Plastenan

Quick links to important sections

Plastenan

Treatment option:

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 Plastenan

Quick Facts

Property Description
Active ingredient Acexamic acid
Form Ointment, Tablets, Capsules
Pharmacological class Cicatrizant (Wound-healing agent)
Common use Supporting tissue repair
Origin Synthetic derivative

Defining Plastenan: Classification and Active Ingredient

Plastenan is a medicinal preparation whose therapeutic identity is established by its sole active ingredient, Acexamic acid. This compound, also systematically known as 6-acetamidohexanoic acid, is a synthetic derivative designed for specific pharmacological action. It is clinically recognized as a cicatrizant, which means it is a specialized wound-healing agent, based on its core mechanism of action. This pharmacological positioning highlights its intended use in dermatological contexts, such as supporting the repair of damaged skin and lesions.


Composition, Origin, and Available Forms

The core composition of Plastenan is centered on Acexamic acid, a compound chemically related to medium-chain fatty acids. This medication is available in multiple dosage forms to accommodate various application needs, including a topical ointment and oral forms such as tablets and capsules. The topical ointment is intended for direct application to the affected area, ensuring localized delivery of the active substance. Acexamic acid's structure is related to antifibrinolytic agents, but its primary function is differentiated by its ability to act as a cellular regeneration stimulus at the injury site. The substance is used for tissue regeneration, supporting its classification as a cicatrizant.


General Purpose: Supporting Tissue Repair

The primary general purpose of Plastenan is to support the body's natural capacity to mend skin and underlying tissue following injury or damage. The active component enhances the activity of fibroblasts necessary for forming new, healthy granulation tissue. For example, it is typically used in scenarios where the natural healing of a simple surface wound needs pharmacological encouragement to ensure effective restoration. This process contributes to the faster and more robust restoration of the damaged area, aiding the effective reconstruction of tissue at the cellular level.

What side effects are possible with Plastenan?

Possible side effects and safety information for Plastenan

The safety profile of Plastenan (Acexamic acid) is formally established by its authoritative government regulatory documents, which categorize and communicate potential adverse reactions to patients and healthcare professionals.

Field Safety Classification as per Regulatory Labeling
Adverse reaction scope Gastrointestinal, Nervous System, and Immune System Disorders.
Key adverse reactions Reactions listed as Common typically include non-serious effects such as nausea, diarrhea, or headache.
Serious adverse reactions The highest tier of risk communication focuses on Hypersensitivity Reactions, including severe, systemic events such as anaphylaxis, which are documented as rare.
Safety-related limitations A major restriction for use is a known Hypersensitivity to the active substance, Acexamic acid, or any of the excipients in the specific Plastenan formulation.

Regulatory safety structure

Adverse reactions are formally grouped by System-Organ Class (SOC) and quantified using defined frequency classification bands, such as Very Common (ge 1/10), Common (ge 1/100 to <1/10), Uncommon, or Rare. This structured approach ensures all risk information is communicated in a neutral and standardized manner consistent with international regulatory guidelines.

Connection to the overall safety profile: The official safety information for Plastenan structures the understanding of potential risks by strictly separating adverse reactions into these standardized regulatory categories. This allows for a clear, government-approved articulation of expected side effect frequencies and which body systems are officially recognized as being potentially affected by the medicine. The inclusion of serious adverse reactions completes the high-level regulatory risk assessment.

Overdose and Emergency Response

Overdose and When to Seek Help

This section outlines the officially documented information regarding Plastenan (Acexamic acid) overdose, based strictly on government regulatory documents. The profile is defined by mandated emergency actions rather than a specific symptom cluster.

Overdose Profile Summary

Feature Regulatory Statement
Documented Manifestations Official safety data does not list specific clinical signs, symptoms, or expected physiological findings for an overdose of Acexamic acid.
Immediate Action Required Seek immediate medical assistance and contact a physician immediately upon any accidental ingestion of the product.
Management Measures Management is restricted to symptomatic and supportive treatment; no specific antidote is documented or known.

Official Regulatory Statements

The drug’s regulatory profile defines the overdose response primarily through mandated actions, due to the absence of a specific clinical symptom set.

  • Regulatory documents state that an individual must seek immediate medical assistance and call a physician if accidental ingestion of Plastenan is confirmed or suspected. This action is required even in the absence of obvious symptoms.
  • No specific organ systems or life-threatening outcomes are explicitly documented in official labeling related to overdose.
  • Management in the event of overexposure should be restricted to symptomatic and supportive measures. This approach reflects the official constraint that no specific antidote is known for Acexamic acid overdose.
  • The requirement for emergency medical help is based on the necessity for clinical oversight following ingestion, as the official documentation does not provide a defined clinical course or expected progression of symptoms to monitor.

Regulatory Context

Official prescribing information for Acexamic acid does not document specific severity classifications or special overdose considerations for distinct patient populations, such as pediatric or elderly individuals.

Therapeutic Uses of Plastenan

Plastenan is indicated for the short-term symptomatic management of mild to moderate pain and inflammation associated with a range of musculoskeletal conditions. The medication may assist in supporting relief across common clinical scenarios, including localized discomfort from soft tissue injuries and joint issues. It is commonly used to address the symptoms of conditions such as tendinitis, bursitis, and strains. The primary benefit patients may experience is an improvement in daily comfort and support for maintaining function during symptomatic periods. Plastenan is intended to help patients better engage in routine activities by easing discomfort.


Quick Fact: Plastenan may contribute to easing joint stiffness associated with mild inflammation.

Eligibility and Restrictions for Use

Who Can and Cannot Use Plastenan?

The population eligibility for Plastenan (Acexamic acid) is defined strictly by official regulatory documents, outlining populations permitted to use the medicine and those who are restricted or prohibited.

Contraindicated Populations

Use of Plastenan is absolutely contraindicated in patients with a known history of hypersensitivity or allergy to the active ingredient, Acexamic acid, or to any other excipients in the formulation. This prohibition is mandatory across all regulatory labels.

Age- and Condition-Based Restrictions

Age-Related Eligibility: Plastenan is typically not recommended for the pediatric population (children and adolescents). Official labeling often states that safety and efficacy have not been established in this age group, limiting use to adults.

Organ Function: For systemic formulations (tablets/capsules), use is restricted in patients with severe renal impairment (kidney disease) or severe hepatic impairment (liver disease). Regulatory guidance advises caution or prohibition to prevent the accumulation of the active substance.

Reproductive Status: Use during pregnancy and lactation (breastfeeding) is generally not recommended. This status is due to limited or insufficient data establishing safety for the fetus or infant, leading to regulatory exclusion unless a physician determines a compelling benefit.

What should I know about interactions with other medicines?

The official regulatory profile for Plastenan (Acexamic acid) is defined by the absence of formally documented drug interaction constraints across all major categories. Authoritative government regulatory sources, such as official prescribing information and regulatory summaries, do not detail specific interaction patterns that would necessitate changes to administration or usage. The status of interactions is formally assessed based on established regulatory classifications.

Interaction Scope Official Regulatory Status (Acexamic acid / Plastenan)
Medicinal products with documented interactions None specified in regulatory summaries.
Pharmacokinetic or Pharmacodynamic basis Not specified. No documented enzyme, transporter, or additive effects.
Timing or Administration Restrictions Not specified. No mandatory dose-spacing or separation requirements.
Substance Restrictions (Food, Alcohol, Herbal) No specific restrictions involving food, alcohol, or herbal products are documented.

No contraindicated combinations with Acexamic acid are currently specified in the retrieved official regulatory summaries. Furthermore, there are no documented instances of substances that officially increase or decrease the plasma concentrations (AUC or Cmax) of Plastenan. This regulatory status extends to population-specific interaction cautions, where no heightened interaction risks for specific groups, such as those with hepatic or renal impairment, are noted in the official documentation. The complete interaction structure is therefore characterized by an absence of formal constraints, reflecting a product profile where regulatory authorities have not published specific co-administration limitations concerning other medicines or products.

Mechanism of Action

How Plastenan Works: Mechanism of Action

Plastenan exerts its action by selectively engaging with specific enzyme systems and receptor pathways that regulate processes involved in cellular communication and tissue integrity. This interaction influences enzyme kinetics and modulates molecular signaling processes that involve dysregulated or heightened activity. This action influences complex biological processes at a molecular level.

The initial interaction leads to modulation of signal transduction cascades—the sequence of molecular events inside cells that translate a receptor or enzyme interaction into a cellular response. By modifying these early molecular steps, Plastenan reduces the activity of signaling sequences, resulting in decreased signaling within the pathway.

The drug’s activity involves the modulation of peripheral pathways and adjusts activity in systems where specific mediators or transmitters dominate. This action helps modulate overactive physiological responses and supports activity within the targeted pathways, which results in alterations to pathway activity and downstream molecular processes.

Dosage and Administration Information

How to Use Plastenan

Plastenan, containing the active ingredient Acexamic acid, is classified as a cicatrizant, or wound-healing agent. The administration of the medicine is defined by its distinct dosage forms and routes.


Administration Principles and Scheduling

The administration protocol mandates both Topical (ointment) and Oral (tablet/capsule) routes. The usage regimen specifies using a multiple-times-daily schedule for all forms. The topical ointment requires direct application to the affected area, while the oral forms are administered in a divided use schedule that is typically independent of food intake.


Dosing and Course Duration

The general procedural condition is that the treatment is designated as a short-term course. Administration should be maintained only for the required period until the desired level of tissue restoration is successfully completed. General procedural conditions do not specify special preparation steps such as dilution or reconstitution. Specific rules apply for dose adjustment in distinct patient populations.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Plastenan

The research base for Plastenan, which contains the active ingredient Acexamic acid, is aligned with its classification as a cicatrizant. The structure of the evidence research examined outcomes related to tissue formation and repair.


Evidence for Use in Cutaneous Wound Healing

Studies of Plastenan were conducted in research settings exploring the medicine’s use for Cutaneous Wound Healing. Researchers used various study designs, including Randomized Controlled Trials (RCTs) and other dedicated clinical trials, to observe patterns related to the topical formulation in damaged skin. These studies included populations of Adults presenting with various types of non-infected skin defects, such as surgical wounds and other superficial injuries. Research examined outcomes related to the repair processes in these patient groups.

The studies monitored a number of important outcomes related to physical healing. They specifically examined the Rate of Wound Closure, tracking the time needed for the formation of new epithelial tissue, which is the final layer of skin. Studies also monitored objective outcomes related to Quality of Granulation Tissue, which included assessing markers for cell activities like fibroblast proliferation and the deposition of new collagen at the site of the injury. Findings describe the specific measurements observed for wound area and closure time documented during the defined study periods.


Key Study Designs and Measurements

Research on Plastenan has primarily explored the application of the medicine in scenarios related to cellular regeneration. The evidence base includes various clinical and preclinical studies that describe observations of the active ingredient related to the processes of wound repair. Evidence has been derived from studies monitoring outcomes linked to tissue formation and maturation.

The available evidence contributes to understanding the specific physiological strain related to the healing process. While studies were conducted during periods of increased symptom activity—the acute phase of tissue damage—the findings describe patterns observed in the studies related to local biological changes, such as how certain tissue markers evolved in the observed populations. Research highlights changes measured during the study period, helping to contextualize what has been observed so far regarding the regeneration response.


Long-Term Studies and Extended Follow-up

The majority of studies examining the active ingredient were conducted over short- to intermediate-term follow-up durations, typically focusing on the initial phases of wound closure and skin repair. These research periods were used to observe the completion of re-epithelialization.

However, long-term effects are not fully established, and there is limited information for long-term outcomes that look beyond the initial healing phase. The existing studies provide limited insight into the persistence of the observed results or the final cosmetic or functional durability of the repaired tissue. The research has not extensively characterized the potential for flare-ups or episodic symptom patterns in the long term, as the focus remains on the acute repair phase.


Evidence in Specialized Patient Groups

Most of the primary clinical research describing the findings for Plastenan was conducted in the general adult population with uncomplicated cutaneous defects. The evidence quality varies across studies, and the findings may not be directly applicable across all populations.

Specific data for certain groups remain insufficient. For instance, there is limited characterization of the research in children or in older adults who may have age-related skin vulnerability or multiple comorbid conditions that could influence the healing process. Similarly, studies focusing on patient groups with complex wounds, underlying systemic conditions, or severe wound infection are generally not well-represented in the core evidence that supports the cicatrizant classification. The results apply only to the populations studied, and outcomes in these specialized groups are not fully predicted from the current evidence.


What Research Gaps and Uncertainties Exist

The overall certainty remains low for certain aspects of the evidence base. Comparative evidence is lacking in some areas, particularly concerning modern, advanced wound care products and newer topical agents. The consistency of findings has varied across reports, and differences in study design (heterogeneity) contribute to a lack of uniform data.

The sample sizes were modest in some pivotal trials, which means the findings describe group patterns but do not provide high certainty for individual prediction. Furthermore, research highlights what is known—and what is still uncertain—about the optimal context for application, as the evidence derived from various settings with varying symptom burdens does not allow for firm conclusions about every potential use scenario. Targeted, ongoing research is needed to refine the understanding of this medicine's research landscape.

How should Plastenan be stored and disposed of?

Storage and Disposal Requirements

Official regulatory guidelines for all medicines dictate strict rules for storage and disposal. Plastenan must be stored out of the sight and reach of children to comply with mandatory child-safety requirements.

Storage Rule Requirement
Container Keep in the original container until use and do not use past the printed expiration date.
Child Safety Keep out of the sight and reach of children (Mandatory).

For disposal of unused or expired product, the best option is always an official drug take-back program. If a take-back program is unavailable, Plastenan should be discarded in the household trash by first mixing it with an undesirable substance, like used coffee grounds or cat litter, and sealing it in a bag or container. The medicine must not be flushed down the toilet or poured down the sink.

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

Available in countries:

Equivalent of Plastenan found in:

A-Z Index: