Alergoftal

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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 Alergoftal

Alergoftal is classified as a fixed-dose combination ophthalmic solution intended for the localized management of allergic eye discomfort, administered via the topical ophthalmic route. This medicine belongs to the pharmacological class of combined ophthalmic antihistamines and decongestants, a categorization intended to provide a broader spectrum of symptomatic relief compared to single-agent formulations. The product is a synthetic preparation, meaning its active components are chemically manufactured rather than naturally derived. As an aqueous solution, it ensures the uniform application of the therapeutic agents directly to the conjunctiva.

The composition of Alergoftal consists of two core active ingredients: Antazoline and Naphazoline Hydrochloride. Antazoline, a first-generation antihistamine, specifically acts as an H₁ receptor antagonist, while Naphazoline Hydrochloride is a sympathomimetic amine characterized as an alpha-adrenergic agonist. The strategic pairing of an allergy blocker with a vascular constrictor is a distinctive feature of this formulation. These two components are dissolved in an aqueous solution base, forming the required eye drops preparation.

The general therapeutic purpose of Alergoftal is to provide comprehensive, rapid symptomatic relief for the ocular irritation and visible vascular changes commonly linked to allergies. This relief is achieved through the dual action principle: Antazoline counters the effects of histamine to mitigate irritation and itching, while Naphazoline Hydrochloride acts as a vasoconstrictor to temporarily reduce the appearance of redness and swelling in the conjunctiva. This mechanism is designed for scenarios where relief from both the feeling of irritation and the appearance of red, swollen eyes is required.

Regulatory References

  1. FDA Label: Naphazoline Hydrochloride Ophthalmic Solution

What side effects are possible with Alergoftal?

Possible Side Effects and Safety Information

This section outlines the adverse effects and safety characteristics of Antazoline and Naphazoline ophthalmic solution as documented in official regulatory sources. The safety profile is characterized by a distinction between common local ocular reactions and potential systemic effects linked to absorption.

Documented Adverse Reactions

Side effects are primarily classified under Eye Disorders, and may include mild transient stinging or burning of the eye, tearing, and blurred vision. A documented ophthalmic effect is Mydriasis (pupil dilation). Systemic effects, classified under Nervous System and Cardiovascular System Disorders, are reported following systemic absorption and may involve headache, dizziness, and irregular heartbeat.

Safety Patterns and Restrictions

Time-Related Safety: Official labeling notes that overuse or prolonged use may paradoxically cause increased eye redness (rebound hyperemia).

Serious Reactions: A documented risk is the potential for a severe hypertensive crisis when the medication is used concurrently with Monoamine Oxidase (MAO) inhibitors. Furthermore, infants and children are noted as being highly sensitive to Naphazoline, with a documented risk of serious toxicity, including Central Nervous System (CNS) depression and hypothermia, following accidental ingestion.

Safety Constraints: The medication is contraindicated in individuals with narrow-angle glaucoma and a known hypersensitivity to its active components. Caution is advised for patients with pre-existing conditions such as hypertension, heart disease, or diabetes mellitus.

Overdose and Emergency Response

Overdose and when to seek help

Overdose with this ophthalmic solution is documented to occur primarily through accidental ingestion, leading to systemic toxicity from the Naphazoline component. Immediate emergency medical care is required if the product is swallowed.

Documented Overdose Manifestations

Systemic overdose is officially associated with severe effects on the Central Nervous System (CNS) and the cardiovascular system. Documented clinical presentations include CNS depression, characterized by somnolence, lethargy, stupor, and the potential progression to coma. Cardiovascular manifestations include significant changes such as bradycardia (slow heart rate), initial hypertension potentially followed by a shock-like hypotensive state, and other cardiac irregularities. Severe systemic signs like marked hypothermia have also been officially documented.

Mandatory Emergency Actions

In the event of accidental ingestion, official regulatory documents mandate that individuals immediately seek emergency medical attention and contact a Poison Control Center or national Poison Help Line right away. Overdose is particularly strongly pronounced in children le 5 years of age, and ingestion by this population has resulted in serious adverse events requiring hospitalization and continuous monitoring of vital signs. The management of overdose is symptomatic and supportive, and official information indicates that no specific antidote is known.

Therapeutic Uses of Alergoftal

Easing Acute Allergic Discomfort

This medication is commonly used to provide supportive relief for the most distressing subjective symptoms of eye allergies. It is applied in addressing sensations like eye itching, burning, and irritation, providing symptomatic relief and contributing to improved day-to-day comfort. Combinations of antihistamine and vasoconstrictor drops are typically utilized for the management of symptoms associated with mild acute presentations.


Summary of Symptom Relief

Alergoftal is used to address the visible signs of irritation associated with allergens, including visible redness of the eye and excessive tearing (watery eyes).


Use for Episodic Flare-ups

It is commonly used to provide supportive relief during acute and episodic flare-ups of allergic eye symptoms, such as those triggered by pollen, dander, or dust. This support is relevant in conditions where symptoms may intensify temporarily, including allergic conjunctivitis and hay fever-related eye discomfort. This assistance is intended for periods of heightened discomfort and to assist with managing symptoms that may interfere with daily functioning.

“This medication may be relevant in contexts where additional symptomatic support is needed, and is used to help with symptoms that interfere with daily comfort.”

Regulatory References

  1. NIH MedlinePlus overview on Allergic Conjunctivitis

Eligibility and Restrictions for Use

Alergoftal, which combines the antihistamine Antazoline and the vasoconstrictor Naphazoline, is generally indicated for adults experiencing symptoms associated with allergic conjunctivitis, such as redness, tearing, itching, and burning. It is intended for short-term symptomatic relief.

However, Alergoftal is not suitable for everyone. Certain conditions and patient groups are considered contraindications due to the potential risks, primarily related to the vasoconstrictive effects of Naphazoline.


Who Should NOT Use Alergoftal

Patient Group or Condition Reason for Contraindication
Narrow-angle glaucoma The vasoconstrictor component can increase intraocular pressure.
Underlying eye disease May complicate or worsen pre-existing ocular conditions.
Hypersensitivity Known allergy to Antazoline, Naphazoline, or any other ingredient (e.g., benzalkonium chloride).
Systemic Conditions Patients with high blood pressure, hyperthyroidism (overactive thyroid), or certain heart diseases should exercise caution due to the risk of systemic absorption of Naphazoline.
Children This formulation is typically not recommended for use in children.

Individuals with diabetes or thyroid disease should also consult a healthcare provider before use. Additionally, those who wear contact lenses must remove them before application and wait at least 10–15 minutes before reinserting them.

What should I know about interactions with other medicines?

Alergoftal eye drops contain naphazoline (a decongestant) and antazoline (an antihistamine). While ophthalmic preparations have limited systemic absorption, potential interactions exist, primarily due to the vasoconstrictive effects of naphazoline.

Major Interactions to Avoid

The most critical interactions involve medications that affect blood pressure and heart rate. Due to the risk of dangerously high blood pressure (hypertensive crisis), Alergoftal should not be used if you have taken or are currently taking certain types of drugs, including:

  • Monoamine Oxidase Inhibitors (MAOIs): These are antidepressants or anti-Parkinson drugs, such as isocarboxazid, phenelzine, selegiline, or tranylcypromine. The risk is present for up to 14 days after stopping the MAOI.
  • Ergot Alkaloids: Medications used for migraines, such as ergotamine or methylergonovine, can increase the risk of severe hypertension and vasoconstriction.

Moderate Interactions and Precautions

Caution is advised when using Alergoftal with other medications that can increase blood pressure or heart rate, or have similar anticholinergic effects as antazoline, which may lead to cumulative side effects like blurred vision or dry mouth. These may include:

  • Tricyclic Antidepressants (TCAs): Such as amitriptyline or imipramine.
  • Other Sympathomimetics: Medications with similar decongestant effects (oral or nasal) or stimulants.
  • Beta-Blockers (Ophthalmic and Systemic): Used to lower blood pressure or eye pressure, as naphazoline may potentially decrease their effectiveness.

Always inform your healthcare provider of all prescription and non-prescription medicines, vitamins, and herbal supplements you are using to ensure the combination is safe.

Mechanism of Action

Alergoftal is a fixed-dose combination containing two active pharmacological agents: antazoline and naphazoline.

Antazoline acts as a competitive antagonist at the Histamine H1-receptor (H1). Antazoline binds to the H1 receptor, preventing endogenous histamine from activating this Gq-coupled receptor. H1 receptor blockade modulates the histamine-mediated intracellular signaling cascade, which involves the activation of phospholipase C and subsequent increase in inositol trisphosphate (IP3) and intracellular calcium (Ca^2+) concentration. This action occurs at the level of conjunctival epithelial cells and other responsive cellular targets, counteracting histamine-driven cellular processes.

Naphazoline is an agonist at alpha-adrenergic receptors (alpha1 and alpha2 subtypes), primarily targeting receptors located on vascular smooth muscle cells in the conjunctiva. Activation of alpha1-receptors, which are typically Gq-coupled, initiates a downstream cascade involving elevated intracellular Ca^2+, leading to vasoconstriction of the small conjunctival arterioles and venules. This localized vasoconstrictive effect modulates regional ocular hemodynamics and reduces vascular permeability at the system level.

Dosage and Administration Information

Alergoftal is an ophthalmic solution that must be administered via the topical ophthalmic route only. The administration of this medicine is structured as an intermittent, short-term treatment intended for as-needed applications.

Standardized Dosing and Frequency

The standardized dose for adults and children 12 years and over is the instillation of one or two drops into the affected eye(s) per application. The medicine is applied up to two or three times daily, establishing a typical interval of approximately six to eight hours between each dose.

Administration Rules and Duration Limits

Guidelines for use limit continuous application to a maximum of 5 days of continuous use. Furthermore, it is specified that use must be discontinued if symptoms are not relieved or if the condition worsens after 48 to 72 hours.

Special Procedural Conditions

Soft contact lenses must be removed prior to instillation, and a minimum waiting period of 15 minutes is required before they can be re-inserted. If another ophthalmic product must be used, an interval of at least 5 minutes is required between the application of the two medicines. As an integrity rule, the solution must not be used if it becomes cloudy or changes color, and the dispenser tip must not touch any surface to prevent contamination. Use in children under 12 years is not generally recommended in standardized labeling.

Recent Clinical Evidence

Recent Clinical Evidence

Clinical research has investigated the use of this agent, which combines an antihistamine (antazoline phosphate) and a vasoconstrictor (naphazoline hydrochloride), in studies of acute allergic conjunctivitis. The dual composition is designed to address both the allergic symptoms and the associated redness.

Key Study Findings

Studies focused on the effect of the combination drop in reducing the core signs and symptoms of allergic conjunctivitis, primarily ocular itching and conjunctival redness.

Research comparing the combination drop to individual components or other treatments has been conducted. One study comparing a combination of naphazoline and antazoline (or pheniramine) to other treatments noted that while all products offered some degree of symptom improvement, the combination product resulted in comparable therapeutic benefit for itching, tearing, and redness.

Comparative Observations

Treatment Comparison Outcome Focus Reported Finding
Naphazoline/Antazoline vs. Levocabastine Onset of Action Combination product reported a more rapid onset (around 30 minutes).
Naphazoline/Antazoline vs. Other Antihistamines Ocular Discomfort The combination product induced a higher level of discomfort compared to newer topical treatments in one study.

Safety Profile

Due to the presence of a vasoconstrictor, studies highlight the importance of short-term use for this specific combination. Potential adverse effects noted in trials and clinical experience typically include local reactions such as pupil dilation (mydriasis), stinging, or persistent redness. Clinicians note that prolonged use of vasoconstrictor agents carries a potential risk of rebound redness (conjunctivitis medicamentosa) when discontinued.

Frequently Asked Questions (FAQ)

Common questions about Alergoftal (FAQ)

Q: What is Alergoftal used for?

A: Alergoftal is officially indicated for the treatment of allergic conjunctivitis of various origins, including seasonal and perennial (non-seasonal) allergies. Regulatory documents state that it is intended to relieve symptoms such as redness, itching, and watering of the eyes associated with these allergic reactions. This medicine is specifically for ophthalmic (eye) use.

Q: How long does it take for Alergoftal to start working?

A: According to the official product information, Alergoftal usually begins to provide relief from symptoms of allergic conjunctivitis shortly after application. Its effect is generally rapid in onset. The rapid onset of action is intended to provide prompt symptom relief, although the overall duration of the effect can vary among individuals.

Q: Can I use Alergoftal if I wear soft contact lenses?

A: Regulatory documents indicate that soft contact lenses should be removed before applying Alergoftal. Official documentation advises that soft contact lenses should be removed before administration. Patients should follow the instructions in the product label regarding the precise waiting period before reinsertion. This is a common precaution related to the product’s ingredients.

Q: Is Alergoftal available over the counter, or do I need a prescription?

A: The official product information specifies the supply status of Alergoftal. This status dictates whether it is available only with a prescription (Rx) or can be obtained without one (Over-the-Counter or OTC). The specific regulatory status (prescription-only or over-the-counter) is determined by local authorities and may vary by country.

Q: Does Alergoftal contain any preservatives?

A: Yes, according to the official product information, Alergoftal contains a specific preservative to maintain the sterility and stability of the eye drop solution. The exact type of preservative, such as benzalkonium chloride, is listed in the regulatory documents. Information regarding the preservative is included in the official labeling for patients who monitor ingredient sensitivities.

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

A: Regulatory documents state that if a dose is missed, it should generally not be compensated for by applying a double dose. The official label provides instructions on when to apply the next dose, which is typically at the regularly scheduled time. Following the labeled dosing frequency is noted as important for optimizing the intended therapeutic effect.

Q: Can children use Alergoftal?

A: Official product information specifies the minimum age for which Alergoftal is indicated and considered safe for use. Official product information specifies the minimum age for which the medicine is approved, such as 4 years or older. Use in children, including the minimum age and specific dosage instructions, is outlined strictly within the official regulatory documentation.

How should Alergoftal be stored and disposed of?

Official Storage and Disposal Requirements

The storage and disposal of Alergoftal (Antazoline and Naphazoline Hydrochloride ophthalmic solution) are strictly defined by regulatory guidelines to maintain sterility and stability.

Requirement Type Official Labeled Condition
Temperature & Protection Store below 25 C (room temperature); protect from light and freezing (do not freeze).
Container & Integrity Keep the container tightly closed. Do not let the dropper tip touch any surface to prevent contamination.
Stability (In-Use) The unused contents must be discarded 4 weeks (1 month) after opening the bottle. Do not use if the solution changes color or is cloudy.
Child Safety Keep the medication out of the reach of children and pets.
Disposal Dispose of unused or expired product according to local regulatory guidelines, typically via drug take-back programs.

These conditions ensure the product's integrity: controlled temperature and protection from light prevent degradation, while the 4-week discard rule maintains sterility after first use.

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

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