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Холудексан

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Холудексан

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Medically reviewed

Laura Arias

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.

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Overview of Холудексан

What is Холудексан? Overview and Identity

Property Description
Active Ingredient Ursodeoxycholic Acid (UDCA) / Ursodiol
Form Capsules, Suspension for oral administration
Pharmacological Class Bile Acid Preparation, Hepatoprotector (ATC Code A05AA02)
Common Use Modifying bile composition, Liver support, Gallstone dissolution
Origin Chemically synthesized secondary bile acid

What Type of Medicine is Холудексан? (Definition and Classification)

Холудексан is a registered prescription pharmaceutical agent classified as a Bile Acid Preparation, whose active substance is Ursodeoxycholic Acid (UDCA), also known as Ursodiol. This classification reflects its specialized function within the therapeutic group of agents used to modify bile composition and flow. It is widely recognized as a Hepatoprotector and is formally listed in pharmacological databases as a Choleretic Agent. The drug is a single-component product and is formulated specifically for oral administration, being available in convenient forms such as capsules and an oral suspension.

Ursodeoxycholic Acid: Composition and Origin (Substance Identity)

The active substance, Ursodeoxycholic Acid, is a secondary bile acid that naturally exists in small amounts in human bile; however, the ingredient in the medication is chemically synthesized to ensure the high standards required for pharmaceutical purity. Its chemical structure is noteworthy because it is a hydrophilic (water-soluble) agent. This property allows UDCA to preferentially replace the body's more toxic, naturally dominant hydrophobic bile acids within the enterohepatic system. This replacement process is central to its therapeutic differentiation.

What is the General Purpose of Ursodeoxycholic Acid? (High-Level Benefit)

The general purpose of Ursodeoxycholic Acid is to favorably modify the bile acid pool to exert a cytoprotective effect on liver tissue and stabilize the physical properties of bile. The medication acts to mitigate the chemical stress associated with compromised bile flow, thus providing support and protection as a hepatoprotector. This mechanism is noted for its ability to promote the solubilization of cholesterol in the bile, a unique functional attribute that addresses the pathology of certain conditions related to bile composition and stone formation.

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What side effects are possible with Холудексан?

Possible Side Effects and Safety Information

The safety profile of Ursodeoxycholic Acid ( Холудексан) is defined by specific patterns of adverse reactions classified by government regulatory authorities.

Frequency-Classified Adverse Reactions

Adverse effects are categorized by the body system affected and their likelihood of occurrence. The most frequently documented issues are generally related to the Gastrointestinal Disorders system.

Classification System-Organ Class Example Reaction
Very Common/Common Gastrointestinal Disorders Diarrhea, pasty stools
Uncommon Skin and Subcutaneous Tissue Disorders Pruritus (itching)
Rare Hepatobiliary Disorders Calcification of gallstones
Very Rare Hepatobiliary Disorders Worsening of cirrhosis symptoms

Clinically Significant and Systemic Safety Notes

The occurrence of diarrhea or pasty stools is often noted in regulatory documents as potentially being dose-dependent and more likely to manifest during the initial phase of treatment or following dose escalation.

A very rare but clinically significant event is the worsening of pre-existing cirrhosis symptoms (hepatic decompensation), which has been documented in patients with advanced Primary Biliary Cholangitis (PBC). This event necessitates careful monitoring.


Safety-Related Restrictions

Official prescribing information outlines specific patient populations for whom treatment is restricted or contraindicated. This medication is not indicated for use in individuals with calcified (radiopaque) gallstones, as it is only effective for dissolving cholesterol-rich stones. Furthermore, its use is generally contraindicated in cases involving acute inflammation of the gallbladder or biliary tract (such as acute cholecystitis) or complete obstruction of the biliary tract.

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Overdose and Emergency Response

Overdose Map: Overdose and when to seek help — Official Regulatory Information for Холудексан (Ursodeoxycholic Acid)

Overdose Scope

Sub-Section Official Regulatory Statement
Documented Overdose Presentations The primary documented manifestation is severe dose-dependent diarrhea and loose stools.
Physiological Systems Affected (as stated in label) Primarily the gastrointestinal system; no severe systemic toxicity is formally documented in acute overdose.
Dose-related or Exposure-related Factors (if applicable) Overdose is associated with high doses; absorption decreases with increasing dose, leading to increased fecal excretion.
Population-specific Overdose Notes (if applicable) No specific increased severity in pediatric, geriatric, or organ-impaired populations is explicitly documented regarding acute overdose severity.
Emergency-response statements (as written in official documents) Seek immediate medical attention for any suspected overdose; Contact a regional poison control centre.
When immediate medical help is required (label-derived phrasing only) Urgent medical care is required for suspected overdose; Treatment should be discontinued if persistent diarrhea occurs, necessitating medical review.

Overdose Classifications (High-Level)

Classification Feature Official Regulatory Statement
Severity classification (as defined in official documents) Overdose is typically classified as non-life-threatening concerning systemic effects, with the main concern being supportive management of gastrointestinal effects.
Regulatory basis (EMA / FDA / etc.) Based on the Summary of Product Characteristics (SmPC) and FDA Prescribing Information.
Overdose-context constraints (as defined in official documents) No specific antidote is known; treatment must be symptomatic and focused on restoring fluid and electrolyte balance.

Resulting Overdose Structure

Official Overdose Statements:

  • The most likely consequence of overdosage is the occurrence of severe diarrhea and loose stools, which are considered dose-dependent.
  • Regulatory labeling states that no specific antidote is known for this medication.
  • The official guidance mandates that patients should seek immediate medical attention for any suspected overdosage.
  • Management is supportive, including the required provision of fluid and electrolyte replacement to counteract dehydration caused by severe diarrhea.
  • Treatment must be discontinued if the severe diarrhea is persistent, necessitating professional medical review and monitoring.

Connection to the overall overdose profile (3 sentences): The regulatory documents define the overdose profile of Ursodeoxycholic Acid as one where severe systemic or organ toxicity is not expected. The primary concern is focused on gastrointestinal symptoms, which requires immediate medical attention to manage the resulting fluid and electrolyte imbalances. This profile confirms that management remains supportive, and no specific intervention beyond symptomatic treatment is required, as no specific antidote is available.

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Therapeutic Uses of Холудексан

Quick Facts

  • Primary Biliary Cholangitis (PBC): This is an approved use for managing this chronic, immune-mediated liver condition.
  • Cholesterol Gallstones: The compound is used to support the dissolution of certain types of gallstones.
  • Select Cholestatic Liver Conditions: May be administered for the therapeutic management of other conditions involving impaired bile flow.

What Холудексан Treats: Main Uses and Benefits

Холудексан, which is a formulation of ursodeoxycholic acid (UDCA), is a prescription medication utilized in the therapeutic management of certain liver and gallbladder conditions. The compound is approved for use in patients diagnosed with Primary Biliary Cholangitis (PBC), a chronic condition that affects the bile ducts in the liver. For individuals with PBC, the medication may help to manage the disease and support overall liver function.

Additionally, the medication is employed for the non-surgical treatment of cholesterol gallstones. In this context, it supports the reduction of cholesterol saturation in the bile, which may facilitate the dissolution of non-calcified, cholesterol-rich gallstones. Treatment is typically reserved for patients who are unable to undergo surgery. The compound is also a treatment option for other selected conditions characterized by cholestasis (impaired bile flow), where it may contribute to symptom management and biochemical improvement. Consult with a healthcare provider to determine if this therapy is appropriate for a specific condition.

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Eligibility and Restrictions for Use

Who Can and Cannot Use Холудексан (Ursodeoxycholic Acid)—Official Regulatory Information

Official regulatory documents strictly define the patient populations eligible for this medicine based on specific medical conditions, age, and physiological status. Use is generally established in adults for conditions like Primary Biliary Cholangitis (PBC) and for dissolving specific non-calcified cholesterol gallstones, provided the gallbladder is functioning.


Contraindicated Populations

The medicine is contraindicated and must not be used by patients with:

  • Hypersensitivity to ursodeoxycholic acid or any component.
  • Complete obstruction of the biliary tract (e.g., occluded common bile duct).
  • Acute inflammation of the gallbladder or biliary tract.
  • Radio-opaque, calcified gallstones.
  • Inflammatory diseases of the small and large intestine (e.g., ulcerative colitis) [Source: EMA].
  • Decompensated hepatic cirrhosis (advanced liver disease).

Age and Reproductive Status Restrictions

Pediatric use is generally not established for all indications, though approved use exists for hepatobiliary disorders associated with cystic fibrosis in children, typically aged six years and older. Pregnancy is a restricted status; use is generally contraindicated during the first trimester, and women of childbearing potential receiving treatment for gallstone dissolution must use effective non-hormonal contraception.

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What should I know about interactions with other medicines?

The interactions profile for Холудексан is structured by documented effects on the drug's own absorption and its modification of co-administered medicines, as stated in regulatory documents.

Official Interaction Statements

  • Absorption Inhibitors and Timing: Agents that bind bile acids, such as the resins Cholestyramine and Colestipol, as well as Antacids containing Aluminium Hydroxide or Smectite, reduce the absorption and efficacy of Холудексан. Regulatory requirements mandate that these products must be administered at least 2 hours before or after Холудексан.

  • Modification of Drug Levels: Холудексан increases the intestinal absorption of the immunosuppressant Ciclosporin, officially necessitating the monitoring of Ciclosporin blood concentrations. Furthermore, a reduction in the therapeutic effect of Dapsone and reduced plasma concentrations of Nitrendipine are documented. Rosuvastatin plasma levels have also been documented to increase, although the clinical relevance is officially unknown.

  • Counteracting Efficacy: The co-administration of Oestrogenic Hormones (e.g., in oral contraceptives) or Clofibrate is restricted when using Холудексан for gallstone dissolution, as these agents increase cholesterol secretion, officially counteracting the drug’s intended therapeutic goal. This latter restriction also extends to a note on the use of non-hormonal contraception for women of childbearing potential in this specific treatment context.

Connection to the Overall Interaction Profile

Regulatory documentation defines this interaction structure based on the need to prevent physical binding in the gut and to address the drug's effect on the exposure of other medicines. This leads to clear, mandated time separation rules for absorption-inhibiting agents and necessary blood level monitoring or use restrictions for agents whose exposure or efficacy is modified.

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Mechanism of Action

How Холудексан Works

Холудексан (Ursodeoxycholic Acid or UDCA) exerts its effect through three primary mechanistic domains. First, it mediates hepatocyte cytoprotection by acting as a hydrophilic bile acid that integrates into the bile acid pool. This action displaces more lipophilic, toxic endogenous bile acids (e.g., DCA, LCA), which reduces their cytotoxic and pro-apoptotic effects on liver cell membranes. This mechanism primarily stabilizes cellular integrity and limits molecular disruption.

Second, the drug promotes choleresis (bile flow). It modulates the activity of transport proteins on the canalicular membrane, including the Bile Salt Export Pump (BSEP), which facilitates enhanced bile secretion. This creates a hypercholeresis effect that increases the kinetic clearance and elimination of accumulated biliary components and xenobiotics from the biliary system.

Third, UDCA influences inflammatory and immune signaling cascades. It can modulate intracellular pathways, such as the Nuclear Factor kappa B (NF-κB) cascade, which attenuates the activity of pro-inflammatory mediators and can reduce the expression of MHC Class I antigens on hepatocytes.

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Dosage and Administration Information

The administration of Холудексан (ursodeoxycholic acid) is strictly through the oral route, available in forms such as capsules, tablets, and a liquid suspension. The fundamental principle of use is a weight-based dosing schedule tailored to the specific condition, with a standard regimen for Primary Biliary Cholangitis (PBC) typically falling in the range of 13 -15 mg/kg/day of the active ingredient. This dosing frequency is initially administered as two to four divided doses daily and is often recommended to be taken with food to support absorption. For gallstone dissolution, a lower weight-based dose is generally prescribed and is frequently taken as a single dose in the evening.

The duration of use varies significantly by the purpose of the treatment. Management of PBC is characterized as a long-term therapeutic plan intended for ongoing use. In contrast, treatment for gallstone dissolution is a time-bound course that may last up to two years and must be continued for several months following confirmation of complete stone clearance.

Solid forms of the medication must be swallowed whole with water. For patients with low body weight, such as pediatric patients with cystic fibrosis-related liver disorders, a specific dosing protocol and the use of the oral suspension formulation are generally applied. If a dose is missed, patients should not take a double dose to compensate. This entire protocol establishes the standardized approach to administering the medicine.

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Recent Clinical Evidence

Холудексан (Ursodeoxycholic Acid): Recent Clinical Evidence

Efficacy in Primary Biliary Cholangitis (PBC)

Холудексан (ursodeoxycholic acid or UDCA) is the primary first-line treatment for Primary Biliary Cholangitis (PBC), a chronic cholestatic liver disease. Research, including long-term post-hoc analyses and real-world data from large patient registries, suggests that UDCA is associated with improvements in key biochemical markers and may delay the progression of the disease.

  • Biochemical Response: Studies demonstrate that UDCA therapy at appropriate doses (typically 13–15 mg/kg/day) can significantly improve serum levels of alkaline phosphatase (ALP) and total bilirubin, which are established surrogate markers of clinical outcomes in PBC.
  • Disease Progression: Randomized controlled trials (RCTs) and long-term observation studies indicate that UDCA therapy is associated with a slower rate of progression of liver fibrosis and a reduced need for liver transplantation in PBC patients compared to placebo groups.

Other Investigated Uses

UDCA has also been studied in other cholestatic liver conditions and for other purposes, with varying degrees of established benefit:

Condition Research Summary
Cholesterol Gallstones UDCA is used to reduce the cholesterol saturation of bile, which can lead to the gradual dissolution of small, non-calcified cholesterol gallstones.
Primary Sclerosing Cholangitis (PSC) Clinical outcomes in PSC are less clear. While UDCA may improve liver enzyme levels in this condition, trials using high doses (28–30 mg/kg/day) were halted due to safety concerns, including an increased risk of liver-related complications and death. UDCA is not conclusively shown to improve long-term survival in PSC.

Safety and Tolerability

UDCA is generally considered to be well-tolerated in patients with PBC. The most frequently reported side effect is loose stool or diarrhea, which is usually dose-dependent and may be reversible upon reducing the dosage.

Key Studies & References

  1. Urosdeoxycholic acid in primary sclerosing cholangitis: a meta-analysis and systematic review
  2. Ursodeoxycholic Acid - StatPearls (for general pharmacology, gallstone, and side effect profile)
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Frequently Asked Questions (FAQ)

Common questions about Холудексан (FAQ)


Q: Is Холудексан a hepatoprotector or a gallstone dissolver?

Official regulatory documents classify this medicine as a bile acid preparation. It serves a dual role: it functions as a hepatoprotector by helping to stabilize and protect liver cells, and it is also officially indicated for dissolving certain types of cholesterol gallstones.


Q: How quickly should I expect to see an effect from Холудексан?

The time it takes to see an effect varies by condition. For gallstone dissolution, observing the initial therapeutic response may take several months. The timeline for a full effect varies significantly among individuals and is monitored by a healthcare professional using blood tests or imaging.


Q: Are there any common digestive issues linked to taking Холудексан? (Beyond diarrhea/stools)

Yes, in addition to the very common side effects of diarrhea and pasty stools, official safety data reports other digestive issues. These may include abdominal discomfort, nausea, vomiting, flatulence, and general indigestion (dyspepsia).


Q: Can Холудексан cause hair loss?

Hair loss, or alopecia, has been reported as an uncommon side effect in regulatory safety literature. Patients who experience this side effect should discuss it with a healthcare provider.


Q: Does Холудексан interact with oral contraceptives? (General question, not limited to dissolution)

Oral contraceptives and other hormonal agents that contain estrogens can increase the secretion of cholesterol, which may potentially reduce the effectiveness of this medicine. The medicine’s product information notes a restriction on certain oral contraceptives when used for gallstone dissolution. Patients should review their contraception use with a professional.


Q: Can I crush or open the Холудексан capsules if I have trouble swallowing them?

Regulatory guidance specifies that solid forms of the medication should typically be swallowed whole. While an oral suspension formulation exists for those with swallowing difficulties, any modification to the capsules should only be made if it is specifically authorized in the official product instructions or by a healthcare professional.


Q: Does Холудексан affect weight or appetite?

Weight-related changes, including unusual weight gain or loss, have been noted in adverse event reports. These are generally not listed as common side effects but should be discussed with a healthcare provider if they are observed.


Q: What are the signs of a potential overdose with this medication?

Regulatory sources indicate that the most significant symptom of an overdose is likely to be severe diarrhea. Individuals should seek emergency medical attention or contact a poison control centre immediately.


Q: Does Холудексан have an effect on cholesterol levels in the blood?

This medicine is primarily designed to reduce cholesterol saturation in the bile. While some clinical studies suggest an association with total cholesterol lowering, its core therapeutic function relates to modifying the composition of bile.


Q: Is a change in stool consistency normal with Холудексан?

Yes, a change in stool consistency is a very common side effect reported in official documents. This typically presents as loose stools or diarrhea, and it is often more pronounced when starting treatment or following a dosage change.


Q: Does the medicine come in different strengths or forms?

Yes, the active ingredient, Ursodeoxycholic Acid, is generally available in various strengths and multiple forms for oral administration. These typically include capsules, tablets, and a liquid oral suspension.


Q: Is there a preferred time of day to take the capsules?

Official information suggests the preferred timing depends on the condition being treated. For gallstone dissolution, a single dose in the evening is often recommended. For liver conditions, the dose is typically taken in two to four divided doses daily, often with food.


Q: Does Холудексан reduce the risk of forming new gallstones?

Yes, in addition to dissolving existing stones, the medicine is indicated in some regulatory guidelines for the prevention of gallstones. This is typically prescribed in high-risk situations, such as patients undergoing rapid weight loss.


Q: Does Холудексан help protect liver cells from damage?

Yes, regulatory documents describe the medicine's mechanism of action as providing hepatocyte cytoprotection. This involves stabilizing the integrity of liver cells and helping to protect them from chemical stress caused by other bile acids.


Q: Can I take Холудексан if I also take cholesterol-lowering medication?

This medicine has documented interactions with certain lipid-modifying agents, such as Clofibrate, which can work against its intended effect in gallstone treatment. The concurrent use of this medication with cholesterol-lowering agents should be monitored by a healthcare professional.


Q: Does Холудексан affect the results of other blood tests?

The medicine is known to interact with and affect the blood levels of certain other medications. For example, regulatory documents state that the levels of the immunosuppressant Ciclosporin must be monitored when taken concurrently.


Q: What are the different conditions Холудексан is typically prescribed for?

According to official product information, this medicine is typically prescribed for three main purposes: as the primary first-line treatment for Primary Biliary Cholangitis (PBC), for the dissolution of small, non-calcified cholesterol gallstones, and for managing specific hepatobiliary disorders associated with cystic fibrosis.


Q: How does Холудексан actually work in the body?

The medicine works through three main pathways: it protects liver cells (cytoprotection) by replacing toxic bile acids, increases the flow of bile (choleresis), and modifies the bile’s composition to dissolve cholesterol.


Q: Is it normal to have mild diarrhea when starting Холудексан?

Yes, official safety data indicates that diarrhea or loose stools are very common side effects. They are generally dose-dependent and are often more pronounced when you first begin the treatment.


Q: What are the less common, but more serious, potential side effects to be aware of?

While rare, a serious side effect documented in official safety information is the worsening of pre-existing cirrhosis symptoms (hepatic decompensation), particularly in patients with advanced liver disease. This condition requires careful monitoring by a professional.


Q: Does Холудексан interact with common pain medications or NSAIDs?

Regulatory documents mention interactions with certain types of anti-inflammatory agents. Patients taking any pain medications, including NSAIDs, should review these with a healthcare professional, as documented interactions with certain anti-inflammatory agents exist.


Q: Can taking antacids affect the absorption or effectiveness of Холудексан?

Yes, antacids that contain aluminum hydroxide, as well as bile acid-binding resins, significantly reduce the medicine’s absorption and efficacy. Regulatory guidelines mandate that bile acid-binding agents and aluminum hydroxide-containing antacids must be taken at least two hours before or after this medicine.


Q: Can children or teenagers take Холудексан?

The medicine is not approved for all pediatric indications. However, approved use exists for treating hepatobiliary disorders associated with cystic fibrosis in children, typically those aged six years and older.


Q: What happens if I miss a scheduled dose of Холудексан?

Official regulatory instructions advise patients not to take a double dose to compensate for a missed dose. Specific missed dose instructions are provided in the Patient Information Leaflet or by a healthcare professional.


Q: How long is a typical course of treatment with Холудексан for gallstones?

Treatment for dissolving gallstones is a prolonged, time-bound course that can last up to two years. It must be continued for several months even after imaging confirms that the gallstones have completely dissolved.


Q: Is Холудексан used to treat Primary Biliary Cirrhosis (PBC)?

Yes, official regulatory documents establish this medicine (Ursodeoxycholic Acid) as the primary first-line treatment for Primary Biliary Cholangitis (PBC).


Q: Why is an allergic rash listed as a very rare side effect?

Allergic reactions and hypersensitivity, which can manifest as a rash or hives, have been reported during the post-marketing surveillance of this medicine. Patients who notice skin changes should consult a healthcare professional.


Q: Does the medicine contain any common allergens or ingredients to be cautious of?

The medicine is strictly contraindicated in anyone with a known hypersensitivity to the active ingredient (Ursodeoxycholic Acid) or any of the non-active components (excipients). The complete list of ingredients is detailed in the official Patient Information Leaflet.


Q: Why do people report feeling abdominal discomfort after starting this medicine?

Abdominal discomfort is listed in official post-marketing reports as a possible gastrointestinal side effect. This may be related to the medicine's effect on bile acid composition and the digestive system, although it is less common than diarrhea.

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How should Холудексан be stored and disposed of?

How to Store and Dispose of Холудексан?

The storage and disposal of Холудексан (ursodeoxycholic acid) must strictly follow the requirements specified in official regulatory labeling to maintain product stability.

Storage Conditions

The medication must be stored at controlled room temperature, typically between 20 C to 25 C. The product must be protected from both moisture and heat, and it is explicitly instructed not to freeze the medicine. To ensure the declared shelf-life, the product should remain in its original container, and the container must be kept tightly closed when not in use. As with all medications, it must be kept out of the reach and sight of children.

Disposal Instructions

Expired or unused medication must be disposed of in accordance with national and local regulations for pharmaceutical waste. The product must not be thrown into household trash or wastewater systems (e.g., sinks or toilets); disposal must occur through official drug take-back programs or an approved waste disposal plant.

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

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