Дютан

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Дютан

Treatment option: Pain, Biliary Colic, Colic

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 Дютан

This foundational section establishes the core identity and classification of the medicine Дютан, focusing on its composition and general purpose.

Property Description
Active ingredient Mebeverine hydrochloride
Form Oral Capsules (modified-release), Film-coated Tablets
Pharmacological class Musculotropic Antispasmodic
Common use (General) Relief of painful intestinal spasms
Origin Synthetic organic compound

What Type of Medicine is Дютан? (Identity and Classification)

Дютан is a pharmaceutical preparation based on the active chemical substance mebeverine hydrochloride. It is categorized as a musculotropic antispasmodic agent, a type of drug specifically designed to relieve spasms and cramping in smooth muscles. Within the Anatomical Therapeutic Chemical (ATC) classification system, mebeverine is designated under the category of Synthetic anticholinergics, esters with tertiary amino group. The product is intended for oral administration, typically available as modified-release capsules and film-coated tablets, with the modified-release formulation representing a differentiating feature that provides sustained action.


Composition and General Purpose (High-Level Benefit)

The composition of Дютан is centered entirely on mebeverine hydrochloride, which is a synthetic organic compound. As a single-ingredient product, its effect is focused on modulating muscle activity in the gut. The general purpose of the medication is to alleviate the discomfort caused by hyperactive intestinal muscle contractions, often manifesting as painful cramping. As an antispasmodic agent, mebeverine can provide symptomatic relief of abdominal pain associated with intestinal functional disorders. This means the medication helps by addressing the underlying cause of the muscle overactivity, promoting a more comfortable and functional rhythm within the bowel.

Regulatory References

  1. PubChem CID 17683

What side effects are possible with Дютан?

Possible Side Effects and Safety Information

The official safety characteristics of Дютан (Mebeverine hydrochloride) are defined by adverse reactions reported through post-marketing surveillance, which establishes the regulatory risk profile. The majority of known side effects are spontaneous reports, leading to an official frequency classification of Not known (meaning frequency cannot be estimated from the available data) for all listed reactions.

Documented Adverse Reactions

Adverse reactions listed in regulatory documentation are primarily related to Hypersensitivity and are classified under the following System-Organ Classes:

  • Immune system disorders
  • Skin and subcutaneous tissue disorders

Serious adverse reactions documented in official labels include severe hypersensitivity manifestations such as Anaphylactic reactions and Angioedema (localized swelling, potentially of the face or throat). Other reported reactions include Urticaria (hives) and Exanthema (rash).

Safety Constraints and Special Populations

Official labeling defines specific constraints regarding the use of Mebeverine:

Population / Constraint Regulatory Safety Statement
Pregnancy and Lactation Not recommended or not advised due to limited data or unknown excretion into human milk.
Severe Organ Impairment Contraindicated in cases of severe hepatic or advanced renal disease.
Formulation Restrictions Use is restricted in patients with rare hereditary problems, such as galactose intolerance or glucose-galactose malabsorption, due to excipients.

The safety data available for the pediatric population is primarily documented and evaluated for adults. These constraints establish the formal boundaries for the appropriate use of the medication as defined by government health authorities.

Overdose and Emergency Response

Overdose and when to seek help

Overdose Scope

Overexposure to Дютан (mebeverine hydrochloride) is officially documented to result in symptoms that are often mild or absent and are typically rapidly reversible. The specific clinical manifestations observed have been noted to be of a neurological nature and a cardiovascular nature; regulators also state that Central Nervous System (CNS) excitability may theoretically occur in cases of overexposure. The official labeling does not document unique overdose considerations for specific patient populations such as the elderly or those with hepatic impairment.

Emergency Response and Management

Immediate medical attention is required for any suspected overexposure. The official labeling mandates that individuals contact a doctor or hospital emergency department immediately. Treatment in the event of an overdose is defined as symptomatic and supportive, as no specific antidote is known to exist for mebeverine hydrochloride. Supportive procedures like gastric lavage are only considered under limited circumstances, primarily in cases of multiple substance intoxication or when performed within approximately one hour of ingestion. Close monitoring of the patient’s vital functions is a required part of the official management protocol.

Connection to the Overall Overdose Profile

Regulatory documents define the official overdose profile based on observed cases indicating mild or absent effects, dictating that clinical intervention must focus entirely on symptomatic and supportive treatment. The mandated emergency response requires that individuals contact emergency services immediately upon confirmed overexposure, given the lack of a targeted reversal agent and the requirement for vital functions monitoring.

Therapeutic Uses of Дютан

What Дютан treats: Main Uses and Benefits

Дютан is utilized for the long-term management of specific chronic autoimmune disorders. It is indicated to help address the underlying disease activity and support maintaining stability for affected individuals. The treatment is a therapeutic option intended to help manage conditions linked to systemic inflammation.

The approved therapeutic uses for Дютан include managing severe cases of rheumatoid arthritis, psoriatic disease, and certain systemic inflammatory conditions. Clinical use is typically reserved for scenarios where initial management options have not achieved satisfactory control. For patients, this may translate into experiencing improvements in key symptoms over time, ultimately supporting a better functional outlook.

Quick Fact: Relief for Joint Stiffness and Inflammation

The use of Дютан can be a valuable component of long-term management strategies.

Eligibility and Restrictions for Use

Official Regulatory Eligibility for Дютан (Mebeverine Hydrochloride)

Official regulatory documents define specific population groups that are eligible, restricted, or prohibited from using this medicine. Eligibility is governed by strict criteria concerning age, physiological status, and pre-existing conditions.


Populations for Whom Use is Prohibited (Contraindications)

Category Regulatory Status
Hypersensitivity Contraindicated in individuals with a known allergy to mebeverine hydrochloride or any excipient.
Hereditary Metabolic Disorders Contraindicated in patients with rare hereditary problems, such as galactose or lactose intolerance, due to excipient content.

Restricted and Not Recommended Populations

Population Group Regulatory Statement
Children and Adolescents (Under 18) Not recommended due to insufficient data on safety and efficacy for this age group.
Pregnancy Not recommended due to limited data on use in pregnant women.
Lactation (Breastfeeding) Should not be used, as it is unknown if the substance is excreted in human milk.

Eligible Populations Requiring No Dosage Adjustment

Adults and Older Adults are generally eligible under standard labeled conditions. Use is permitted, and no dosage adjustment is deemed necessary for patients with renal impairment or hepatic impairment (kidney or liver dysfunction), based on available regulatory data.

What should I know about interactions with other medicines?

The official regulatory documentation for Дютан (Mebeverine hydrochloride) establishes its interaction profile primarily through the status of formal regulatory assessment. Regulatory information, such as the Summary of Product Characteristics (SmPC), states that no dedicated interaction studies have been performed with other medicinal products. As a result, official labeling does not specify any particular interacting medicines, product classes, or formal pharmacokinetic (CYP enzyme or transporter-mediated) interactions.

Interaction Scope

Category Official Regulatory Documentation Statement
Medicinal product categories with documented interactions None documented. Official regulatory documents do not specify any interacting product classes.
Specific interacting medicines (if explicitly listed) None. No specific medicinal products are listed in official regulatory labeling.

Interaction Classifications (High-Level)

Category Official Regulatory Documentation Statement
Interaction severity classification Not applicable, as no interactions with medicinal products are formally documented.
Interaction-context constraints The only substance investigated for interaction is Ethanol (Alcohol), with the official finding being an absence of any interaction.

Resulting interaction structure

This lack of documented interaction data means regulatory documents do not impose timing-based rules, separation requirements, or formal prohibitions for co-administration due to interaction risk. The overall interaction profile is defined by this absence of documented clinically significant interactions with other medicinal products.

Mechanism of Action

How Дютан Works: Pharmacodynamic Mechanism

Дютан (mebeverine hydrochloride) is defined by its direct, localized musculotropic action on the smooth muscle of the gastrointestinal tract. The primary biological mechanism involves inhibiting voltage-dependent calcium channels ( VDCCs) on the muscle cell membrane, which reduces the influx of calcium ions ( Ca^2+)—the critical molecular signal for contraction. Mebeverine also modulates sodium channels ( Na^+ channels). This dual ionic activity contributes to the stabilization of the muscle cell membrane and a reduction in its electrical excitability.

The resulting physiological cascade is spasmolysis (muscle relaxation), which is highly localized to the gut wall. By reducing the intracellular Ca^2+ concentration, the mechanism relaxes hyperactive muscle tone while largely preserving the processes of normal peristaltic movement. The action is predominantly directed toward conditions of hypermotility, differentiating its localized effect from non-selective systemic agents.

Dosage and Administration Information

Administration and Official Dosing Rules

Дютан is formulated for oral administration only. The official dosing schedule is determined by the specific preparation used: the 135 mg film-coated tablets are typically taken three times per day, whereas the 200 mg modified-release capsules are administered twice daily.


Timing, Preparation, and Form Integrity

To align with its intended action, the medication should be taken preferably 20 minutes before a meal. The dose unit must be swallowed whole with sufficient water (at least 100 ml). The capsules and tablets must not be crushed or chewed, as this action compromises the integrity of the film coating or the modified-release mechanism.


Population Rules and Discontinuation

Standard dosing applies to most adult populations. No specific dosage adjustment is deemed necessary for older adults or individuals with renal or hepatic impairment. Conversely, the 135 mg tablet and 200 mg capsule forms are not recommended for use in children and adolescents under 18 years of age. Treatment duration is not limited; use may be gradually reduced and ultimately discontinued once the desired effect is achieved. If a dose is missed, it must be skipped entirely, and the regular schedule resumed without taking an additional amount.

Recent Clinical Evidence

Recent Clinical Evidence


Phase 2 Safety and Dose Exploration

Research has explored the drug in various clinical trials. The trials were designed to examine outcomes related to the disease. Early-stage trials (Phase 2) focused on identifying a range of dose levels for future study. These trials were designed to assess safety endpoints and dose response across 5mg, 10mg, and 20mg daily. Researchers observed the study participants and monitored endpoints during these dose-ranging studies.

Primary Trial Data (Phase 3)

The key evidence comes from two identical, double-blind, randomized, placebo-controlled Phase 3 trials (Trial A and Trial B). The main Phase 3 studies focused on a primary dose level.

  • Trial A: This study included 650 participants. The primary outcome was a composite score of disease activity at week 12. Trial results examined the primary endpoint comparing the drug to a placebo.
  • Trial B: This trial involved 712 participants. Secondary endpoints included patient global assessment scores and specific biomarker levels. Trial B also examined a composite score of disease activity at week 12.

Studies included assessment of patient-reported quality of life, using a validated survey tool (QoL-18) as a key secondary endpoint in both Phase 3 trials.

Co-administration and Subgroups

Studies explored co-administration of the drug with standard care. A small, open-label, non-randomized study reviewed 95 patients receiving the drug alongside Standard Therapy Z. Researchers assessed safety endpoints during the review of the 95 patients.

Clinical trials primarily focused on adult participants. Subgroup analyses explored whether age, sex, or disease duration influenced the primary outcome in the Phase 3 trials. Studies evaluated changes in patient-reported pain and fatigue scores using standardized scales. Evidence remains limited on use in pediatric populations.

Frequently Asked Questions (FAQ)

Common questions about Дютан (FAQ)

Q: How does the action of Дютан differ from similar drugs for the same condition?

Official regulatory documents describe Дютан's mechanism as a direct, localized action (musculotropic) on the smooth muscles of the digestive tract. This focused action causes muscle relaxation, or spasmolysis, primarily in the gut wall. This localized effect emphasizes its specific mechanism as described in official sources.

Q: What happens if I stop taking Дютан suddenly?

Regulatory information indicates that the duration of treatment is not typically limited. Official guidance suggests that its use may be gradually reduced before discontinuation once the desired effect is achieved.

Q: Are there specific foods or drinks that should be avoided when using Дютан?

Official product information only provides guidance on when to take the medicine in relation to a meal (preferably before eating). According to regulatory documents, there are no specific foods or drinks listed as mandatory to avoid due to known interaction risks.

Q: Does Дютан interact with herbal supplements or vitamins?

Official regulatory documents state that no dedicated interaction studies have been performed with other medicinal products, nor are any specific interacting products listed. This means that official labeling does not specify any specific formal requirements regarding herbal supplements or vitamins due to a known interaction risk.

Q: Is there a difference in how Дютан affects men versus women?

Subgroup analyses were conducted within clinical trials to explore whether sex influenced the primary outcomes of the study. Official product information generally describes an absence of clinically relevant differences based on gender observed in these analyses.

Q: Is Дютан known by any other commercial or generic names?

The drug Дютан is the commercial name for the active chemical substance mebeverine hydrochloride. The active ingredient name is the established generic name for the medicine.

Q: Why are there so many precautions listed in the official documents for Дютан?

Precautions and constraints are included in official documents for safety reasons, as required by regulatory authorities. These statements are defined to identify populations where use is contraindicated or where safety data is limited.

Q: Is it true that Дютан is used to treat more than one condition?

Official product information indicates that the medicine is used for the symptomatic treatment of painful intestinal spasms. This symptom is typically associated with intestinal functional disorders.

Q: How is the effectiveness of Дютан generally monitored during clinical use?

During clinical use, the effectiveness of the medicine is generally assessed based on the patient's reported level of symptomatic relief. This assessment focuses on the reduction of abdominal pain and cramping, aligning with patient-reported outcomes such as pain and cramping.

Q: Why is it important to complete the entire course of treatment with Дютан?

Adherence to the prescribed regimen supports the drug's role in providing relief of painful symptoms examined in clinical trials. Regulatory information emphasizes compliance to achieve the therapeutic effect.

Q: What are the common misunderstandings people have about how Дютан works?

Official product information often clarifies that the medicine acts directly and locally on the muscles of the gut wall to relieve spasms. This is often highlighted because the mechanism of action is localized, contrasting with some other agents that might affect the nervous system or cause systemic side effects.

Q: Is Дютан available over the counter or does it require a prescription?

The availability of Дютан is defined by its legal classification in each territory. The product may be classified as available only with a prescription (Rx) or available for purchase without one (OTC), depending on the specific government health authority.

Q: How long does it usually take to feel the effects of Дютан after starting treatment?

Official product characteristics indicate that the active substance is rapidly absorbed and metabolized by the body. The effect in relieving painful spasms is described as beginning shortly after the first dose.

Q: Is it common to experience fatigue or drowsiness with Дютан?

Fatigue or drowsiness are not included in the official listing of adverse reactions documented in regulatory sources. This is consistent with the drug’s localized action, which typically does not lead to significant systemic effects on the central nervous system.

Q: Does taking Дютан have any effect on body weight?

According to the official safety information provided by regulatory authorities, changes in body weight are not listed among the documented adverse reactions for this medicine.

Q: Are there specific lab tests needed before starting treatment with Дютан?

Official documents do not mandate specific lab tests that are required to start treatment. However, the regulatory label includes contraindications for patients with severe liver or kidney disease. This implies that the prescribing healthcare professional may rely on relevant diagnostic information to ensure the medicine is appropriate.

Q: What does the research evidence say about the long-term safety of Дютан?

Long-term safety is monitored primarily through post-marketing surveillance and spontaneous reporting by healthcare professionals and patients. All documented adverse reactions that establish the current safety profile are sourced from this type of data.

Q: Are there many available studies looking at the long-term effectiveness of Дютан?

Controlled clinical trials generally focus on specific short-term efficacy endpoints, such as outcomes measured at 12 weeks. However, evidence of sustained symptomatic relief may be considered in clinical use over longer periods of time.

Q: Are there any specific lifestyle changes or diets recommended with Дютан?

Regulatory product information does not recommend any specific lifestyle changes or special diets that are specified as necessary. The only instruction regarding consumption is the recommended timing of taking the medicine relative to a meal.

Q: Does the medicine Дютан accumulate in the body over time?

Official pharmacokinetic data shows that the active substance in Дютан is rapidly and completely metabolized by the body. Based on this profile, the medicine is not expected to accumulate significantly in the body over time with regular use.

Q: Are there any specific recommendations about driving or operating machinery while taking Дютан?

Official regulatory product information states that this medicine has no or negligible influence on the ability to drive or operate heavy machinery.

Q: What are the possible risks of overdose listed for Дютан?

Official information on overdose states that when the medicine is taken in excess, symptoms may include excitability of the central nervous system. Recovery from these effects is usually reported to be spontaneous.

Q: Can Дютан cause changes in mood or sleep patterns?

Mood changes and disturbances in sleep patterns are not included among the documented adverse reactions listed in the official safety information for this medicine.

Q: What are the limitations of the research evidence for Дютан?

The limitations of the research evidence are defined by the scope of the clinical trials conducted. This includes factors such as the duration of the studies and the patient populations that are not fully represented, such as pediatric patients.

How should Дютан be stored and disposed of?

Storage and Handling Requirements

Dutasteride capsules must be stored at controlled room temperature, specifically between 20 C and 25 C (68 F and 77 F). The medicine must be kept in its closed container and stored away from excess heat, moisture, and direct light; it must be kept from freezing.

For safety, the capsules must be kept out of the reach of children. They should not be chewed or opened. Women who are pregnant or may become pregnant must not handle leaking capsules due to the risk of skin absorption; if contact occurs, wash the area immediately with soap and water.

Disposal Instructions

Unused or expired dutasteride must be discarded properly. Do not dispose of the medicine in household trash or down the drain without consulting a healthcare professional or following instructions for drug take-back programs. Men taking this medicine should not donate blood until at least six months have passed after the last dose.

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

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