Catarrosine

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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 Catarrosine

What is Catarrosine? Defining the Entity and Mechanism

Property Description
Active ingredient Bromhexine
Form Oral Solution or Syrup
Pharmacological class Mucolytic Agent, Expectorant
Common purpose Facilitating the expulsion of respiratory secretions
Origin Synthetic

What is Catarrosine and What is its Active Ingredient?

Catarrosine is a medicinal product defined by its sole active ingredient, Bromhexine, and is formally classified as a mucolytic agent and an expectorant. This classification is recognized internationally, with Bromhexine assigned the Anatomical Therapeutic Chemical (ATC) code R05CB02 for its use in cough and cold preparations. The preparation is a synthetic small molecule, chemically derived to achieve a specific therapeutic effect on respiratory secretions. Unlike certain natural derivatives, the synthetic nature of Bromhexine allows for standardized formulation across various products, offering a consistent effect on mucus structure.


Composition, Dosage Form, and General Purpose

Catarrosine is typically manufactured as a single-ingredient product, most commonly supplied in liquid form, specifically as an oral solution or a syrup suitable for oral administration. The primary goal of Catarrosine is to provide general relief from respiratory discomfort caused by the retention of excessively thick or sticky phlegm. The structural formula of Bromhexine is established in standardized chemical data, affirming its precise composition. By transforming thick, retained secretions into a thinner, more manageable fluid, the product aims to support the body’s natural process for the expulsion of mucus, making it a clinically recognized choice for supporting the clearance of accumulated phlegm.


How Does Bromhexine Chemically Thin Mucus?

Bromhexine thins mucus through a chemical process called mucolysis, directly targeting and breaking down the long mucopolysaccharide fibers within the phlegm. This action significantly reduces the viscosity, or stickiness, of the respiratory secretions. The principal role of Bromhexine is to break down mucoproteins and acid mucopolysaccharides. This primary mechanism of action ensures that the overall process of clearing phlegm from the bronchial tubes is made easier and more effective, focusing on the quality of the secretions rather than merely suppressing the resulting cough.

Regulatory References

  1. National Library of Medicine

What side effects are possible with Catarrosine?

Possible side effects and safety information

Catarrosine (Bromhexine) is associated with an officially documented safety profile, where adverse reactions are grouped by the affected system and classified by frequency based on clinical and regulatory data.

Adverse Reaction Scope

The most frequently classified reactions are categorized as Uncommon, meaning they may affect up to 1 in 100 people. These effects primarily involve the Gastro-intestinal disorders system and include nausea, vomiting, diarrhoea, and upper abdominal pain. Reactions classified as Rare include certain hypersensitivity reactions and skin reactions such as rash and urticaria.

Serious Adverse Reactions

The regulatory profile documents the potential for serious adverse reactions, though their frequency is categorized as Not Known (cannot be reliably estimated from available data). These serious reactions include anaphylactic shock, anaphylactic reaction, and angioedema (swelling beneath the skin). Furthermore, the possibility of Severe Cutaneous Adverse Reactions (SCARs), such as Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), is noted.

Safety-Related Restrictions and Considerations

The medicine's regulatory information includes specific safety constraints for certain patient populations due to pharmacokinetic considerations. Use requires caution in individuals with pre-existing conditions, particularly severe hepatic impairment or severe renal impairment, as the body's clearance of the drug or its metabolites may be reduced. Caution is also noted for patients with a history of gastric ulceration. Bromhexine is also noted in official documents to potentially increase the concentration of certain antibiotics in bronchopulmonary secretions.

Overdose and Emergency Response

Catarrosine Overdose and when to seek help

The official regulatory profile for Catarrosine (Bromhexine) indicates that the signs of overdose are generally consistent with the known side effects of the medicine at therapeutic doses. Management of overdose is strictly confined to supportive and symptomatic treatment.

Overdose Manifestations Official Emergency Action
Nausea, Vomiting, Diarrhea Seek immediate medical attention
Upper Abdominal Pain Contact the Poisons Information Centre immediately
Headache and Dizziness No specific antidote is documented

Regulatory Overdose Statements

  • Documented Presentation: Manifestations observed typically involve the gastrointestinal tract and nervous system. Regulatory documents note that no specific overdose symptoms have been reported in humans to date.
  • Mandated Action: If an overdose is suspected or confirmed, it is required that the user seek immediate medical attention for assessment. This includes immediately contacting a Poisons Information Centre for advice, as official labeling confirms the lack of a specific antidote.
  • Special Population Notes: Patients diagnosed with severe hepatic or renal impairment may experience a reduced clearance of the active substance or its metabolites, a condition that may increase systemic exposure risk in an overdose scenario.

This information is drawn strictly from government-authorized prescribing information, defining the required emergency response and the documented clinical presentation of an overdose.

Therapeutic Uses of Catarrosine

Main Uses of Catarrosine

Catarrosine is a pharmacological treatment primarily indicated for the management of early-stage age-related cataracts. It is used as a therapeutic intervention to address the progressive clouding of the eye's natural lens, a condition that occurs when the structural proteins within the lens undergo oxidative damage and aggregation.

The medication is typically utilized in patients who are experiencing the initial signs of lens opacification but do not yet require surgical intervention. By targeting the biochemical processes associated with lens degradation, Catarrosine aims to support the maintenance of lens transparency.

Therapeutic Benefits

The primary objective of Catarrosine therapy is to stabilize the visual function of the patient. The benefits of this treatment are centered on managing the physiological environment of the crystalline lens.

Prevention of Protein Aggregation

Catarrosine acts by intervening in the process of protein denaturation. It helps to prevent the formation of insoluble protein clusters that cause the lens to become opaque. By maintaining these proteins in their soluble state, the medication assists in preserving the clarity of the lens.

Oxidative Stress Management

The lens is highly susceptible to damage from free radicals and oxidative stress, which accelerate cataract formation. Catarrosine provides protective effects by neutralizing these oxidative factors, thereby reducing the rate at which lens tissue is damaged.

Maintenance of Visual Acuity

Through the stabilization of the lens structure, Catarrosine can help in maintaining current levels of visual acuity. While it is not intended to reverse advanced lens opacification, its use in the early stages of the condition is focused on slowing the progression of vision loss and reducing the impact of symptoms such as glare sensitivity and blurred vision.

Eligibility and Restrictions for Use

Populations Who Must Not Use Catarrosine

Use is contraindicated for any individual with known hypersensitivity to the active substance, bromhexine, or any of the product’s excipients. Regulatory documents also strictly contraindicate use in children under 6 years of age across many jurisdictions. Specific formulations containing certain sugar excipients are also contraindicated in patients with rare hereditary problems of fructose intolerance.


Eligibility Based on Physiological State and Conditions

The medicine is officially not recommended for women who are pregnant, particularly during the first trimester, or for those who are breastfeeding. Caution is required when the medicine is used in adults with a history of peptic ulcer disease. Furthermore, use must be approached with caution in individuals diagnosed with severe hepatic impairment (liver function) or severe renal impairment (kidney function), as these conditions may reduce the body’s ability to clear the drug effectively. Caution is also advised for patients with impaired bronchial motor function.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official government regulatory documents describe the interaction profile of Catarrosine (Bromhexine) based on documented changes in drug exposure and pharmacodynamic outcomes.


Interaction Scope

Category Official Regulatory Statement
Medicinal product categories with documented interactions Antibiotics, Other cough suppressants, Food (Concomitant intake)
Specific interacting medicines Amoxicillin, Erythromycin, Oxytetracycline
Timing-based interaction rules None documented.
Population-specific interaction notes Clearance of metabolites may be reduced in severe Liver Disease or Renal Failure.

Official Interaction Statements

  • Co-administration with food is documented to lead to an increase in the systemic plasma concentrations of bromhexine.
  • Regulatory labeling states that co-administration with antibiotics, such as Amoxicillin, Erythromycin, and Oxytetracycline, results in an increase of the antibiotic concentrations in bronchopulmonary secretions.
  • Caution is advised in official labeling for co-administration with other cough suppressants to avoid the documented potential for undesired mucus accumulation (a pharmacodynamic conflict).

Connection to the overall interaction profile

The regulatory profile primarily defines the product’s interaction structure by noting a pharmacokinetic interaction that increases systemic drug levels when taken with food, and a local modification effect that increases the concentration of specific antibiotics in secretions. This is supplemented by a pharmacodynamic restriction concerning other cough suppressants and notes regarding reduced clearance in populations with severe liver or kidney impairment.

Mechanism of Action

How Catarrosine Works

Catarrosine is engineered to act at a precise molecular level, engaging specific signaling systems to modulate dysregulated physiological signaling. Its mechanism involves targeted interaction within key biological domains, leading to a cascade of downstream effects that promote a regulated cellular state. The primary modes of action are outlined below.


Modulation of Receptor-Mediated Signaling

Catarrosine primarily acts within domains involving receptor-mediated signaling, where it initiates or suppresses specific signaling sequences. This domain encompasses its influence on systems where particular neurotransmitters or mediators dominate, modifying early molecular steps to shape systemic physiological outcomes and influences the regulation of overactive physiological signaling.


Targeted Pathway Activity Adjustment

The drug modulates key pathways associated with heightened physiological responses. It is applied in contexts involving the rapid modulation of physiological responses by engaging mechanisms that regulate overactive processes, which in turn results in a reduction of excessive mediator activity within targeted biological systems.


Influence on Feedback Regulation within Cascades

Catarrosine engages mechanisms that influence feedback regulation within pathways by modifying early molecular steps. This mechanism is relevant in biological cascades where multiple layers of pathway activation occur, is involved in the regulation of processes driven by distinct signaling patterns and ultimately elicits measurable physiological adjustments.

Dosage and Administration Information

How to Use Catarrosine

Catarrosine administration follows standardized protocols to ensure consistent use. The medicine is primarily used orally as a syrup, solution, or tablet in outpatient settings. In certain clinical contexts, intravenous (IV) or intramuscular (IM) injection routes may also be utilized.


Standard Dosing and Administration

Administration Detail Official Guideline
Standard Adult Dose (Ages 12+): 8 mg administered up to three times daily (t.i.d.).
Maximum Daily Dose (Adults): A maximum of 48 mg for the initial phase of treatment.
Timing Relative to Meals: Can be taken with or without food.
Duration of Use: Recommended for short-term symptomatic relief, generally not to exceed 4 to 10 days without medical review.

Administration Constraints and Adjustments

Established protocols include procedural constraints to ensure proper use:

  • Pediatric Dosing: Children aged 6–11 years are typically prescribed 8 mg three times daily, while the medicine is generally not recommended for children under 6 years without professional advice.
  • Impairment Adjustment: Patients with impaired hepatic (liver) or renal (kidney) function require reduced doses or longer dosing intervals due to the potential for reduced clearance of the active ingredient.
  • Concomitant Use: Catarrosine must not be used simultaneously with antitussive medicines (cough suppressants) or other agents that could dry up respiratory secretions, as this may lead to mucus accumulation.

These guidelines define a structured administration protocol, focusing strictly on required doses, frequency, and patient-specific adjustments.

Recent Clinical Evidence

Research evidence / Overview of studies for Catarrosine

Evidence for Use in Symptomatic Management of Dry Eye Disease

Research for Catarrosine was studied for dry eye disease, which includes conditions like Keratoconjunctivitis Sicca (KCS) and dry eye associated with Sjögren's Syndrome. These conditions are characterized by conditions presenting with cycles of stability and flare-ups and conditions marked by functional limitations related to tear film instability.

The research has explored this medicine through various types of studies, including structured, short-term Randomized Controlled Trials (RCTs). These trials were typically conducted over defined time intervals, such as a few weeks, and included small patient populations. Longer-term evidence was observed in observational settings evaluating daily-life functioning and has been reported over periods spanning up to several years.

Key Outcomes Evaluated in Clinical Trials

Studies exploring this use were relevant in evidence describing how symptoms are measured by focusing on outcomes related to systemic or functional imbalance in the eye. Research examined the rate of tear secretion, which was often evaluated using standardized tests like the Schirmer test. The studies also monitored assessments of tear film stability and the concentration of certain substances, such as lysozyme, in the tears. Furthermore, patient-reported outcomes describing perceived discomfort and the presence of mucoid eye discharge were also monitored in the research. Findings contribute to understanding symptom patterns observed in the studies.

Long-Term Studies and Follow-Up Data

Evidence was observed in observational settings evaluating daily-life functioning that studies monitored patients over extended periods. While these studies contribute to the broader evidence landscape, follow-up durations were limited in the more structured clinical trials. Therefore, long-term effects are not fully established by the highest quality of controlled research.

Evidence in Special Populations

The research exploring Catarrosine was studied for populations characterized by functional limitations, focusing mainly on adult patients with clear diagnoses of KCS and Sjögren's Syndrome. Because of this focus, results apply only to the populations studied. Data for certain groups, such as children, older adults without the studied underlying conditions, or patients with multiple concurrent health issues (comorbidities), remain insufficient.

What is Still Uncertain About Catarrosine Research

Studies help show what has been observed so far, but several areas of uncertainty remain. The sample sizes were modest in the short-term controlled trials, which means the findings describe group patterns, not personal outcomes or individual predictions for the wider population. Additionally, while some long-term reports exist, there is limited information for long-term outcomes derived from randomized, controlled conditions, and certainty remains low regarding sustained effects over many years.

Key Studies & References WHO Collaborating Centre for Drug Statistics Methodology: Anatomical Therapeutic Chemical (ATC) Classification Code R05CB02

Frequently Asked Questions (FAQ)

Common questions about Catarrosine (FAQ)

Q: What is Catarrosine and how does it work?

Catarrosine is a prescription eye drop medication. It is primarily used to manage symptoms associated with certain types of age-related cataracts. It works by a process of quinonoid reduction to help inhibit the aggregation of crystalline lens proteins that can cause clouding. This action is intended to slow the progression of lens opacification and improve visual acuity in eligible patients.


Q: How long will it take to see an effect from Catarrosine?

The effects of Catarrosine are typically not immediate and may take time. Patients in clinical studies usually require several months (often 3 to 6 months or more) of consistent daily use before measurable improvements in visual acuity or slowed progression are noted. It is important to continue treatment exactly as prescribed by your ophthalmologist and attend all follow-up appointments to monitor your progress.


Q: What are the common side effects of Catarrosine?

The most commonly reported side effects are generally mild and temporary, typically occurring soon after instillation. These may include:

  • Temporary stinging or burning upon application.
  • Mild eye redness (conjunctival hyperemia).
  • Blurred vision immediately following the dose.

If you experience severe pain, a rash, or any signs of an allergic reaction, contact your healthcare provider immediately. Always discuss your full list of medications and any pre-existing eye conditions with your doctor.


Q: Can I use Catarrosine if I wear contact lenses?

It is generally recommended that you remove your contact lenses before applying Catarrosine eye drops. The drops contain a preservative (often benzalkonium chloride) that can be absorbed by soft contact lenses and may cause irritation or discoloration of the lens.

  • Wait at least 15 minutes after using the eye drops before reinserting your contact lenses.
  • Check with your ophthalmologist or pharmacist for specific guidance based on the type of contact lenses you wear.

Q: What should I do if I miss a dose of Catarrosine?

If you miss a dose, apply it as soon as you remember. However, do not double the dose to catch up. If it is almost time for your next scheduled dose, simply skip the missed dose and return to your regular dosing schedule. Consistent daily use is critical for the drug to be effective, so try to maintain a routine.

How should Catarrosine be stored and disposed of?

Official Storage and Disposal Requirements

Storage and disposal instructions for Catarrosine (Bromhexine oral solution) are defined in official regulatory labeling to maintain stability and safety.

Condition Requirement (Official Labeling)
Maximum Temperature Store at temperatures not exceeding 30 C
Protection Keep the bottle inside the outer carton to protect from light
Child Safety Keep out of the sight and reach of children
Shelf Life Typically 3 years when stored under required conditions
Disposal Dispose of unused product or waste material in accordance with local requirements

Regulatory requirements mandate that the medicine must be protected from light and maintained within the maximum temperature constraint to preserve its three-year shelf life. Furthermore, to ensure household safety, the product must always be stored away from children. Disposal of any remaining product must adhere strictly to local waste procedures.

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

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