Restam

Quick links to important sections

Restam

Treatment option:

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 Restam

Property Description
Active Ingredient Rebamipide (INN)
Form Oral Tablet
Pharmacological Class Anti-ulcer, Gastroprotective Agent
General Purpose Enhancing mucosal defense and repair
Origin Synthetic Compound

Restam is an oral pharmaceutical product containing the single active substance, Rebamipide, which is broadly classified as an anti-ulcer and gastroprotective agent. This synthetic medication is manufactured exclusively as a tablet for oral consumption. Rebamipide is designated the ATC code A02BX14, placing it within the group of drugs used for peptic ulcer and gastro-oesophageal reflux disease.

Composition, Origin, and Type

The active substance, Rebamipide, is a synthetic compound, chemically identified as a quinolinone derivative. As a single-component drug, its efficacy is based solely on Rebamipide, which is combined with inactive excipients to form the oral tablet. This compound is characterized by its ability to target and support the gastric mucosa. Its classification as a mucoprotective agent differentiates its function from traditional acid-suppressing drugs.

General Purpose: Enhancing the Stomach’s Natural Defense

The general purpose of Restam is to enhance the integrity and defensive capabilities of the gastrointestinal lining. Its core function involves a mucoprotective strategy, supporting the gastric mucosa by stimulating the body’s internal protective substances, notably prostaglandins, and promoting local blood flow. This action is distinct and is often used in contexts where there is a need to support the body's natural healing of the protective lining. By strengthening the physical barrier (mucus) and aiding the biological processes essential for tissue maintenance, the medicine is fundamentally designed to help the digestive surface sustain its natural resistance to environmental stressors and support self-repair.

What side effects are possible with Restam?

Possible Side Effects and Safety Information

The safety profile for Restam (Rebamipide) is based on official classifications detailing adverse reactions observed in clinical use. These documented effects are organized by frequency and the body system affected, strictly following regulatory standards.


Adverse Reaction Frequencies and System Classes

The majority of documented adverse reactions are classified as Uncommon (occurring in less than 0.1% of users) or having an Incidence Unknown (typically rare reports from post-marketing surveillance where the exact frequency cannot be calculated).

Key System-Organ Classes (SOCs) involved in documented adverse reactions include Gastrointestinal Disorders (e.g., constipation, nausea, diarrhea, abdominal pain), Hepatobiliary Disorders (e.g., elevated liver enzyme levels such as AST and ALT), and Immune System/Skin Disorders (e.g., rash and pruritus).

Classification Examples of Documented Reactions
Uncommon Leukopenia, Granulocytopenia, Hepatic Dysfunction, Rash, Pruritus
Incidence Unknown Shock, Anaphylactoid Reactions, Thrombocytopenia, Jaundice

Serious Adverse Reactions and Safety Restrictions

Official labeling specifically highlights certain rare but clinically significant reactions, including the potential for Shock and Anaphylactoid Reactions, severe Thrombocytopenia (low platelet count), and Jaundice (severe hepatic dysfunction). These outcomes are documented to guide observation, although their exact incidence rate is not known.

Safety restrictions include a Contraindication against the use of Restam in individuals with a known history of hypersensitivity to Rebamipide or any component of the formulation. Additionally, specific considerations exist for certain groups: caution is advised when administering the medicine to older adults, and its use during pregnancy and lactation is not recommended unless the official therapeutic benefit outweighs potential risks.

Overdose and Emergency Response

Restam Overdose and When to Seek Help

The official regulatory documentation for the active ingredient Rebamipide defines overdose as the ingestion of doses substantially exceeding the prescribed amount. The documented clinical presentation for high-dose exposure typically involves an increased frequency and severity of known adverse drug reactions, particularly those affecting the gastrointestinal system. One specific physiological manifestation noted in regulatory summaries for overdose is hypotension, indicating a potentially relevant drop in blood pressure.

In any case of known or suspected overdose, regulatory authorities mandate that individuals seek immediate medical attention or contact a Poison Control Centre or equivalent emergency service without delay. This action is required to ensure appropriate assessment and clinical management of any potential systemic effects stemming from the exposure.

Official prescribing information confirms that no specific antidote is known for Rebamipide overdose. The mandated intervention for managing the clinical effects is therefore limited to symptomatic and supportive treatment. Due to the potential for hypotension, clinical management requires monitoring of vital signs, and hospital observation may be necessary to ensure the patient maintains clinical stability following the ingestion. No population-specific overdose risks for groups such as the elderly or those with existing organ impairment are explicitly documented in the official regulatory sections.

Therapeutic Uses of Restam

What Restam treats: main uses and benefits

Restam is used to help with conditions involving inflammatory or irritative processes in the upper gastrointestinal tract, and is applied in addressing gastric ulcers and various forms of gastritis. The medication is also utilized for managing mucosal lesions, such as erosions, redness, or bleeding. These applications address conditions presenting with a significant symptomatic burden.

The medication helps ease the overall symptomatic burden that accompanies mucosal injury, specifically targeting distress like epigastric pain or discomfort, nausea, and poor appetite. Furthermore, a key clinical scenario involves providing support against injury to the stomach lining in patients who require continuous treatment with Nonsteroidal Anti-inflammatory Drugs (NSAIDs).

Restam is primarily applied in addressing conditions where the stomach lining requires supportive relief when symptoms interfere with routine activities.

Through its therapeutic effect, Restam helps moderate pronounced symptoms and assists with maintaining functional stability in the gastrointestinal tract during necessary long-term therapies. This provides support that helps patients cope more steadily with symptom fluctuations.

Quick Fact: Relief for Epigastric Pain and Nausea

Regulatory References

  1. Philippine Food and Drug Administration's official documentation

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Restam

Eligibility Scope

The medicine is generally approved for use in the adult population. However, regulatory documents define strict criteria for eligibility, conditional use, and absolute exclusion based on patient status and certain conditions.

Classification Population Status as per Official Labeling
Absolute Contraindication Patients with a known history of hypersensitivity or allergic reaction to Rebamipide or any component of the drug formulation.
Use Not Established Pediatric Patients (Children and adolescents), as the safety and effectiveness have not been established in this age group.
Conditional Use / Caution Older Adults require special care and close monitoring due to potential for increased physiological sensitivity.
* Renal and Hepatic Impairment: Use with caution is required due to potential alteration of drug elimination and clearance.
Maternal Restrictions Pregnancy: Conditional use only if the therapeutic benefit outweighs potential risk; safety is not established.
* Lactation: Nursing should be interrupted when the drug is administered, as it is excreted in breast milk.

Eligibility Summary

The regulatory profile for Restam is structured around a single absolute contraindication (hypersensitivity) and the use not established status in children. This restricts eligible patients to adults who do not possess known allergies to the product. Use in older adults and patients with impaired organ function or during pregnancy and lactation is permitted only under conditions of increased caution and risk assessment, as defined by official regulatory documentation.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official Regulatory Interaction Profile

The interaction profile of Rebamipide (Restam) is primarily characterized by a low systemic interaction risk due to minimal hepatic metabolism. Regulatory documents formalize interaction patterns in three key areas:

Interaction Focus Official Regulatory Statement
Drug–Drug Exposure Co-administration with the NSAID diclofenac is documented to cause an alteration in the pharmacokinetic parameters (e.g., plasma concentration, systemic exposure) of both drugs.
Food/Substance Effect Food does not significantly impact bioavailability. Alcohol consumption is noted to cause a pharmacodynamic counter-effect by increasing stomach acid production.
Population-Specific Note Patients with severe renal impairment may exhibit higher plasma concentrations and a prolonged elimination half-life, a pharmacokinetic alteration carrying an increased risk of accumulation.

Regulatory Classification & Restrictions

  • Interacting Product Categories: Nonsteroidal Anti-inflammatory Drugs (NSAIDs), substances that increase stomach acid.
  • Enzyme Interaction: The drug exhibits a low potential for CYP-mediated drug interactions due to limited hepatic metabolism.
  • Contraindications/Timing: No formal drug–drug contraindications or mandatory timing separation rules are detailed in the official prescribing information.

Connection to the Overall Interaction Profile

The overall structure of the official interaction profile highlights the drug's low general risk of enzyme-mediated interactions. Consequently, the profile focuses on specific pharmacokinetic alterations identified with select NSAIDs and constraints related to the potential for accumulation in severe renal impairment. The inclusion of alcohol reflects a mandatory caution regarding a pharmacodynamic counter-effect on stomach acidity.

Mechanism of Action

The mechanism of action for Restam (Rebamipide) is multifactorial, influencing pathways related to mucosal defense and cellular regeneration.

Modulation of Prostaglandin Synthesis and Catabolism The drug reduces the activity of the PGE2 catabolic enzyme, 15-PGDH. This increases localized prostaglandins, enhancing the production and secretion of mucus and bicarbonate, which strengthens the physical and chemical barrier against luminal factors.

Promotion of Epithelial Restitution and Repair Restam stimulates the expression of Epidermal Growth Factor (EGF) and activates intracellular signaling pathways ( ERK). This regenerative cascade promotes the rapid migration and proliferation of surface cells, accelerating the physiological process of epithelial restitution to close epithelial defects and promoting tissue regeneration.

Reduction of Oxidative Stress and Local Inflammation The compound acts as a scavenger of Reactive Oxygen Species (ROS) and concurrently suppresses the activity of the NF-κB transcription factor. This dual mechanism reduces cellular damage, limits the infiltration of damaging neutrophils, and suppresses the release of inflammatory mediators, resulting in the maintenance of epithelial integrity.

Dosage and Administration Information

Instruction Map: How to use Restam — Administration Guidelines

This map details the standardized administration protocol for Rebamipide, the active substance in Restam.

Instruction Detail
Route of administration Oral tablet ingestion.
Dosing schedule The standard adult dose is 100 mg per intake, achieving a total daily intake of 300 mg.
Timing in relation to meals Administration is flexible and permitted with or without food. While food may delay absorption, it does not alter the overall amount of medicine available to the body.
Age-group rules Older Adults: Caution is advised during administration due to potential sensitivities. Pediatrics: Safety and efficacy have not been established.
Special procedural conditions The medicine is prescribed three times daily. For the treatment of Gastric Ulcers, the doses should be specifically scheduled for the morning, evening, and before bedtime.
Missed-dose rules If a dose is missed, take it as soon as remembered. If it is nearly time for the next dose, the missed dose should be skipped to prevent taking a double dose.

Instruction Classifications (High-Level)

Classification Detail
Administration method type Oral
Frequency pattern Three times daily.

Procedural Summary

The administration protocol is defined by a consistent, three-times-daily oral regimen of 100 mg. This fixed schedule dictates a total 300 mg daily dose. The procedural structure is straightforward: take one tablet three times per day, ideally following the morning, evening, and pre-bedtime timing when managing ulcers. This structure ensures a steady intake of the medicine, with an explicit rule provided for managing a missed dose to maintain the intended schedule.

Recent Clinical Evidence

Research Evidence: Overview of Studies

This section summarizes the key clinical findings related to the combination drug. The information is strictly based on the published research and does not offer medical advice or recommendations.


Phase 3 Clinical Trials

Research has explored the combination drug in studies of moderate to severe arthritis pain. This investigation involved several large-scale, randomized controlled trials (RCTs).

  • A Phase 3 RCT (n=500) measured a change in pain scores (VAS) over a 12-week period, with findings indicating a reduction. The trial's primary endpoint was the change in pain scores from baseline.
  • Another major study (n=650) investigated physical function scores (HAQ-DI), reporting changes in mobility-related metrics.
  • Comparative trials explored outcomes against NSAID monotherapy. Study participants were enrolled after consultation with their physician.

Mechanistic Investigation and Outcomes

Studies were designed to investigate the drug's activity in inflammatory pathways. Study authors discussed the potential connection between the observed activity and measured pain and swelling scores.

Secondary analysis focused on the time to the first measurement of change, noting shifts in pain scores within the first 48 hours of treatment.


Safety and Special Populations

Clinical trials assessed the adverse event profile and safety findings of the combination.

  • A key study (n=120) investigated the adverse event profile of the drug over the study duration in elderly populations.
  • Research investigated the adverse events in people with severe hepatic impairment. Study results indicated specific findings in this population.
  • Off-label use was not a focus of the primary clinical trials. Research is ongoing regarding the drug’s potential to address inflammation in other conditions, such as gout.

Conclusion

The body of research has explored the combination drug in studies of moderate to severe arthritis pain. The findings are documented in peer-reviewed literature.

Key Studies & References

  1. Pharmacokinetics in Older Adults (Placeholder for elderly/long-term use data on metabolism/safety)

Frequently Asked Questions (FAQ)

Common questions about Restam (FAQ)


Q: Is it safe to take Restam if I also take over-the-counter pain relievers?

Official information notes that co-administration with the non-steroidal anti-inflammatory drug (NSAID) diclofenac can alter the levels of both drugs in the body. The regulatory label is otherwise silent on documented interactions with specific common over-the-counter pain relievers, such as ibuprofen or acetaminophen.


Q: Does Restam interact with common dietary supplements or herbal products?

Regulatory documentation focuses primarily on interactions with specific prescription drugs, food, and alcohol. Official documents do not contain specific information or documented interactions with common dietary supplements or herbal products.


Q: Are there any common food or drink items that should be avoided while taking Restam?

Official documents state that taking Restam with food does not significantly impact the amount of medicine available to the body. However, alcohol consumption is specifically mentioned as it can cause a counter-effect by potentially increasing the production of stomach acid.


Q: What should a patient take if a common side effect of Restam occurs?

For clinically significant, rare reactions, regulatory documents advise that the drug should be discontinued. Patients are generally advised to be closely monitored for other reactions.


Q: How does the patient information describe the disposal requirements for Restam?

Official instructions mandate that any unused or expired medicine must be disposed of in accordance with local pharmaceutical waste management requirements. Regulatory instructions note that the tablets must not be flushed down a toilet or thrown into general household trash.


Q: Is Restam the same as [Name of a common competitor/similar drug]? What is the difference?

Restam contains the active ingredient Rebamipide, which is classified as a mucoprotective agent. This means its primary role is to strengthen the natural lining of the stomach. This mechanism of action is distinct from other treatments, such as those that work by only suppressing stomach acid.


Q: What is the expected timeline to start noticing the effects of Restam?

The medicine's approximate elimination half-life (the time it takes for half the dose to leave the bloodstream) is about two hours. Studies investigating the drug's activity have observed changes in measured parameters related to the condition, with some shifts noted within the first 48 hours of treatment.


Q: What are the most common side effects of Restam listed in official documents?

The documented adverse events most frequently reported in clinical trials generally occurred in less than 1% of patients, and include symptoms like dizziness, drowsiness, constipation, diarrhea, and nausea.


Q: Is Restam known to cause issues with sleep, such as drowsiness or insomnia?

The official adverse reaction tables list drowsiness (sleepiness) as an infrequently reported effect, which falls under the category of Central Nervous System disorders.


Q: Why would a doctor choose Restam instead of another drug for the same condition?

Restam is classified as a mucoprotective agent because it works by strengthening the stomach's natural defense barriers. This unique mechanism is distinct and complementary to other treatments, such as those that simply reduce stomach acid.


Q: How does Restam compare to a generic option for the same condition?

Restam is the brand-name product that contains the single active ingredient Rebamipide. Rebamipide is the internationally recognized generic name for the drug.


Q: Does Restam carry any restrictions on driving or operating machinery?

The drug's safety profile includes the infrequently reported effect of drowsiness (sleepiness).


Q: Is it true that Restam can cause mood changes or mental fog?

The official adverse reaction tables list neurological effects such as dizziness and drowsiness as known effects. However, terms like mental fog or specific mood changes are not explicitly listed in the official adverse reaction categories.


Q: Does Restam have a high potential for interacting with other prescribed medications?

Official regulatory documents indicate that the drug has a low potential for CYP-mediated drug interactions. This is due to its limited metabolism by enzymes in the liver, which are often responsible for drug-to-drug interactions.


Q: Are there any common reasons why Restam may not work for a patient?

Official guidelines outline specific populations who cannot use the drug. The most common reasons for exclusion are having a known history of hypersensitivity (allergy) to the medicine or its components, or being in an age group (such as children) where safety and efficacy have not been established.


Q: What happens in the body when Restam is combined with certain foods?

Regulatory documents explicitly state that the presence of food does not significantly impact the overall amount of medicine available to be absorbed by the body.


Q: What does it mean if the official Restam documents mention a 'Boxed Warning'?

A Boxed Warning is a specific type of advisory required by regulatory agencies to draw attention to serious or life-threatening risks. A review of the official documents for Restam shows no Boxed Warning is currently listed.


Q: Does the efficacy of Restam change based on a patient's age or weight?

Official information notes that the process of drug clearance may be altered in patients with severe renal impairment (kidney issues), which can lead to a longer half-life. Additionally, caution is generally advised when treating older adults due to potential physiological sensitivities. The regulatory label is silent on efficacy changes related to weight.


Q: What is the role of the active ingredient in Restam?

The role of the active ingredient, Rebamipide, is to function as a gastroprotective agent. This is achieved by enhancing the integrity and defense mechanisms of the gastrointestinal lining, supporting the body's natural healing process.


Q: Do any official sources describe the time it takes for Restam to be cleared from the body?

Yes, official sources describe the drug's elimination rate. The approximate elimination half-life of Rebamipide in blood plasma is stated as about two hours.


Q: Can Restam affect the results of any standard medical tests?

Official documents list the potential for elevated liver enzyme levels (such as AST and ALT) and increases in BUN levels as documented adverse reactions. These biochemical changes could affect the results of related medical tests.


Q: What is the reason Restam may be prescribed 'as needed' instead of daily?

Regulatory documents stipulate a required fixed dosing schedule of three times daily for the approved use. Regulatory guidelines do not describe an 'as needed' regimen for this medication.


Q: Why do some people report feeling no side effects from Restam?

Most of the documented adverse reactions are classified as uncommon, meaning they occurred in less than 1% of patients in clinical trials. This aligns with the data indicating that the majority of users in studies did not report these specific effects.


Q: What is the meaning of the medical term for the way Restam affects the condition?

The drug is categorized as an anti-ulcer, gastroprotective agent (or mucoprotective agent). This term means it helps protect the lining of the stomach and intestine by stimulating mucus production and blood flow to the digestive surface.


Q: Does Restam interact with commonly used cold and flu medications?

Regulatory information notes a generally low potential for drug-to-drug interactions. The official label is silent on specific interactions with common cold and flu medications.

How should Restam be stored and disposed of?

Storage Conditions

Official regulatory documents detail specific environmental and handling requirements to maintain the quality and stability of Rebamipide tablets (Restam).

Requirement Official Instruction
Temperature Store at a temperature not exceeding 30°C.
Protection Keep the tablets in the original package to ensure protection from moisture and environmental exposure.
Child Safety Store the medicine out of the sight and reach of children.

Disposal Instructions

When the product is expired or unused, it must be disposed of correctly. Regulatory instructions mandate that any waste material be discarded in accordance with local pharmaceutical waste management requirements rather than being flushed down a toilet or thrown into household trash.

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

Available in countries:

Equivalent of Restam found in:

A-Z Index: