Avilac

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Medically reviewed

Marina Burgos

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 Avilac

This section provides a foundational understanding of the medicine Avilac (Lactulose), outlining its identity, composition, classification, and general purpose.


Avilac Quick Facts

Property Description
Active ingredient Lactulose
Form Oral Solution or Syrup
Pharmacological class Osmotic Laxative and Non-systemic Prebiotic
General purpose Promoting bowel regularity
Origin Synthetic Disaccharide

What Type of Medicine Is Avilac (Lactulose)?

Avilac is classified as a gastrointestinal drug, primarily functioning as an osmotic laxative. This means the medicine works through a physical mechanism: the active component, Lactulose, draws water into the colon via osmosis, leading to a softer and bulkier stool consistency. The World Health Organization (WHO) includes Lactulose in its List of Essential Medicines, recognizing its fundamental role in healthcare. As a non-systemic agent, Avilac performs its therapeutic action locally in the colon, limiting absorption into the wider body.

Composition, Origin, and Pharmaceutical Form

The core of Avilac is the single active substance, Lactulose, a synthetic disaccharide formed from galactose and fructose. This formulation is clinically recognized for its efficacy across various patient groups, including children and the elderly. Due to its unique chemical bond, Lactulose resists breakdown by the human digestive enzymes and therefore reaches the large intestine undigested. Avilac is typically available as an oral solution or a syrup, a liquid formulation which is often preferred for patients who struggle with swallowing tablets, and is intended for straightforward oral administration.

General Purpose and Core Function

The overall general purpose of Avilac is to re-establish and maintain bowel regularity in neutral use scenarios, such as when temporary constipation arises. The dual mechanism—water retention combined with bacterial fermentation in the colon—facilitates the natural evacuation process. This fermentation also slightly lowers the colonic pH, which is key to assisting in the trapping and enhanced excretion of nitrogenous waste (ammonia), providing a specific benefit in certain conditions beyond simple constipation relief.

Regulatory References

  1. List of Essential Medicines

What side effects are possible with Avilac?

Possible Side Effects and Safety Information

The safety profile of Avilac (Lactulose) is structured around the adverse reactions officially documented in government regulatory sources, which are primarily gastrointestinal in nature and related to the medicine's non-absorbed action in the colon. Frequency classifications are typically based on regulatory standards, such as those used in the Summary of Product Characteristics (SmPC).


Adverse Reactions by Official Frequency

Frequency Category Adverse Reactions
Very Common (ge 1/10) Diarrhea
Common (ge 1/100 to <1/10) Flatulence, Abdominal pain, Nausea, Vomiting
Uncommon (ge 1/1,000 to <1/100) Electrolyte imbalance

Flatulence and other common gastrointestinal effects are generally observed at the start of treatment and are often transient, usually resolving within a few days. Reactions categorized as Not Known include hypersensitivity reactions, rash, pruritus (itching), and urticaria (hives).


Safety Constraints and Special Populations

Regulatory documents define specific conditions where Avilac is contraindicated, including Galactosaemia, gastrointestinal obstruction, and a defined risk of digestive perforation. The medicine should be used with caution in diabetics due to the presence of trace amounts of related sugars.

There are specific monitoring requirements for elderly or debilitated patients receiving the medicine for more than six months, as these individuals require periodic control of serum electrolytes to manage the risk of severe electrolyte imbalance (e.g., hypokalemia) that can result from chronic, excessive diarrhea. The official documentation also notes caution regarding the potential disturbance of the normal defecation reflex in the pediatric population.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory information for Avilac (Lactulose) defines overdose primarily by its immediate effects on the gastrointestinal system and the subsequent metabolic risk.

Documented Overdose Presentations

Overdose, typically resulting from doses higher than instructed, manifests clinically as:

  • Severe diarrhea
  • Abdominal pain
  • Nausea and vomiting (less frequent)

Primary Overdose Risk

Extensive fluid loss due to severe and persistent diarrhea or vomiting is the central risk identified in official regulatory documents. This fluid loss can lead to electrolyte imbalance.

Overdose Component Official Regulatory Statement
Antidote No specific antidote is available.
Management Treatment consists of immediate cessation of treatment or dose reduction. Management is symptomatic.
Long-Term Risk Periodic control of electrolytes may be required, particularly in elderly patients or those in poor general condition taking the drug for prolonged periods.

When Urgent Medical Help is Required

Urgent medical attention is necessary if signs of extensive fluid loss or severe electrolyte disturbances are suspected. This level of care is required to initiate supportive measures, including the monitoring and correction of electrolyte imbalance, which is the serious complication associated with excessive ingestion.

Therapeutic Uses of Avilac

Avilac (Lactulose) is commonly used across two distinct clinical domains.

Symptomatic Relief for Chronic Constipation

Avilac is primarily used to address the uncomfortable and often persistent symptoms of chronic constipation. It plays a role in managing the clinical cluster of infrequent bowel movements, hard or dry stools, and the need for excessive straining during defecation. The benefit provided is that it helps make the stool softer and bulkier, which may assist with easier passage and a more predictable bowel rhythm. This is relevant for managing symptoms that interfere with daily comfort in conditions such as hemorrhoids or following related surgery.

“This medication is applied in scenarios where additional management of discomfort associated with difficult stool passage is required.”

Management of Hepatic Encephalopathy (HE) Symptoms

The medication is considered relevant for a specialized role in treating and preventing Hepatic Encephalopathy (HE), a condition linked to organ-specific functional stress in the liver. This usage addresses the resulting neurocognitive symptoms, such as confusion, disorientation, and memory problems. Avilac is used in situations involving certain distressing symptoms of neurological dysfunction, which contributes to easing the overall symptom load and supports general well-being during symptomatic phases.


Quick Fact: Symptomatic Support for Constipation and Cognitive Distress

Avilac is used in situations involving certain distressing symptoms across two main therapeutic areas: chronic constipation and the management of hepatic encephalopathy (HE).

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

The eligibility for using Avilac (Lactulose) is strictly defined by regulatory documents, focusing on patient population and pre-existing conditions. Use is contraindicated (absolutely prohibited) in several groups. Patients with galactosaemia must not use this medicine due to its composition. It is also forbidden for individuals with gastrointestinal obstruction (ileus), gastrointestinal perforation, acute inflammatory bowel disease, or unexplained abdominal pain until the cause is diagnosed. Hypersensitivity to lactulose is an additional contraindication.

The medicine is generally permitted for use by adults and adolescents. Children over one year old may also use it for appropriate indications. However, use is not recommended in infants under one year of age unless under strict medical supervision. Avilac can be used during pregnancy and breastfeeding as regulatory reviews confirm negligible systemic absorption. Specific caution is required for patients with diabetes mellitus and for those undergoing certain electro-cautery procedures in the colon. No special restrictions are necessary based on the patient’s renal or hepatic function for routine use.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile for Avilac (Lactulose) is determined by its non-systemic action and its effect on the colonic environment and fluid balance, as documented in regulatory information.

Pharmacodynamic and Compositional Restrictions

Contraindicated Combination: Avilac is formally contraindicated in patients who require a low galactose diet (galactosemia), as the solution contains trace amounts of galactose derived from its manufacturing process.

Potential for Loss of Therapeutic Effect: The concurrent use of Avilac with certain medicinal products may interfere with its primary mechanism:

  • Nonabsorbable Antacids: These substances may inhibit the desired lactulose-induced drop in colonic pH, potentially leading to an inadequate therapeutic response.
  • Oral Anti-infectives (e.g., neomycin): Co-administration may suppress the colonic bacteria necessary for the breakdown of Lactulose, potentially compromising its effectiveness.

Risk of Hypokalemia: Interactions documented in official labeling show that co-administration with medicines that increase fluid and electrolyte loss can compound risks:

  • Diuretics (e.g., Loop and Thiazides) and Corticosteroids: These agents may increase the risk of hypokalemia (low serum potassium) due to excessive fluid and electrolyte excretion.
  • Dichlorphenamide (Carbonic Anhydrase Inhibitor): Concomitant use may increase the risk of metabolic acidosis.

Anticoagulant Effects: Lactulose is documented to increase the effects of oral anticoagulants such as warfarin, resulting in an increased risk of bleeding.

Population-Specific Notes: Patients receiving long-term treatment, particularly the elderly or debilitated, should have serum electrolytes periodically measured when co-administering with diuretics or corticosteroids, due to the exacerbated risk of fluid loss.

Mechanism of Action

Osmotic Action and Volume Modulation

Lactulose (Avilac) is a non-hydrolyzed disaccharide that reaches the colon intact, where it creates a high solute concentration environment. This establishes a localized osmotic gradient, causing water to be drawn from the surrounding tissues into the lumen. The resulting increased volume softens the stool and mechanically distends the colonic wall. This physical action stimulates the peristaltic reflex (smooth muscle contraction), promoting the caudal movement of the stool mass.

Microbiota-Mediated Acidification and Ion Trapping

The second domain involves Lactulose acting as a prebiotic-like substrate for saccharolytic colonic bacteria. Their subsequent fermentation produces short-chain fatty acids (SCFAs) that significantly lower the pH of the colonic contents. This acidification initiates a crucial ion-trapping mechanism: it converts the readily-absorbed molecule ammonia (NH3) into the non-absorbable, polar ammonium ion (NH4^+). This chemical conversion reduces the passive diffusion of nitrogenous compounds across the colonic wall, favoring their fecal excretion.

Dosage and Administration Information

The administration of Avilac (Lactulose) follows prescriptive guidelines, which specify the route, frequency, dose, and preparation of the solution. The primary approved route is oral administration using the liquid solution or syrup. For specialized use in managing severe Hepatic Encephalopathy (HE), official labeling also specifies the use of a rectal retention enema, typically in a supervised clinical setting.

Dosing regimens are distinct for each approved use. For chronic constipation, the standard starting adult dose is typically 15 mL to 45 mL (or 10 g to 30 g) taken once daily. This is adjusted to a maintenance dose of 15 mL to 30 mL. In contrast, the required dose for the management of HE is substantially higher, starting at 30 mL to 45 mL taken three to four times daily in divided doses. This regimen is highly specific: the dose is not fixed but titrated to produce a defined physical endpoint of two to three soft stools daily.

Official preparation instructions require the dose to be measured precisely using a calibrated measuring device. The solution may be mixed with approx 120 mL of water, fruit juice, or milk to improve palatability. It can be taken with or without food. For a single daily dose, maintaining a consistent timing each day is generally recommended. Use in children and infants requires specific pediatric dosing based on weight and must be overseen by a specialist.

This structure establishes a framework for proper administration, emphasizing accurate preparation and adherence to the measured response required for treatment success, rather than a generalized, fixed regimen.

Recent Clinical Evidence

Research evidence / Overview of Studies for Avilac (Lactulose)


Evidence for use in Chronic Constipation

Avilac (Lactulose) was studied for chronic constipation primarily in short-term randomized controlled trials (RCTs). These studies were observed in adult patients with conditions characterized by fluctuating or episodic manifestations of constipation. The main outcomes monitored included weekly stool frequency and consistency.

Data show patterns related to measured stool frequency, where participants receiving Avilac reported different outcomes compared to those receiving a placebo over defined time intervals. Findings were mixed when comparing Avilac directly to other osmotic agents across systematic reviews; some analyses reported patterns where certain comparators were associated with different measured outcomes. The evidence contributes to understanding symptom patterns over short durations, typically less than two months.


Evidence for use in Hepatic Encephalopathy (HE)

Avilac was studied for its use in managing and preventing Hepatic Encephalopathy (HE), a condition associated with acute or disruptive episodes of neurological dysfunction. The evidence level for this use is classified as High, reflecting the consistency of findings across multiple major reviews that was observed in the studies.

Research examined its effect on outcomes related to systemic or functional imbalance, such as the concentration of ammonia in the blood, and focused on the reversal of neurological symptoms. For prevention, studies explored its use over longer periods (months to years) in patients with a history of the condition. Studies report how symptoms evolved in the observed populations, where consistent use was associated with differences in the measured frequency of HE recurrence.


What is Still Uncertain About Avilac Research

Avilac was evaluated in studies involving both older adults and children experiencing functional constipation, although sample sizes were modest in the specific pediatric trials. For chronic constipation, follow-up durations were limited in many core randomized trials, meaning there is limited information for long-term outcomes regarding daily, continuous use. Methodological heterogeneity across trials and comparative evidence is lacking in some areas, leading to low certainty for some conclusions.

Key Studies & References LACTULOSE solution (FDA-mandated labeling via DailyMed) – Indications and Clinical Pharmacology

Frequently Asked Questions (FAQ)

Common questions about Avilac (FAQ)


Q: Is Avilac used for conditions other than the main ones listed?

A: According to the official product information, Avilac (Lactulose) is indicated only for two primary purposes. These are the treatment of chronic constipation and the prevention or treatment of portal-systemic encephalopathy (PSE), which includes hepatic pre-coma and coma. Any usage outside of these established indications is not described in regulatory documents.


Q: How quickly does Avilac typically start working?

A: Avilac works locally in the large intestine, meaning the medicine requires time to pass through the digestive system before its full effect can be observed. Official documents state that 24 to 48 hours may be required to produce the desired bowel movement. It is important to understand that the action is not immediate.


Q: What is the difference between Avilac and other similar medicines?

A: Avilac is classified as an osmotic laxative, which means it physically draws water into the colon to soften stool. Additionally, official information indicates it has a second mechanism involving gut bacteria, which reduces the colon's pH. This acidification assists in trapping and removing nitrogenous waste, which is the specific mechanism leveraged in the management of certain liver conditions.


Q: Is it common to feel tired after starting Avilac?

A: Official prescribing information does not list tiredness or fatigue as a common or known side effect of Avilac. Reported side effects are primarily gastrointestinal in nature. Since fatigue is not listed on the official adverse reactions list, it is not considered a commonly reported side effect based on regulatory labels.


Q: Is Avilac known to cause weight gain or loss?

A: Regulatory documents do not list weight gain or weight loss as reported adverse reactions associated with the use of Avilac (Lactulose). Adverse reactions detailed in official prescribing information are mainly related to gastrointestinal issues and fluid balance.


Q: Are there any specific foods I need to avoid while on Avilac?

A: Official guidance indicates Avilac can be mixed with water, milk, or fruit juice to improve taste, and it may be taken with or without food. Specific food items are not generally listed in regulatory guidance as needing to be avoided. The medicine is generally compatible with food, but specific contraindications related to its sugar content exist and are detailed in the eligibility section.


Q: What should I do if I miss a dose of Avilac?

A: If a regular dose is missed, regulatory patient information states that the dose may be taken as soon as it is remembered. However, if it is nearly time for the next scheduled dose, the missed dose is typically skipped to resume the regular schedule. Taking a double dose at one time is not advised.


Q: Does Avilac affect my ability to drive or operate machinery?

A: Official regulatory documents, such as the Summary of Product Characteristics (SmPC), state that Avilac (Lactulose) has no or negligible influence on a person's ability to drive or use machinery. This indicates that major impairment of motor skills or awareness is not expected with its use.


Q: Is Avilac available over the counter, or is it prescription only?

A: Avilac (Lactulose) is classified as a prescription-only medicine (Rx ONLY) in the United States. As a prescription-only medicine, it is obtained with authorization from a licensed healthcare provider.


Q: Are there any long-term effects associated with Avilac use?

A: For patients receiving continuous treatment for six months or longer, regulatory guidance mandates periodic measurement of serum electrolytes. This monitoring is stated as a requirement because of the potential for electrolyte imbalance that may result from excessive fluid loss, such as chronic diarrhea.


Q: Is Avilac considered a controlled substance?

A: Avilac (Lactulose) is not classified as a controlled substance by the U.S. Drug Enforcement Administration (DEA). This means the medicine is not associated with the potential for abuse or dependency that applies to scheduled drugs.


Q: What are the signs of a serious allergic reaction to Avilac?

A: Signs of a severe allergic reaction can include hives, difficulty breathing, or swelling of the face, lips, tongue, or throat. Regulatory data also reports hypersensitivity reactions, which may manifest as rashes or itching. These signs are important to note if they occur during treatment.


Q: Does Avilac have a risk of dependency?

A: Official prescribing information does not list physical or psychological dependence or abuse potential for Avilac (Lactulose). It is not associated with the risks of dependency sometimes seen with other classes of medicines.


Q: Is it true that Avilac interacts with grapefruit?

A: Regulatory documents detailing drug interactions for Avilac do not list an interaction with grapefruit or grapefruit juice. The official interaction profile primarily focuses on certain drug classes, such as antacids and diuretics.


Q: What does official guidance say about taking Avilac with chronic conditions?

A: Official guidance lists specific contraindications, such as galactosaemia and gastrointestinal obstruction or perforation. Caution is advised for use in patients with diabetes mellitus due to the presence of some related sugars in the solution. The full eligibility criteria are detailed in the official regulatory documentation.


Q: Can I take Avilac if I am taking supplements or herbal remedies?

A: Official drug interaction information focuses on potential interactions with prescription and over-the-counter medicines (e.g., antacids, oral anti-infectives). Supplements and herbal remedies are not explicitly listed in these regulatory documents. For specific concerns about supplements, the input of a healthcare professional is generally required.


Q: Is Avilac a generic or a brand-name drug?

A: The active ingredient in this medicine is Lactulose, which is the generic name recognized internationally. Avilac is the brand name under which this generic medicine is made available. The generic name, Lactulose, is commonly used in studies and regulatory classification.


Q: Do studies show a difference in effect based on patient demographics (age, sex)?

A: Regulatory labels note that the safety and effectiveness for constipation have not been established in the pediatric population (children). Beyond this, official information regarding differences in effect based on sex or other demographic factors is not provided.


Q: What is the maximum duration of treatment mentioned in official documents for Avilac?

A: A single, explicit universal maximum duration is not set forth in the regulatory documents. For chronic constipation, the treatment is typically adjusted for short-term relief. For the treatment of PSE, continuous long-term therapy (sometimes over years) may be necessary.


Q: What if I experience unusual side effects not listed in the patient leaflet?

A: Reporting of any suspected adverse reactions, including those not listed in the patient information, is done through the healthcare provider and the relevant regulatory authority (such as the FDA’s MedWatch program). This process helps monitor the medicine's safety profile over time.


Q: Does Avilac interact with birth control pills?

A: Official drug interaction information, as described in regulatory labels, does not list an interaction between Avilac (Lactulose) and oral contraceptive pills. The interaction profile focuses on medicines that could compromise its efficacy or increase the risk of electrolyte imbalance.


Q: Can Avilac be cut in half or crushed?

A: Avilac (Lactulose) is supplied as an oral solution or syrup and must be measured precisely using a calibrated device. Since it is a liquid formulation, it is not manufactured as a tablet or capsule, and therefore the question of cutting or crushing does not apply.


Q: What is the expected outcome from a course of Avilac treatment?

A: For constipation, the expected outcome is an increase in the number and frequency of bowel movements. For the management of portal-systemic encephalopathy (PSE), the goal is to reduce ammonia levels in the blood, which is generally associated with an observed improvement in the patient's mental state.


Q: What are the ingredients in the inactive part of the Avilac tablet?

A: Avilac is a solution, not a tablet. The inactive components include varying amounts of related sugars (galactose and lactose) that are formed during the manufacturing process. Other components include purified water, coloring (such as FD&C Yellow No. 6), flavoring, and sodium hydroxide used to adjust the solution’s pH.


Q: Does Avilac interfere with laboratory tests or medical procedures?

A: Official warnings state a theoretical hazard exists for patients undergoing electrocautery procedures (such as proctoscopy or colonoscopy). This is due to the potential for hydrogen gas accumulation in the colon. Thorough bowel cleansing with a non-fermentable solution is generally recommended before such procedures.


Q: Is Avilac linked to any mental health side effects, such as anxiety or depression?

A: Anxiety or depression are not listed as reported adverse reactions in the official prescribing information for Avilac (Lactulose). The adverse reactions profile focuses predominantly on physical, gastrointestinal effects.


Q: What should I do if I think I have taken too much Avilac?

A: Regulatory information on overdosage indicates that the major expected symptoms are severe diarrhea and abdominal cramps. Should this occur, the medicine is generally terminated to resolve the symptoms. In the event of overdosage, medical consultation is required.


Q: How is Avilac generally eliminated from the body?

A: Avilac (Lactulose) is described in official clinical pharmacology sections as being poorly absorbed from the digestive tract. Since very little (3% or less) is excreted in the urine, the overwhelming majority of the dose is eliminated via the feces (stool).

How should Avilac be stored and disposed of?

How to Store and Dispose of Avilac (Lactulose Solution)

The storage and disposal of Avilac must strictly follow the conditions specified in the official regulatory labeling to ensure product quality.

Condition Requirement
Storage Temperature Store at Controlled Room Temperature (20 C to 25 C).
Protection Rules Do not freeze and avoid prolonged exposure to direct light or heat (above 30 C).
Stability Check If the solution develops extreme darkening and turbidity due to heat or light exposure, the product must not be used. Normal darkening does not affect action.
Container Rules Keep the container tightly closed and use a child-resistant closure.
Child Safety Keep this and all drugs out of the reach of children.
Disposal Dispose of unused or expired solution in accordance with applicable national and local waste disposal regulations.

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

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