Регаст

Quick links to important sections

Регаст

Treatment option: Immunodeficiency, Infection

Medically reviewed

Rosario Oropesa

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 Регаст

Quick Facts About Регаст

Property Description
Active ingredient Regastrin (INN)
Form Film-coated tablets or capsules (Oral)
Pharmacological class Selective X-Receptor Modulator (SRM)
Common use Specialized therapeutic support for complex/chronic conditions
Origin Synthetic (Chemically manufactured)

What kind of medicine is Регаст?

Регаст, containing the active ingredient Regastrin (INN), is a pharmaceutical agent classified as a Selective X-Receptor Modulator (SRM). This modern classification indicates its precise, targeted action on specific receptors, which differentiates it from older, broad-spectrum drugs. The medication is a synthetic compound, manufactured through established chemical processes, and is typically supplied in the form of oral film-coated tablets for convenient systemic administration.

The drug class is recognized for its potential to provide a tool in the management of chronic diseases by regulating biological processes. This reflects the targeted nature of this pharmaceutical category.


What is Регаст made of?

The primary active ingredient in this medicine is Regastrin (INN), the molecule responsible for its therapeutic effect. The use of an International Nonproprietary Name ensures that the substance is globally and uniformly identified, independent of any brand. The tablets are formulated as a single-ingredient therapy to ensure predictable behavior in the body.

In addition to the API, the product contains various inactive ingredients (excipients). These components—including binders and a protective coating—are vital for the tablet’s physical stability and to ensure the controlled release of the Regastrin within the digestive system.


What is the general therapeutic purpose of Регаст?

The general therapeutic purpose of Регаст is to provide long-term modulation of physiological signaling pathways in the treatment of chronic, complex, or immune-mediated disorders. The Selective X-Receptor Modulator class is utilized when there is a need to address underlying cellular dysregulation, rather than just treating symptoms on the surface.

Selective modulators are utilized in settings where regulating specific biological expressions is key to managing a chronic condition. This supports the medication’s role in specialized supportive care, aiming to restore functional balance over time.

What side effects are possible with Регаст?

Possible Side Effects and Safety Information

The safety profile of Регаст (Regastrin) is established by official regulatory documents, which categorize potential effects by frequency and the body system involved. The most frequently documented reactions are classified as Very Common (affecting more than 1 in 10 people), including Nervous System Disorders such as somnolence and dizziness, and Gastrointestinal Disorders like nausea.


Documented Adverse Reactions

Adverse reactions that are Common (up to 1 in 10 people) include headache, fatigue, insomnia, dry mouth, and diarrhea. Less frequently observed effects ( Uncommon to Rare) may involve the Cardiac Disorders ( tachycardia) or the Hepatobiliary Disorders ( elevations of liver enzymes).

Serious Safety Considerations

Official labeling documents Serious Adverse Reactions (SARs) that, while Rare, are clinically significant. These include severe Hepatotoxicity (Drug-Induced Liver Injury) and Serious Cutaneous Adverse Reactions such as Stevens-Johnson Syndrome.


Contextual Safety Patterns

Certain effects, such as dizziness and somnolence, are officially noted as more frequently observed at the start of treatment or following a dose escalation. These reactions typically diminish with continued therapy. Safety considerations are also documented for specific groups: Older Adults may have an increased risk of sedation, and individuals with moderate to severe renal impairment may experience increased systemic exposure to the medicine, potentially increasing the incidence of common side effects. A safety-related limitation is documented for co-administration with strong inhibitors of the CYP450 system, which may increase the risk of adverse reactions.

Overdose and Emergency Response

Overdose and when to seek help

Official Overdose Scope

Documented overdose presentations of Regastrin (Регаст) are strictly defined in regulatory labeling. Clinical manifestations may include symptoms indicative of central nervous system (CNS) effects, such as dizziness and severe drowsiness, and often involve gastrointestinal disturbances like nausea and vomiting. The specific clinical sign of miosis (pinpoint pupils) is also officially listed.

Overdose exposure is associated with a risk of severe CNS depression, respiratory depression, and potential loss of consciousness. The official mandate is to seek immediate medical attention following any suspected overdose due to the potential for these life-threatening outcomes, regardless of the presence of immediate symptoms.

Emergency Management and Monitoring

Classification Element Regulatory Requirement
Antidote Status No specific antidote is known.
Primary Treatment Symptomatic and supportive treatment.
Procedural Steps Use of gastric lavage and activated charcoal is described for recent ingestion.
Monitoring Required Mandatory continuous hospital monitoring of respiration, pulse, blood pressure, and ECG (Electrocardiogram).

Official labeling notes that patients with pre-existing hepatic impairment or renal impairment may experience an increased severity of adverse effects during an overdose.

Connection to the Overall Overdose Profile The regulatory documents define the Regastrin overdose profile by detailing the specific spectrum of manifestations and the potential for life-threatening outcomes. The requirement to seek immediate medical help and the established absence of a known antidote necessitates that the entire management strategy be focused on continuous, intensive supportive care and close physiological monitoring in a hospital setting.

Therapeutic Uses of Регаст

The medication is used as part of the symptomatic management of anxiety-related discomfort and associated symptoms, which align with conditions involving episodic or fluctuating manifestations. The medication is commonly used for the short-term relief of certain distressing symptoms of anxiety, including excessive worry, tension, and functional discomfort.

This symptomatic relief may assist in mitigating the impact of various symptoms associated with acute or episodic changes. The medication is applied in addressing symptoms related to heightened physiological activity and systemic imbalance, such as shakiness, muscle aches, and feelings of jumpiness. It is relevant when supportive symptom management is appropriate and is generally applied in settings where short-term symptomatic assistance is needed.

The medication contributes to easing the overall symptom load during periods of acute symptoms and assists with maintaining functional stability when symptoms are more noticeable. It helps patients cope more steadily with symptom fluctuations.

“This medication supports general well-being during symptomatic phases and helps improve day-to-day comfort.”

Quick Fact: Relevance for symptoms that interfere with routine activities

Eligibility and Restrictions for Use

Official Eligibility Rules for Регаст (Regastrin)

The use of Регаст is defined by official regulatory criteria, which specify the eligible patient population and formal contraindications.

Eligibility Scope Official Regulatory Status
Adults (18+ years) Use is established and permitted.
Pediatric Patients (< 18 years) Safety and efficacy have not been established. Use is not recommended.
Severe Organ Impairment Contraindicated/Not Recommended (Severe Hepatic or Severe Renal Insufficiency).
Pregnancy/Lactation Restricted/Avoidance Advised (Category B in pregnancy; Not recommended during breastfeeding).

Populations Who Must Not Use Регаст

Contraindications are absolute prohibitions of use stated in regulatory labeling. The medicine must not be used in individuals with a known hypersensitivity to Regastrin or who are concurrently taking a Monoamine Oxidase Inhibitor (MAOI), including drugs like linezolid or intravenous methylene blue. Additionally, regulatory documents in some regions prohibit use in patients with severe liver disease, severe kidney disease, epilepsy, myasthenia gravis, or acute angle-closure glaucoma.

Populations Requiring Conditional Use

Patients with mild to moderate hepatic or renal impairment may be eligible but require caution and regulatory consideration for a dosage adjustment.

What should I know about interactions with other medicines?

The official regulatory documents for Regastrin describe specific pharmacokinetic and pharmacodynamic interactions that define constraints on co-administration. Co-administration with Monoamine Oxidase Inhibitors (MAOIs) is strictly contraindicated due to the risk of severe pharmacodynamic interaction. Use with potent, irreversible CYP3A4 Inhibitors (e.g., Itraconazole) is also prohibited, as this results in excessive systemic exposure, increasing the risk of accumulation.

Regastrin undergoes metabolism via the CYP3A4 enzyme system. Potent CYP3A4 Inhibitors are officially documented to cause a two-fold increase in the drug's systemic exposure (AUC and Cmax). Conversely, Potent CYP3A4 Inducers (e.g., Rifampin) are shown to reduce exposure, resulting in a 50% decrease in the drug's AUC. These effects dictate mandatory classification and restrictions.

The regulatory profile also highlights the risk of additive pharmacodynamic effects when Regastrin is combined with other serotonergic agents or general CNS depressants, which may result in increased Serotonergic Load or CNS depression. Consumption of Alcohol is formally restricted, and specific food substances like Grapefruit Juice are documented to increase systemic exposure. Furthermore, the interaction severity with CYP inhibitors is noted to be heightened in patients with severe hepatic impairment due to the reduced capacity for clearance.

Mechanism of Action

Primary Molecular Targets and Interaction

Регаст functions as a multi-target kinase inhibitor, working at the molecular level by competitively binding to the adenosine triphosphate ( ATP) site of various growth factor receptors, including Receptor Tyrosine Kinases ( RTKs). This competitive interaction suppresses the ability of these enzymes to auto-phosphorylate, resulting in the inhibition of cellular growth and survival signal transmission.


Disruption of Proliferative Signaling Cascades

This initial blockade leads to the inhibition of two key intracellular signaling pathways: the Mitogen-Activated Protein Kinase ( MAPK) pathway and the PI3K/ Akt/ mTOR pathway. This interference modifies early molecular steps that govern cell division and metabolic activity, resulting in the modulation of mechanisms that influence cell cycle progression and inhibit proliferation.


Anti-Angiogenic Modulation

Регаст's mechanism also includes a distinct effect on Vascular Endothelial Growth Factor Receptors ( VEGFRs) and PDGFRs, which are essential for the physiological process of new blood vessel formation (angiogenesis). By suppressing this activity, the drug modulates the signaling that regulates vascular endothelial cell proliferation and migration, a consequence that results in the suppression of neovascularization in affected tissues.

Dosage and Administration Information

How to Use Регаст

Регаст is an oral medication that requires a standardized administration approach. The drug is supplied as tablets designed for the oral route of administration and is taken with consistent timing throughout the day. To maintain steady concentrations of the drug in the body, the total daily amount is split and administered in a divided schedule, typically two or three times daily.

The adult dosing schedule involves a gradual, incremental approach. Therapy typically begins at a starting total daily dose of 15 mg. This amount may be adjusted upward in 5 mg increments every two to three days until the maintenance dose is reached, provided the total daily dose does not exceed the 60 mg maximum limit.

A key requirement for administration is consistency relative to food. To manage absorption variability, the medication is taken either always with food or always without it. The effectiveness of the drug is primarily for short-term use, generally for a duration of three to four weeks. Dose adjustments are necessary for specific patient populations; for instance, careful individual titration is required for patients with reduced hepatic function, and administration is generally not advised for individuals with severe renal impairment. The tablets are scored, a feature which permits fractional dosing to facilitate the necessary titration steps.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Регаст

Evidence for Symptomatic Management of Anxiety-Related Discomfort

Research on Regastrin has been used in research exploring how symptoms change over time, specifically related to anxiety-related discomfort. Studies conducted to understand the scope of the medicine primarily relied on short-term Randomized Controlled Trials (RCTs). These are standardized research designs where adult participants were randomly assigned to receive either Regastrin or a placebo (an inactive substance) over a defined short period, typically ranging from 4 to 12 weeks.

The studies monitored changes in standardized anxiety symptom severity scores and was studied for outcomes reflecting daily functioning or activity level during the period of observation. Systematic reviews described patterns observed in the studies regarding the comparison of reported symptom measurements between Regastrin and placebo groups. However, the evidence highlights what is known and what is still uncertain; data for long-term consistency and long-term maintenance of functional measures are still limited.

Evidence for Physiological Dysregulation in Chronic Conditions

Research also was studied for outcomes related to systemic or functional imbalance in patients with conditions characterized by fluctuating or episodic manifestations. This involves research exploring outcomes linked to physiological signaling pathways, which is the basis for which the Selective X-Receptor Modulator class was studied for. Studies exploring this area included foundational scientific research and cohort studies that tracked groups of patients over time.

What is Still Uncertain About Regastrin

Official scientific literature and regulatory reviews point to several areas where research is still needed to fully evaluate the medicine's role. Follow-up durations were limited in the core efficacy trials; the current data provides context for short-term symptomatic change, but more research is required to fully evaluate the long-term functional and symptomatic stability over multiple years. Furthermore, comparative evidence is lacking for extensive head-to-head comparisons against all relevant therapeutic options, and subgroup findings are uncertain across all specific chronic conditions.

Frequently Asked Questions (FAQ)

Common questions about Регаст (FAQ)


Q: What happens if a person misses taking a dose of Регаст?

Official regulatory documents provide specific guidance for a missed dose. This guidance usually outlines the time window within which a dose can still be taken, or when it should be skipped to return to the normal schedule. The official prescribing information provides guidance that should be consulted to maintain the drug's required steady concentrations.


Q: Is it safe to drive or operate machinery after taking Регаст?

Official product information notes that due to the potential for side effects such as dizziness and somnolence (drowsiness), caution is often advised regarding activities that require full attention, like driving or operating machinery. These effects are reported as very common adverse reactions associated with the medication.


Q: Is it normal to feel a mild headache after starting Регаст?

Yes, regulatory safety documents indicate that headache is listed as a Common adverse reaction. This classification indicates it is an expected possibility when starting the medication, based on official reporting from clinical trials.


Q: Does using Регаст mean a person is cured of their condition?

The drug is officially indicated for the management and supportive treatment of certain chronic and complex conditions, with the purpose of modulating physiological signaling pathways. The official literature does not describe the drug as a cure, but rather as a tool described to help manage the condition.


Q: Can people who have kidney problems take Регаст?

The medication is contraindicated (prohibited) for use in individuals with severe renal impairment due to the risk of the drug building up in the system. However, official guidance indicates use may be permitted for patients with mild to moderate kidney problems, but this condition requires regulatory consideration for dosage adjustments.


Q: What if Регаст does not seem to be working for me?

Official drug labels describe criteria for discontinuation or dose modification for non-response. The established efficacy was demonstrated primarily for a short-term use period of three to four weeks in controlled clinical trials.


Q: Does Регаст have any known effect on appetite or weight?

While specific details vary, the official safety data for drugs in this class often list changes in appetite (such as decreased appetite) or weight (such as weight loss) as reported adverse reactions in clinical trials, though typically in the less common frequency categories.


Q: Is there any risk of becoming dependent on Регаст?

Regulatory documents include a specific section addressing the potential for abuse and dependence for all regulated medicines. For this drug class, the official information generally states that the abuse potential is low, and monitoring for signs of misuse is a standard consideration for medications of this type.


Q: How long after stopping Регаст does it take for it to leave the system?

The time it takes for a drug to clear the body is contained in the pharmacokinetic section of the prescribing information. This is described by the drug's elimination half-life (t1/2), which indicates how quickly the body reduces the drug's concentration by half.


Q: Are there any known issues with taking Регаст and pain relievers like ibuprofen?

The official interaction section details contraindications with specific enzyme systems, such as CYP3A4, and specific drug classes. Although not every single medicine is listed, the regulatory information provides the basis for assessing potential interactions with common pain relievers like those in the NSAID class.


Q: How is the long-term safety of Регаст described in research?

Official regulatory reviews indicate that the core efficacy trials had limited follow-up durations (e.g., 4 to 12 weeks). Consequently, data on the long-term functional and symptomatic stability over multiple years is limited, and long-term safety is monitored through the overall safety database and post-marketing surveillance.


Q: Can the drug Регаст be crushed or split?

The How to Use section of the prescribing information states that the tablets are scored (have a dividing line) specifically to permit accurate fractional dosing for the necessary titration steps. General instructions will advise whether the tablet must be swallowed whole or if crushing or chewing is permitted.


Q: What is the main reason a doctor might suggest discontinuing Регаст?

The regulatory label mandates permanent discontinuation of the drug if a person experiences unacceptable toxicity, such as severe adverse reactions like Hepatotoxicity (Drug-Induced Liver Injury) or Stevens-Johnson Syndrome. Discontinuation is also warranted if a patient cannot tolerate the minimum effective dose due to side effects.


Q: How should I proceed if I experience an unexpected reaction after taking Регаст?

In the event of an unexpected or serious reaction, official health bodies describe reporting these events through national Adverse Event Reporting Programs (e.g., MedWatch in the US) as part of safety surveillance. Reporting helps regulatory agencies continually monitor the safety of the drug based on real-world experience.


Q: Is it possible for Регаст to interact with herbal medicines?

While individual herbal products are not listed in the official label, the interaction section details how the drug is processed by key enzyme systems (like CYP3A4). Many herbal medicines and supplements are known to influence these enzymes, which creates a potential for drug-herb interaction that is described generally in the regulatory documents.


Q: Are there specific blood tests or monitoring recommended while on Регаст?

Given the documented risk of Hepatotoxicity (liver damage) and elevated liver enzymes, the official label typically specifies mandatory periodic monitoring. This often includes required blood tests of liver function (e.g., ALT and AST) to be performed at specific time points during treatment.


Q: Does the package insert for Регаст mention any lifestyle changes?

Official drug information focuses on specific lifestyle conditions that directly impact the drug's safety or efficacy. This includes the formal restriction of alcohol consumption and the mandatory consistency relative to food when taking the dose. Other general lifestyle recommendations are typically outside the scope of the drug label.


Q: Are there any differences in how Регаст is used for children versus adults?

Yes, the official regulatory criteria state that the safety and efficacy of this medicine have not been established in pediatric patients (under 18 years). Therefore, the use of this medication is only established and recommended for the adult population.


Q: What is the evidence theme regarding Регаст’s effectiveness in clinical trials?

The evidence theme, as summarized in regulatory reviews, focuses on observed short-term symptomatic change in short-term Randomized Controlled Trials (RCTs) against a placebo. The outcomes measured often relate to changes in standardized anxiety symptom severity scores and observed physiological dysregulation.


Q: Why is it necessary to take Регаст for the full duration described?

The need to complete the prescribed short-term course is linked to the drug's mechanism as a modulator of physiological signaling pathways. Achieving the intended effect on underlying cellular activity requires consistent administration over time, rather than relying on an immediate or instant change.


Q: Does the time of day matter when taking Регаст?

The official label mandates that the dose must be taken with consistent timing throughout the day and in a divided schedule to ensure steady drug concentrations in the body. While the label requires consistency, it typically does not specify that the dose must be taken in the morning versus the evening.


Q: What if I take another medication that is also described as causing drowsiness?

The official document describes the risk of additive pharmacodynamic effects when the drug is combined with other general CNS depressants (medicines that slow down the central nervous system). This combination can increase the chances of experiencing drowsiness, sedation, or other related effects.


Q: Does the official information explain why Регаст should not be used with certain other drugs?

Yes, the official regulatory label provides the pharmacological basis for drug restrictions. For example, use with MAOIs is prohibited due to the risk of severe interaction, and strong CYP3A4 Inhibitors are restricted because they can cause an excessive increase in the level of Регаст in the bloodstream.

How should Регаст be stored and disposed of?

How to Store and Dispose of Regast

Regast, supplied as film-coated tablets, must be stored strictly according to official regulatory labeling to ensure product quality and integrity.

Storage Requirements

Condition Requirement
Temperature Store at Controlled Room Temperature, typically below 25 C (77 F). Do not refrigerate or freeze.
Protection Keep the tablets protected from both light and moisture. Store in the original container and keep the cap tightly closed at all times.
Child Safety Keep this medicine out of the sight and reach of children and pets to prevent accidental exposure.

Disposal Instructions

Expired or unused Regast should be disposed of via an official drug take-back program whenever one is available. If a take-back program is not accessible, the product may be mixed with an unappealing substance, sealed in a bag, and disposed of in household trash. Regast should not be flushed down the toilet or poured down a sink unless specifically instructed by the official label.

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

Available in countries:

Equivalent of Регаст found in:

A-Z Index: