extensive, supported by systematic reviews. Studies consistently report how symptoms evolved in the observed populations, and data describe patterns related to recorded blood ammonia levels. Research highlights changes measured during the study period that corresponded with neurological assessments related to observed changes in HE grade for many participants experiencing acute HE episodes. For prevention, studies monitored long-term outcomes and examined rates of HE recurrence in groups undergoing maintenance therapy.


Areas of Uncertainty and Research Gaps

Despite being a decades-old medication, the evidence base for Lactulose still contains some research limitations. For chronic constipation, comparative evidence against newer pharmaceutical options is limited, and findings for the trials that explored this comparison showed variability. Furthermore, sample sizes were modest in some of the subgroup analyses, meaning data for certain complex groups remain insufficient. These gaps mean that while findings describe group patterns, long-term effects, especially for chronic constipation, are not fully established. Similarly, research continues to explore whether Lactulose alone or in combination with other treatments provides different long-term outcomes for complex patient subsets in HE.

Key Studies & References

  1. Lactulose: MedlinePlus Drug Information (Authoritative overview of indications and use)
  2. Lactulose - StatPearls - NCBI Bookshelf (Comprehensive overview of indications, efficacy patterns, and pediatric use limitations)
  3. Summary of Product Characteristics - Lactulose Fresenius 670mg/ml oral solution (EMA/EU Regulatory Document supporting approved indications and specific population use)
  4. Chronic constipation: Update on management - Cleveland Clinic Journal of Medicine (Context on comparative evidence for osmotic laxatives, including lactulose)

Frequently Asked Questions (FAQ)

Common questions about Дуфалак (FAQ)


Q: Is Дуфалак considered a fast-acting medicine?

According to official labeling, Дуфалак is not typically considered fast-acting. Since its therapeutic action begins locally in the colon, it may require 24 to 48 hours before the desired bowel movement occurs.


Q: How long after taking Дуфалак should an effect generally be expected?

Official product information indicates that the initial effect, often the first sign of improvement in bowel function, may be expected to occur within one to two days (24 to 48 hours) after starting the medication.


Q: Can Дуфалак be used for long periods?

The official instructions indicate that for certain patients, particularly the elderly or debilitated, who receive continuous therapy for longer than six months, periodic checks of serum electrolytes (salts in the blood) are formally recommended. This monitoring is formally recommended by regulatory bodies to address the potential for electrolyte imbalance.


Q: What does official research say about the use of Дуфалак in older adults?

Regulatory guidelines state that no special dosage recommendations are needed for elderly patients with normal kidney or liver function. However, as with other populations, official information indicates that periodic checks of serum electrolytes are formally recommended if continuous therapy extends beyond six months.


Q: Does taking Дуфалак require any changes to my normal diet?

Regulatory information specifies that patients must ensure adequate fluid intake—such as 1.5 to 2 litres of water—daily while taking this medication. This requirement supports the osmotic action of the drug in the colon.


Q: Are there research studies comparing Дуфалак to placebos?

Studies supporting the use of the drug include Randomized Controlled Trials (RCTs). These trial designs are used to examine the effects of the medication compared to other treatments or control groups.


Q: How does the action of Дуфалак differ from stimulant laxatives?

The medication is officially classified as an Osmotic Laxative. This means its primary action is drawing water into the bowel to soften contents, which differs from stimulant laxatives, which actively increase the movement and secretion of the intestines.


Q: Is the sensation of feeling full or bloated common when starting Дуфалак?

Official product information lists common gastrointestinal effects. These include flatulence (gas), abdominal cramps, and a sensation of bloating or feeling full. These effects are usually observed during the first few days of treatment and are often described as transient.


Q: Can I take Дуфалак with food or on an empty stomach?

Official administration guidance indicates that the daily dose for constipation should be taken at the same time each day, giving the example of during breakfast. The solution can be taken alone or mixed with liquids like water or fruit juice.


Q: Does the time of day I take Дуфалак matter?

Regulatory instructions indicate that if taken as a single daily dose for constipation, administration should be at the same time each day, with the example provided being during breakfast. Consistent timing is advised.


Q: Does Дуфалак contain any sugar or sweeteners?

The active substance, Lactulose, is a synthetic disaccharide (a type of sugar). Trace amounts of other sugars, such as galactose and lactose, are present in the final product as remnants from the manufacturing process. The presence of these sugars is relevant to patients with conditions like diabetes.


Q: Can Дуфалак cause stomach discomfort or cramps?

Official documents list common gastrointestinal discomfort as a potential effect. Initial dosing may produce abdominal cramps and intestinal cramps. These effects are generally described in regulatory documents as transient and often resolve as treatment continues.


Q: Are there different forms of Дуфалак available, like liquid or tablets?

The medication is available primarily as an oral solution (liquid). In some formulations, it may also be available as crystals for oral solution (a powder that is mixed with liquid) or in pre-measured single-dose sachets.


Q: Does Дуфалак need to be stored in the refrigerator?

The official requirement is that the product is stored at Controlled Room Temperature. The labeling also states that the solution must not be refrigerated or frozen, and protection from prolonged exposure to temperatures above 30 C is advised.


Q: Are there specific drinks or foods to avoid when taking Дуфалак?

Official drug interaction information notes that combining the medication with non-absorbable antacids may reduce its intended effect, particularly when used for Hepatic Encephalopathy. There are no general contraindications against specific common foods or alcohol documented in official labeling.


Q: Why is Дуфалак sometimes mentioned for conditions other than constipation?

The medication holds a dual official indication. In addition to treating constipation, regulatory documents state it is also indicated for the prevention and treatment of portal-systemic encephalopathy (a neurocognitive condition associated with severe liver disease).


Q: Why do some people report feeling dizzy after taking Дуфалак?

Dizziness is not listed as a common or isolated side effect. Official labeling lists it as a potential symptom of a severe adverse reaction, such as an overdose or severe diarrhea leading to a clinically significant electrolyte imbalance (low potassium or high sodium).


Q: What should I do if I suspect a severe reaction to Дуфалак?

Official labeling describes that patients should contact their physician if they experience an unusual diarrheal condition or any severe symptoms. Severe adverse reactions can also be formally reported to the appropriate governmental regulatory bodies.


Q: Is it possible for Дуфалак to interact with herbal supplements?

Authoritative public health information indicates there are no known problems specifically documented regarding mixing this drug with herbal remedies. However, standard regulatory caution suggests discussing all supplements with a healthcare provider.


Q: What information is available about long-term safety studies of Дуфалак?

Regulatory data states that there are no known human data on the long-term potential for carcinogenicity, mutagenicity, or impairment of fertility. It is noted that treatment for the indication of Hepatic Encephalopathy has been explored in studies extending over two years.


Q: Can Дуфалак be used by infants under one year old?

Regarding the use for infants, US labeling states that the safety and effectiveness in pediatric patients have not been established. However, some international regulatory documents do provide specific, low-dose guidance for infants under one year for constipation, while noting that use of the drug in children is typically covered by official warnings related to medical supervision.


Q: Can Дуфалак be used if I am taking blood pressure medication?

Official drug interaction information cautions about using the medication concurrently with potassium-depleting agents, such as certain types of diuretics (which may be used for blood pressure). This is because such combinations may increase the risk of potassium loss in the body.


Q: How long does the main ingredient of Дуфалак stay in the body?

The active ingredient, Lactulose, is poorly absorbed by the body and is not intended to circulate systemically. The small amount that does enter the bloodstream is primarily excreted in the urine, a process which is essentially complete within 24 hours.


Q: Is it possible to have an allergic reaction to Дуфалак?

Regulatory documents list known hypersensitivity (an allergic reaction) to the active substance (Lactulose) or any of the inactive ingredients (excipients) as a contraindication for using the medication.

How should Дуфалак be stored and disposed of?

How to Store and Dispose of Duphalac (Lactulose Solution)

Duphalac must be stored according to official regulatory labeling to ensure product stability.

Storage Requirements

  • Temperature: Store the solution at Controlled Room Temperature, typically 20 C to 25 C (68 F to 77 F), or below 25 C.
  • Prohibitions: The solution must not be refrigerated or frozen. Avoid prolonged exposure to temperatures above 30 C (86 F).
  • Protection: Keep the container tightly closed and protect the product from direct light.
  • Child Safety: Duphalac must be stored out of the sight and reach of children.

Stability and Disposal

Normal darkening of color is expected and does not affect the medicine's action; however, the product must not be used if it develops extreme darkening and turbidity. Unused or expired Duphalac must not be disposed of in household waste or wastewater. Patients must consult their pharmacist for instruction on proper disposal.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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