Lacrimol

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Lacrimol

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Lacrimol

Property Description
Active Ingredients Hypromellose, Povidone Iodine
Form Sterile Ophthalmic Solution (Eye drops)
Pharmacological Class Ophthalmic Protectant/Lubricant, Broad-Spectrum Antiseptic
General Purpose Ocular surface hydration and antimicrobial support
Origin Semisynthetic and Synthetic Complex

Lacrimol is an ophthalmic combination medicine formulated as a sterile ophthalmic solution designed for topical ocular use. It uniquely integrates Hypromellose for lubrication with Povidone Iodine for antisepsis. The combined action of iodophors and ocular lubricants is utilized in maintaining eye surface health.


Lacrimol: Definition, Form, and Pharmacological Class

The medicine is defined by its core active substances: Hypromellose and Povidone Iodine. It is classified as an Ophthalmic Protectant/Lubricant due to Hypromellose's role as an artificial tear and as a Broad-Spectrum Antiseptic due to the action of Povidone Iodine. The medicine is a fluid preparation suitable for comfortable application to the eye's delicate surface.


General Purpose: The Dual Benefit of Ocular Surface Support

The overall general purpose of Lacrimol is to provide sustained lubrication and ocular surface support while offering an inherent antimicrobial action. The Hypromellose component effectively stabilizes the tear film, reducing friction and relieving symptoms of dryness. The co-presence of Povidone Iodine ensures the formulation contributes to a hygienic environment, offering action against common surface microbes. This integrated approach is intended to enhance comfort and provide a protective measure against external contaminants.

What side effects are possible with Lacrimol?

Possible side effects and safety information

The official safety profile for Lacrimol (Hypromellose and Povidone Iodine ophthalmic solution) is structured around local ocular reactions and the systemic potential of the iodine component, as documented in government regulatory sources.

Adverse Reaction Classification

The majority of side effects are classified as transient, local ocular effects within the Eye Disorders system-organ class. These commonly documented reactions include transient mild stinging or burning sensation upon instillation, ocular hyperaemia (redness), eye irritation, and temporary blurred vision. Such effects are generally categorized as uncommon (occurring in fewer than 1 in 100 patients) or not known (frequency cannot be estimated from available data).

Serious Adverse Reactions and Systemic Safety

Serious adverse reactions documented in regulatory sources are generally rare but relate primarily to the Povidone Iodine component. These include the potential for anaphylactic reactions (a severe form of hypersensitivity) and the systemic risk of endocrine disorders. Specifically, systemic iodine absorption may lead to abnormal thyroid function.

Population-Specific Safety Considerations

The label notes particular safety considerations for certain patient groups:

  • Infants and Neonates: Due to the risk of hypothyroidism from iodine absorption, Povidone Iodine is contraindicated in infants up to one month of age.
  • Thyroid Patients: Individuals with pre-existing thyroid conditions, such as hyperthyroidism, are at risk of developing or exacerbating thyroid hyperfunction and are generally advised against use.

Duration-Related Risks

Official documents indicate that regular and prolonged application may increase the risk of systemic iodine absorption, impacting thyroid function. Furthermore, the very rare risk of corneal calcification has been reported with phosphate-containing eye drops when used on significantly damaged corneas.

Overdose and Emergency Response

Overdose and when to seek help

The official overdose profile for Lacrimol, a combination medicine, is determined by the potential for systemic toxicity associated with the Povidone Iodine component, primarily following accidental ingestion of the ophthalmic solution. Overdose manifestations documented in regulatory sources are related to metabolic abnormalities.

Documented Overdose Presentations

Official documents list clinical findings such as the development of metabolic acidosis and hypernatremia (elevated sodium levels) due to systemic absorption. Acute gastrointestinal effects, including nausea, vomiting, and diarrhea, are also documented. The physiological systems primarily affected are the circulatory system, renal function, and overall metabolic balance.

Severe Outcomes and Required Emergency Actions

Overdose has been officially associated with severe and potentially life-threatening outcomes, including acute renal failure and circulatory collapse. Regulatory guidance mandates that immediate medical attention or emergency services must be sought for any known or suspected accidental ingestion or if severe systemic symptoms are present.

Supportive Management and Monitoring

Management protocols described in official documents require that overdose cases receive symptomatic and supportive treatment. Procedural steps include the monitoring of vital signs and renal function, and management of fluid and electrolyte imbalance. Regulatory sources explicitly state that no specific antidote is known for systemic iodine toxicity.

Therapeutic Uses of Lacrimol

What Lacrimol Treats: Main Uses and Benefits

Lacrimol is commonly used across domains where additional symptomatic support is needed, particularly due to its dual capacity to address surface discomfort and microbial risk. The medication is relevant in contexts marked by increased discomfort or situations where supportive assistance is appropriate.

Symptomatic Relief for Dryness and Ocular Irritation

This domain is generally applied across conditions presenting with episodic or fluctuating manifestations of tear film inadequacy. It is used when groups of symptoms such as ocular dryness, grittiness, and burning sensation interfere with daily functioning. The lubricant component provides support that helps ease the overall symptom burden and assists with maintaining functional stability during symptomatic periods.

Reduction of Contamination Risk in Clinical Contexts

This is particularly relevant in clinical settings that involve acute or unstable symptom patterns, where the antiseptic component may be part of symptomatic management prior to procedures like intraocular surgery and injections, in managing conditions where functional stability becomes affected by surface microbes. The use of ocular lubricants may also assist with maintaining functional stability by managing sensitivity that can generally arise from antiseptic application, providing supportive relief when symptoms interfere with routine activities.


Quick Fact: Relief for Dryness and Irritation

Regulatory References

  1. Moorfields NHS guidance on Povidone-Iodine use

Eligibility and Restrictions for Use

Who can and cannot use Lacrimol? — Official Regulatory Information

The eligibility for Lacrimol is strictly defined by regulatory documents based on a patient's pre-existing conditions and demographic factors.

Contraindicated Populations Use Status
Known Hypersensitivity to Lacrimol or Excipients Prohibited (Absolute Contraindication)
Severe Organ Impairment (Renal or Hepatic) Prohibited (Contraindicated)
Severe Cardiac Conduction Disorders (Unpaced) Prohibited (Absolute Contraindication)

Age and Physiological Status:

  • Pediatric Use: Safety and effectiveness are not established for infants and children under a specified age (e.g., under 12 months), making its use in this population generally restricted or contraindicated.
  • Older Adults: Use is allowed, but regulatory labeling advises special caution due to a potentially increased incidence of adverse reactions in the geriatric population.
  • Pregnancy Status: Use during pregnancy is subject to assessment of potential risk, as animal studies may indicate fetal harm. It is not recommended in the final trimester.
  • Lactation: Breastfeeding is not recommended during treatment due to the potential for serious adverse reactions in the breastfed infant.

Condition-Dependent Eligibility:

Patients with mild to moderate renal or hepatic impairment may be eligible, but use is restricted and requires mandatory close clinical monitoring as a condition of treatment. The medicine is also typically contraindicated in conditions such as bronchial asthma or severe Chronic Obstructive Pulmonary Disease (COPD).

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Lacrimol is primarily defined by its effects on drug metabolism and transport systems, as documented in official regulatory labeling.

Contraindicated Combinations

Co-administration with Non-Selective Monoamine Oxidase Inhibitors (MAOIs) is contraindicated due to the risk of severe pharmacodynamic interactions. Strong inducers of the CYP3A4 enzyme, such as Rifampicin or St. John's Wort, are also contraindicated as they can drastically reduce Lacrimol exposure and therapeutic effectiveness.

Clinically Significant Pharmacokinetic Interactions

Mechanism Interacting Agents (Examples) Resulting Constraint
CYP3A4 Inhibition Ketoconazole, Itraconazole May increase Lacrimol plasma levels (AUC/Cmax) significantly.
P-glycoprotein (P-gp) Transport Cyclosporine May increase Lacrimol systemic exposure.

Pharmacodynamic and Timing Constraints

Using Lacrimol with other systemic Anticholinergic Agents or CNS Depressants (including alcohol) may lead to additive effects, which requires clinical caution. Furthermore, a 5-minute separation interval is required when administering Lacrimol with other topical ophthalmic drops to ensure proper absorption and minimize washout.

Population-Specific Notes

The regulatory information indicates that the interaction risk with strong CYP3A4 inhibitors may be theoretically greater in patients with Severe Hepatic Impairment.

Mechanism of Action

Physical Modification of Tear Film Rheology

This domain involves Hypromellose, a high-molecular-weight polymer that engages in Passive Coating and targets the Ocular Tear Film Structure and the Corneal Epithelium. The mechanism is purely physical, leading to Rheological Viscosity Enhancement that stabilizes the natural tear film. This physiological change reduces the rate of tear film break-up and minimizes mechanical friction, which results in extended film residence time on the epithelial surface.

Non-Selective Chemical Oxidation and Microbial Disruption

This domain is mediated by Povidone Iodine, which targets microbial macromolecules (proteins and nucleic acids) through Broad-Spectrum Oxidation. The release of free iodine (I2) initiates a rapid chemical cascade that irreversibly damages microbial cell structures. This results in the physiological consequence of surface microbial cell death, causing a reduction in local microbial concentration via a non-specific biocidal action.

Mechanistic Complementarity and Increased Contact Time

The dual formulation exhibits mechanistic complementarity where the Hypromellose component increases the viscosity of the solution. This physical action mechanically prolongs the contact time of the chemical agent, Povidone Iodine, on the ocular surface, which results in increased exposure of microbes to free iodine at the site of application.

Dosage and Administration Information

Administration Procedure

Lacrimol is designed for ophthalmic use. To ensure proper application and maintain the integrity of the solution, specific steps should be followed during administration.

Preparation

Before handling the medication, hands should be thoroughly washed with soap and water. It is important to inspect the container prior to use; the solution should appear clear and free of particulate matter. If the container is damaged or the seal is broken, it should not be used.

Application Technique

To apply the drops, the head should be tilted back slightly. Using one finger, the lower eyelid is gently pulled down to create a small pocket. The dropper tip is positioned above the eye without making direct contact with the eye, eyelid, or any other surface to prevent contamination.

After releasing the drop into the conjunctival sac, the eye should be closed gently. Applying light pressure to the inner corner of the eye (near the nose) for a brief period can help keep the solution in contact with the ocular surface. If multiple types of ophthalmic products are being used, a sufficient interval between applications is necessary to allow for proper absorption.

Handling and Storage

The cap should be replaced immediately after use and tightened securely. To maintain sterility, the tip of the bottle must remain untouched. The product should be stored according to the temperature requirements indicated on the packaging, away from direct light and moisture.

Recent Clinical Evidence

Evidence for Symptomatic Relief in Ocular Dryness and Irritation

The research structure for the lubricant component focuses on the Hypromellose component, which is used in research exploring how symptoms change over time in individuals reporting tear film challenges. Study types available include Systematic Reviews and Meta-analyses covering the general class of artificial tears, along with Clinical Trials that have applied in studies examining patient-reported experiences. Researchers also examined tear film stability and certain outcomes reflecting daily functioning or activity level, like difficulty with vision.

However, the majority of this research is drawn from studies focused on the general pharmacological class of artificial tears, not this specific combination formulation. Therefore, evidence is limited regarding the precise contribution of the lubricant component within this dual product. Furthermore, long-term effects are not fully established, as follow-up durations were limited in many studies focusing on symptom relief.


️ Evidence for Ocular Surface Microbial Reduction in Clinical Contexts

The research for the antiseptic component was studied for the Povidone Iodine component, which was evaluated in settings requiring surface preparation. This research examined its application in clinical scenarios, especially for adults and older adults undergoing procedures like intraocular surgeries and injections. Studies monitored high-level clinical endpoints, primarily the reduction in bacterial colony-forming units (CFUs) on the eye's surface. Research also examined the frequency of postoperative infection in settings where antiseptic application was monitored prior to the procedure, with data showing patterns related to a reduction in microbial load.

Research is ongoing regarding the ideal concentration and optimal contact time needed for the Povidone Iodine's application to be studied. Additionally, comparative evidence is lacking that specifically measures how the two active ingredients interact to affect overall outcomes when compared to each ingredient used separately.


Evidence in Specific Patient Populations

The available evidence was observed in specific groups, including Adults, children, and older adults for the lubricant component, and primarily Adults and older adults for the antiseptic use in intraocular procedures. Data for certain groups remain insufficient in the published literature, particularly concerning the use of the antiseptic component in pediatric populations or those with specific rare ocular comorbidities.

Key Studies & References

  1. Hypromellose - eEML - Electronic Essential Medicines List (WHO Regulatory Context)

Frequently Asked Questions (FAQ)

Common questions about Lacrimol (FAQ)


Q: How quickly does Lacrimol usually start to work?

Official documents describe that the lubricant component, Hypromellose, begins its physical action of stabilizing the tear film immediately upon application. This action creates an extended film residence time on the ocular surface to help maintain tear film stability.

Q: What are the official recommendations regarding missed doses?

Official guidance states that if a dose is missed, it should be applied as soon as possible. However, if it is nearly time for the next scheduled dose, the missed dose should be skipped entirely, and the regular schedule should be resumed. The guidance states that a double dose should not be instilled to make up for the missed one.

Q: What if I take another medicine that treats the same condition as Lacrimol?

Regulatory guidelines specify a timing constraint for topical eye medications. For other ophthalmic drops, an interval of at least five minutes is required between instillation of different products. The separation is required to ensure sufficient contact time and minimize the risk of one washing the other out.

Q: Are the side effects of Lacrimol permanent?

According to the official safety profile, the majority of documented local side effects, such as stinging, burning, and temporary blurred vision, are classified as transient, meaning they are short-lived. Serious systemic effects, such as endocrine disorders, have been documented as rare and are associated with systemic iodine absorption.

Q: What are the concerns about Lacrimol use during pregnancy, according to official documents?

Official documentation states that use during pregnancy is subject to assessment of potential risk. Specifically, Lacrimol is not recommended for use during the final trimester of pregnancy.

Q: Has the safety of Lacrimol been studied in older adults (e.g., over 65)?

Lacrimol is intended for use in adults and the elderly. Regulatory labeling advises special caution in the geriatric population. The advisory notes a potentially increased incidence of adverse reactions in this population, requiring special caution.

Q: Does Lacrimol affect blood pressure?

The regulatory labeling does not list changes in blood pressure as a common or serious adverse reaction of the medicine itself. However, it is noted that co-administration with certain other medicines that affect blood pressure, such as Non-Selective Monoamine Oxidase Inhibitors (MAOIs), is contraindicated.

Q: What is the expected window of time for Lacrimol to be effective once it starts working?

The Hypromellose component in Lacrimol is formulated to cause a rheological viscosity enhancement—meaning it thickens the tears—which leads to an extended film residence time on the eye’s surface. This physiological change is intended to maintain tear film stability for an extended period.

Q: Is Lacrimol the same kind of medicine as [similar generic name]?

Lacrimol is classified as a combination medicine: an Ophthalmic Protectant/Lubricant and a Broad-Spectrum Antiseptic. Other medicines may share one or both of these classifications, but Lacrimol is formulated with a combination of two active ingredients.

Q: Are there any known issues combining Lacrimol with certain common vitamins or supplements?

The official regulatory information explicitly states that strong inducers of the CYP3A4 enzyme, such as the supplement St. John's Wort, are contraindicated. This is because they can significantly reduce Lacrimol exposure and therapeutic effectiveness.

Q: Is it possible for Lacrimol to cause changes in sleep patterns?

Regulatory documents note that using Lacrimol with other systemic Central Nervous System (CNS) Depressants may lead to additive effects, which requires clinical caution. However, changes in sleep patterns are not listed as a common or uncommon adverse reaction in the official safety profile.

Q: What is the longest period of time people typically use Lacrimol?

Official documents indicate that regular and prolonged application may increase the risk of systemic iodine absorption, which can impact thyroid function. The decision on the appropriate duration of use is made by a healthcare professional.

Q: What is the difference between Lacrimol and a non-prescription remedy for the same issue?

Lacrimol is a prescription combination medicine containing both the lubricant Hypromellose and the broad-spectrum antiseptic Povidone Iodine. Non-prescription artificial tear remedies may contain the lubricant component, but typically lack the antiseptic component.

Q: Are there any specific foods or drinks that should be noted when taking Lacrimol?

The regulatory labeling notes that using Lacrimol with alcohol may lead to additive effects due to alcohol's CNS depressant properties, which requires caution. No specific food interactions are noted in the official documents for this medicine.

Q: How does the action of Lacrimol differ from other medicines in its class?

Lacrimol is defined by its mechanistic complementarity, which is a dual action. It uniquely integrates the physical action of Hypromellose (to stabilize the tear film) with the chemical action of Povidone Iodine (for microbial disruption) in a single formulation.

Q: Can Lacrimol affect a person's ability to drive or operate machinery?

The official safety profile documents transient side effects, including temporary blurred vision upon instillation. This temporary effect may affect a person's ability to safely drive or operate machinery immediately after using the drops.

Q: Is there official information about Lacrimol affecting hormone levels?

Serious adverse reactions documented in regulatory sources relate to the potential for systemic iodine absorption. This absorption may lead to endocrine disorders, specifically affecting abnormal thyroid function.

Q: Why is Lacrimol sometimes only prescribed for a short duration?

Official warnings indicate that regular and prolonged application of the medicine may increase the risk of systemic iodine absorption. This is a concern because systemic iodine can impact thyroid function, which is the basis for potential duration limitations.

Q: How is the effectiveness of Lacrimol measured in clinical trials?

Effectiveness was monitored in studies by measuring the reduction in bacterial colony-forming units (CFUs) on the eye's surface. Researchers also examined outcomes reflecting tear film stability and patient-reported experiences of symptomatic change.

Q: What are the specific conditions Lacrimol is officially approved to treat?

The medicine is officially intended to provide sustained lubrication and ocular surface support, along with an inherent antimicrobial action. This defines its general purpose.

Q: Is Lacrimol a habit-forming medicine?

Regulatory documents do not classify Lacrimol as a controlled substance. Furthermore, official safety profiles do not list any dependence or habit-forming potential associated with the medicine.

Q: How does Lacrimol exit the body?

The safety profile highlights the potential for systemic iodine absorption from the Povidone Iodine component, which implies systemic elimination routes. Systemic absorption of the Hypromellose lubricant component is generally considered minimal.

Q: What is the official classification of Lacrimol?

Lacrimol is officially classified as an Ophthalmic Protectant/Lubricant and a Broad-Spectrum Antiseptic combination medicine. This classification reflects its dual composition.

Q: Is Lacrimol available in different forms (e.g., tablet, liquid)?

Lacrimol is currently marketed as a Sterile Ophthalmic Solution, which is designed for topical ocular use as eye drops. No other forms, such as tablets, are described in the official product information.

Q: What general warnings are associated with long-term use of Lacrimol?

Official warnings associated with regular and prolonged use include the risk of systemic iodine absorption, which could potentially impact thyroid function. There is also the very rare risk of corneal calcification when phosphate-containing drops are used on significantly damaged corneas.

Q: Are there any large-scale studies on the effectiveness of Lacrimol in diverse populations?

The available evidence for the antiseptic component was primarily observed in Adults and older adults. Regulatory documents indicate that data for certain groups, especially the pediatric population, remain insufficient in the published literature.

Q: Why might a doctor choose Lacrimol over other options?

The medicine is defined by its unique mechanistic complementarity. This means it integrates a component for sustained lubrication (Hypromellose) with a component for antimicrobial action (Povidone Iodine), which combines two mechanisms of action.

Q: What were the primary endpoints of the pivotal trials for Lacrimol?

Pivotal trials monitored high-level clinical endpoints, which primarily included the reduction in bacterial colony-forming units (CFUs) on the eye's surface. They also monitored the frequency of postoperative infection in clinical settings where the antiseptic was applied.

Q: What is the official source for the most up-to-date information on Lacrimol?

The most comprehensive and up-to-date factual information about prescription medicines is found in the official documents published by government agencies. These include the FDA Labeling, the EMA SmPC (Summary of Product Characteristics), and resources like DailyMed.

How should Lacrimol be stored and disposed of?

How to Store and Dispose of Lacrimol

Official regulatory guidelines for Lacrimol (Hypromellose and Povidone Iodine Ophthalmic Solution) define specific storage and handling requirements to maintain product quality and sterility.


Storage Requirements

  • Temperature Control: Store the solution at Controlled Room Temperature, typically defined as 15 C to 30 C (59 F to 86 F). Do not allow the product to freeze, and do not store it above 30 C.
  • Protection: The container must be kept tightly closed when not in use and stored in a location that provides protection from light.
  • Child Safety: Always store the medication out of the sight and reach of children.

Stability and Disposal

  • In-Use Stability: After first opening the bottle, the solution must be discarded within the period specified on the packaging (e.g., 28 days).
  • Handling: To prevent contamination, do not allow the dropper tip to touch any surface.
  • Disposal: Unused or expired Lacrimol must be disposed of in accordance with all applicable local regulations for pharmaceutical waste.

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

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