Xalacom

Quick links to important sections

Xalacom

Selected form

Treatment option:

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 Xalacom

Quick Facts

Property Description
Active Ingredients Latanoprost, Timolol maleate
Form Ophthalmic solution (Eye drops)
Pharmacological Class Prostaglandin Analogue + Beta-Blocker
General Purpose Lowering elevated intraocular pressure (IOP)
Origin Synthetic

Xalacom: Classification as a Fixed-Combination Ophthalmic Agent

Xalacom is a clear, colorless, synthetic fixed-combination ophthalmic solution designed for topical ocular administration as eye drops. Its distinguishing feature lies in combining two active agents—Latanoprost and Timolol maleate—into one single-bottle preparation. This integrated delivery mechanism is recognized for potentially improving adherence in patients requiring both therapeutic pathways. The product's classification as a fixed combination makes it a specific step-up option in therapy, intended for adults who require the complementary action of both compounds for consistent management of their ocular condition.


Composition and Dual Pharmacological Class of Latanoprost/Timolol

The active ingredients in Xalacom are Latanoprost, a Prostaglandin Analogue, and Timolol maleate (INN), a non-selective Beta-Adrenergic Receptor Blocker (beta-blocker). The strategic inclusion of agents from these two different pharmacological classes is the basis of its efficacy. The combination is designed to achieve a greater overall reduction in pressure compared to either agent used alone.

Latanoprost works by increasing the eye’s fluid outflow, while Timolol lowers pressure by reducing the rate of fluid production, offering a comprehensive strategy for fluid balance.


General Therapeutic Purpose: Management of Ocular Pressure

The primary general purpose of the Latanoprost/Timolol fixed combination is the reliable and sustained lowering of elevated intraocular pressure (IOP). This therapeutic benefit is achieved through the additive effect from the combination, which is important for long-term IOP control. This medication is utilized in the management of ocular hypertension and open-angle glaucoma. This medication is used for maintaining appropriate eye pressure levels, which is a key objective of long-term ocular health management.

What side effects are possible with Xalacom?

Possible Side Effects and Safety Information

The safety profile for the Latanoprost/Timolol combination is based on the distinct effects of its two active components. Side effects are classified by regulatory authorities according to their incidence rate in clinical use.

Frequency-Classified Adverse Reactions

The most frequent adverse reaction documented is an increase in the brown pigmentation of the iris, classified as Very Common. This change is typically gradual, may appear over months or years of treatment, and is often considered a permanent effect of the Latanoprost component. Common reactions include local effects such as eye irritation, eye pain, and conjunctival hyperaemia (redness).

Systemic Safety and Serious Adverse Reactions

Due to the systemic absorption of the Timolol (beta-blocker) component, potential effects on the Cardiac and Respiratory systems are documented. Serious adverse reactions, though uncommon, include cardiac failure and severe bronchospasm (including fatal events in patients with asthma), which are linked to the beta-blocker's systemic effects. Other documented systemic effects include hypotension and bradycardia.

Safety Restrictions and Contraindications

The medicine is contraindicated and should not be used in individuals with certain severe pre-existing conditions, specifically reactive airway diseases (such as bronchial asthma or severe COPD) and serious cardiac diseases (including sinus bradycardia, second- or third-degree atrioventricular block, or overt cardiac failure). These restrictions are mandated by official labeling due to the risk of serious systemic adverse reactions from the Timolol component. Safety and effectiveness in the pediatric population have not been established.

This structured safety information ensures that the documented risks, frequency of events, and necessary restrictions are clearly communicated, separating frequent, localized changes from less common but more serious systemic risks.

Overdose and Emergency Response

Overdose and when to seek help — Official Regulatory Information for Xalacom

This section reflects the explicit descriptions and mandated actions contained only within the overdose or emergency sections of government regulatory documents for Xalacom (Latanoprost/Timolol).

Domain Official Regulatory Statement
Documented Overdose Manifestations Bradycardia (slow heart rate), hypotension (low blood pressure), and bronchospasm are documented systemic signs. Local ocular presentations include irritation and conjunctival hyperemia (redness).
Life-Threatening Outcomes Risks include cardiac arrest, severe trouble breathing, passing out (syncope), and fatal bronchospasm in susceptible individuals, primarily linked to the systemic absorption of the beta-blocker component (Timolol).
Emergency Actions Call emergency services (e.g., 911) for serious, life-threatening symptoms. Contact a poison control center immediately for suspected accidental oral ingestion.
Supportive Management Treatment is mandated to be symptomatic and supportive. Regulatory documents confirm that the Timolol component is not readily dialyzable.

The overdose profile is defined by the expected systemic toxicity from the Timolol component, which necessitates the immediate and urgent help-seeking actions. The potential for severe cardiopulmonary events dictates the regulatory requirement to call emergency services when symptoms like severe trouble breathing or passing out occur. There is no specific human data available on overdosage with the fixed combination.

Therapeutic Uses of Xalacom

Quick Facts

  • Key Therapeutic Domains: Elevated intraocular pressure (IOP).
  • Conditions Managed: Open-angle glaucoma and ocular hypertension.
  • Intended Patient Group: Individuals who have not responded adequately to single-agent treatments (monotherapy).

What Xalacom Treats: Main Uses and Benefits

Xalacom is a prescription medication utilized in adult patients to support the management of certain eye conditions linked to elevated pressure inside the eye. Its primary therapeutic purpose is the sustained reduction of elevated intraocular pressure (IOP). This action is a component of the treatment protocol for patients diagnosed with open-angle glaucoma or ocular hypertension.

Elevated intraocular pressure is a key factor in these conditions and its effective management is intended to help preserve visual function. This combination therapy is generally reserved for individuals who have shown insufficient responsiveness to single-component topical IOP-lowering agents, such as beta-blockers or prostaglandin analogs alone.

The goal of therapy is to achieve and maintain reduced eye pressure to support ocular health and long-term well-being. This agent is an option for dual-agent support in eye pressure management.

Eligibility and Restrictions for Use

The eligibility for using Xalacom (latanoprost/timolol) is defined by strict regulatory criteria, primarily due to the systemic effects of the beta-blocker component, timolol.

Contraindicated Populations (Must Not Use)

Use is absolutely forbidden for patients with:

  • Reactive airway diseases: Including bronchial asthma or a history of asthma, and severe Chronic Obstructive Pulmonary Disease (COPD).
  • Specific cardiac conditions: Such as sinus bradycardia (abnormally slow heart rate), overt cardiac failure, cardiogenic shock, and second or third-degree atrioventricular (AV) block not controlled by a pacemaker.
  • Known hypersensitivity (allergy) to latanoprost, timolol, or any other ingredient, including the preservative benzalkonium chloride.

Use Not Recommended or Restricted

Population Category Regulatory Status
Children and Adolescents Not recommended; safety and effectiveness have not been established.
Pregnancy Should not be used; there is no adequate experience in pregnant women.
Breastfeeding Should not be used; potential for active ingredients to pass into breast milk and cause harm to the infant.

Populations Requiring Caution

Use requires critical assessment and close monitoring for patients with mild/moderate COPD, certain cardiovascular diseases (e.g., first-degree heart block), diabetes (may mask hypoglycemia symptoms), and severe peripheral circulatory disorders.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section describes the officially documented interaction patterns for Xalacom (Latanoprost/Timolol) as classified in government regulatory sources, focusing on documented pharmacodynamic and pharmacokinetic risks.

Documented Interaction Patterns

Interaction Type Interacting Substances / Classes Official Constraint or Outcome
Topical Restriction Other Prostaglandin Analogues (Ophthalmic) Not Recommended/Contraindicated due to risk of paradoxical intraocular pressure (IOP) elevation.
Systemic Pharmacodynamic Oral Beta-Blockers, Calcium Channel Blockers, Antiarrhythmics (e.g., Amiodarone), Digitalis Glycosides Risk of additive systemic effects, including marked bradycardia and hypotension.
Pharmacokinetic CYP2D6 Inhibitors (e.g., Quinidine, Fluoxetine, Paroxetine) Leads to potentiated systemic beta-blockade due to increased Timolol exposure.

Administration Timing Rules

Administration of Xalacom and any other topical ophthalmic drug must be separated by an interval of at least five minutes. This mandatory separation rule also applies when co-administering with ophthalmic solutions containing Thiomersal, a requirement based on documented chemical incompatibility and precipitation risk. The regulatory documentation does not explicitly classify interactions with food, alcohol, or common herbal products.

Mechanism of Action

Dual Action on Intraocular Fluid Dynamics

Xalacom operates by simultaneously modulating the two main factors determining Intraocular Pressure (IOP): fluid production and fluid drainage. This dual approach results in an additive reduction in pressure by restricting the inflow of aqueous humor while actively facilitating its outflow.


Latanoprost: Enhancing Uveoscleral Outflow

The latanoprost component works by acting as an agonist at the prostaglandin F2alpha ( FP) receptors in the ciliary muscle. This molecular activity leads to the remodeling of the extracellular matrix, effectively increasing the permeability and space for fluid to drain through the unconventional uveoscleral pathway.


Timolol: Suppressing Fluid Formation

The timolol component is a non-selective beta-adrenergic antagonist (beta-blocker) that targets receptors in the ciliary body epithelium. By blocking sympathetic signaling, it reduces the active secretion and formation of aqueous humor, thereby decreasing the volume of fluid entering the eye's chambers.

Dosage and Administration Information

Xalacom (latanoprost and timolol maleate) ophthalmic solution is a prescription medication used to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Administration and Dosage

  • The usual dosage is one drop into the affected eye(s) once daily. It is generally recommended to apply the drop in the evening for optimal effectiveness.
  • Do not use Xalacom more than once a day, as more frequent use may decrease its pressure-lowering effect.
  • If a dose is missed, skip the forgotten dose and continue with the next scheduled dose at the usual time. Do not use a double dose to make up for a missed one.

Instillation Technique

To ensure proper medication delivery and minimize systemic absorption, follow these steps:

  1. Wash your hands thoroughly before handling the bottle.
  2. Remove the cap and avoid touching the dropper tip to any surface, including the eye or fingers, to prevent contamination.
  3. Tilt your head back, pull down the lower eyelid with a finger to form a small pocket.
  4. Hold the bottle tip close to the eye and gently squeeze to administer one drop into the pocket.
  5. Gently close your eye (do not blink or squeeze the eyelid) and immediately press your finger to the inner corner of your eye, near the nose, for at least two minutes. This technique, known as nasolacrimal occlusion, reduces the amount of medication absorbed into the bloodstream.
  6. Wipe away any excess liquid with a clean tissue.

Important Precautions

  • If you wear soft contact lenses, remove them before instilling the drops. Wait at least 15 minutes before reinserting the lenses, as the preservative (benzalkonium chloride) can be absorbed by the lens material.
  • If you are using other topical ophthalmic medications, wait at least five minutes between the administration of Xalacom and the other eye drops.
  • Continue using Xalacom as directed by your healthcare provider, even if you feel well. Do not stop treatment without consulting your doctor.

Recent Clinical Evidence

Research evidence / Overview of Studies for Xalacom

Evidence for Use in Elevated Intraocular Pressure (IOP)

The research foundation for the latanoprost/timolol fixed combination stems from short-term, high-quality Randomized Controlled Trials (RCTs). These studies were designed to examine the fixed combination in adults diagnosed with conditions characterized by elevated eye pressure, such as open-angle glaucoma and ocular hypertension. The trials commonly involved comparing the fixed combination against the individual components—latanoprost alone or timolol alone—to explore the measured difference when the two agents were studied together.

Studies primarily focused on measuring Intraocular Pressure (IOP). Researchers extensively monitored IOP levels and recorded the proportion of participants who reached specific, pre-determined pressure targets. Studies monitored the measured IOP levels, and observations indicated differences between the fixed combination group and the groups receiving either single-ingredient eye drop. This research describes the IOP measurements recorded when these two pharmacological classes are combined.


Long-Term Evidence and Durability of Study Observations

Following the initial short-term RCTs, some studies monitored patient data over extended time frames, sometimes extending up to five years. These longer-duration studies were typically observational rather than randomized. Findings describe patterns where the IOP measurements recorded initially were sustained over these extended periods in the observed populations. This evidence helps contextualize the long-term IOP measurements recorded during the study periods.

A key research limitation is that these long-term studies still primarily focus on the measurement of IOP itself. There is limited information from high-quality, randomized trials that directly examine functional outcomes over many years, such as the preservation of peripheral vision or the prevention of vision deterioration, which are key outcomes related to glaucoma management. Therefore, the long-term patterns related to these specific functional outcomes are not fully established by the existing RCT data.

Frequently Asked Questions (FAQ)

Common questions about Xalacom (FAQ)


Q: What is the difference between Xalacom and drops that just contain timolol?

A: Xalacom is a fixed-combination medicine that contains two active ingredients: latanoprost and timolol. Drops that contain only timolol are single-component medicines. Regulatory documents explain that the combination is noted to result in a greater intraocular pressure-lowering effect compared to the individual components.


Q: Can Xalacom cause eyelashes to grow longer or thicker?

A: Official documents state that the latanoprost component in Xalacom may cause gradual changes to your eyelashes. These changes can include increased length, thickness, pigmentation, and number of lashes. These changes are generally documented as being reversible upon discontinuation of the medicine.


Q: Is it normal for the eyelids to darken slightly while using Xalacom?

A: Regulatory information documents pigmentation of the periorbital tissue, which is the skin around the eyelid, as a potential documented change associated with the medicine. This change is described as potentially reversible upon the medicine's discontinuation.


Q: Can Xalacom cause headaches or dizziness?

A: The medicine's safety profile includes reports of headache and dizziness as potential adverse reactions. Because Xalacom contains a beta-blocker that is absorbed systemically, patients are advised to be aware of these types of effects.


Q: How quickly can a person expect Xalacom to start reducing eye pressure?

A: According to official product information, the reduction of eye pressure is generally expected to begin within one hour of application. The maximal pressure-lowering effect is typically reached within six to eight hours.


Q: What happens if I miss a day of using Xalacom?

A: Official administration instructions advise that if a dose is missed, the patient should skip the forgotten dose. Treatment then continues with the next scheduled dose at the usual time. Doubling the dose to make up for a missed one is not advised.


Q: Is Xalacom related to treatments for macular degeneration?

A: Official regulatory documents indicate that Xalacom is approved for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Macular degeneration is not listed as an approved indication for this medication.


Q: Are there any restrictions on driving or operating machinery after using Xalacom?

A: Official documents advise that if the eye drops cause transient blurring of vision, patients are advised against driving or using machines until vision has cleared.


Q: Are there specific warnings about Xalacom and diabetes?

A: The timolol component, a beta-blocker, may mask the signs and symptoms of acute low blood sugar (hypoglycemia). Official documentation notes that caution is required for use in patients with diabetes.


Q: Is Xalacom considered a lifetime treatment for eye pressure issues?

A: The treatment of the underlying conditions often requires sustained, long-term management to control pressure. Official documentation references studies that have monitored treatment for periods of up to five years, with measured intraocular pressure levels being maintained over that time.


Q: Does Xalacom interact with supplements like fish oil or multivitamins?

A: Official regulatory documents primarily focus on known interactions with other prescription medications. There is no explicit classification of interactions with general dietary supplements, such as fish oil or multivitamins, in the official product information.


Q: Are there foods or drinks that should be avoided while using Xalacom?

A: Official regulatory documentation does not explicitly classify interactions with food or alcohol in relation to Xalacom. Interactions are primarily documented for other prescription drug classes.


Q: Can Xalacom affect blood pressure readings?

A: Due to the systemic absorption of the timolol component, the medicine can cause effects on the cardiovascular system. Documented effects include hypotension (low blood pressure) and a slowed heart rate (bradycardia).


Q: What is the process for discontinuing Xalacom treatment?

A: Official patient information advises that treatment should not be stopped suddenly. Due to the beta-blocker component, abrupt discontinuation may lead to certain health effects, especially in patients with existing heart conditions.


Q: Is Xalacom a prescription-only medicine?

A: Yes, Xalacom is classified as a prescription-only medication in regulatory documents. It must be dispensed by a licensed professional.


Q: Is Xalacom suitable for pediatric patients?

A: Official regulatory documents state that the safety and effectiveness of Xalacom have not been established in the pediatric population. For this reason, its use in children and adolescents is not recommended.


Q: Can Xalacom cause irritation to the skin around the eye?

A: Regulatory documents list several local adverse reactions, including eye irritation and conjunctival redness. Pigmentation of the periorbital tissue (skin around the eye) is also documented as a potential change.


Q: Can Xalacom make existing dry eye symptoms worse?

A: The medicine contains the preservative benzalkonium chloride, which may cause eye irritation. Regulatory documentation advises close monitoring for patients with existing dry eye conditions.


Q: Does Xalacom interact with common over-the-counter pain relievers?

A: Regulatory sources note potential interactions with several drug classes. While general over-the-counter pain relievers are not explicitly listed, the official label warns against potential additive effects with other systemic medications.


Q: What research studies are commonly cited regarding the effectiveness of Xalacom?

A: The medicine's regulatory approval is supported by short-term Randomized Controlled Trials (RCTs) and longer-duration observational studies. These studies primarily focus on measuring and comparing the reduction of intraocular pressure achieved by the fixed combination.


Q: How long does it take for Xalacom to clear out of the system?

A: Official pharmacokinetic properties indicate that the active component of latanoprost has a rapid plasma half-life of approximately 17 minutes. The timolol component has a longer plasma half-life of approximately 4 hours.


Q: Why does Xalacom sometimes cause eyes to appear bloodshot?

A: Redness, which is officially described as conjunctival hyperaemia, is a Common adverse reaction that has been documented in clinical use. This is related to the medicine's local effects on the eye.


Q: Is a stinging sensation immediately after use normal with Xalacom?

A: A burning and stinging sensation is listed in official documentation as one of the most common adverse reactions reported in clinical trials. It is a frequently reported experience.


Q: Does official evidence suggest Xalacom helps prevent blindness?

A: Official research summaries note that existing data primarily focuses on the measurement of intraocular pressure (IOP). There is limited information from high-quality, randomized trials that directly study long-term functional outcomes related to vision, such as the prevention of vision deterioration.


Q: Is Xalacom the same as just using latanoprost drops?

A: No. Xalacom is a fixed-combination solution containing latanoprost and a second active ingredient, timolol. Latanoprost-only drops are single-component medicines that do not contain the additive beta-blocker component.


Q: Does Xalacom have a generic version available?

A: Yes, the medicine is available as a generic fixed-combination solution containing latanoprost and timolol maleate. The generic formulation is approved by regulatory bodies (e.g., FDA) as a therapeutically equivalent alternative.


Q: Why is Xalacom only used in the eye and not for other body parts?

A: Xalacom is an ophthalmic solution (eye drops) specifically designed and approved only for topical ocular administration to the eye. Its formulation is intended for localized action.


Q: Can Xalacom affect vision clarity?

A: Official documentation lists blurred vision as one of the most common adverse reactions reported in clinical trials. This is a temporary effect that patients should be aware of.

How should Xalacom be stored and disposed of?

How to Store and Dispose of Xalacom

Xalacom (latanoprost/timolol maleate) ophthalmic solution requires specific storage conditions to maintain its stability.

Storage Requirements

Condition Requirement
Unopened Bottle Must be stored in a refrigerator at 2 C to 8 C (36 F to 46 F). Do not freeze.
Opened Bottle Store at room temperature, not exceeding 25 C (77 F).
Protection Must be kept in the original outer carton and tightly closed to protect from light.
Shelf-Life Discard any unused portion four weeks after the bottle is opened.

Disposal and Safety

The medication must be kept out of the sight and reach of children.

Official disposal mandates state that expired or unused medicine must not be thrown into household trash or wastewater. The product should be returned to a pharmacist for proper pharmaceutical waste disposal.

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

Available in countries:

Equivalent of Xalacom found in:

A-Z Index: