Каталин

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Каталин

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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 Каталин

Property Description
Active ingredient Pirenoxine sodium salt
Form Ophthalmic solution (Eye drops)
Pharmacological class Anti-cataract agent
General purpose Conservative management of lens opacification
Origin Synthetic small molecule (Xanthomatin derivative)

Каталин is a specialized, prescription ophthalmic medicament whose active ingredient is the Pirenoxine sodium salt. This drug is therapeutically classified as an anti-cataract agent, positioning it as a distinct option for conservative management of age-related eye changes. This drug is utilized primarily in Asian countries, reflecting its unique developmental history.

Pirenoxine is a synthetic small molecule that specifically addresses the biochemical deterioration of the lens. It functions by acting as a powerful antioxidant and a specific inhibitor of protein aggregation. This mechanism forms the basis for its intended therapeutic role: retarding the progression of lens clouding. Pirenoxine is utilized for its potential to stabilize lens proteins, offering a non-surgical management option for conditions like early senile or diabetic cataract. This substance acts to stabilize the eye's lens structure against the changes that lead to clouding.

The medication is uniquely supplied as a two-component preparation to maintain the stability of the active ingredient. This requires combining the sterile, aqueous buffered solvent with the separate lyophilized powder or tablet containing Pirenoxine sodium salt immediately before its first use. This mixing yields the final ophthalmic solution (eye drops). This monopreparation method ensures the patient receives a potent, chemically stable form of the anti-cataract agent for local application.

What side effects are possible with Каталин?

Possible Side Effects and Safety Information

The safety profile for Pirenoxine sodium ophthalmic solution, as documented in official regulatory sources, focuses primarily on reactions local to the eye and surrounding tissues. The adverse effects reported in clinical use are predominantly classified under the category of commonly reported adverse reactions.

Common Adverse Reactions and Affected Systems

The officially documented adverse effects are associated mainly with Eye disorders and local Skin and subcutaneous tissue disorders, reflecting the medicine's topical route of administration. These commonly reported reactions include specific manifestations of localized irritation and inflammation:

  • Ocular Inflammation: Blepharitis (inflammation or erosion of the eyelids), conjunctivitis, and diffuse superficial keratitis.
  • Ocular Discomforts: Experiences such as stinging, itchy eyes, foreign body sensation, bloodshot eyes (ocular hyperemia), and increased lacrimation or eye mucus.
  • Visual Disturbance: Blurred vision is also listed among the commonly reported reactions.

General Safety Constraints and Cautions

Official regulatory information details specific circumstances requiring caution during the use of this ophthalmic solution. A primary constraint is related to administration: soft contact lenses must be removed before the application of the drops. Furthermore, the official label includes cautionary statements for certain patient populations, specifying the need for prudence in individuals with a known history of hypersensitivity to any medicines or foods, as well as during pregnancy and lactation.

For most severe outcomes, the official safety documentation does not list specific events in the category of serious adverse reactions. The overall safety structure is thus concentrated on predictable local intolerance and defined patient constraints.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory profile for Pirenoxine sodium salt ophthalmic solution is defined strictly by its localized route of administration. Consequently, the authoritative documentation focuses primarily on the mandatory actions required following local over-application, rather than detailing patterns of severe systemic toxicity or critical clinical outcomes. The regulatory focus is constrained to scenarios of accidental use exceeding the prescribed amount, which is the only overdose scenario specifically referenced in official documents.

No specific systemic symptoms, such as significant cardiovascular or central nervous system manifestations, are formally described in the regulatory overdose documentation for this ophthalmic preparation. The absence of documented severe outcomes reflects the expected limited systemic absorption resulting from the topical route of administration.

In the event this overdose scenario occurs—application exceeding the prescribed amount—the regulator-defined instruction is to consult with your doctor or pharmacist. This mandate serves as the official, non-advisory threshold for seeking professional guidance and medical advice. The official documentation confirms that no specific antidote is known for Pirenoxine sodium salt overdose.

Furthermore, no specialized supportive management procedures, such as gastric lavage, or requirements for continuous observation, such as hospital monitoring, are explicitly listed in the regulatory overdose sections. All presented information is derived exclusively from government regulatory sources and strictly describes the official label content regarding overdose and mandated help-seeking conditions.

Therapeutic Uses of Каталин

What Каталин Treats: Main Uses and Benefits

The primary clinical focus of the ophthalmic solution containing Pirenoxine sodium salt is the conservative management of lens opacification—the development of cataracts—particularly in the early stages. The medication is generally used to slow the progression of chronic lens changes and supports the management of progressive changes in the lens structure, addressing age-related (senile) cataract and diabetic cataract as primary clinical scenarios. Within these contexts, the medicine is utilized to slow the progression of early senile cataract.

It is relevant when patients begin to notice subtle visual disturbances, such as mild blurring or increased glare/haloes, which signal the onset of lens clouding. The key benefit is providing long-term structural support to the lens to help with managing the progression of opacification, offering a non-surgical option.

“This approach helps vulnerable patient groups, like older adults and those with diabetes, contribute to improved comfort during periods of symptomatic changes.”

Quick Fact: Relief for Early Visual Disturbances

The main therapeutic focus is supporting the structural integrity of the lens early on, thereby supporting the management of developing opacities and easing the impact of symptoms that may interfere with functional stability, often used when symptoms become more noticeable.

Regulatory References

  1. Kusuri-no-Shiori (Drug Information Sheet)

Eligibility and Restrictions for Use

The eligibility for using Каталин (Pirenoxine sodium salt ophthalmic solution) is determined by official constraints outlined in regulatory documents, focusing on patient tolerance and the availability of safety data for specific populations.

Contraindications and Restrictions

The medicine must not be used by any patient with a known hypersensitivity or allergic reaction to Pirenoxine sodium salt or to any non-active component (excipient) in the ophthalmic solution. This represents the primary absolute contraindication stated in the official prescribing information.

Population Group Regulatory Eligibility Status
Standard Eligible Patients Adults and older adults with early senile cataract or diabetic cataract.
Pregnant or Breastfeeding Women Conditional Use/Caution. Use is recommended only if prescribed by a physician due to limited or not well-documented safety data in these populations.
Pediatric Population (Children) Use Not Established. Safety and efficacy have not been established in the pediatric age group.

Eligibility criteria are thus structured by established use in adult populations affected by age-related lens changes, while use in children and during pregnancy/lactation is subject to caution due to insufficient data.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile for Каталин (Pirenoxine sodium salt ophthalmic solution) is highly specific, reflecting its topical application and minimal absorption into the bloodstream. Regulatory documents primarily focus on ensuring the proper local action of the eye drops.

The official label establishes an administration timing constraint when the solution is used alongside other eye drops. This rule is documented to prevent the active ingredient from being washed away, ensuring the correct amount remains on the ocular surface.

Interaction Scope (Ophthalmic) Official Regulatory Information
Interacting Product Category Other ophthalmic solutions/eye drops.
Timing-based Rule Administration must be separated by more than 5 minutes.
Mechanistic Basis Local administration timing interaction (to maintain ocular exposure).

The prescribing information confirms that no contraindicated combinations are formally listed for this medication. Furthermore, no systemic interactions—such as those involving metabolic enzymes or drug transporters—are documented in official regulatory materials. There are also no formally documented interactions with food, alcohol, or herbal products. The interaction profile is solely constrained by the required separation time for co-administered local treatments.

Mechanism of Action

Mechanism for Lens Structural Protein Stability

The drug's mechanism involves the chemical stabilization of structural lens proteins, the Crystallins. It acts as a competitive inhibitor, preventing the binding of intermediate oxidation products, known as quinoid substances, to the proteins' vital sulfhydryl ( -SH) groups. This interaction inhibits the initial biochemical steps of protein cross-linking and subsequent precipitation.


Modulation of Oxidative and Chelation Pathways

Pirenoxine engages in two complementary biochemical actions. First, it functions as a scavenger of Reactive Oxygen Species (ROS), resulting in the chemical consumption of oxidative compounds in the lens. Second, it acts as a chelating agent, binding to free Calcium ions ( Ca^2+). This chelation indirectly prevents the activation of Ca^2+-dependent proteolytic enzymes, such as Calpain, which catalyze the cleavage of lens proteins.


Physiological Consequences of Pathway Modulation

These targeted molecular actions engage a cascade of inhibitory events. By modulating ROS levels, inhibiting proteolysis, and sustaining protein solubility, Pirenoxine influences lens protein homeostasis. The mechanistic consequence is the inhibition of progressive protein aggregation and insolubility, which is the physiological requirement for lens transparency.

Dosage and Administration Information

The administration of the Pirenoxine ophthalmic solution (Каталин) follows a precise protocol to ensure accurate use. This medication is administered via topical ophthalmic instillation, meaning it is applied directly to the eye surface. The solution is typically used over a long-term duration consistent with the conservative management of chronic lens opacification.

Official Usage and Dosing Rules

Protocol Component Official Administration Rule
Preparation The solution is a two-component product that must be reconstituted by dissolving the Pirenoxine tablet or powder in the provided solvent immediately before its first use.
Standard Dose 1 to 2 drops are applied for a single application.
Frequency The standard application pattern is 3 to 5 times a day.
Post-Mixing Constraint The prepared ophthalmic solution must be used within 3 weeks of the initial mixing date due to stability limitations.

Special Administration Procedures

Contact lens wearers must remove soft contact lenses prior to instillation, observing a waiting period of 5 to 10 minutes before reinsertion. Furthermore, when using other ophthalmic medicines, a mandatory interval of more than 5 minutes must separate the application of the different products. If an application is missed, it should be applied as soon as possible, but users must never apply two doses at one time to compensate for a missed dose. These procedures constitute the framework for the application of this medicine.

Recent Clinical Evidence

Каталин: Recent Clinical Evidence

Clinical research on pirenoxine (the active ingredient in Catalin) is primarily focused on its use for age-related cataracts and its potential influence on presbyopia. Evidence from trials and basic research points toward its proposed mechanism of action, which involves mitigating biochemical changes in the eye lens.

Mechanism of Action Studies

Studies suggest that pirenoxine may work by targeting processes related to protein denaturation in the lens, a key factor in cataract development.

  • Chelation: Research indicates pirenoxine can chelate or bind to metal ions, such as calcium and selenite, which are thought to contribute to the aggregation and clouding of lens proteins.
  • Antioxidation: In vitro and animal studies have demonstrated that the compound possesses antioxidant properties, which help counteract oxidative stress associated with cataract formation.

Efficacy and Safety Research

Clinical investigations, including randomized controlled studies, have been conducted to evaluate the effects of pirenoxine ophthalmic solutions.

  • Cataract Progression: Some clinical trials, particularly those involving patients with incipient (early-stage) cortical cataracts, have documented an effect on delaying the progression of lens opacity. This effect has been reported to be more noticeable in younger patients with early cataracts.
  • Presbyopia: A randomized controlled clinical study exploring the use of pirenoxine in individuals in their fifties suggested that the medication may suppress the age-related hardening of the lens, which is linked to the development of presbyopia (age-related farsightedness).
Study Type Focus of Observation Recorded Findings
Early Clinical Trials Incipient Cortical Cataracts Delay in the rate of lens opacification.
Recent RCT Presbyopia (5th decade subjects) Suppression of lens hardening over a six-month period.

Safety Data: Throughout the clinical trials, pirenoxine has been associated with a favorable safety profile. The adverse events reported were typically mild and transient, such as temporary eye irritation or burning sensation upon administration.

Frequently Asked Questions (FAQ)

Common questions about Каталин (FAQ)


Q: Is Каталин considered a cure for cataracts or a way to slow progression?

Official documentation describes Каталин as a treatment used for the conservative management of lens opacification. The medicine is described as being used to slow the progression of early-stage cataracts, rather than being classified as a definitive cure. Its mechanism is focused on stabilizing the proteins in the eye lens to inhibit the process of clouding.


Q: Is the color of the dissolved solution always a yellowish-orange?

This color is consistent with the chemical properties of the active ingredient and is generally the expected appearance of the prepared solution. The active ingredient, Pirenoxine, and the resulting ophthalmic solution are often characterized in official product descriptions as a clear, yellowish or orange-yellow liquid.


Q: What should be done with the remaining solution once the usage period is over?

The prepared solution has a strict in-use stability limit, typically defined as three weeks (21 days) from the date of initial mixing. Due to sterility and stability constraints, any unused or remaining product must be discarded after this period. Official guidelines recommend consulting a pharmacy or medical institution for guidance on proper disposal methods.


Q: What is the chemical name of the active ingredient in Каталин?

The active ingredient in Каталин is Pirenoxine sodium salt. The systematic chemical name for the active compound, Pirenoxine, is documented by official chemical databases as 1,5-Dioxo-4H-pyrido[3,2-a]phenoxazine-3-carboxylic acid.


Q: What does the term 'anti-cataract effect' actually mean in the context of this drug?

The anti-cataract effect is described in regulatory documents by its biochemical action. This action involves competitively inhibiting the binding of harmful quinone compounds to lens proteins and preventing lens protein degeneration. This process is intended to suppress the formation and progression of cloudiness in the lens.


Q: Does using the drops require any special handling procedures or hygiene practices?

As a standard hygiene practice for ophthalmic solutions, it is important to avoid contact between the dropper tip and the eye or any surface to prevent contamination. The official instructions also include requirements for the proper initial mixing and reconstitution of the two components.


Q: Does Каталин help with cataracts that are already developed or only early stages?

Official documentation states the medicine is indicated for the treatment of early senile cataract. Its purpose is to inhibit the progression of the condition. Clinical research and labeling focus on its use for conservative management in these earlier, incipient stages.


Q: Is Каталин widely available or only in certain countries?

Pirenoxine eye drops are primarily utilized in Asian countries and have been prescribed worldwide for many decades. However, the regulatory status varies by region; for instance, the drug is not an approved prescription medicine for this use in certain Western countries, such as the U.S. and Canada.


Q: Why is this drug sometimes described as a phenoxazine derivative?

The active ingredient, Pirenoxine, is related to the phenoxazine chemical family. Chemical databases and regulatory monographs indicate that Pirenoxine's core structure is systematically classified as a pyrido[3,2-a]phenoxazine derivative, which belongs to the broader group of phenoxazine compounds.


Q: Is it common to feel a stinging or burning sensation after applying the drops?

The official safety documentation lists a stinging or itchy sensation in the eye as one of the reported adverse reactions (side effects). While these local effects are generally mild and transient, this experience may occur following the application of the drops.


Q: What are the possible signs of an allergic reaction to Каталин?

The official document advises using caution if a patient has a known history of allergic reactions to medicines or foods. Signs of an allergic reaction may include local symptoms such as itch or rash involving the eyes or surrounding skin. If an unusual reaction occurs, the prescribing information advises consulting with a healthcare provider.


Q: Does the efficacy of Каталин change depending on the patient's age?

Clinical studies have noted that the observed effect on delaying lens opacity progression may be more noticeable in younger patients with early-stage cataracts, indicating a potential variation in observed benefit. The medicine's effect is generally studied in adult populations with age-related lens changes.


Q: Is Каталин used for any other eye conditions besides cataracts?

While the main indication is for senile and diabetic cataracts, research has also investigated the use of pirenoxine in a clinical study focusing on its potential to suppress the age-related hardening of the lens. This hardening is the underlying change associated with presbyopia (age-related farsightedness).


Q: Is the concentration of the dissolved solution always 0.005%?

The most commonly described and clinically studied concentration of the Pirenoxine ophthalmic solution is 0.005%. This specific concentration is often referenced in official product labels and clinical trial protocols where its effectiveness and safety profile were evaluated.


Q: Do studies suggest Каталин is more effective for a specific type of cataract (e.g., cortical)?

Clinical trials evaluating the effect of the drug have specifically focused on and documented the effects on incipient (early-stage) cortical cataracts. This indicates that the research base is particularly strong for the use of the medicine against this specific type of age-related cataract.

How should Каталин be stored and disposed of?

How to Store and Dispose of Каталин

Official regulatory guidelines for Каталин (Pirenoxine) Ophthalmic Solution specify different storage conditions before and after the two components are mixed.

Product Stage Temperature Requirement Protection Requirement
Undissolved Components Room temperature (1 C to 30 C) Away from direct sunlight
Prepared Solution Cold place (1 C to 15 C) Away from light

Once prepared, the ophthalmic solution has a strict in-use stability limit and must be used within three weeks (21 days). The solution must not be transferred to a different container, and the medicine must be stored out of the reach of children. Any unused or remaining product must be discarded after the three-week period. For guidance on disposal methods, individuals are directed to consult a pharmacy or medical institution.

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

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