The active compound is derived from the Liquorice Root, which has documented properties. This medication is relevant across domains where additional symptomatic support is needed. It is commonly used to help with symptom clusters that may become intense or disruptive across three main therapeutic areas, including support for chronic inflammation and organ functional stress (such as the liver), localized skin and recurrent viral symptoms, and mucosal and airway irritative symptoms (like persistent cough or gastrointestinal discomfort).

This medication is applied in clinical settings that involve conditions presenting with systemic or localized discomfort, particularly those characterized by ongoing inflammatory or irritative processes. It is relevant for managing symptoms related to systemic imbalance and offers symptomatic relief that helps patients cope more steadily with difficult episodes.

“It is helpful for managing symptoms that interfere with daily comfort, such as persistent itching and redness, providing supportive relief when symptoms intensify.”

Quick Fact: Support for Inflammatory Symptoms

The medicine assists with maintaining functional stability and supports general well-being during symptomatic phases, making it useful in situations involving certain distressing symptoms across the respiratory, dermatological, and hepatological domains.

Regulatory References

1. Final assessment report by the European Medicines Agency on Liquorice Root

Official Eligibility Rules for Реглисам (Glycyrrhizinic Acid)

Official regulatory documentation strictly defines the populations who may or may not use Реглисам. Eligibility is determined by age, physiological status, and the presence of severe underlying conditions.

Absolute Contraindications

Use is prohibited for the following populations and conditions, regardless of the intended use:

• Patients with known hypersensitivity to Glycyrrhizinic Acid or any component of the formulation.
• Women during pregnancy or the period of lactation (breastfeeding).
• Children under the age of 5 months.
• Patients with severe hepatic failure (impaired liver function).
• Patients with severe renal failure (impaired kidney function).
• Patients with severe organic lesions of the heart or other parenchymal organs.

Age-Related Eligibility and Limitations

Age Group	Eligibility Status
Infants (< 5 months)	Contraindicated
Children (5 months to 10 years)	Approved for Granule for Oral Solution form.
Adolescents and Adults	Approved for the Tablet form.

Conditional Use Restrictions

The medicine is designated for use with caution in patients with specific comorbidities, including Arterial Hypertension and Diabetes Mellitus. Restrictions related to excipient intolerance (e.g., lactose) may apply depending on the specific dosage form.

Interactions with other medicines and products

The interaction profile of Реглисам (Glycyrrhizinic Acid) is defined by its two primary, officially documented interaction patterns: pharmacodynamic potentiation and pharmacokinetic modulation.

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Documented Interaction Classes

Interaction Type	Interacting Product Classes
Pharmacodynamic Potentiation	Exogenous Corticosteroids and Potassium-depleting Drugs (e.g., Loop and Thiazide Diuretics).
Pharmacokinetic Modulation	Substrates of specific CYP450 Enzymes (e.g., CYP1A2, CYP2E1, CYP3A) and P-glycoprotein (P-gp).

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Official Interaction Statements

• Co-administration with exogenous corticosteroids may result in a pharmacodynamic interaction that potentiates their mineralocorticoid effects, increasing the official risk of fluid retention and hypokalemia (low potassium).
• The drug is documented as a potential inhibitor of CYP1A2 and CYP2E1 and an inducer of CYP3A, which may increase or decrease the plasma concentration of co-administered sensitive drug substrates.
• The active metabolite is officially noted as an inhibitor of P-glycoprotein (P-gp), which may alter the systemic exposure of co-administered P-gp substrates.
• Official regulatory documents place a formal restriction on the chronic, high intake of Licorice Root or products containing it, as this compounds the mineralocorticoid-like effects of the medicine.

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Interaction-Context Constraints

Caution regarding interaction outcomes is heightened for patients with pre-existing hypertension or hypokalemia, as they are noted to be more susceptible to the adverse effects related to the pharmacodynamic interaction. The regulatory profile emphasizes that this effect is dose- and duration-dependent.

Mechanism of Action

Реглисам's primary pharmacodynamic activity is centered on Glycyrrhizinic Acid (GA), which acts across three distinct mechanistic domains.

First, a core anti-inflammatory mechanism involves the competitive inhibition of the enzyme 11beta-Hydroxysteroid Dehydrogenase Type 2 (11beta-HSD2) by the active metabolite, Glycyrrhetinic Acid . Restricting 11beta-HSD2 activity prevents the metabolic inactivation of endogenous cortisol at the tissue level, raising its effective local concentration and resulting in augmented glucocorticoid receptor activation.

Second, the molecule functions as a signaling pathway modulator by directly suppressing the cellular regulator Nuclear Factor-kappa B (NF-kappa B)

. This interference with the transcription factor reduces the expression of genes responsible for producing pro-inflammatory mediators like cytokines, thereby lowering the overall cellular inflammatory output and modulating immune cell signaling.

Third, GA demonstrates direct interference with the viral lifecycle. This includes blocking viral entry and fusion processes and inhibiting the activity of viral polymerases within the host cell, an action that results in the suppression of viral proliferation.

The use of Реглисам is governed by specifications that define its administration method and dosing schedule, focusing on localized application via two routes: inhalation (via nebulization) and topical use.

The medication is provided as an aqueous solution concentrate, and its dosing is based on a specified measured volume for each application session. For inhalational administration, the prescribed volume of the concentrate (e.g., 1 mL to 2 mL for adults) must be immediately diluted with 0.9% Sodium Chloride solution (Saline) before use, as per the preparation requirements. This prepared solution must be administered using a non-thermal nebulizer device, as required for proper delivery of the standardized dose.

The dosing schedule typically follows a fixed frequency, such as two to four times per day, consistent with a multiple-day treatment course. Topical application generally uses the concentrate undiluted and is applied directly to the affected mucosal or skin surface. Official instructions dictate that the overall use of the medication must be managed within defined courses, such as 7 to 14 days.

For pediatric patients, specifications indicate that the administration volume must be adjusted; a reduced amount of concentrate (e.g., 0.5 mL to 1 mL) is used per session, following age- or weight-based dosing tables. Following a missed dose, the standard procedural guidance is to return to the regular schedule and omit the skipped dose if the next one is imminent. These structured protocols define the entire administration profile of the solution.

Research evidence / Overview of Studies for Реглисам

The research evidence for Реглисам centers on its active component, Glycyrrhizinic Acid, which is the subject of global study across various formulations and for specific health conditions. The evidence summarizes observations from preclinical, systematic review, and clinical research, contributing to the broader evidence landscape without offering individual predictions. Research findings reflect the specific conditions under which they were conducted.

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Evidence for Support in Liver Functional Stress

The research base most frequently studied for the active ingredient includes Randomized Controlled Trials (RCTs) and Systematic Reviews in populations studied for chronic viral diseases, such as Hepatitis, and certain forms of acute or chronic liver injury. These studies monitored outcomes related to systemic or functional imbalance, primarily focusing on changes in liver enzyme biomarkers, such as Alanine Aminotransferase (ALT) and Aspartate Transaminase (AST).

However, the high-quality evidence in this area primarily involves systemic administration (e.g., injections) of the active compound. Since Реглисам is an aqueous solution intended for localized, topical, and inhalational use, the findings derived from systemic trials may not directly apply to this specific product formulation. Therefore, data for the degree of systemic influence from this localized route remain insufficient.

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Evidence for Respiratory and Mucosal Symptom Support

Glycyrrhizinic Acid was studied for its application in respiratory and mucosal inflammatory states, with research primarily relying on preclinical studies and basic science. Studies conducted during periods of increased symptom activity have been used to investigate the molecule’s effect on inflammatory cell counts and molecular biomarkers linked to inflammatory or irritative states in the airways (e.g., in animal models of lung injury).

What remains uncertain is the translation of these preclinical findings to human outcomes. The certainty remains low for the general use of this preparation for airway irritation, as the results apply only to the specific conditions under which they were conducted. Follow-up durations were typically limited to short time intervals.

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Key Limitations and Research Gaps

Research has explored the active component in studies involving some specialized patient groups, such as children with specific acute liver conditions. However, data for certain groups remain insufficient (e.g., pregnant populations, older adults with multiple comorbidities). Key limitations include the fact that results apply only to the populations studied, and evidence quality varies across studies, particularly between basic science models and human trials. A primary gap is the lack of high-quality comparative evidence is lacking for the localized aqueous solution against other treatments.

Common questions about Реглисам (FAQ)

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Q: What is Реглисам?

A: Реглисам is a pharmaceutical compound containing Glycyrrhizic acid which is thought to possess anti-inflammatory and antiviral properties. It has been studied in contexts related to immunomodulation.

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Q: What conditions has Реглисам been studied for?

A: Clinical research and preclinical models have investigated the use of Реглисам for conditions involving inflammation and immune system response. This includes its use in studies focused on chronic skin conditions and specific viral infections. The evidence is primarily drawn from clinical trials conducted in Russia and other related regions.

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Q: Is Реглисам an antiviral drug?

A: Some laboratory studies and clinical investigations have observed an effect of the active component, Glycyrrhizic acid, on the replication of certain viruses. However, its classification and mechanism of action are primarily related to its proposed anti-inflammatory and immunomodulatory effects. Always consult a healthcare professional for specific therapeutic information.

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Q: How does Реглисам work in the body?

A: Preclinical research suggests that the active ingredient, Glycyrrhizic acid, may interact with the body’s inflammatory pathways, potentially by influencing cytokine production and the activity of specific enzymes. This potential mechanism is the subject of ongoing research and is not a clinical claim.

How to Store and Dispose of Reglisam

Reglisam (Glycyrrhizinic Acid solution) must be stored strictly according to the conditions defined in the official regulatory label to preserve its stability and quality.

Official Storage Requirements

Condition	Requirement
Temperature	Store at a temperature not exceeding 25 C (Room temperature).
Protection	Keep the product protected from light and avoid freezing.
Container	Store in the original package and keep the container tightly closed to prevent contamination.
Access	Must be stored out of the sight and reach of children.

Disposal

Disposal of unused or expired Reglisam and any related waste material must be carried out in accordance with local regulatory requirements. The product should not be disposed of in wastewater or household trash to prevent potential environmental contamination.