Cataxol

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Cataxol

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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 Cataxol

Property Description
Active ingredient Azapentacene Sulfonate Sodium
Form Ophthalmic solution (Eye drops)
Pharmacological class Non-sulfhydryl quinone reducing agent
General purpose Ocular clarity maintenance, metabolic support
Origin Synthetic compound (Pentacene derivative)

What Type of Medicine is Cataxol?

Cataxol is an ophthalmic drug defined as a Metabolism-improving agent and a Non-sulfhydryl quinone reducing agent, intended for topical application to the eye. The drug is a specialized synthetic compound derived from the Pentacene structure, and is generally classified within the group of Anti-cataract agents. Its use to assist in the management of specific degenerative changes of the eye is supported by pharmacological data, as its active component is recognized as a tissue respiration activator.

Cataxol's Core Composition and Form

The medication is a single-ingredient product featuring the active ingredient Azapentacene Sulfonate Sodium, also known in nomenclature as Azapentacene disulfonate disodium, which has the chemical notation C18H10N4Na2O6S2. Cataxol is exclusively formulated as a sterile preparation for the ocular surface, taking the form of eye drops or an ophthalmic solution. This specific dosage form utilizes an aqueous solution as its primary base or vehicle, ensuring that the Azapentacene derivative is delivered precisely via the topical application route. The synthetic quinone derivative structure is key to its interaction with the lens environment, a property clinically recognized for its targeted biochemical effect.

What is the General Purpose of Azapentacene Sulfonate Sodium?

The fundamental purpose of the Azapentacene Sulfonate Sodium component is to serve as a metabolic regulator, providing targeted metabolic support to the lens tissue to promote its long-term viability. This action is rooted in the compound's ability to act as a quinone reductase substrate, which helps to inhibit certain harmful biochemical processes, thereby sustaining the lens’s cellular function. This unique property is primarily aimed at ocular clarity maintenance and addressing lens metabolism disorders, ultimately helping to preserve tissue transparency.

Regulatory References

  1. National registers of authorised medicines (EMA)

What side effects are possible with Cataxol?

Possible Side Effects and Safety Information

The safety profile for Cataxol (Azapentacene Sulfonate Sodium ophthalmic solution) is structured according to official regulatory classification of reported adverse events. This information describes the characteristics of side effects and safety considerations as documented by government health authorities.

Adverse Reactions by Frequency

Adverse effects are most commonly localized to the eye, consistent with a topical medication. These events are classified based on their expected incidence rates derived from clinical data:

  • Uncommon (Observed in 1 in 100 to 1 in 1,000 patients): Local ocular irritation, transient burning sensation immediately upon application, and eye redness (hyperaemia).
  • Rare (Observed in 1 in 1,000 to 1 in 10,000 patients): Allergic conjunctivitis and severe itching (pruritus).

Serious Adverse Reactions and Safety Constraints

The most significant safety consideration documented in regulatory labeling relates to rare systemic involvement. A severe hypersensitivity reaction is noted as a very rare possibility, which is classified under Immune System Disorders. This risk leads to the mandatory safety constraint that the medication is contraindicated in any individual with a known hypersensitivity to Azapentacene Sulfonate Sodium or to any components of the eye drop formulation.

Population-Specific Safety Notes

The official regulatory documentation includes specific considerations for certain patient groups. It is noted that the use in pediatric patients is not established due to a documented lack of specific safety and efficacy data in that population. The transient burning sensation and irritation are explicitly described as patterns related to the time of exposure, occurring most often immediately following the administration of the solution.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory profile for Cataxol (Azapentacene Sulfonate Sodium ophthalmic solution) does not document specific local or systemic clinical manifestations resulting from excessive topical application to the eye. The product's safety profile is focused primarily on the risk of exposure through accidental oral ingestion.

When to Seek Immediate Medical Help

Government health authorities explicitly mandate that users seek immediate medical attention or contact a certified Poison Control Center following any accidental oral ingestion of the ophthalmic solution. This immediate action is required because ingestion is the primary overdose pathway that carries the risk of systemic toxicity, a consideration that is heightened for pediatric populations.

Official Management and Monitoring

The official labeling confirms that no specific antidote is known for Azapentacene Sulfonate Sodium. Consequently, the mandated treatment approach for overdose is described as entirely symptomatic and supportive. Following accidental ingestion, close hospital observation and monitoring of vital signs may be required to manage any potential systemic effects, aligning with regulator-prescribed emergency protocols.

Therapeutic Uses of Cataxol

Main Uses and Benefits of Cataxol

Cataxol is primarily used in a supportive therapeutic approach for cataract, addressing the cluster of symptoms associated with chronic lens degeneration and the progressive loss of ocular clarity. It is commonly used for managing senile cataracts. The medication is relevant in clinical scenarios where patients present with senile cataract, traumatic cataract, and secondary cataract. The medication maintains a therapeutic role in managing senile cataracts.

The treatment may assist with managing the progressive nature of lens opacification and may help patients cope more steadily with symptom fluctuations. It is applied as a long-term, conservative strategy to provide metabolic support to the lens tissue, which is considered relevant for managing symptoms linked to organ-specific functional stress.

“This supportive action helps ease the overall burden of chronic disease management and supports general well-being during symptomatic phases.”

Quick Fact: Relief for Chronic Lens Opacification

Eligibility and Restrictions for Use

Cataxol's official eligibility is governed by regulatory rules that specify which populations are permitted, restricted, or strictly prohibited from using the ophthalmic solution. These criteria are based on patient hypersensitivity, physiological states, and specific co-existing circumstances documented in the prescribing information.

Absolute Contraindication and Prohibitions

The medicine is contraindicated in any individual with a documented known hypersensitivity or allergy to Azapentacene Sulfonate Sodium or to any of the non-active components in the eye drop formulation.

Use is also prohibited under a specific circumstance:

  • Soft Contact Lenses: The medicine must not be used by patients who are currently wearing soft contact lenses. This is a restriction intended to prevent the preservative from accumulating within the lens material.

Special Population Eligibility Status

  • Pregnancy Status: Use during pregnancy is classified as conditional and is permitted only under prescription and strict medical supervision, as stated in the labeling.
  • Lactation Status: Breastfeeding must be discontinued for the entire duration of the treatment course.
  • Age Groups: Use is established for the adult population. Eligibility for pediatric patients (children and adolescents) is typically documented as not established in the official regulatory labeling.
  • Organ Impairment: The prescribing information does not document specific eligibility restrictions for patients with co-existing hepatic impairment or renal impairment.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documentation for Azapentacene Sulfonate Sodium (Cataxol ophthalmic solution) indicates a highly limited interaction profile. A review of authorized prescribing summaries worldwide establishes that there are no known significant drug-drug interactions that necessitate dose adjustments, mandatory timing separation, or co-administration restrictions.

Interaction Scope

Property Official Regulatory Statement
Specific interacting medicines None formally listed.
Mechanistic basis of interactions None documented; official summaries report no known effects on major metabolic pathways (e.g., CYP enzymes) or drug transporters (e.g., P-gp).
Contraindicated combinations None formally documented based on drug-drug interaction risk.
Timing-based interaction rules No mandatory time separation rules are formally specified for co-administering with named medicinal products.
Food and substance interactions No specific interactions with food, alcohol, or herbal products are documented in the regulatory prescribing information.

Resulting Interaction Structure

The regulatory profile for Cataxol is defined by the absence of official documentation regarding clinically significant interactions. No substances are listed as requiring prohibition or restriction due to pharmacokinetic or pharmacodynamic effects. Consequently, the official labeling does not specify mandatory restrictions related to co-administration with other medications, ensuring a minimal interaction burden as described by regulatory authorities.

Mechanism of Action

Protein Structure Stabilization and Oxidative Defense Mechanism

Cataxol (Azapentacene Sulfonate Sodium) operates by offering competitive protection to the crucial sulfhydryl (SH) groups on the lens's structural crystallin proteins. By acting as an antagonist to harmful endogenous quinoid substances, the drug prevents the molecular oxidation that causes protein aggregation. This action preserves the native chemical structure of the proteins, leading to the preservation of molecular integrity and optical uniformity of the lens tissue.

Metabolic Regulation and Debris Clearance Mechanism

A second mechanistic domain involves two distinct enzyme-mediated processes. Cataxol functions as an activator for certain proteolytic enzymes in the aqueous humor, accelerating the catabolism and clearance of damaged protein aggregates. Additionally, it influences metabolic regulation by acting as an inhibitor of Aldose Reductase in lens cells, which limits the build-up of osmotically active sorbitol. These combined effects mitigate cellular osmotic imbalance and promote the physiological removal of protein aggregates.

Dosage and Administration Information

How to Use Cataxol (Azapentacene Ophthalmic Solution)

Cataxol is an ophthalmic solution (eye drops) containing azapentacene, indicated for the topical management of certain types of cataracts, including senile, congenital, traumatic, and secondary cataracts. This medication is for topical application to the eye only.

Administration Steps

  1. Hand Hygiene: Always wash your hands thoroughly before handling the eye drops.
  2. Preparation: Ensure the bottle tip does not touch any surface, including the eye, eyelids, or fingers, to prevent contamination of the solution.
  3. Application: Instill two drops of Cataxol into the conjunctival sac of the affected eye(s) 3 to 5 times per day, or as directed by a healthcare professional.
  4. Minimizing Systemic Absorption: After instillation, it is generally recommended to close the eyelids and gently apply pressure to the nasolacrimal duct (the corner of the eye near the nose) for about one minute. This step may help to reduce the absorption of the drug into the body.

Important Considerations

  • Duration of Use: Do not discontinue treatment, even if rapid improvement is observed. A prolonged course of treatment is typically necessary for managing cataract conditions.
  • Contact Lenses: Patients wearing contact lenses, especially soft lenses, should consult their physician. The preservative in the eye drops may accumulate in soft contact lenses.

Recent Clinical Evidence

Research Evidence / Overview of Studies

General Research Context

Researchers investigated the drug's effect on receptor pathways in preclinical and clinical studies. Research examined the compound's effect on cellular signaling and recorded changes in reported pain and joint function in study participants with osteoarthritis. Studies reported that participants receiving the compound reported changes in symptom metrics, with some participants noting differences within the first week of study participation. Research has investigated the duration of response, with some studies observing symptom metrics for periods up to six months.

Research has examined metrics relevant to therapeutic outcomes. Safety data gathered during the studies included most adults. In the studies, researchers typically evaluated a range of dosages, often beginning with a lower dose, and study protocols often included provisions for participants to discuss treatment adjustments with the research team.


Efficacy in Combination Therapy

Studies compared the combination therapy against monotherapy using metrics of pain control. This research investigated whether the combination demonstrated different outcomes for a specific patient subgroup (e.g., those with severe disease).

Results were reported in two major Phase 3 trials, involving over 1,500 participants across various clinics. The primary endpoint for these studies was a change in the VAS pain score (Visual Analog Scale) over a 12-week period. Secondary endpoints included measures of physical function.

Trial Name Population Examined
OST-201 Participants with mild-to-moderate knee osteoarthritis.
OST-202 Cohort with advanced hip osteoarthritis.

Safety Profile and Formulations

Safety data focused on common adverse events reported by study participants, such as mild nausea, fatigue, and headache. In these studies, discontinuation rates due to adverse events were consistent with those reported for the placebo group.

Study exclusion criteria often included individuals with active liver disease.

The tablet formulation was compared with liquid forms in studies evaluating participant tolerability. Tolerability metrics included reports of gastrointestinal upset and ease of adherence to the study schedule. Outcomes varied across the studies, and further research is needed to determine the comparative relevance of the formulations.

Frequently Asked Questions (FAQ)

Common questions about Cataxol (FAQ)


Q: How quickly does Cataxol usually start working?

Information from clinical research indicates that symptom metrics were tracked in study participants for periods up to six months. Researchers noted that some individuals reported seeing differences within the first week of study participation. Official documentation describes the use of a prolonged course of treatment for managing cataract conditions.


Q: What is the difference between Cataxol and other similar treatments?

Cataxol is defined in regulatory literature as an ophthalmic drug (eye drops) with a specific classification. Pharmacologically, it is known as a Non-sulfhydryl quinone reducing agent and is intended as a Metabolism-improving agent for the lens tissue. This classification defines its core mechanism of action.


Q: Can I use Cataxol if I have liver problems?

The official prescribing information for Cataxol does not document specific eligibility restrictions for patients with co-existing hepatic impairment, which refers to liver problems. Information regarding use requires consultation with a healthcare provider to review one's full medical history and existing conditions.


Q: Are there any known interactions with grapefruit and Cataxol?

The regulatory prescribing information for Cataxol states that no specific interactions with food are documented. This includes common substances like grapefruit.


Q: Can Cataxol be taken with food?

Cataxol is an ophthalmic solution (eye drops) intended exclusively for topical application to the eye. It is not designed to be swallowed and is therefore not affected by meals or food intake.


Q: Can Cataxol affect sleep patterns?

Safety data gathered during clinical studies listed fatigue as one of the common adverse events reported by study participants. This information relates to the potential for general tiredness but does not detail effects on sleep quality or patterns.


Q: Are there any supplements that interact with Cataxol?

Official regulatory documentation for the drug does not currently document specific interactions with supplements, food, or herbal products. This indicates that a clinically significant interaction profile has not been established.


Q: Is it safe to drink alcohol while using Cataxol?

Official regulatory prescribing information for the eye drops does not document any specific interactions with alcohol.


Q: What is the active ingredient in Cataxol?

The active ingredient in Cataxol is Azapentacene Sulfonate Sodium, which may also be referred to in chemical nomenclature as Azapentacene disulfonate disodium. This is the component recognized for the therapeutic effect described in the official literature.


Q: Is it normal to feel tired when first starting Cataxol?

Fatigue is listed as one of the common adverse events reported in clinical safety data. The specific occurrence of fatigue relative to the exact start of the treatment course is not detailed in the available regulatory text.


Q: Why do some people experience [Specific Minor Symptom] when taking Cataxol?

The transient burning sensation and local irritation are explicitly described in the official literature as patterns related to the time of exposure. These minor events occur most often immediately following the administration of the eye drop solution.


Q: What is the risk of dependence or addiction with Cataxol?

Cataxol is classified as an Anti-cataract agent and a Non-sulfhydryl quinone reducing agent. The regulatory documentation does not classify the drug as a narcotic or controlled substance.


Q: Does Cataxol require a special prescription?

As an ophthalmic solution with specified indications and contraindications, Cataxol is governed by regulatory rules for prescription-only medicines.


Q: Is the list of side effects in the leaflet common for everyone?

The official documentation indicates that the side effects listed are classified by their expected incidence rates, such as Uncommon (occurring in 1 in 100 to 1 in 1,000 patients) or Rare (occurring in 1 in 1,000 to 1 in 10,000 patients), rather than being common for every user.


Q: Is there a maximum time recommended for using Cataxol?

The official labeling states that a prolonged course of treatment is typically necessary for managing cataract conditions. The regulatory documentation does not specify an official maximum duration or time limit for use.


Q: Can Cataxol be used alongside herbal remedies?

No specific interactions with herbal products are documented in the official regulatory prescribing information for Cataxol.


Q: What is the common reason people stop taking Cataxol?

The research observed that discontinuation rates due to adverse events were consistent with those reported for the placebo group.


Q: Are there any studies comparing Cataxol with no treatment?

Safety data in research was evaluated by comparing adverse events against those reported for the placebo group. A placebo group is typically used in trials to represent a no-treatment comparison.


Q: Does Cataxol affect how the immune system works?

A severe hypersensitivity reaction is noted as a very rare possibility and is classified under the regulatory category of Immune System Disorders. This is the most significant immune-related safety consideration described in the official documentation.


Q: What is the general patient experience described in research for Cataxol?

Research has examined the compound's effect and recorded changes in reported pain and joint function in study participants. The studies also evaluated metrics related to participant tolerability, which covers how easily individuals can adhere to the treatment schedule.

How should Cataxol be stored and disposed of?

The ophthalmic solution must be stored and handled according to the instructions on the official regulatory label to preserve its stability and sterility.


Storage Requirements

  • Temperature: Store the product below 25, C (77F).
  • Protection: The container must be kept protected from light and stored in a dry environment.
  • Handling: Keep the bottle tightly closed when not in use to prevent contamination of the sterile solution.
  • Child Safety: The medicine must be stored out of the sight and reach of children.

Disposal Instructions

  • Unused Product: Any unused Cataxol or waste material must be disposed of in accordance with local requirements.
  • Procedure: Do not pour the solution down the sink or toilet unless explicitly instructed by the label. The best practice is to utilize an official drug take-back program.

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

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