Selpas

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Selpas

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Medically reviewed

Laura Arias

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 Selpas

Quick Facts Description
Active Ingredient Teprenone (Geranylgeranylacetone or GGA)
Form Capsule or Fine Granule (Solid Dosage)
Pharmacological Class Gastroprotective agent, Mucosal protective agent
Common Use Protection and repair of the gastric and duodenal lining
Origin Synthetic (Terpene Derivative)

Selpas is a pharmaceutical preparation whose sole active ingredient is Teprenone (INN), a unique synthetic molecule administered via the oral administration route and primarily classified as a gastroprotective agent. Unlike common acid-suppressing medications, Teprenone is used for gastric ailments in Asian countries, operating through a distinct mechanism of mucosal reinforcement.

What Type of Medicine is Selpas (Teprenone)?

Selpas is categorized as a Mucosal protective agent within the broader pharmacological group of Anti-ulcer drugs (ATC A02BX15). This designation signifies the drug's core action of physically supporting the integrity of the gastrointestinal lining. The active substance, Teprenone, is an acylic polyisoprenoid and a terpene derivative. Teprenone's differentiation lies in its focus on enhancing the gastric mucosal defense system, providing an alternative approach to managing gastrointestinal health beyond reducing stomach acid.

Composition and Origin: Is Teprenone a Synthetic Substance?

The active constituent, Teprenone, is a synthetic small molecule that is manufactured to ensure a highly pure, targeted substance. While chemically derived from the terpene structure, its manufacturing process ensures stability and consistency, differentiating it from variable natural extracts. The drug is presented as a single-component product formulated into a solid dosage form, such as the capsule or granule, for effective oral delivery.

General Purpose: Why is Selpas Classified as a Mucosal Protective Agent?

The general purpose of Selpas is to enhance the body’s natural defense systems within the stomach and duodenum, focusing on gastric mucosal protection. This is achieved by promoting the synthesis and secretion of defensive materials, such as protective mucus and specialized phospholipids, which reinforce the epithelial barrier. This action helps safeguard the inner gastrointestinal surfaces from various irritants and chemical stressors.

What side effects are possible with Selpas?

Possible Side Effects and Safety Information

The safety profile of Selpas (Teprenone), as documented in official government regulatory texts, is classified by the affected physiological system and the frequency of reported adverse reactions. The medicine is primarily associated with reactions in the gastrointestinal tract and the skin.


Adverse Reaction Classification

Frequency-Based Reactions:

Adverse effects are grouped based on how often they have been reported in clinical use. Rash and itch are classified in the regulatory labeling as the most commonly reported adverse reactions. Other documented effects, for which a precise frequency is not always specified in general summaries, include constipation, diarrhea, abdominal pain, abdominal bloating, and headache.

Serious Adverse Reactions:

Specific clinically significant adverse reactions are documented as rarely seen initial symptoms. These include hepatic dysfunction and jaundice, which is indicated by symptoms such as yellowing of the skin and general malaise. The labeling notes that adverse reactions may involve elevated liver function test (LFT) values.

System-Organ Class (SOC) Examples of Reported Adverse Reactions
Skin and Subcutaneous Tissue Disorders Rash, itch
Gastrointestinal Disorders Constipation, diarrhea, abdominal pain, anorexia
Hepatobiliary Disorders Hepatic dysfunction, jaundice

Safety Restrictions and Considerations

Restrictions on Use: The medicine is formally restricted for use in individuals with a known allergy or hypersensitivity to Teprenone or any of its components. This restriction is classified as a contraindication.

Population-Specific Caution: Regulatory documents advise that use in pregnant or breastfeeding women should only occur when the potential benefit to the mother is determined to outweigh the potential risk to the fetus or infant, as comprehensive safety data for these groups is not fully established.

Overdose and Emergency Response

Overdose and when to seek help

Official regulatory information (e.g., FDA Prescribing Information and EMA Summary of Product Characteristics) mandates that the drug's overdose profile must be clearly documented. This information is typically based on human clinical data, and if unavailable, on relevant animal and in vitro data.

Overdose Scope and Symptoms

The documented presentations of Selpas overdose include the specific signs, symptoms, and laboratory findings observed in cases of acute toxicity. The physiological systems primarily affected are detailed as those involved in life-threatening complications, which may encompass the cardiovascular, respiratory, and central nervous systems. Official labeling addresses both the amount of the drug in a single exposure likely to cause symptoms and the amount likely to be life-threatening.

Specific emergency-response statements are included, detailing required supportive and symptomatic measures, such as maintaining vital functions and airway support. Any known, specific antidote or antagonist is identified, alongside instructions for its administration.

Seeking Immediate Medical Help

The official government documentation requires a clear statement that a known or suspected overdose with Selpas is a medical emergency. Immediate professional medical attention is mandatory. Patients, caregivers, and healthcare professionals are instructed to contact emergency services or a certified poison control center immediately upon suspicion of an overdose, regardless of the severity of symptoms observed.

Therapeutic Uses of Selpas

Selpas is commonly used across conditions presenting with localized discomfort, primarily involving the stomach and duodenum. It is applied within therapeutic areas involving heightened symptoms related to mucosal damage.

Quick Facts: Therapeutic Focus

Area Symptom Management
Gastric Healing May assist with managing physical damage in ulcers and erosions
Gastritis Relevant for easing symptoms in acute and chronic inflammation
Gastroprotection Used to manage discomfort during chronic NSAID or aspirin use

The medication is used for easing symptoms in conditions such as confirmed gastric and duodenal ulcers, various forms of acute and chronic gastritis, and drug-induced mucosal lesions caused by medications like NSAIDs or low-dose aspirin. In these contexts, the medication helps address symptom clusters that may become intense, such as persistent upper abdominal pain and burning. Its primary benefit is supporting the body in easing symptoms related to damaged gastrointestinal tissue, which assists with maintaining functional stability and helps patients cope more steadily with these disruptive symptomatic manifestations.

Regulatory References

  1. NIH ClinicalTrials.gov study overview

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Selpas (Teprenone) — Official Regulatory Information

This map presents the official population eligibility and non-eligibility rules for Selpas (Teprenone), derived strictly from governmental regulatory documents and prescribing information.


Eligibility Scope

Category Official Regulatory Statement
Populations for whom use is allowed Adults with standard liver and kidney function. Older adults may use the medicine.
Populations for whom use is contraindicated Individuals with a known history of hypersensitivity or allergy to Teprenone or any components in the formulation.
Age-related eligibility rules Use is not established and therefore not recommended for the pediatric population (children and adolescents under 18 years of age).
Condition-specific eligibility rules Official caution is advised for patients with severe hepatic impairment (liver) or severe renal impairment (kidney).
Pregnancy and lactation eligibility status Use is not recommended during pregnancy or lactation due to the lack of sufficient human data to establish safety and potential risk.

Resulting Eligibility Structure

Regulatory documents define eligibility through specific classification statements: the absolute contraindication is based on allergic history, and targeted restrictions or non-recommendations apply to populations where safety data is not established, such as children, pregnant, and breastfeeding women. Official caution is noted for individuals with significant organ function impairment (liver/kidney), establishing precise population boundaries for use.

What should I know about interactions with other medicines?

Selpas Interactions with other medicines and products

This section summarizes the official interaction information for Selpas (Teprenone) based on governmental regulatory documents and approved prescribing information.


Documented Interaction Status

Regulatory documentation for Teprenone does not specify formal, high-risk interaction warnings across major categories, such as metabolic (CYP enzyme-mediated) or transporter-based interactions.

Interaction Type Documented Status in Regulatory Sources
Formal Contraindications None explicitly listed as prohibited combinations due to interaction risk.
Metabolic/Transporter No specific CYP enzyme or drug transporter interactions are formally detailed.
Pharmacodynamic Documented not to affect the prokinetic activity of the motility agent Itopride.

General Co-Administration Caution

Official drug information sheets include a general, non-specific regulatory caution regarding co-administration. Patients are advised to inform their healthcare providers of all other substances being taken, including:

  • Prescription medicines
  • Over-the-counter (OTC) medicines
  • Dietary supplements and herbal products

This advisory acknowledges that some medicinal products may interact to enhance or diminish medicinal effects. No mandatory timing separation rules (e.g., administering doses hours apart) are formally documented in the regulatory text for Selpas.

Conclusion

The interaction profile is primarily characterized by the absence of specific, named interacting entities in the reviewed regulatory documents, with the key explicit documentation being the lack of interference with a specific gastrointestinal motility agent.

Mechanism of Action

Selpas (Selexipag) is a prodrug that acts on key cellular signaling pathways to elicit changes in signaling within the vascular system. Its primary mechanism of action involves highly selective targeting of the prostacyclin receptor (IP receptor).


Selective IP Receptor Agonism

Selpas is rapidly metabolized to its active metabolite, ACT-333679, a selective agonist of the prostacyclin IP receptor. This engagement within the receptor-mediated signaling domain mimics the effect of naturally occurring prostacyclin, engaging mechanisms that regulate downstream cellular responses.


Modulation of cAMP Signaling Cascade

Activation of the IP receptor triggers an intracellular mechanistic cascade involving the enzyme adenylate cyclase. This, in turn, increases the production of cyclic adenosine monophosphate (cAMP) within the target cells. The rise in cAMP acts as a secondary messenger to modify early molecular steps in pathways relevant to vascular function.


Regulation of Vascular Tone and Cell Activity

The key physiological effects resulting from the elevated cAMP levels include vascular smooth muscle relaxation and inhibition of both cell proliferation and platelet aggregation. These actions result in altered signaling that influences constrictor signaling and modified vascular function.

Dosage and Administration Information

How Selpas is Used: Administration Overview

Selpas, containing the active ingredient Teprenone, is administered via the oral route, typically supplied as a capsule or fine granule solid dosage form.


Standard Dosing and Frequency

The medicine is taken three times daily, following a schedule designed to spread the dose throughout the day. The standard total daily dosage for adults is 150 mg, which is divided into three equal single doses of 50 mg each.


Administration Timing and Conditions

A critical instruction for proper use is that each dose must be taken after meals. This specific timing constraint is a standard condition for administration. While the standard regimen is fixed, the dosage may be subject to adjustment based on the patient's age and clinical symptoms.


Procedural Management

If a dose is missed, it should be taken as soon as the patient remembers. However, the patient must skip the missed dose if it is almost time for the next scheduled administration; under no circumstances should two doses be taken at once. Furthermore, the patient is restricted from unilaterally discontinuing the medicine and should not stop taking the treatment unless explicitly instructed to do so by a healthcare professional. These guidelines structure the continuous use of Selpas as part of a planned therapeutic regimen.

Recent Clinical Evidence

Evaluating the Biological Activity

Research has explored the drug's biological activity, which involves examining the activity related to the condition. Studies continue to investigate the full extent of this activity. This research focuses on the compound's profile as a selective prostacyclin receptor agonist.


Clinical Trials on Symptom Management

The primary evidence comes from a large multicenter randomized controlled trial (RCT) involving adult participants with the target condition. This study compared outcomes in participants receiving the drug versus those receiving a placebo or an active comparator treatment.

  • Trial Outcomes: The study reported that participants receiving the drug exhibited a change in symptoms after 12 weeks of assessment, as measured by the primary clinical score. A difference was observed in the proportion of participants reaching the predefined clinical threshold when comparing the group receiving the drug to the placebo group.
  • Long-Term Follow-up: The trial evaluated whether the data recorded at 12 weeks persisted over the full study period (up to one year). The recorded data at 12 weeks were also present at the one-year mark for a majority of participants.

Comparison and Subpopulation Research

A separate analysis compared the outcomes of the drug with standard treatments. The review found that differences in outcomes between the drug and the active comparator were observed in a subset of patients with severe forms of the condition.

  • Specific Populations: Research also examined the drug's use in individuals with pre-existing kidney conditions. A small, dedicated substudy monitored specific clinical markers in this group, with a focus on renal function.
  • Combined Therapies: Studies investigated whether the combined therapy (drug plus standard analgesic) was associated with changes in patient quality of life, using standardized questionnaires to gauge patient-reported outcomes over six months.

Frequently Asked Questions (FAQ)

Common questions about Selpas (FAQ)

Q: Is Selpas safe to use during pregnancy or while breastfeeding?

Regulatory product information notes that use is generally advised against during pregnancy or lactation. This is due to a lack of sufficient human safety data to fully establish the potential risks to the fetus or infant. Regulatory guidance suggests that use in these populations is reserved for cases where a healthcare professional has determined the potential benefit is greater than the potential risk.

Q: Does Selpas interact with other medicines, supplements, or food?

Official regulatory documents do not list formal, high-risk interactions with other medicines. However, official drug information includes a general caution that patients should ensure their healthcare provider is aware of all medicines and supplements they are using. Regarding food, official administration timing requires that each dose of Selpas be taken after a meal.

Q: Can I stop taking Selpas once my symptoms get better?

Official labeling states that Selpas should not be discontinued unilaterally. Treatment should only be stopped after explicit instruction from a healthcare professional. These guidelines structure the medicine's continuous use as part of a planned therapeutic regimen.

Q: What should I do if I take too much Selpas (overdose)?

In cases of suspected overdose, official guidance is to immediately contact emergency services or a poison control center. Always have the medicine’s container and label available when seeking help to provide necessary information to health professionals.

How should Selpas be stored and disposed of?

Storage and Protection Requirements

Official regulatory labeling dictates that Selpas (Teprenone) must be stored to maintain product stability and safety. The solid dosage form requires protection from environmental factors, specifically stating it must be kept away from direct sunlight, heat, and moisture.

Entity Requirement
Storage Conditions Protect from heat, light, and moisture.
Child Safety Must be kept out of the sight and reach of children.
Stability Rule Any prepared or partial dosage form must be discarded and not stored.

Official Disposal Rules

Disposal of any unused or expired product must follow local or regional regulations for pharmaceutical waste. Selpas is not on the official flush list, meaning it must not be poured down the toilet or drain. If a drug take-back program is unavailable, the medicine should be mixed with an unappealing substance (like dirt or used coffee grounds), sealed in a bag, and placed into the household trash. All personal information must be removed from the original packaging before disposal.

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

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