Aurigoutte

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Aurigoutte

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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 Aurigoutte

Quick Facts

Property Description
Active ingredient Hexamidine diisethionate, Lidocaine Hydrochloride
Form Ear drops (Aqueous Solution)
Pharmacological class Antiseptic and Local Anesthetic Combination
General Function Localized discomfort relief and surface disinfection
Origin Synthetic
Route Topical, Otic

What Type of Medicine is Aurigoutte and Its Primary Classification?

Aurigoutte is defined as a specialized, fixed-dose combination product formulated as an otological preparation for targeted application in the ear canal. This medicine comprises two distinct, synthetic active ingredients: the antiseptic agent Hexamidine diisethionate and the local anesthetic agent Lidocaine Hydrochloride. This combination is widely recognized in clinical practice for its dual therapeutic strategy, combining a fast-acting pain reliever with a topical microbial suppressant. Lidocaine Hydrochloride, categorized as an amide-type anesthetic, provides immediate numbing by stabilizing nerve cell membranes. The primary function of this dual formulation is to deliver concurrent surface disinfection and rapid relief from discomfort associated with superficial irritation or contamination in the external ear.

Composition and Physical Form of the Otic Preparation

The medicine is supplied as a sterile, clear aqueous solution, packaged as ear drops suitable for topical, otic administration. The two key components, Hexamidine and Lidocaine, are delivered in a base vehicle that includes ethylic alcohol and medicinal glycerine. Hexamidine belongs to the class of antiseptics and disinfectants, compounds known for their properties in microbial suppression. The specific presentation as a dropper bottle ensures that the biocidal action of the Hexamidine and the membrane-stabilizing effect of the Lidocaine remain confined to the area of application within the ear canal.

Regulatory References

  1. pharmacological data from the NIH

What side effects are possible with Aurigoutte?

Aurigoutte is an ear preparation containing an antiseptic (hexamidine) and a local anesthetic (lidocaine). Its safety profile is defined by significant contraindications and specific risk monitoring related to the condition of the ear.

Serious Safety Risks and Contraindications

Ototoxicity Risk: The most serious safety concern is the potential for ototoxicity (ear damage) if the medication reaches the inner ear. This is specifically linked to use in the presence of a perforated eardrum (tympanic membrane perforation). Due to this risk, medical verification of the eardrum's integrity is a mandatory safety step before use.

Absolute Contraindications: The medication is formally contraindicated (must not be used) in the following situations:

  • Known allergy or hypersensitivity to lidocaine, hexamidine, or any other excipients in the formula.
  • Confirmed or suspected perforation of the eardrum.

Adverse Reactions and Specific Considerations

Adverse effects are primarily local and involve the ear and immune system. While specific frequencies (e.g., very common, rare) are not formally published in all regulatory summaries, any undesirable effect should be reported.

  • Local Reactions: Irritation, burning, itching, or other discomfort at the application site may occur.
  • Allergic Reactions: Hypersensitivity reactions are possible.

Population-Specific Notes:

  • Athletes: The use of Aurigoutte should be declared, as one of its components may potentially yield a positive result in anti-doping tests.
  • Pregnancy and Breast-feeding: Consultation with a healthcare professional is necessary before use, as is standard for all medications during these periods.

Limitations of Use: The duration of treatment is restricted, typically limited to a short, specified period (e.g., 5 days) as defined in the regulatory documents for the product. Use beyond this duration is not covered by the registered safety profile.

Overdose and Emergency Response

The official regulatory profile for an overdose with the active ingredients in Aurigoutte focuses primarily on the risks associated with excessive systemic exposure to Lidocaine Hydrochloride, the local anesthetic component. Overdose manifestations are formally documented across several physiological systems. Initial signs often involve the Central Nervous System, with symptoms that may include confusion, lightheadedness, dizziness, tinnitus, tremors, and slurred speech. These effects are documented as potentially escalating to more severe manifestations, specifically seizures and loss of consciousness.

Severe or life-threatening outcomes documented in regulatory prescribing information include profound cardiovascular and respiratory compromise, such as severe hypotension, cardiac depression, respiratory arrest, and cardiac arrest. Furthermore, official warnings identify a risk of Methemoglobinemia following excessive exposure, a serious blood disorder, particularly in vulnerable populations like infants under six months of age.

Immediate medical help must be sought when an overdose is suspected or if any severe symptoms occur, including seizures, difficulty breathing, or the presence of blue or gray skin coloration (cyanosis). The official regulatory strategy for management emphasizes symptomatic and supportive treatment and requires hospital monitoring for patients who present with signs of severe CNS or cardiovascular toxicity, given that no specific antidote is known for Lidocaine systemic toxicity.

Therapeutic Uses of Aurigoutte

What Aurigoutte Treats: Main Uses and Benefits

Aurigoutte is commonly used to provide symptomatic support for conditions affecting the external ear canal. Its therapeutic role is considered relevant for easing distressing symptoms while supporting management of superficial microbial presence. Topical anesthetics are utilized in otic conditions for managing symptomatic discomfort and acute pain.

This medicine is primarily applied in addressing symptoms related to inflammatory or irritative states, localized otic pain and discomfort, and external ear canal irritation. It is applicable in contexts involving conditions marked by symptoms that create noticeable interference with daily stability. It helps with symptomatic discomfort, throbbing, and general irritation associated with conditions presenting with disruptive symptom manifestations, such as external otitis.

This product is used when supportive symptom management is appropriate, as its dual action offers relevant assistance. This dual action may assist with maintaining functional stability when symptoms become more noticeable, contributing to the patient's general well-being during symptomatic phases.


Quick Fact: Relief for Otic Discomfort
Symptom Category Localized pain, throbbing, itching
Therapeutic Benefit Helps ease symptomatic discomfort and supports functional stability
Relevant Symptomatic Use Symptomatic management of external otitis
Use Context Applied when symptoms become more noticeable

Eligibility and Restrictions for Use

Who can and cannot use Aurigoutte? — Official Regulatory Information

Aurigoutte (Fluocinolone Acetonide Oil 0.01% ear drops) is an ear-specific corticosteroid medicine approved for use in adults and pediatric patients 2 years of age and older for chronic eczematous external otitis.

Contraindicated Populations

Official regulatory documents state that this medicine must not be used by individuals with a known hypersensitivity or allergy to fluocinolone acetonide or any ingredient in the specific formulation. If the ear drop formulation is used, it is contraindicated if the patient has a perforated eardrum or a tympanostomy tube (ear tube) in place.

Use Restrictions and Special Considerations

  • Age: Use is not established for pediatric patients under 2 years of age.
  • Infections: The medicine is not recommended in the presence of an untreated active ear infection (such as bacterial, fungal, or viral infections). If an infection develops or is present, appropriate antifungal or antibacterial treatment must be used, and Aurigoutte should be discontinued if the infection does not respond promptly.
  • Pregnancy and Lactation: Use during pregnancy is advised only if the potential benefit justifies the potential risk to the fetus, as animal studies have shown potential harm. For lactation, caution is advised because it is unknown if the drug is absorbed systemically in a quantity that would be excreted in human milk. Discuss any use during these periods with a healthcare provider.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official interaction profile for Aurigoutte, which contains Hexamidine diisethionate and Lidocaine Hydrochloride, is determined by the potential for systemic exposure of Lidocaine. Interactions documented in regulatory labels focus on substances that affect Lidocaine’s pharmacokinetics and pharmacodynamics.

Pharmacokinetic Interactions

Co-administration with substances that inhibit Cytochrome P450 1A2 (CYP1A2) or CYP3A4 may increase Lidocaine plasma concentrations by reducing its clearance. Examples of such inhibitors include Fluvoxamine and Propofol. Conversely, CYP Inducers like Phenytoin may decrease Lidocaine levels. Changes in exposure are relevant, as they may alter the systemic effects of the active ingredient.

Pharmacodynamic Interactions

Due to the local anesthetic action of Lidocaine, co-administration with Other Local Anesthetics is associated with the risk of additive systemic toxic effects. The combination with certain Antiarrhythmic Drugs (e.g., Amiodarone) may also result in additive or antagonistic cardiac effects as noted in official prescribing information.

Interaction-Related Constraints

Constraint Type Regulatory Statement
Timing-based Rule A 60-minute separation from food or alcohol is a requirement for topical Lidocaine formulations used on the oral/pharyngeal mucosa, a restriction relevant to the component’s use.
Population Note Hepatic Dysfunction may lead to a prolonged half-life, and Renal Dysfunction may increase the accumulation of metabolites.

These constraints summarize how regulatory documents define the product’s interaction structure without providing advice or therapeutic context.

Mechanism of Action

Localized Inhibition of Neural Signal Transmission

This mechanism involves the interaction of one component with voltage-gated sodium channels ( Nav) found on sensory nerve cells. By binding to these channels, the drug acts as a blocker, preventing the necessary influx of sodium ions and inhibiting the generation and propagation of action potentials. The resulting physiological effect is the localized prevention of neural impulse transmission.


Non-Specific Surface Microbial Disruption

A second component interacts with and disrupts the structural integrity of surface microbes, targeting their cell walls and membranes. This non-specific chemical interference causes denaturation and breakdown, which inhibits the microbes' ability to maintain structure and reproduce. The chemical interaction with surface microbes leads to the inhibition of growth and multiplication.

Dosage and Administration Information

Aurigoutte is administered via the Topical, Otic route as ear drops. The medicine is used following a fixed-dose schedule, and the total duration of the treatment course is limited to a maximum of five days.

Administration Schedule and Dosage Rules

The administration of Aurigoutte involves instillation into the ear to be treated, following a frequency pattern of three times per day (TID). The number of drops per dose is determined by the patient’s age group. For adults, the standard dose is four drops per administration. A pediatric dose adjustment is specified for use in infants and children, who receive two drops per administration, three times daily.

Procedural Constraints

A procedural constraint for this medicine is to ensure the eardrum is closed (intact) prior to beginning use. The administration protocol is designed for short-term application; if symptoms persist beyond the five-day course duration, a physician should be consulted. This protocol ensures standardized application of the preparation.

Recent Clinical Evidence

Research evidence / Overview of Studies for Aurigoutte

Evidence for Symptomatic Support in External Otitis (OE)

Research has explored whether topical preparations containing a local anesthetic and an antiseptic ingredient are relevant in studies examining patient-reported experiences, exploring how symptoms change over time for acute External Otitis. This condition is marked by functional limitations and may involve periods of heightened symptoms.

Studies focused on outcomes related to physical discomfort, specifically localized ear pain, throbbing, and irritation. The evidence describes patterns in patient-reported outcomes for conditions associated with acute or disruptive episodes.


Summary of Findings from Short-Term Clinical Trials

The research structure includes Randomized Controlled Trials (RCTs) and multicenter studies, designs often used to evaluate symptom changes. These trials were typically conducted during periods of increased symptom activity and evaluated outcomes describing episodic or acute changes. The primary goal was to monitor changes in pain intensity scores in study participants over defined time intervals.

Studies report how symptoms evolved in the observed populations, often comparing the drops to an inactive preparation (placebo) or usual care. Data show patterns related to measurements of discomfort in the short term. However, evidence quality varies across studies, and findings were heterogeneous in nature, or imprecise in some smaller trials that examined changes in patient-reported discomfort.


Key Limitations and Areas of Research Uncertainty

Long-term effects are not fully established because follow-up durations were limited in the primary clinical trials, which focused mainly on the acute phase (up to about 10 days).

Notably, the research exploring short-term symptom changes includes a limited number of high-quality RCTs focused specifically on the fixed-dose combination of Hexamidine and Lidocaine. In some relevant trials, sample sizes were modest, which means the certainty remains low on the precise measurements of symptomatic changes across all potential user groups. Furthermore, the distinct measurement patterns of the antiseptic component (Hexamidine) in the overall patient discomfort scales, when used in conjunction with the anesthetic, is an area where comparative evidence is lacking.

Key Studies & References

  1. Anatomical Therapeutic Chemical (ATC) Classification System: D08AC04 (Hexamidine)
  2. Otitis externa: diagnosis and management. National Institute for Health and Care Excellence (NICE) Guideline NG64.

Frequently Asked Questions (FAQ)

Common questions about Aurigoutte (FAQ)


Q: How quickly does Aurigoutte start to work after the first time I use it?

A: The official product information indicates that Aurigoutte contains Lidocaine, which is a local anesthetic. The function of this component is to stabilize nerve cell membranes, blocking nerve signals that cause pain. This mechanism, which involves stabilizing nerve cell membranes, is typically recognized for its potential to provide quick localized relief from discomfort.


Q: How soon after starting Aurigoutte should I generally expect to notice an improvement?

A: The medicine is intended as an acute treatment, and the total duration of the course is strictly limited to a maximum of five days. Official instructions advise that consultation with a professional is necessary if symptoms persist or worsen beyond the prescribed five-day course. The advice to consult a professional if symptoms persist beyond five days is used as a guidance benchmark for when treatment should be reviewed.


Q: Is it normal to feel a mild stinging or burning when using Aurigoutte?

A: The official product information lists local reactions at the application site as possible adverse effects, which can include temporary irritation, burning, or itching. In situations where these sensations are severe, worsen, or do not go away, consultation with a healthcare professional is described as necessary.


Q: Why is the treatment duration restricted (e.g., 5 days)?

A: The short duration is defined in the regulatory documents to limit potential risks, such as local irritation or sensitization, which can occur with prolonged use of certain topical medications. This limitation helps confine the usage to the limited timeframe covered by the registered clinical safety profile, restricting the potential for risks such as local irritation or sensitization.


Q: Can I stop using Aurigoutte as soon as my symptoms improve?

A: The official regulatory labeling strictly limits the total duration of treatment to a maximum of five days. Discontinuing before the prescribed course is complete is generally not addressed in the summary documents. Decisions regarding course duration must be based on the assessment of the healthcare professional who prescribed the medicine.


Q: What if the liquid from Aurigoutte leaks out of the ear after using it?

A: Aurigoutte is administered via instillation into the ear. Standard application protocols often recommend keeping the head tilted for a short time after application to ensure the medicine coats the ear canal. If some liquid leaks out, this is a common occurrence due to the ear canal’s small capacity, and the excess liquid is typically wiped away with a clean tissue.


Q: Does using Aurigoutte require any special preparation, like shaking the bottle?

A: The official regulatory summary focuses on the mandatory procedural constraint of having the eardrum checked before use. Specific handling instructions, such as whether to shake the bottle or warm it, are detailed in the product’s full Patient Information Leaflet. The specific preparation instructions are found in the official Patient Information Leaflet, which provides product-specific details.


Q: Do I need a prescription to get Aurigoutte?

A: The dispensing status of Aurigoutte (prescription-only, over-the-counter, or pharmacy-only) is determined by the regulatory authority in each specific country where it is marketed. In many regions, the medicine is classified as non-prescription, available through direct dispensing by a pharmacist or over-the-counter, depending on local rules.


Q: Is Aurigoutte the same thing as a common over-the-counter ear drop?

A: Aurigoutte is a specific, fixed-dose combination product containing both an antiseptic (Hexamidine) and a local anesthetic (Lidocaine). This dual-action combination is different from the active ingredients typically found in common over-the-counter products intended solely for wax removal or basic symptom relief.


Q: Does Aurigoutte contain steroids?

A: No. Official labeling states that Aurigoutte is a fixed-dose combination containing the antiseptic Hexamidine and the local anesthetic Lidocaine Hydrochloride. It is not classified as a medicine that contains a corticosteroid (steroid) ingredient.


Q: What color is the Aurigoutte liquid supposed to be?

A: Official regulatory documents describe the product as a sterile, clear aqueous solution formulated as ear drops. Therefore, the liquid is expected to be clear or colorless when administered.


Q: Are there different strengths of Aurigoutte available?

A: The regulatory documents define this product as a fixed-dose combination. The product information specifies a single, standardized strength for the combination of Hexamidine diisethionate and Lidocaine Hydrochloride in the otic solution.


Q: Does Aurigoutte interact with vitamins or herbal supplements?

A: The official interaction profile focuses exclusively on medicines that affect the clearance of Lidocaine. Information regarding specific interactions with vitamins or herbal supplements is not detailed in the core regulatory summaries for this topical preparation.


Q: Can Aurigoutte affect my ability to drive or operate machinery?

A: Official patient information states that there are no known effects on the ability to drive or operate machinery. This is due to the topical administration to the ear canal, which typically results in minimal systemic exposure of the active ingredients.


Q: Is Aurigoutte safe to use during pregnancy? (Factual status, not advice)

A: For both pregnancy and breast-feeding, the official safety note advises that consultation with a healthcare professional is necessary before using this medicine. As with many medications, data on the systemic absorption and excretion into human milk is limited, which is why official labeling advises professional consultation.


Q: Can I use Aurigoutte if I am currently taking a common systemic drug?

A: The regulatory interaction profile focuses on specific classes of medicines that can affect the clearance or action of Lidocaine, such as certain enzyme inhibitors or antiarrhythmic drugs. This assessment requires review by a healthcare professional, and patients typically provide details of all other medicines they are using to their doctor or pharmacist.


Q: Can Aurigoutte be stored in the refrigerator?

A: Official regulatory information specifies that Aurigoutte should be stored at a temperature not exceeding 30 C to maintain its stability. This is typically considered room temperature, and the specific instructions do not include a requirement for refrigeration.


Q: How do doctors monitor the use of Aurigoutte in patients?

A: The official regulatory text requires verification of the eardrum's integrity prior to beginning use. Monitoring also involves advising patients to consult their doctor if they experience no improvement or if symptoms worsen.


Q: Are there any specific contraindications for elderly patients using Aurigoutte?

A: There are no specific contraindications based solely on advanced age listed in the core regulatory documents. However, official notes highlight that hepatic and renal dysfunction, which are more common in elderly populations, may affect the metabolism of the Lidocaine component.


Q: What should I do if I miss using a round of Aurigoutte?

A: Official regulatory documents describe the need to strictly follow the fixed-dose schedule and frequency pattern as prescribed. However, specific instructions for managing a single missed dose are not provided in the summary. For guidance on how to proceed, consultation with the prescribing professional is recommended.


Q: Are there any common foods or drinks that interact with Aurigoutte?

A: The official regulatory summary explicitly states that an interaction profile with food and drinks is 'Not applicable' for the otic route of administration. This means there are no known food or drink restrictions for this topical ear medicine.

How should Aurigoutte be stored and disposed of?

How to Store and Dispose of Aurigoutte

Official regulatory information requires specific conditions for storing and disposing of this medicine.

Mandatory Storage Requirements

The following conditions ensure product stability and safety:

  • Temperature: Store at a temperature not exceeding 30 C.
  • Expiration: Do not use the medicine after the expiry date printed on the carton.
  • Child Safety: Keep this medicine out of the sight and reach of children.

Disposal Instructions

To prevent environmental contamination, specific disposal rules must be followed:

  • Prohibited Disposal: Do not dispose of unused or expired Aurigoutte in the sewage system or household garbage.
  • Required Action: Disposal must occur via appropriate pharmaceutical collection programs, such as those at pharmacies.

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

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