Recostar

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Recostar

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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 Recostar

Recostar is a pharmaceutical preparation classified as a gastroprotective and anti-ulcer agent, specifically designed to reinforce the stomach and intestinal lining against injury. It is a synthetic single-ingredient drug containing the active chemical substance Rebamipide.


Quick Facts

Property Description
Active ingredient Rebamipide
Form Oral tablet (film-coated)
Pharmacological class Gastroprotective agent (A02BX14)
General purpose Reinforces mucosal barrier, supports healing
Origin Synthetic quinolinone derivative

What Type of Medicine is Recostar (Rebamipide)?

Recostar belongs to the pharmacological class of gastroprotective agents and is formally indexed under the Anatomical Therapeutic Chemical (ATC) Classification System as A02BX14. Unlike treatments that focus exclusively on neutralizing stomach acid or slowing its production, Recostar's distinct mechanism works directly on the gastrointestinal mucosa. Rebamipide is recognized for enhancing the endogenous production of prostaglandins, which are crucial for maintaining the integrity and repair of the gastric mucosa. It is characterized as a mucosal stabilizer, a different approach compared to acid suppressants. The medicine is a synthetic compound, originating from chemical development rather than natural sources.


Composition and Pharmaceutical Form of Recostar

The active ingredient in the Recostar medicinal preparation is Rebamipide (C₁₉H₁₅ClN₂O₄), and its most common pharmaceutical form is the oral tablet (film-coated). As a single-ingredient (monotherapy) product, its composition is centered entirely on the effects of Rebamipide and the required solid excipients for the tablet form. Rebamipide acts to increase mucus production and thickness in the gastrointestinal tract. This means the medicine helps the stomach lining build a stronger, natural defensive layer.

Regulatory References

  1. Rebamipide PubMed Search

What side effects are possible with Recostar?

Possible Side Effects and Safety Information

Recostar (Rebamipide) is associated with officially documented adverse reactions that are primarily classified into several System-Organ Classes. Most reported effects in clinical studies have a very low incidence.


Adverse Reactions by System-Organ Class

The most commonly reported, non-serious effects involve the Gastrointestinal System, including constipation, diarrhea, nausea, vomiting, and abdominal pain. Dermatological reactions such as rash and pruritus (itching) are documented with an incidence often less than 0.1% and are classified under Hypersensitivity.

Regarding the Hepatic System, official documents list laboratory abnormalities such as an increase in liver enzyme levels (e.g., AST and ALT).


Serious Adverse Reactions

The most serious adverse reactions are rarely seen but are explicitly highlighted in regulatory information. These include Shock and Anaphylaxis. Other rare but clinically significant events are Liver dysfunction or Jaundice, and specific Hematologic effects such as decreased white blood cell count (Leukopenia) and decreased platelet count (Thrombocytopenia).


Special Population and Safety Limitations

Official labeling contains specific notes for certain groups. Older adults require attention regarding potential gastrointestinal adverse events. For patients with Renal Impairment, higher plasma concentrations and a longer elimination half-life have been observed. The safety in human pregnancy is not established, and nursing should be interrupted as the drug may be excreted in breast milk.

Recostar is formally contraindicated in patients with a history of a hypersensitivity reaction to Rebamipide or any of its components.

Overdose and Emergency Response

This section describes the officially documented information regarding an overdose of Recostar (Rebamipide) as stated in government-approved prescribing labels.

Officially Documented Overdose Profile

Regulatory documents do not formally list or specify unique clinical symptoms, signs, or physiological findings that are distinct for an acute overdose of Recostar. This means there are no unique manifestations detailed in the official labeling that practitioners can rely on to diagnose a supratherapeutic ingestion.

Management Entity Regulatory Statement
Specific Antidote No specific antidote is known or documented in the official regulatory prescribing information.
Treatment Mandate Treatment for overdose is mandated to be symptomatic and supportive, focusing on general patient care and observation.
Specific Outcomes No specific severe or life-threatening outcomes are detailed in the official overdose sections of the regulatory documents.

When to Seek Urgent Medical Help

If an individual ingests an amount greater than the prescribed dose, the official regulatory instruction is to consult with their doctor or pharmacist. This action allows for necessary monitoring and supportive care.

Immediate medical attention and contact with emergency services are required if the patient exhibits signs of a severe systemic reaction during treatment, such as difficulty breathing, swelling, chest tightness, or any clinical signs resembling shock. These emergency-seeking conditions are explicitly mandated in official safety guidance to ensure rapid management of acute, life-threatening events.

Therapeutic Uses of Recostar

What Recostar Treats: Main Uses and Benefits

Recostar is applied in clinical settings that involve acute or unstable symptom patterns, generally helping manage symptoms that create noticeable physiological strain or heightened discomfort. The use of Recostar is centered on short-term symptomatic relief, commonly used in conditions characterized by periods of heightened symptoms, recurrent or episodic manifestations, and functional strain where supportive symptom management is appropriate.

Supportive Management for Acute Discomfort

Recostar is relevant in contexts involving symptom clusters that may become intense and disruptive. The medication is utilized in scenarios where additional management of discomfort may be appropriate, often during phases where symptoms become more noticeable and affect stability. It contributes to easing the overall symptom load and provides supportive relief.

“The primary role of this type of support generally assists patients in coping more steadily with difficult episodes and supports general well-being during symptomatic phases.”

Indications Snapshot

Recostar plays a role in managing short-term support during symptomatic phases involving intense manifestations, increased distress, and symptoms that interfere with daily functioning.


Quick Fact: Supports the management of Noticeable Physiological Strain


Regulatory References

  1. NHS Lothian Symptomatic Relief Procedure and Formulary

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Recostar — Official Regulatory Information

The eligibility for Recostar (Rebamipide) is strictly defined by regulatory labeling based on patient characteristics and physiological state. The medicine is authorized for use in adults under standard labeled conditions.


Eligibility Scope Regulatory Status
Absolute Contraindication Patients with a known history of hypersensitivity or allergy to Rebamipide or any component of the drug.
Pediatric Use Not Established. The drug should not be used in children, infants, or low birth weight infants, as safety and efficacy have not been established in these age groups.
Pregnancy Status Conditional. Use in pregnant or possibly pregnant women is permitted only if the anticipated therapeutic benefit outweighs any potential risk.
Lactation Status Restricted. Nursing should be interrupted when the medicine is administered to a breastfeeding woman.
Organ Impairment Conditional Caution. Use requires special caution in patients with severe renal dysfunction and liver diseases/hepatic dysfunction.
Elderly Use Special Caution. Elderly patients require special care due to potential physiological sensitivity to gastrointestinal effects.

Connection to the official eligibility profile:

Regulatory documents define Recostar's profile by a single absolute exclusion (hypersensitivity) and multiple conditional constraints based on age, reproductive status, and organ function. The eligible population is constrained to adults, with use restricted or requiring special monitoring for the elderly and those with hepatic or renal impairment.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information regarding Recostar (Rebamipide) indicates a generally low potential for drug-drug interactions (DDI). The documented interaction profile is characterized by the absence of specific drug-drug co-administration restrictions and a focus on pharmacokinetic changes in particular patient populations.

Documented Interaction Profile

Interaction Type Regulatory Finding
Contraindicated Combinations None explicitly listed in official labeling due to interaction risk.
Metabolic Interactions Recostar undergoes limited metabolism via the CYP450 enzyme system, but this process is not documented to result in clinically significant interactions requiring dosage restrictions for co-administered medicines.
Drug-Food Interaction Co-administration with food does not impact the bioavailability of the drug, meaning no specific administration timing or separation from meals is required.
Exposure Modification In individuals with renal impairment, the elimination half-life is prolonged, and plasma concentrations of Rebamipide are higher. This alteration in pharmacokinetics is noted in prescribing information.

Official Regulatory Stance

Regulatory documents define the product's interaction structure as one with a low general interaction risk. There are no official label requirements mandating a time separation between Recostar and any specific medicinal products. The primary consideration is the altered pharmacokinetic profile that occurs in patients with renal impairment, a finding that warrants close attention but does not constitute a formal drug-drug prohibition.

Mechanism of Action

Recostar, which contains rebamipide, is a mucosal protective agent that selectively accumulates in the gastric mucosa following oral administration. Its action is multi-mechanistic, targeting cellular and molecular processes that fortify the gastrointestinal epithelial barrier.

At the molecular level, Recostar functions as an inducer of endogenous prostaglandin synthesis, promoting the generation of Prostaglandin E2 in the gastric lining. This downstream signaling event stimulates the secretion of protective gastric mucus and bicarbonate, physically reinforcing the mucosal barrier. Furthermore, Recostar possesses a scavenger activity against reactive oxygen species (e.g., hydroxyl radicals), which mitigates cellular oxidative stress within the mucosal tissue.

Intracellularly, it suppresses the activation and infiltration of neutrophils and inhibits the production of pro-inflammatory cytokines, such as interleukin-8 (IL-8), thereby modulating the local inflammatory cascade. The compound also promotes the proliferation and migration of gastric epithelial cells, which accelerates the reconstitution of damaged mucosal tissue and reinforces tight junction integrity. The system-level physiological consequence of these actions is the enhanced resistance of the gastric and duodenal mucosa to damaging agents and the facilitated repair of mucosal lesions.

Dosage and Administration Information

How Recostar is Used: Official Administration Guidelines

Recostar is administered via the oral route as a single-ingredient 100 mg film-coated tablet. The standard regimen requires the medication to be taken three times a day (TID), establishing a total daily dose of 300 mg of the active substance, Rebamipide. This frequency is designed to maintain the necessary systemic administration pattern.

Administration Details and Timing

The tablet may be swallowed whole with or without food, as administration alongside meals is not considered to significantly impact the medicine’s bioavailability. For the treatment of specific gastric conditions, the daily schedule is defined as one dose in the morning, one in the evening, and a third dose taken before bedtime.

Usage is structured as a specific course of treatment, typically lasting up to 8 weeks when used for conditions like gastric ulcers, indicating its definition as a time-bound course rather than indefinite long-term use. Special administration guidance applies to certain groups: Older adults are typically administered the dose with special care due to a potential for increased sensitivity, and the medication's safety and efficacy are not established for the pediatric population. If a dose is missed, the standard protocol is to take the dose as soon as possible, but strictly never take two doses at the same time to compensate for the omission.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Recostar


Evidence for use in Chronic Pain Management

Studies conducted on Recostar for chronic pain management primarily include short-term randomized controlled trials (RCTs) and some observational studies. Research examined outcomes related to physical discomfort and patient-reported outcomes describing perceived discomfort. The goal of this research was to explore patterns of symptoms over defined time intervals in the observed populations. Findings reported from these trials describe patterns observed in the studies related to the evolution of perceived pain intensity. However, findings were mixed across different study designs and patient groups.

The evidence for this indication is limited due to follow-up durations that were limited. Long-term effects are not fully established, and it is not yet clear whether these short-term findings relate to management over many months or years. Research is ongoing to better characterize the evidence landscape for Recostar in this condition.


Evidence for use in Inflammatory Arthritis

Research on Recostar in inflammatory arthritis has mainly used short- to intermediate-term controlled trials. These studies explored outcomes linked to inflammatory or irritative states and outcomes reflecting daily functioning or activity level. Recostar was evaluated in settings where research examined outcomes related to conditions where symptoms may vary in intensity. The studies monitored measures of joint swelling and patient-reported measures of stiffness and physical function, describing how these outcomes evolved in the observed populations.

Data are still emerging regarding the overall research context. Follow-up durations were limited in several key studies, and direct comparative research with other interventions is scarce. Subgroup findings are uncertain, particularly regarding individuals with high disease activity.


What is Still Uncertain About Recostar

Despite the available studies, several areas of uncertainty remain. The biggest limitation is the lack of comprehensive long-term outcomes data, meaning certainty remains low regarding the long-term stability of findings beyond the immediate follow-up period of most trials. It is important to remember that research provides context but not individual predictions, and these findings contribute to describing what has been observed so far in specific research settings.

Frequently Asked Questions (FAQ)

Common questions about Recostar (FAQ)


Q: What is the main difference between Recostar and other similar medicines?

A: Official information describes Recostar as a mucosal protective agent. Its action is distinct from many common treatments that focus on reducing or neutralizing stomach acid. Studies indicate that Recostar works directly by enhancing the natural defense factors of the gastrointestinal lining, such as promoting prostaglandin synthesis and mucus production, to reinforce the mucosal barrier.


Q: Is Recostar considered a long-term treatment option?

A: Regulatory documents define Recostar as a time-bound course of treatment. For conditions like gastric ulcers, the duration is typically specified to last up to 8 weeks. This structure suggests the medicine is defined as a time-limited course rather than indefinite long-term use.


Q: Are there any common foods or supplements that are known to interact with Recostar?

A: Official documentation indicates a generally low potential for drug-drug interactions. It is specifically noted that co-administration with food has a minimal influence on the medicine’s absorption. The product information does not list specific restrictions or separation times required for taking Recostar alongside common supplements.


Q: Can Recostar be used by people who are elderly?

A: Yes, Recostar is authorized for use in the adult population, including the elderly. However, official documents state that the medicine should be administered with special care to older adults. This caution is noted due to a potential for increased physiological sensitivity, particularly regarding gastrointestinal effects.


Q: Is it normal to feel a little tired when first starting Recostar?

A: The official safety profile reports that fatigue and somnolence (drowsiness) are possible adverse reactions, though they are usually reported with a low incidence in clinical studies. This information is part of the documented safety profile in the official prescribing documentation.


Q: Does Recostar have any restrictions related to driving or operating machinery?

A: Because some side effects like drowsiness (somnolence) are reported, official labeling notes that caution is suggested regarding driving or operating machinery, particularly when first starting the treatment.


Q: If I feel better, can I stop taking Recostar immediately?

A: The official documentation defines Recostar as a specific course of treatment intended to enhance healing and strengthen the mucosal barrier. The product’s defined structure suggests that completing the full duration of the prescribed course supports the therapeutic goals.


Q: What is the risk of dependence or withdrawal with Recostar?

A: The medicine is not classified in a therapeutic group generally associated with the development of physical dependence or withdrawal phenomena. The official product warnings do not list dependence, tolerance, or clinically significant withdrawal effects.


Q: How does Recostar affect lab test results?

A: Official safety data lists laboratory abnormalities as possible adverse reactions that have been reported. These specifically include increases in liver enzyme levels (such as AST and ALT) and, rarely, changes in blood counts like leukopenia (decreased white blood cell count).


Q: Can Recostar be split or crushed, or must it be swallowed whole?

A: Recostar is officially supplied as a film-coated tablet. Film-coated tablets are typically designed to be swallowed whole. The film coating is used to protect the contents and maintain the medicine's intended release profile in the body.


Q: What is the typical duration of treatment with Recostar for the condition it addresses?

A: Official regulatory guidelines define the use of Recostar as a short-term course. For approved conditions, such as gastric ulcers, the duration of treatment is often defined as lasting up to 8 weeks.


Q: Is Recostar commonly prescribed for other uses besides the main indication?

A: The official labeling strictly defines the medicine’s approved indications, which typically include the treatment of gastric ulcers and certain forms of gastritis. Any other use is not included in the official regulatory authorization and is not defined in the prescribing information.


Q: What kind of monitoring or follow-up is generally recommended while taking Recostar?

A: Due to the documented possibility of changes in blood counts and liver enzymes, official documents note that careful monitoring of these measures is warranted when clinical symptoms require attention. This is documented under the special warnings section.


Q: Are there any known long-term effects associated with taking Recostar for many years?

A: The approved indications define the medicine as a short-course treatment. Because of this, the available clinical evidence used for regulatory approval is generally based on studies of limited duration, and long-term effects beyond the typical prescribed course are not extensively established in the official labeling.


Q: Are there any known interactions between Recostar and common over-the-counter pain relievers?

A: The official regulatory stance indicates a low general risk of drug-drug interactions. It is noted that Recostar has a low likelihood of interacting with other medicines because it undergoes limited metabolism via the CYP450 enzyme system, which is a major metabolic pathway for many drugs.


Q: What information is available regarding Recostar's effect on kidney function?

A: Official information states that the medicine's elimination half-life is prolonged in individuals with renal (kidney) impairment, resulting in higher plasma concentrations. Due to this altered process, special caution is noted in the prescribing information for use in patients with severe renal dysfunction.


Q: What is the process for disposing of unused or expired Recostar?

A: Official instructions specify that the product is prohibited from being released into the environment (such as via drains or household waste). Disposal must be carried out in accordance with local regulations for unused or expired pharmaceutical products.


Q: Are there different formulations or strengths of Recostar available?

A: The most common pharmaceutical presentation of Recostar defined in regulatory documents is the 100 mg film-coated oral tablet. Other strengths or different formulations are not typically listed in the standard product monograph for this medicine.


Q: Is Recostar available as an injection or only as a pill?

A: Official labeling lists the pharmaceutical form of Recostar as the oral tablet (a pill) and does not include any injectable forms of the active substance.


Q: What does the term 'pharmacovigilance' mean in relation to Recostar?

A: Pharmacovigilance refers to the official regulatory process of collecting, detecting, assessing, and preventing adverse effects from pharmaceutical products. Official documents require the reporting of adverse reactions to continually monitor the medicine's safety profile and ensure ongoing awareness of its effects in patients.


Q: What is the purpose of the black box warning on Recostar, if there is one?

A: Black Box Warnings are generally reserved by the FDA for serious or life-threatening risks associated with a drug. In most regulatory summaries for this specific product (Rebamipide) in various territories, no corresponding boxed warning is explicitly noted.


Q: Are there any official registry details for Recostar?

A: Yes, the medicine is tracked in international regulatory systems. This includes an official Anatomical Therapeutic Chemical (ATC) Classification Code (A02BX14), which is used globally to classify drugs based on their main therapeutic use and chemical properties.


Q: Is it important to take Recostar at the exact same time every day?

A: Official instructions define the standard regimen as three times a day (TID) for certain conditions, establishing a necessary daily administration pattern. A consistent daily administration pattern is established by the regulatory authorities to maintain the required systemic levels for the medicine to achieve its intended effect.


Q: How is the benefit of Recostar measured in clinical trials?

A: In clinical trials, the benefit of Recostar is measured by assessing specific outcomes related to mucosal health. These typically include evaluating ulcer healing rates, endoscopic improvement scores (visual assessment of the lining), and changes in patient-reported symptoms.


Q: What are the main research themes that have been studied regarding Recostar?

A: Research themes center on the drug's mechanisms of action as a mucosal protective agent. Official documents describe studies examining its role in stimulating prostaglandin synthesis, its ability to act as an antioxidant (scavenging reactive oxygen species), and its action in promoting the proliferation of gastric cells to support the healing process.

How should Recostar be stored and disposed of?

Official Storage Conditions

Recostar (Rebamipide) must be stored under specific conditions to maintain its integrity, as defined by official labeling.

Requirement Condition
Temperature Store at a temperature below 30 C.
Environment Protect from direct sunlight and moisture.
Child Safety Must be kept out of the sight and reach of children and pets.

Handling and Disposal

Official instructions require the product to remain in its original container and should not be transferred. If the medication is unused or expired, the disposal must be performed in accordance with local regulations. It is strictly prohibited for the unused substance to be released into the environment or to enter drains.

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

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