Эксхол

Quick links to important sections

Эксхол

Selected form

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.

Overview of Эксхол

What is Exchol?

Exchol is a pharmacological agent containing ursodeoxycholic acid (UDCA) as its active pharmaceutical ingredient. UDCA is a naturally occurring bile acid that is found in small quantities in human bile. When administered as a medication, it serves to modify the composition of bile and influence the function of the hepatobiliary system.

Mechanism of Action

The therapeutic effects of Exchol are primarily centered on its ability to interact with bile acids and cholesterol. The medication operates through several key physiological pathways:

  • Reduction of Cholesterol Saturation: The drug inhibits the absorption of cholesterol in the intestines and reduces the secretion of cholesterol into the bile. This process helps to decrease the cholesterol saturation index.
  • Bile Acid Displacement: By increasing the concentration of UDCA in the bile, the medication displaces more toxic, hydrophobic bile acids. This shift helps protect liver cells (hepatocytes) and the epithelial cells lining the bile ducts from chemical irritation and damage.
  • Cholesterol Dissolution: Through the formation of liquid crystals with cholesterol molecules, the medication facilitates the gradual breakdown of existing cholesterol-based formations within the gallbladder.
  • Choleretic Effect: The agent promotes the flow of bile, aiding in the clearance of bile acids and reducing stasis within the biliary tracts.

Primary Uses

Exchol is utilized in clinical practice for the management of conditions affecting the liver and gallbladder. Its application is generally focused on:

  1. Dissolution of Gallstones: It is used for the degradation of small to medium-sized cholesterol gallstones in patients where the gallbladder remains functional.
  2. Biliary Gastritis: It helps neutralize the damaging effects of bile reflux on the stomach lining.
  3. Chronic Liver Diseases: It is employed in the symptomatic treatment of primary biliary cholangitis and other cholestatic liver conditions characterized by impaired bile flow.

By stabilizing cell membranes and improving the metabolic profile of bile, Exchol supports the functional integrity of the hepatobiliary system.

What side effects are possible with Эксхол?

Possible Side Effects and Safety Information

Official regulatory documents classify the medicine's safety profile based on the body systems affected and the frequency of reported adverse events, strictly detailing known risks without providing clinical recommendations.


Adverse Reactions by Frequency

Adverse reactions are classified based on their observed frequency in clinical trials and post-marketing surveillance:

  • Common (may affect up to 1 in 10 people): Loose stools or diarrhea. This side effect is often dose-dependent.
  • Very Rare (may affect up to 1 in 10,000 people): Calcification of gallstones; hepatic decompensation (worsening of liver function), which has been observed in patients with advanced primary biliary cholangitis (PBC).

System-Organ Class and Serious Risks

Adverse effects are primarily reported in the Gastrointestinal disorders class, mainly characterized by common stool changes. Very rare but clinically significant adverse reactions fall under Hepatobiliary disorders (hepatic decompensation) and may require immediate discontinuation of the medicine.

Safety Monitoring and Restrictions

Mandatory safety monitoring is required, involving periodic checks of liver function tests (AST, ALT, gamma-GT, alkaline phosphatase, and bilirubin) upon therapy initiation and thereafter. This measure is intended to detect potential hepatic deterioration early.

Restrictions include contraindications for patients with acute inflammation of the gallbladder or biliary tract, biliary tract obstruction (e.g., of the common bile duct), and non-functioning gallbladder. Furthermore, concomitant use with certain medications, such as bile acid sequestrants (e.g., cholestyramine) or aluminum-containing antacids, is restricted due to reduced absorption and efficacy.

Overdose and Emergency Response

Overdose and when to seek help

The information below is based strictly on regulatory prescribing documents and defines the official response required in cases of suspected overdose of Эксхол (ursodeoxycholic acid).


Documented Overdose Manifestations

The primary and most likely clinical manifestation of an acute overdose is Diarrhea.

Regulatory assessments indicate that serious or life-threatening systemic outcomes are generally unlikely to occur. This is because the body's absorption of ursodeoxycholic acid decreases at high doses, leading to increased excretion via the gastrointestinal system.


Emergency Actions and Management

In the event of a suspected overdose, regulatory guidance mandates that a patient contact a poison control center or emergency room at once.

Management Focus Official Regulatory Statement
Antidote Availability No specific antidote is known or required.
Symptomatic Treatment Management is symptomatic, requiring restoration of fluid and electrolyte balance to counteract the effects of severe diarrhea.
Monitoring Liver function monitoring is indicated as an observation measure following an overdose event.

High doses in the context of certain off-label conditions, such as Primary Sclerosing Cholangitis, have been associated with increased serious undesirable effects, reflecting a specific consideration in the regulatory profile.

Therapeutic Uses of Эксхол

What Эксхол Treats: Main Uses and Benefits

Эксхол contains ursodeoxycholic acid (UDCA). It may be part of symptomatic management in conditions where symptoms may intensify temporarily, primarily those involving the liver and bile ducts. Its therapeutic application is considered relevant for easing symptoms related to Primary Biliary Cholangitis (PBC) and managing symptoms associated with radiolucent, cholesterol gallstones.

This medicine is commonly used to help with these two main therapeutic areas. For patients with chronic conditions like PBC, it contributes to easing the overall symptom load. For acute scenarios, such as managing gallstones in individuals not suitable for surgery, it provides support that helps maintain a sense of stability.

“It helps improve day-to-day comfort during symptomatic periods.”

It may assist with managing the risk of gallstone formation in certain clinical scenarios, such as when patients experience rapid weight loss. This supportive use helps patients cope more steadily with symptom fluctuations and supports general well-being during symptomatic phases.

Quick Fact: Relief for symptoms related to physical discomfort.

Regulatory References

  1. NIH MedlinePlus Drug Information overview

Eligibility and Restrictions for Use

Who Can and Cannot Use Эксхол?

Regulatory agencies define strict population eligibility for Эксхол (Ursodeoxycholic Acid/UDCA) based on a patient's underlying health status and age.


Contraindicated Populations (Absolute Non-Eligibility)

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

  • Acute inflammation of the gallbladder or biliary tract (e.g., acute cholecystitis/cholangitis).
  • Obstruction of the common bile duct or cystic duct.
  • Radio-opaque (calcified) gallstones, as the drug is only authorized for radiolucent cholesterol stones.
  • Impaired gallbladder contractility or frequent episodes of biliary colic.
  • Decompensated hepatic cirrhosis.
  • Hypersensitivity to bile acids or any formulation components.

Restricted and Conditional Use

  • Pregnancy and Lactation: Use is not recommended during pregnancy, particularly in the first trimester; pregnancy must be excluded before starting. Women of childbearing potential must use effective non-hormonal contraception during treatment. Use is also not recommended while breastfeeding.
  • Age-Group: Use is established for adults and the elderly. Eligibility for children (6 to 18 years) is limited to hepatobiliary disorders associated with cystic fibrosis; use is generally not established for other pediatric indications.

What should I know about interactions with other medicines?

The interaction profile for Эксхол, which contains ursodeoxycholic acid (UDCA), is defined by its effects on absorption, efficacy, and the plasma levels of co-administered medicines.

Interactions that Affect Efficacy or Absorption

Substance Category Interaction Consequence Separation Requirement
Bile Acid Sequestering Agents (e.g., Cholestyramine, Colestipol) Reduces UDCA absorption, interfering with its action. Must be taken at least 2 hours before or 2 hours after UDCA.
Aluminum-based Antacids Binds UDCA, reducing its absorption and efficacy. Must be taken at least 2 hours before or 2 hours after UDCA.
Oestrogenic Hormones (e.g., Oral Contraceptives) Counteracts UDCA efficacy by promoting hepatic cholesterol secretion. Avoid co-administration during gallstone dissolution therapy.
Lipid-Lowering Drugs (e.g., Clofibrate) Counteracts UDCA efficacy by increasing cholesterol secretion into bile. Avoid co-administration.

Interactions that Alter Co-administered Drug Exposure

UDCA may affect the plasma concentration of other medicines:

  • UDCA can increase the absorption and plasma levels of the immunosuppressant ciclosporin.
  • UDCA can reduce the plasma concentrations and therapeutic effect of certain drugs, including the calcium antagonist nitrendipine and the antibiotic dapsone.

The regulatory documents establish clear timing rules for efficacy-reducing agents and mandate avoidance of substances that promote cholesterol secretion, structuring the profile around these two functional interaction types.

Mechanism of Action

The mechanism of Эксхол (Ursodeoxycholic acid, UDCA) is strictly confined to the biological and physiological level, centering on the modulation of bile composition, the enhancement of bile flow, and the provision of cellular cytoprotection.

Modulating Bile Composition and Solubilization

This domain involves the drug's action on bile chemistry by reducing the cholesterol saturation of bile and promoting the formation of mixed micelles. This mechanism physically modifies the bile environment, leading to the solubilization of cholesterol aggregates in the biliary system.

Cytoprotection and Enhanced Bile Flow

Эксхол targets the plasma membranes of liver and duct cells, improving their membrane stability upon exposure to hydrophobic bile acids. Concurrently, it engages nuclear receptors to enhance bile flow (choleresis), resulting in the displacement of hydrophobic bile acids and the systemic removal of accumulated bile components via enhanced flow.

Regulating Bile Acid Signaling Pathways

The mechanism of UDCA influences pathways governed by nuclear receptors (e.g., FXR) that control the synthesis and transport of bile acids. This modulation of signaling dynamics affects the set point for bile acid homeostasis, resulting in an alteration of the overall composition of the bile acid pool.

Dosage and Administration Information

How to Use Эксхол

Эксхол (ursodeoxycholic acid or UDCA) is administered through the oral route as capsules or tablets. Its usage follows specific patterns focusing on precise dose calculation, timing, and duration.


Administration Guidelines

Administration is largely dictated by body weight and indication, establishing consistent use protocols.

Usage Entity Instruction
Dosing Schedule Dosing is weight-based, typically 13–15 mg/kg/day for Primary Biliary Cholangitis (PBC) and 8–12 mg/kg/day for cholesterol gallstone dissolution.
Timing & Meals Doses are generally taken with food to assist absorption. The largest or entire daily dose should be taken at bedtime for optimal efficacy.
Frequency Pattern Can be taken as divided doses (two to four times daily), or as a single daily dose once initial improvement is achieved in certain conditions.
Preparation Capsules and tablets must be swallowed whole with fluid; they should not be crushed or chewed, even if scored.

Duration and Specific Population Rules

Treatment duration for chronic conditions is long-term and open-ended, such as for PBC. In contrast, gallstone dissolution requires an extended, cyclical course typically lasting 6 to 24 months, with continued use for approximately three months after successful stone clearance.

For pediatric use, dosing for conditions like Cystic Fibrosis-associated Liver Disease is also specified and calculated based on body weight, often at a higher mg/kg/day rate than adult regimens. In cases of a missed dose, the instruction is to take it as soon as remembered, but to skip it if it is nearly time for the next scheduled dose.

Recent Clinical Evidence

Research evidence / Overview of studies for Эксхол (Ursodeoxycholic Acid)


Evidence for Use in Primary Biliary Cholangitis (PBC)

Research exploring the use of ursodeoxycholic acid (UDCA), the active ingredient in Эксхол, for Primary Biliary Cholangitis (PBC) primarily involves Randomized Controlled Trials (RCTs). These studies evaluate whether patterns related to outcomes are observed when compared against control groups. Researchers tracked changes in liver biochemical markers (like alkaline phosphatase) and major clinical endpoints such as the need for liver transplantation and survival. Studies reported patterns related to measured changes in biochemical markers. Systematic reviews pooling RCT data describe mixed findings when research examined long-term outcomes, including all-cause mortality and transplant-free survival.

Evidence for Use in Cholesterol Gallstone Dissolution

UDCA was evaluated in studies for the dissolution of radiolucent (cholesterol-rich) gallstones in patients who are not suitable for surgery. Studies examined outcomes related to physical discomfort. Findings indicate that success in dissolving the stones was observed primarily in patients with small, non-calcified cholesterol stones. Research tracking patients post-dissolution describes patterns indicating that stones may reappear over time. This research applies only to cholesterol stones and not to other stone types.

Long-Term Research and Durability of Study Findings

Follow-up periods in UDCA research often extend for extended periods, with some systematic reviews monitoring patient outcomes for up to 7 to 12 years. This long-term evidence contributes to the broader evidence landscape by examining how outcomes evolved in the observed populations over time. However, data for long-term monitoring of quality of life or symptom progression remain inconsistent or limited.

Evidence in Specific Patient Populations

Research has primarily focused on the adult population with compensated PBC. Data for certain groups, such as children with chronic cholestatic liver disease or older adults with multiple comorbidities, remain limited in comparison to the core adult study population. The results apply only to the populations studied.

What Remains Uncertain in the Research Landscape

A primary uncertainty relates to the consistency of findings across different studies regarding clinical outcomes in PBC. The evidence base has documented limitations, including modest sample sizes in many older trials and the fact that the research for gallstones applies only to the specific type of stone studied (cholesterol).

Key Studies & References Ursodiol (Ursodeoxycholic Acid) Drug Information - MedlinePlus

Frequently Asked Questions (FAQ)

Common questions about Эксхол (FAQ)


Q: Is Эксхол a type of steroid or hormone medication?

A: Official documents state that Эксхол is a choleretic agent, which means it is a substance that helps increase bile flow. Its active ingredient, ursodeoxycholic acid (UDCA), is a naturally occurring bile acid found in the body. It is classified as neither a steroid nor a hormone medication.


Q: What is the difference between Эксхол and generic ursodeoxycholic acid?

A: Эксхол is a brand name for the medicine containing the active ingredient ursodeoxycholic acid (UDCA). While the drug has the same therapeutic component as generics, regulatory documents acknowledge that the specific formulation, such as the inactive ingredients or excipients, of the brand product may differ.


Q: How is the effectiveness of Эксхол usually monitored by a healthcare provider?

A: According to official product information, liver function tests are routinely monitored both for patient safety and to help assess the condition being treated. These tests, which measure markers like ALT, AST, and Alkaline Phosphatase, are periodically checked to track the patient's response.


Q: Where can I find the official regulatory document (e.g., SmPC or DailyMed) for Эксхол?

A: You can find the most authoritative information published by government drug agencies. For example, the European Medicines Agency (EMA) publishes the Summary of Product Characteristics (SmPC), and the U.S. FDA publishes the Prescribing Information (also known as DailyMed), which contain comprehensive details about the drug.


Q: Is it true that Эксхол has any anti-inflammatory properties?

A: The medicine's mechanism of action is officially described as primarily cytoprotective (protecting liver cells) and choleretic (enhancing bile flow). While these actions relate to liver health, official descriptions focus on these mechanisms rather than explicitly labeling the medicine as having anti-inflammatory properties.


Q: In what forms is Эксхол typically available (e.g., tablet, capsule, liquid)?

A: Official product information states that Эксхол is typically available in the form of capsules and tablets. An oral suspension (a liquid form) is also available and mentioned in official documents for certain preparations.


Q: Is fatigue or tiredness a commonly reported side effect of Эксхол?

A: Fatigue or a tired feeling is a known adverse event that has been reported in clinical use. Fatigue is a reported adverse event that should be discussed with a healthcare provider.


Q: Is it safe to drive or operate heavy machinery while taking Эксхол?

A: Official documents do not typically carry a specific restriction on driving or operating machinery. Adverse events like dizziness or headache are sometimes reported, which is relevant information for activities such as driving or operating machinery.


Q: Can Эксхол be used by people who have a known history of kidney problems?

A: The medicine's active ingredient, ursodeoxycholic acid, is primarily metabolized and eliminated through the liver and bile. For this reason, official safety information indicates that kidney impairment is not listed as a primary contraindication for its use.


Q: Does Эксхол cause changes in appetite or weight gain/loss?

A: A decrease in appetite, known as anorexia, is a reported adverse event in official documents. Changes in appetite may sometimes lead to changes in weight.


Q: Are there any specific foods or supplements that are known to interact with Эксхол?

A: According to official product information, specific interactions with food or common herbal products (like St. John's Wort) have not been formally established. Known drug-drug interactions are listed separately in the medicine's full prescribing information.


Q: What should I do if I experience a mild side effect of Эксхол?

A: Official instructions indicate that if the most common side effect (diarrhea) becomes persistent, the dose may be reduced or the therapy discontinued. Decisions regarding therapy changes are exclusively made by a healthcare professional.


Q: Can people with diabetes safely use Эксхол?

A: While diabetes is not listed as a contraindication, regulatory documents indicate that elevated blood sugar (hyperglycemia) has been reported as an adverse event in clinical studies. The occurrence of elevated blood sugar is a reported adverse event that may be relevant for patients with pre-existing high blood sugar levels.


Q: What are the reported signs of overdose for Эксхол?

A: Official safety information identifies diarrhea as the main reported symptom of overdose. This is limited because the drug’s absorption decreases at high doses. Contact information for a poison control center is typically provided for guidance in such an event.


Q: Is there a reported rebound effect if treatment with Эксхол is suddenly stopped?

A: Regulatory documents indicate that when used for gallstone dissolution, there is a known potential for the stones to recur after successful clearance. For patients with advanced Primary Biliary Cholangitis (PBC), a worsening of liver function has also been observed after treatment cessation.


Q: Is a metallic taste in the mouth reported as a potential side effect of Эксхол?

A: A metallic taste in the mouth has been reported as an adverse event in post-marketing surveillance reports. This means it is a known possible side effect, though it may be infrequent.

How should Эксхол be stored and disposed of?

Storage and Disposal of Эксхол (Ursodeoxycholic acid)

The official storage conditions for Эксхол, which contains ursodeoxycholic acid, are strictly defined by regulatory documents to maintain product quality.

Mandatory Storage Conditions

Requirement Specific Instruction
Temperature Store below 30 C or 25 C, or at controlled room temperature.
Protection Protect the medicine from both light and moisture.
Container Keep the medicine in its original container and ensure it is tightly closed.

Handling and Disposal

The product must always be stored out of the sight and reach of children to prevent accidental ingestion. For liquid forms (suspension), any unused portion must be discarded 4 months after opening the bottle. Expired or unused Эксхол must be disposed of in accordance with local regulatory requirements for pharmaceutical waste.

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

Available in countries:

Equivalent of Эксхол found in:

A-Z Index: