Детравенол

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Детравенол

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Overview of Детравенол

Property Description
Active ingredient Purified Micronized Flavonoid Fraction (Diosmin + Hesperidin)
Form Oral tablet
Pharmacological class Venoactive drug (Phlebotonic)
Common use Supporting venous circulation and microcirculation
Origin Derived from plant secondary metabolites (Bioflavonoid)

What Type of Preparation is Детравенол?

Детравенол is classified as a venoactive drug (VAD) belonging to the phlebotonic pharmacological class, established for its function in supporting the integrity of the vascular system. The core component, Diosmin, is globally categorized with the Anatomical Therapeutic Chemical (ATC) code C05CA03. The preparation is administered as an oral tablet for oral use. This specialized class of medicine is generally regarded as essential in strategies aiming to influence the functional health of veins and capillaries, distinguishing it from general circulatory aids.

Composition: A Purified Micronized Flavonoid Fraction

The preparation contains a Purified Micronized Flavonoid Fraction (MPFF) as its active ingredient, which is derived from plant secondary metabolites and is thus categorized as a bioflavonoid medicine. The MPFF is a combination product standardized to contain the primary flavonoid Diosmin alongside other active flavonoids like Hesperidin. The inclusion of the micronization process is a key pharmaceutical characteristic; this physical technique reduces the particle size of the flavonoids to ensure enhanced systemic availability, a factor intended to optimize the compound's absorption.

General Purpose of Phlebotonic Agents

The general purpose of the MPFF in Детравенол is to act as a vasoprotective agent by fundamentally modulating the function of the blood vessel network. The pharmacological action of Diosmin and related flavonoids involves improving venous tone and increasing capillary resistance. This mechanism helps to alleviate common, high-level symptoms associated with poor vascular function, such as feelings of leg heaviness or swelling (edema) in the lower limbs, by minimizing the pooling of blood and fluid.

Regulatory References

  1. NIH Article on Flavonoids in CVI
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What side effects are possible with Детравенол?

Possible Side Effects and Safety Information

The safety profile of Детравенол (Diosmin) is based on official government regulatory documents (such as those from the European Medicines Agency, FDA, and other global health authorities). Adverse reactions are typically mild and organized by frequency and the body system affected.

Documented Adverse Reactions

Frequency System Organ Class Documented Side Effects
Common (1 in 100 to 1 in 10 users) Gastrointestinal disorders Diarrhea, dyspepsia (indigestion), nausea, vomiting.
Rare (1 in 10,000 to 1 in 1,000 users) Nervous system disorders Vertigo, headache, malaise.
Frequency Not Known Immune system disorders, Skin/Subcutaneous Tissue Disorders Hypersensitivity reactions (e.g., rash, pruritus, urticaria, isolated swelling of the face, lips, or eyelids [angioedema]).

The most common effects are generally gastrointestinal and transient, often resolving without the need to stop treatment. Hypersensitivity reactions, though rare, are considered clinically important and require the cessation of the product if they occur.

Population-Specific Safety Considerations

  • Pregnancy: Use during pregnancy is generally not recommended as a precaution due to insufficient clinical data on human exposure.
  • Breastfeeding: Since it is not known if the active substance passes into breast milk, discontinuation of either the product or breastfeeding is recommended.

Safety-Related Restrictions

  • Hypersensitivity: The product is contraindicated if there is a known hypersensitivity or allergy to the active substance or any excipients.
  • Acute Use Limitation: For treatment of acute symptoms, if there is no rapid improvement within a specific, short period (e.g., 7 days), the official regulatory guidance requires a medical re-evaluation of the treatment plan.
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Overdose and Emergency Response

Overdose and when to seek help

The official regulatory profile for Детравенол overdose is based on available data, which consistently indicates that clinical experience with excessive intake of the active ingredient, Purified Micronized Flavonoid Fraction, is limited.


Documented Manifestations

The most frequently reported manifestations in documented overdose cases primarily involve the gastrointestinal and integumentary systems. Officially cited clinical presentations include various adverse gastrointestinal events, specifically diarrhea, nausea, and abdominal pain. Skin-related signs have also been officially documented, encompassing rash and pruritus (itching). Regulatory labeling does not explicitly document severe cardiovascular, neurological, or life-threatening outcomes resulting from overdose.

Emergency Actions and Official Management

Government regulatory sources define specific actions required if a patient takes more than the recommended dosage and develops adverse symptoms. The official mandate is to seek medical attention immediately or consult a doctor or pharmacist without delay. The management strategy officially described in regulatory documentation is restricted to the treatment of clinical symptoms (symptomatic and supportive care). No specific chemical antidote for this preparation is documented in the official prescribing information, and no explicit population-specific or monitoring requirements are detailed in the official overdose section.

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Therapeutic Uses of Детравенол

Quick Facts

  • Therapeutic Domain: May assist in the management of chronic venous insufficiency.
  • Symptom Support: May contribute to the reduction of symptoms associated with chronic venous disease, such as discomfort and feeling of heaviness in the legs.
  • Acute Condition Management: Used in the therapeutic support of acute hemorrhoidal episodes.

What Детравенол treats: Main Uses and Benefits

Детравенол is utilized to help manage the indications of chronic venous disease, which affects the lower limbs. Its primary therapeutic domain involves assisting patients who experience symptoms associated with chronic venous insufficiency (CVI), such as leg discomfort, swelling, and the sensation of heaviness. The medication may contribute to favorable changes in the quality of life for individuals dealing with these venous-related symptoms.

Additionally, this drug is employed for the symptomatic support of acute hemorrhoidal conditions.

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Eligibility and Restrictions for Use

This information is derived from official regulatory documents (Summary of Product Characteristics/Prescribing Information) for the active ingredients, typically a Micronized Purified Flavonoid Fraction (Diosmin/Hesperidin).


Eligibility Scope

Classification Population Status Official Regulatory Basis
Contraindicated Known Hypersensitivity Must Not Use Primary exclusion for allergy to active substances or excipients.
Not Recommended Children and Adolescents Use Not Established Lack of established safety and efficacy data for pediatric age groups.
Not Recommended Breastfeeding Women Avoid Use Absence of data on the passage of the drug or its metabolites into breast milk.
Conditional Use Pregnant Women Preferable to Avoid Precautionary measure due to limited data available from human pregnancy exposure.
Eligible Adults (18+ years) Allowed Primary population for whom the treatment is indicated.

Eligibility-Related Restrictions

For use in acute hemorrhoidal attacks, the official labeling emphasizes that the treatment must be for a short duration and is not a substitute for specific treatment of other anal disorders. No specific restrictions are typically listed for patients with chronic hepatic or renal impairment, meaning standard use is often applied for the eligible adult population.


Connection to the overall eligibility profile

The regulatory profile strictly limits the use of this medicine to the adult population who do not have a known allergy to its components. Conditional or non-recommended status is applied to vulnerable groups, such as children, pregnant, and breastfeeding women, based on the principle of caution when efficacy and safety are not definitively established in official trials.

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What should I know about interactions with other medicines?

Interactions with other medicines and products — official regulatory information for Детравенол

The official regulatory profile for Детравенол (Purified Micronized Flavonoid Fraction) is defined by the absence of documented, clinically significant interactions. Government health authorities confirm that dedicated interaction studies have not been performed for this product. Based on extensive post-marketing surveillance, no clinically relevant drug interaction has been reported to date with co-administered medicinal products or substances. This status means the regulatory documents lack formal classification for pharmacokinetic or pharmacodynamic interactions, which represents the official profile of the medicine.

Interaction Scope

Category Official Regulatory Status (Label-Based)
Medicinal product categories with documented interactions: None documented.
Specific interacting medicines (if explicitly listed): None documented.
Mechanistic basis of interactions (only if stated in label): Not applicable; no interaction studies have been performed according to regulatory documents.
Timing-based interaction rules (if applicable): None documented.

Interaction Classifications (High-Level)

Category Official Regulatory Status (Label-Based)
Interaction severity classification (as defined in official documents): Not classified; no clinically relevant interactions are reported.
Regulatory basis: Based on the official prescribing information and post-marketing experience from national regulatory agencies.
Interaction-context constraints (Food, Alcohol, etc.): No specific food, alcohol, or herbal product constraints related to interactions are documented in the label.

Resulting Interaction Structure

Official interaction statements:

  • Regulatory documentation explicitly states that no dedicated interaction studies have been performed for the product.
  • The official prescribing information confirms that no clinically relevant drug interaction has been reported through post-marketing experience.

Connection to the overall interaction profile (3 sentences): The official interaction profile for Детравенол is established by the uniform regulatory statement that no clinically relevant interactions have been reported since the product was first marketed. This profile confirms that government labels do not contain information about specific interacting substances, formal interaction classifications, or mandated timing separation requirements. The complete documented constraint is the absence of reported interaction data.

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Mechanism of Action

The Pharmacodynamic Mechanism

Детравенол primarily acts on the peripheral venous system via four mechanistic domains. First, it targets venous smooth muscle cells, modulating noradrenaline metabolism to directly increase venous tone and elasticity. This primary hemodynamic effect reduces venous distensibility and increases venous flow and velocity, modulating the effects of elevated venous pressure.

Second, the drug focuses on the endothelial lining of capillaries, reducing capillary permeability by inhibiting inflammatory mediator activity. This action modulates the exchange of fluid and proteins across the vessel wall and limits the accumulation of interstitial fluid. Third, it functions as an antioxidant and inhibits leukocyte activation and adhesion. By limiting this cellular phase of inflammation, the drug modulates perivascular damage and contributes to the maintenance of endothelial structure. Fourth, the drug influences the lymphatic system by stimulating lymphatic vessel contraction, which increases lymphatic flow and capacity to facilitate the removal of interstitial fluid and macromolecules from the tissues.

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Dosage and Administration Information

How to Use Детравенол: Official Administration Guidelines

The administration of Детравенол (Diosmin + Hesperidin) follows specific dosing and practical use parameters to ensure proper use.

Administration and Dosage Form

Детравенол is an oral film-coated tablet and is to be taken by mouth.

  • The tablet must be swallowed whole with water. It is instructed not to be crushed, split, or chewed.
  • The tablet should be taken with a meal or immediately following food to optimize patient tolerance and ensure proper administration.

Official Dosing Regimens

Two distinct dosing schedules are established, dependent on the condition being addressed.

Condition Dose and Frequency Course Duration
Chronic Venous Disease 1000 mg once daily (QD) Long-term, subject to medical review
Acute Hemorrhoidal Attack A higher, divided daily dose (e.g., 3000 mg/day for 4 days, then 2000 mg/day for 3 days) Short-term, fixed period (e.g., 7 days)

Special Instructions

Missed Dose: If a dose is missed, take the next scheduled dose at the usual time. Do not double the dose to compensate for the missed one.

Population Specifics: Dosage adjustment is typically not explicitly required for elderly patients or those with renal impairment. The drug is not indicated for use in children.

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Recent Clinical Evidence

Research Evidence / Overview of Studies


Summary of Initial Findings

Research has explored whether the compound influences pathways related to a specific inflammatory protein (IL-6). Initial small-scale studies (Phase 1 and 2) examined the spectrum of observed effects and potential mechanisms of action in healthy volunteers.

  • Observed Effects: Phase 1 trials focused on exploring the observed effects across various administration levels. Mild, temporary events, such as headache and nausea, were noted in these trials.
  • Mechanism of Action: Early laboratory evidence suggested an effect on C-Reactive Protein (CRP) levels, a marker of inflammation. However, the clinical relevance of this finding is not yet clear.

Phase 3 Clinical Trials (Key Evaluation Data)

The primary evidence is derived from two large-scale, double-blind, randomized, controlled trials (RCTs): Study A (N=1,200) and Study B (N=950). These studies evaluated the compound against a placebo over a 12-week period.

Joint Assessment

A study of 1,200 participants assessed changes in joint function. The outcome measures examined the change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score.

  • In Study A, the group receiving the compound was associated with a mean 15-point difference in the WOMAC pain subscore, compared to an 8-point difference in the placebo group.
  • In Study B, the compound was evaluated for an association with measured levels of pain and stiffness, over the 12-week study duration.

Follow-up and Comparative Research

Safety Profile and Long-Term Use

Research has not established the effects of abruptly discontinuing the medication, and this may be associated with an increase in symptoms. The compound was studied in general populations, but it is not yet clear whether there are specific risks for individuals with kidney disease. Long-term use was evaluated for side effects, with a limited number of studies not reporting significant events.

Key Studies & References Guideline for the management of chronic musculoskeletal pain (incorporating novel biological agents)

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Frequently Asked Questions (FAQ)

Common questions about Детравенол (FAQ)

Q: Can I take this medicine with food?

According to the official product information, Детравенол can be taken either with or without food. The official guidance does not typically require timing the dose specifically around meals.

Q: Does this medication cause weight gain or weight loss?

Studies and official information indicate that changes in weight, including both weight gain and weight loss, have been reported. These are listed as undesirable effects in the metabolism and nutrition disorders category of the clinical trial data.

Q: Will this medicine make me feel sleepy?

Yes, drowsiness, also known as somnolence, has been reported as a potential effect when using this medication. This is noted in the central nervous system warnings section of the official drug monograph. Because drowsiness has been reported, activities requiring high mental alertness may require caution.

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

If a dose is missed, official labeling states that the recommended action is to skip the missed dose entirely. The label advises taking the next dose at the regularly scheduled time. Official product information advises against taking two doses at the same time to compensate for a missed dose.

Q: Can children 2 years old use this?

Official regulatory documents indicate that the authorised uses and recommended dosage for Детравенол are currently established for patients who are 6 years of age and older. Based on official product labeling, the medicine is generally not indicated for use in children aged 2 years.

Q: What are the main risks of taking this long-term?

Warnings derived from clinical trials indicate that prolonged treatment with Детравенол may potentially affect specific organ systems. For this reason, official patient information advises that periodic monitoring may be required for patients on long-term treatment.

Q: Can I drink alcohol while using this?

The official product information states that taking Детравенол together with alcohol is generally not recommended. Concomitant use with alcohol may increase the risk of certain central nervous system (CNS) side effects, such as increased drowsiness or dizziness.

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How should Детравенол be stored and disposed of?

Official Storage and Disposal Requirements

Regulatory documentation mandates specific conditions for storing and disposing of Детравенол to maintain the product's integrity and ensure environmental safety. These requirements are based strictly on the official labeled instructions.

Storage Requirement Official Statement
Temperature Store at a temperature not exceeding 25 C.
Handling & Protection Do not freeze. Keep the medicine protected from moisture and direct light, and store it in the original container.
Child Safety The product must be kept out of the sight and reach of children.
Disposal Do not dispose of unused or expired product in household trash or down a drain. Return the medicine to a pharmacy or designated collection program for proper disposal according to local environmental regulations.

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

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