Auripax

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Auripax

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Medically reviewed

Marina Burgos

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 Auripax

Quick Facts

Property Description
Active Ingredients Phenazone, Lidocaine Hydrochloride
Form Solution (Ear Drops)
Pharmacological Class Local Analgesic and Anti-inflammatory Combination
Common Use Symptomatic relief of ear pain (otalgia)
Origin Synthetic

What Type of Medicine is Auripax?

Auripax is a synthetic combination medicinal product classified as an Otological Agent, designed exclusively for local use in the ear. It belongs to the high-level pharmacological class of Local Analgesic and Anti-inflammatory Combinations, recognized for addressing pain and inflammation concurrently. Pharmacological properties support the use of local anesthetics like Lidocaine for managing acute, localized discomfort. This positioning is unique as it targets symptoms directly at the site of origin, such as the acute, localized pain experienced in middle ear conditions.

What is the Composition and Form of Auripax?

The core composition of Auripax involves two distinct active pharmaceutical ingredients: Phenazone (Antipyrine), a pyrazolone derivative that provides the anti-inflammatory component, and Lidocaine Hydrochloride (Lignocaine), a local anesthetic of the amide group. This product is manufactured as a solution and is administered as ear drops via the auricular route of administration. Clinically, the combination is formulated to be therapeutically effective for rapid symptomatic management, with phenazone enhancing the anesthetic effect of lidocaine. The active substances are carried in a base predominantly composed of Glycerol, a viscous excipient that ensures the solution remains in contact with the local tissue for an extended duration.

What is the General Therapeutic Purpose of the Dual-Action Formulation?

The general therapeutic purpose of this dual-action formulation is to deliver localized and efficient symptomatic management of ear discomfort, or otalgia. The preparation relies on the synergistic effect of its components: the anesthetic quickly acts to block pain signals, while the anti-inflammatory agent works to mitigate the localized irritation and swelling. This combination offers a rapid response that addresses both the immediate sensation of pain and the inflammatory process contributing to the discomfort, limiting the pharmacological action strictly to the application site.

Regulatory References

  1. EMA PSUSA for Lidocaine/Phenazone
  2. WHO Essential Medicines List (Lidocaine)

What side effects are possible with Auripax?

Possible Side Effects and Safety Information

The official safety profile for Auripax (Phenazone/Lidocaine) is primarily defined by its local action as an ear drop solution, concentrating most documented adverse reactions at the application site. Adverse effects are officially classified within the Ear and Labyrinth Disorders and Skin and Subcutaneous Tissue Disorders system-organ classes.

The most frequently observed adverse reactions are local in nature. These include local irritation and redness (hyperaemia) of the auditory meatus, which are typically classified with a frequency of Not Known. More serious effects, such as local allergic reactions, including a maculopapular rash, are officially classified as Rare (may affect up to 1 in 1,000 people).

Regulatory Safety Constraints

Official regulatory documents emphasize specific safety limitations crucial for use. Auripax is contraindicated in cases where the tympanic membrane (eardrum) is perforated due to the risk of exposure to middle ear structures, which may lead to adverse effects including ototoxicity (damage to the auditory system).

Another significant safety note concerns the potential for methemoglobinemia, a rare but serious condition, which requires caution in specific populations. Use is officially advised with caution in susceptible patients, including infants under 3 months of age and individuals with conditions such as haemoglobinopathies or G6PD deficiency. The regulatory basis for use during Pregnancy and Lactation suggests no adverse effects are anticipated under normal conditions due to negligible systemic exposure.

Finally, an official warning states that the presence of Phenazone may cause a positive finding in anti-doping tests.

Overdose and Emergency Response

Overdose and when to seek help

The regulatory profile for Auripax (Phenazone and Lidocaine Hydrochloride ear drops) indicates that a conventional overdose is not expected and no cases of overdosage have been reported in official prescribing information. This determination is based on the product’s external, local route of administration, which is designed to prevent significant systemic absorption when the tympanic membrane is intact.


Documented Toxicity and Urgent Actions

While a classical overdose is not applicable, the official documents highlight two specific toxicity risks and mandate corresponding emergency actions:

  • Systemic Toxicity Risk: The use of topical local anesthetics like Lidocaine carries the risk of Methemoglobinemia, a severe hematologic condition. Caution is specifically required for susceptible populations, including infants under three months of age and individuals with G6PD deficiency.
  • Local Toxicity Risk: The primary local complication is the potential for Ototoxicity if the product is administered in the presence of a perforated tympanic membrane.

When Immediate Medical Help is Required

Official labeling mandates that users stop use and seek medical advice immediately if ear discharge develops during treatment. This is required because ear discharge may signal a severe local complication, such as a perforated eardrum, which necessitates urgent clinical assessment. Additionally, medical advice must be sought if the symptoms being treated do not improve within seven days or if they worsen rapidly or significantly.

Therapeutic Uses of Auripax

What Auripax Treats: Main Uses and Benefits

Auripax is considered relevant when supportive symptom management is appropriate for painful, acute middle ear conditions. The formulation is intended for application in contexts marked by increased discomfort where symptomatic management is appropriate.

Symptomatic Relief of Acute Ear Pain (Otalgia)

Auripax is commonly used for managing acute, localized symptoms related to physical discomfort in the ear. The primary therapeutic objective is to help address symptom clusters that may become intense, supporting the patient during difficult episodes by easing distress.

Supportive Care for Otitis Media-Related Symptoms

The medication is commonly used across conditions associated with acute or disruptive episodes, such as those involving middle ear inflammation or pain due to pressure changes. This is relevant in conditions involving inflammatory or irritative processes.

Mitigation of Localized Irritation and Swelling

This combination is relevant for managing symptoms related to inflammatory or irritative states affecting the middle ear. The formulation supports general well-being during symptomatic phases by helping to ease the overall symptom load, which contributes to improved comfort when symptoms are more noticeable.


Quick Fact: Symptom Management
Primary Therapeutic Goal Helps address symptoms related to physical discomfort and inflammatory states.
Symptom Clusters Covered Symptoms that may become intense, including acute pain and localized irritation.
Clinical Context Applied in contexts involving acute or disruptive symptomatic episodes.
Patient Benefit Supports the patient during difficult episodes by helping to ease the overall symptom load.

Eligibility and Restrictions for Use

Official Eligibility and Contraindications

Auripax (similar to other antipyrine and benzocaine otic solutions) is an ear-specific medication whose use is strictly defined by regulatory guidelines based on certain patient characteristics and clinical conditions. Eligibility is determined by the absence of specific contraindications, which are formal reasons the drug must not be used.

Eligibility Domain Regulatory Status / Restriction
Hypersensitivity Contraindicated in any person with a known allergy or hypersensitivity to the active drug, any of its components, or chemically related substances.
Tympanic Membrane Integrity Contraindicated in the presence of a spontaneous perforation of the tympanic membrane (a hole in the eardrum).
Active Ear Condition Contraindicated if there is any discharge from the ear, as this may indicate a contraindication (e.g., a perforated eardrum).
Pregnancy Use should be considered only if clearly needed, as animal reproduction studies have not been conducted and potential for fetal harm is unknown.
Lactation (Nursing Mothers) Caution should be exercised; it is not known whether the components are excreted into human milk.

Age-Related Eligibility: There are no explicit restrictions against use in pediatric or geriatric populations in the official contraindications section.

Patients are considered eligible for use only if they do not present with any of the formally listed contraindications. Official labeling restricts use based on local clinical findings—specifically the integrity of the eardrum—and patient history of allergic response, requiring that the drug is applied to the ears only.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Regulatory information states that clinically significant drug–drug interactions are generally not anticipated when Auripax (Phenazone and Lidocaine hydrochloride otic solution) is used as directed. The product's ear drop formulation, intended for local use, results in negligible systemic exposure of its active ingredients when the tympanic membrane is intact, a finding that constrains the overall interaction profile. Formal pharmacokinetic interaction studies are not typically performed for products with such limited absorption.


Documented Interaction Risk

Official labeling identifies a specific pharmacodynamic interaction risk due to the Lidocaine component. Co-administration with other methemoglobinemia-inducing agents (a category including certain local anesthetics, nitrates, nitrites, and sulfonamides) may pose an additive risk of methemoglobinemia. This risk is a label-based caution pertaining to the drug class.


Population-Specific Interaction Notes

Susceptibility to this additive pharmacodynamic interaction is formally noted as being increased in certain patient groups. Regulatory documents emphasize caution for infants under 3 months of age and individuals with conditions such as haemoglobinopathies or Glucose-6-phosphate dehydrogenase (G6PD) deficiency.

No interactions with food, alcohol, herbal products, or supplements are explicitly documented in the regulatory labeling for this otic solution.

Mechanism of Action

Auripax is a fixed-dose otic solution combining two active pharmacological agents: phenazone and lidocaine. The action is purely localized to the external and middle ear structures following topical administration.

Phenazone acts as a non-steroidal antipyretic-analgesic. Its mechanism involves non-selective inhibition of cyclooxygenase (COX) activity, which reduces the local synthesis of pro-inflammatory prostaglandins, particularly within the inflamed mucosa of the middle ear. This molecular inhibition decreases local inflammatory signaling and subsequent tissue congestion.

Lidocaine functions as a local anesthetic. It binds to the inner portion of the voltage-gated sodium channels in the neuronal cell membrane of peripheral sensory nerves, stabilizing the inactive state of the channel. This interaction blocks the influx of sodium ions, thereby inhibiting the generation and conduction of action potentials. The blockage prevents the afferent transmission of pain signals from the peripheral nociceptors to the central nervous system. The combined effect of phenazone's modulation of prostanoid synthesis and lidocaine's neuronal blockade results in localized signal attenuation at the site of administration.

Dosage and Administration Information

Auripax is a solution for instillation intended for local administration into the ear canal, and contains the active ingredients phenazone and lidocaine. Phenazone is a pain-relieving and anti-inflammatory agent, while lidocaine is a local anesthetic that works to numb the area. This medication is typically used for the symptomatic treatment of ear pain caused by certain types of otitis (ear infection) where the eardrum remains intact, such as acute congestive otitis media or barotraumatic otitis.


Administration Instructions

Auripax should only be used after a healthcare professional has examined the ear to confirm that the tympanic membrane (eardrum) is not perforated. Use of this medication in the presence of a perforated eardrum may lead to complications.

Step Instruction Detail
1. Preparation Warm the bottle by holding it in your hands before use to prevent a cold solution from causing discomfort.
2. Application Tilt the head to the side, positioning the affected ear upward. The typical dose is 4 drops in the affected ear, two to three times per day, or as directed by your physician.
3. Technique Gently pull on the outer part of the ear (pinna) several times to ensure the solution penetrates the ear canal.
4. Post-Application Keep the head tilted for approximately 10 to 15 minutes to allow the solution to remain in contact with the ear canal (an 'ear bath').

Important Considerations

Do not use this medication for more than 10 consecutive days. If symptoms persist or worsen after this period, consult your healthcare provider for reassessment. Since the active substances in Auripax are intended for local action and are not expected to pass into the systemic circulation under proper use with an intact eardrum, the medication is typically evaluated as suitable for use during pregnancy and breastfeeding, but this must always be confirmed with a healthcare professional.

Recent Clinical Evidence

Research Evidence: Overview of Studies for Auripax

This section summarizes the official research evidence that describes the clinical evaluation of the phenazone and lidocaine ear drop combination, based on findings reported by regulatory bodies and systematic reviews. The information below details what types of studies exist and the populations they monitored, but it does not offer clinical advice or personal recommendations.

Evidence for Symptomatic Relief of Acute Otalgia (Ear Pain)

Research has primarily focused on the potential role of the topical analgesic combination in managing ear pain (otalgia) associated with acute middle ear inflammation, such as acute otitis media (AOM). The evidence base for this use relies on short-term Randomized Controlled Trials (RCTs) and meta-analyses that compared the drops to placebo drops or to standard care, which usually includes oral pain medication.

Researchers studied outcomes related to physical discomfort, primarily monitoring ear pain intensity and scores using validated scales, with measurements often taken quickly. Findings from systematic reviews indicate that studies reported measurements of differences in pain scores between the groups studied.

Research into Supportive Symptom Management in Other Acute Conditions

Beyond the primary focus on AOM, the ear drops were evaluated in studies examining symptomatic relief in other acute ear conditions, such as otitis in influenza (viral bullous otitis) and barotraumatic otitis (pain due to pressure changes). The research exploring these conditions is less extensive and often involves smaller-scale trials or observational assessments conducted in specialized clinical settings. Outcomes captured focused on patient-reported outcomes describing perceived discomfort and monitoring localized signs of irritation.

Evidence Gaps and Areas of Uncertainty

The existing evidence base primarily reflects research exploring short-term symptom changes over minutes to hours, with antibiotic consumption tracked up to seven days. There is limited information for long-term outcomes regarding the use of this specific combination. Studies monitoring responses over defined time intervals beyond the acute phase are scarce. This means that data for longer-term questions—such as the outcomes of the drops if used repeatedly for chronic or recurrent symptoms—are not fully characterized.

Crucially, the results apply only to the populations studied who had an intact tympanic membrane (eardrum). Research repeatedly notes the boundary that the medication was not studied for use in the presence of a known or suspected eardrum perforation, as this is an area that has not been sufficiently studied for safety.

Key Studies & References

  1. Topical anaesthetics for pain relief in acute otitis media: A systematic review and meta-analysis
  2. Management of acute otitis media in children: NICE guideline [NG91]
  3. Clinical Trials Registry Search for Otological Analgesic Preparations (Representative Public Registry Source)

Frequently Asked Questions (FAQ)

Common questions about Auripax (FAQ)


Q: Can Auripax be taken by older adults or seniors?

Regulatory information indicates that the medicine is generally described as suitable for use in adults. Advanced age is not formally listed as a contraindication in the official documents for Auripax.

Q: Can Auripax be prescribed to teenagers or children?

Official documents state that the medicine is used for the local treatment of pain in children over 6 months of age and adults. Information on safety and efficiency for children under 6 months of age is not proven according to regulatory data.

Q: Are there any major drug-to-drug interactions that are specifically highlighted for Auripax?

Official labeling highlights a pharmacodynamic interaction risk when Auripax is used with other methemoglobinemia-inducing agents. This category includes certain local anesthetics, nitrates, nitrites, and sulfonamides, and the risk is noted due to the Lidocaine component.

Q: Can I take other prescription medications while using Auripax?

Due to its local administration, regulatory data does not suggest the possibility of clinically significant systemic interactions with most other treatments. However, it is consistent with medical guidance to inform a healthcare provider of any and all treatments being used.

Q: Do I need to have regular blood tests while taking Auripax?

Official documents do not mention a requirement for routine blood tests for all users of Auripax. Caution regarding use is emphasized for specific susceptible populations, such as infants under 3 months or individuals with certain hereditary conditions like haemoglobinopathies or G6PD deficiency.

Q: How is Auripax different from the medicine my friend takes for a similar condition?

Auripax is a specific type of combination medicinal product designed exclusively for the ear. It provides a dual action by containing both Phenazone (to help with inflammation) and Lidocaine (a local anesthetic) for localized, symptomatic ear pain relief.

Q: What does official guidance say about missing a dose of Auripax?

Official guidance states that if a dose is missed and it is close to the time for the next scheduled dose, the missed dose should be skipped entirely. The subsequent dose is typically resumed at the regularly scheduled time.

Q: What is the main difference between Auripax and other medicines in the same category?

Auripax is classified as a local analgesic and anti-inflammatory combination. Its main difference is its specific dual-action containing Phenazone and Lidocaine, which is intended to target both pain and local inflammation directly at the site of administration in the ear.

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

Pain relief is typically reported to begin within a few minutes of instilling the ear drops. This response is understood to be related to the local anesthetic action of the Lidocaine component.

Q: Is it okay to drink coffee or caffeine while taking Auripax?

No interactions with food, alcohol, herbal products, or supplements, including caffeine, are explicitly documented in the regulatory labeling for this otic solution. This is consistent with the drug’s local-only action and negligible systemic absorption.

Q: Why do some people say Auripax made them tired?

Official information indicates that systemic absorption of the active ingredients is negligible when the eardrum is intact. Because of this local action, systemic side effects such as tiredness or sleepiness are unlikely to occur or are not officially listed.

Q: Are there any specific foods to avoid when taking Auripax?

No specific foods are explicitly documented in the regulatory labeling as needing to be avoided when taking this otic solution. This aligns with the drug's intended purpose for local use and negligible systemic exposure.

Q: What happens if I forget to take a dose of Auripax?

If a dose is forgotten and it is close to the time for the next scheduled dose, official guidance recommends skipping the missed dose entirely. The subsequent dose is typically resumed at the regularly scheduled time.

Q: Does Auripax have a risk of dependence or addiction?

The medicine is an analgesic/anti-inflammatory combination indicated for short-term, local use for no longer than 10 days. Due to its limited use duration and local mechanism of action, it does not suggest a risk of dependence.

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

Official labeling states that there are No effects on the ability to drive and use machines for this medicine. Its action is highly localized and does not typically affect central nervous system function.

Q: What are the general safety guidelines described for Auripax?

General safety guidelines require confirming that the eardrum is intact before use to prevent complications. Treatment should be limited to 10 days, and a medical professional should be consulted if symptoms persist beyond this period.

Q: Why is Auripax sometimes prescribed instead of other options?

The medicine is intended to provide rapid, localized symptomatic relief of ear pain by using a dual-action combination (analgesic and anesthetic) applied directly at the site of discomfort, making it a targeted option for acute otalgia.

Q: Does Auripax cause any issues with blood pressure or heart rate?

Due to the medicine's local action and negligible systemic absorption when used properly, systemic effects such as changes in blood pressure or heart rate are not typically anticipated or officially documented as side effects.

Q: Does Auripax come in different strengths?

Official product information describes one standard composition of the solution (Phenazone and Lidocaine hydrochloride) and one standard dose (4 drops). Regulatory labeling does not mention variations in strength.

Q: Is it known if Auripax interacts with birth control pills?

Formal interaction studies are generally not performed for this product due to the negligible systemic exposure of the active ingredients. As such, no explicit interaction with hormonal birth control is documented in the regulatory information.

Q: What official documents say about Auripax's safety profile?

Official documents primarily describe local reactions as the main part of the safety profile. They emphasize the key contraindication of a perforated eardrum and include a warning that the presence of Phenazone may cause a potential positive finding in anti-doping tests.

Q: How quickly can I expect to see the 'full effect' of Auripax?

Research evidence primarily focuses on short-term symptom changes and initial pain relief, which is often reported within minutes to hours. Information regarding long-term outcomes beyond initial, short-term pain relief is not fully characterized in the existing evidence.

Q: Is there a link between Auripax and increased risk of bleeding?

The Phenazone component is a non-steroidal anti-inflammatory agent. However, due to the medicine's local route of administration, regulatory safety data does not specifically document an increased risk of bleeding as a systemic side effect for this otic solution.

Q: Can Auripax cause trouble sleeping or insomnia?

Given the product's local action and negligible systemic absorption, systemic effects like trouble sleeping or insomnia are not typically anticipated or officially listed as documented side effects.

Q: What is the role of Auripax in a complete treatment plan?

The medicine is intended for the localized and efficient symptomatic management of ear discomfort (otalgia) associated with specific acute ear conditions. It may be used alongside other treatments as determined within a professional treatment plan.

How should Auripax be stored and disposed of?

Official Storage Requirements

Regulatory labeling dictates that Auripax ear drops must be stored at a temperature below 25°C. It is mandatory to do not refrigerate and do not freeze the medicine to maintain its stability. The product must be kept in its original outer carton and protected from light and moisture. After the bottle is first opened, the solution has a limited in-use stability period and must be discarded after a specified duration, typically 28 days.

Disposal and Child Safety

For child protection, the medicine must be stored out of the sight and reach of children. The disposal of unused or expired Auripax must adhere to specific instructions. To protect the environment, the product must not be thrown away via wastewater or household waste, and patients are required to ask a pharmacist for guidance on proper disposal.

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

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