1. Disclaimer
This medication commentary is intended for general educational and informational purposes and is not a substitute for professional medical advice, diagnosis, or treatment. Product formulations, approved indications, contraindications, age restrictions, dosing instructions, excipients, regulatory status, and marketing authorization may differ between countries and may change over time. The current package leaflet and prescribing information supplied with the locally marketed product should therefore be checked before use.
We do not guarantee the accuracy, currency or completeness of information regarding medications or medical products, and official sources should be verified before making any decisions. By using this blog, you agree to assume personal responsibility for relying on the information provided.
2. Summary
Audax Ear Drops is an otic solution containing choline salicylate and glycerol, intended primarily for the symptomatic relief of ear pain and local inflammation and, in some regulatory product information, for softening earwax and assisting its removal.
Choline salicylate is a salicylate-derived non-steroidal anti-inflammatory/analgesic agent. When applied topically in the external auditory canal, it provides local analgesic and anti-inflammatory effects. Glycerol contributes to the formulation and may assist in softening cerumen.
Importantly, Audax is not an antibacterial or antifungal treatment and should not be used as a substitute for appropriate antimicrobial therapy when an ear infection requires specific antimicrobial treatment. The historical product description stated that Audax had its own "spectrum of antimicrobial activity"; however, this claim could not be independently verified in the more authoritative regulatory product information reviewed and should therefore not be interpreted as evidence that Audax treats bacterial or fungal ear infections.
A major safety consideration is the tympanic membrane: the regulatory product information lists a perforated eardrum as a contraindication. Contemporary otitis externa guidance also recommends a non-ototoxic preparation when tympanic membrane perforation or a tympanostomy tube is known or suspected.
3. Brand Name
AUDAX Ear Drops
The product is marketed as an otic solution. A current Egyptian drug-reference listing identifies AUDAX Ear Drops, solution 20% and lists Pharco as the laboratory in Egypt.
4. Category
Therapeutic class:
- Otological preparation
- Topical otic analgesic
- Salicylate-containing preparation
- Local anti-inflammatory agent
- Cerumen-softening/earwax-removal aid
The international ATC classification reported for the Audax product is S02D – Other otologicals; the Irish regulatory record also identifies the product within S02DA – Analgesics and anesthetics.
5. Active Ingredient
Choline Salicylate
Each 1 mL of the supplied Egyptian formulation is stated to contain:
- Choline salicylate solution 432 mg
- Glycerol 126 mg
The regulatory product information for Audax describes the formulation as approximately choline salicylate 20% w/v and glycerol 12.6% w/v in one authorized presentation, while the corresponding patient leaflet expresses the choline salicylate solution as 43.22% w/v. This difference reflects the way the choline salicylate solution/active component is expressed in the product documentation and should not be interpreted as evidence that the product contains 43.22% free choline salicylate.
Because formulations can vary by market, the local package label should be considered authoritative for the Egyptian product.
6. Pharmaceutical Form & Strength
Pharmaceutical form: Ear drops / otic solution.
The regulatory description characterizes Audax as a clear, faintly tan solution with a characteristic odor.
The supplied Egyptian product information states:
Each 1 mL contains:
- Choline salicylate solution 432 mg
- Glycerol 126 mg
Pack size: 10 mL bottle supplied with a dropper.
A regulatory product record for an Audax presentation also documents 8-mL and 10-mL amber glass bottles with a polypropylene pipette.
7. Manufacturer & Marketing Authorization Holder
For the Egyptian product, the supplied product information states:
Manufactured by: Pharco Pharmaceuticals, Alexandria, Egypt
Under licence of: Mundipharma AG, Basel, Switzerland
Current Egyptian drug-reference sources continue to associate Audax with Pharco and Mundipharma.
Pharco confirms that it is an Egyptian pharmaceutical manufacturer based in Alexandria.
Official company websites:
Important regulatory note: the exact marketing authorization holder can differ between countries. For example, the Irish authorization historically listed LanesHealth (Ireland ) Limited as the marketing authorization holder, while other markets list Mundipharma entities. Therefore, the Egyptian registration/package should be used when determining the current Egyptian MAH.
8. Mechanism of Action
Choline Salicylate
Choline salicylate is a salicylate derivative with analgesic and anti-inflammatory activity.
Its pharmacological effects are associated primarily with inhibition of prostaglandin synthesis through inhibition of cyclooxygenase-mediated pathways. Reduced prostaglandin formation decreases inflammatory signaling and contributes to reduction of pain and inflammation. Choline salicylate belongs pharmacologically to the salicylate/NSAID family.
When administered otically, its intended therapeutic action is predominantly local, providing symptomatic relief of pain and inflammation in the external auditory canal and adjacent ear structures.
Glycerol
Glycerol is a polyol used in pharmaceutical formulations. In otic preparations it can contribute to the physical characteristics of the formulation and may assist in softening earwax, facilitating subsequent removal. Audax product information includes earwax softening/removal among its uses.
9. Spectrum of Activity
Audax should not be classified as an antimicrobial ear drop.
The older product description supplied with the medication states that:
"AUDAX Ear Drops ... have their own spectrum of antimicrobial activity."
However, this statement was not supported by the current/authoritative regulatory information reviewed, which describes the product in terms of analgesia, local inflammation, and cerumen softening rather than antimicrobial treatment.
Therefore:
- Audax should not be relied upon to eradicate bacterial otitis externa.
- It should not replace topical antibiotics when antibiotic treatment is indicated.
- It should not replace antifungal treatment for otomycosis.
- If an ear infection requires antimicrobial treatment, Audax may only have a symptomatic/adjunctive role when its use is otherwise appropriate.
Contemporary Egyptian guidance for acute otitis externa recommends appropriate topical therapy for uncomplicated disease and specifically emphasizes choosing a non-ototoxic preparation when the tympanic membrane is non-intact.
10. Pharmacokinetics
Detailed pharmacokinetic data for otic administration of Audax are limited.
The product is intended for topical administration into the external auditory canal, and its therapeutic purpose is primarily local.
Systemic exposure is expected to be substantially lower than with equivalent systemic salicylate administration when used appropriately in an intact ear canal; however, it should not be assumed that systemic absorption is zero.
This is clinically relevant because salicylates can produce systemic toxicity at sufficiently high exposure, and the amount absorbed may theoretically increase with excessive use, prolonged administration, damaged tissue, or inappropriate administration.
The regulatory information reviewed does not provide a detailed human pharmacokinetic profile for Audax following otic administration.
11. Indications
Verified/relevant uses include:
1. Relief of ear pain
Audax is indicated for symptomatic relief of pain associated with:
- Acute otitis externa
- Chronic otitis externa
- Otitis media-associated ear pain
- Local inflammatory conditions of the ear
- Pain associated with furuncles/boils of the external auditory canal
The historical product description specifically listed:
- Acute or chronic otitis media
- Acute or chronic otitis externa
- Pruritus and inflammation of the external auditory canal
- Pain associated with boils and furuncles in the external auditory canal.
The regulatory product information also lists relief of pain in otitis externa and media, furuncles, and other local inflammation.
2. Earwax softening
Audax has also been documented as a cerumen-softening agent and an aid to earwax removal.
Evidence concerning cerumenolytic agents generally suggests that ear drops may help soften wax, but superiority of one formulation over another is not consistently established.
Important limitation
Audax provides symptomatic relief. It does not by itself establish the diagnosis or treat the underlying cause of ear pain.
Persistent ear pain, discharge, hearing loss, fever, severe swelling, recurrent symptoms, or suspected perforation requires appropriate ear examination.
12. Administration
Audax is administered topically into the affected ear.
The historical instructions supplied with the product state:
- Place the head to one side with the affected ear uppermost.
- Completely fill the ear canal with the ear drops using the supplied dropper.
- A cotton-wool plug previously soaked in the drops may be placed at the entrance of the canal.
- If a doctor has inserted an ear wick, the drops may be used to keep the wick moist.
- The drops may be instilled every 3–4 hours until satisfactory relief is obtained.
The regulatory SmPC similarly describes topical administration and the use of a cotton-wool plug or wick when appropriate.
Practical administration points
- Do not touch the dropper tip to the ear canal or other surfaces.
- Wash hands before and after administration.
- Do not share the bottle between patients.
- Do not use the preparation if the tympanic membrane is perforated or suspected to be perforated.
- If the ear canal is markedly swollen and drops cannot penetrate, a clinician may need to perform aural toilet and/or place an ear wick.
Current Egyptian acute otitis externa guidance specifically recognizes aural toilet and wick placement as methods of improving delivery when the canal is obstructed.
13. Method of Preparation
No reconstitution is required.
Audax is supplied as a ready-to-use otic solution.
The bottle should be used directly with the supplied dropper.
14. Contraindications
1. Salicylate hypersensitivity
Audax should not be used in patients with known hypersensitivity to salicylates/choline salicylate.
2. Perforated tympanic membrane
Audax is contraindicated when the eardrum is perforated according to the regulatory product information.
It should also be avoided when perforation is suspected unless an ENT/qualified clinician has specifically assessed the product as appropriate.
3. Allergy to other ingredients
The patient leaflet also identifies hypersensitivity to glycerol or other ingredients as a reason not to use the product.
15. Warnings & Precautions
Tympanic membrane integrity is critical
Before using Audax for ear pain, the integrity of the tympanic membrane should be considered.
If there is:
- Known tympanic membrane perforation
- Suspected perforation
- Tympanostomy tube
- Bloody otorrhea
- Significant otorrhea with inability to visualize the tympanic membrane
- Previous ear surgery
Audax should not be self-administered without appropriate medical assessment.
The 2024 Egyptian Health Council acute otitis externa guideline recommends a non-ototoxic topical preparation when the tympanic membrane is known or suspected to be perforated.
Persistent symptoms
The supplied older information advises medical review if pain and inflammation persist after 24 hours.
The regulatory patient information reviewed advises consultation if symptoms persist beyond several days or worsen.
Because these timeframes differ between product documents, the safest approach is:
Persistent, worsening, severe, or unexplained ear pain should prompt medical assessment rather than repeated self-treatment.
Propylene glycol and excipients
Regulatory information for an Audax presentation states that the formulation contains propylene glycol and other excipients, which may cause skin irritation.
Infection requiring antimicrobial treatment
If the underlying ear condition requires a topical or systemic antimicrobial, Audax should be considered only as symptomatic/adjunctive treatment and not as antimicrobial monotherapy.
Excessive or prolonged use
Because choline salicylate is a salicylate, excessive or inappropriate use should be avoided. Although the intended route is topical, systemic absorption is possible.
16. Drug Interactions
The Audax regulatory SmPC reviewed reports:
"None stated."
No clinically significant drug interactions have been specifically established for appropriately administered otic Audax.
Nevertheless, caution is reasonable with:
- Other salicylate-containing products
- High-dose systemic NSAIDs/salicylates
- Drugs that increase bleeding risk, particularly in patients who may have significant systemic salicylate exposure
- Other otic preparations used simultaneously
The practical significance of systemic interactions is expected to be considerably lower with appropriate topical otic use than with systemic salicylate therapy, but systemic absorption should not be assumed to be impossible.
If multiple ear drops are prescribed, they should generally be administered according to the prescriber's instructions and separated appropriately when necessary.
17. Side Effects
The regulatory product information reviewed did not identify a specific list of established adverse effects for Audax and states that no undesirable effects were stated in that product documentation.
Nevertheless, possible local reactions may include:
- Burning or stinging
- Ear-canal irritation
- Skin irritation
- Itching
- Hypersensitivity reactions
- Contact dermatitis
Propylene glycol and other excipients may contribute to local irritation.
Rare/systemic concern
Excessive exposure to salicylates theoretically carries the risk of systemic salicylate toxicity. This is unlikely with correct short-term otic administration but becomes more relevant with inappropriate use, ingestion, or potentially increased absorption.
Symptoms of significant salicylate toxicity can include:
- Nausea or vomiting
- Sweating
- Dizziness
- Tinnitus
- Hyperventilation
- Confusion
The documented Audax regulatory information notes that the contents of a bottle contain a substantial amount of choline salicylate and that accidental ingestion is particularly concerning in small infants.
Accidental ingestion, especially by an infant or young child, warrants urgent medical/toxicological assessment.
18. Use in Special Populations
Pregnancy
There is an important discrepancy between historical/currently accessible Audax documents.
The 2019 SmPC states that there is no known hazard with use during pregnancy and lactation, whereas the corresponding patient information leaflet states that Audax should not be used during pregnancy or if pregnancy is suspected/planned.
Because of this discrepancy and because salicylates are pharmacologically active agents, the most conservative and clinically appropriate recommendation is:
Pregnant patients should not self-medicate with Audax; use during pregnancy should be determined by a physician after assessment of the indication and the current locally approved product information.
Breastfeeding
The 2019 SmPC states that there is no known hazard during lactation, while the patient leaflet advises breastfeeding patients to ask their doctor or pharmacist before use.
Therefore, breastfeeding use should be based on clinical necessity and the current local product information.
Children
The reviewed patient leaflet states that Audax should not be used in children younger than 1 year unless advised by a doctor.
Because pediatric formulations and regulatory labeling can differ between countries, the current Egyptian package leaflet should be checked before use in infants and young children.
Elderly patients
No specific age-related dose adjustment has been established for topical otic use.
However, elderly patients may have a greater prevalence of:
- Chronic otitis media
- Tympanic membrane abnormalities
- Previous ear surgery
- Multiple medications
- Hearing impairment
Therefore, persistent or recurrent ear symptoms should be evaluated rather than repeatedly treated empirically.
Renal impairment
No specific renal dosing recommendation has been established for otic Audax.
However, because choline salicylate is a salicylate compound and systemic salicylates are primarily eliminated through the kidneys, prolonged/excessive exposure should be avoided in patients with significant renal impairment.
19. Storage Conditions
The supplied Egyptian product information states:
- Store in a cool and dry place.
- Protect from light.
- Keep out of the reach of children.
A regulatory Audax product record from another market specifies storage not above 25°C.
Because storage requirements may vary by marketed formulation, the temperature and storage instructions printed on the Egyptian package should take precedence.
20. Additional Sections
Important Clinical Consideration: Audax Does Not Treat Every Cause of Ear Pain
Ear pain is a symptom rather than a diagnosis.
Possible causes include acute otitis externa, acute otitis media, chronic otitis media, cerumen impaction, furunculosis, tympanic membrane perforation, Eustachian tube dysfunction, trauma, foreign body, otomycosis, and referred pain from dental, temporomandibular-joint, pharyngeal, or other head-and-neck pathology.
Therefore, an analgesic ear drop should not delay diagnosis when symptoms are severe, recurrent, atypical, or associated with discharge or hearing changes.
Audax and Acute Otitis Externa
For uncomplicated acute otitis externa, contemporary guidelines emphasize appropriate topical therapy and adequate pain control. If the tympanic membrane is not intact or a tympanostomy tube is present, a non-ototoxic preparation should be selected.
Audax and Otitis Media
Audax may provide symptomatic relief of ear pain associated with otitis media, but it does not replace treatment directed at the underlying cause when such treatment is required.
Audax and Earwax
Audax has documented cerumen-softening activity and may be used as an aid to earwax removal.
21. Frequently Asked Questions (FAQ)
Q1: Is Audax an antibiotic? A: No. Audax is primarily an otic analgesic/anti-inflammatory preparation containing choline salicylate, with glycerol as a formulation component. It should not be relied upon as antibiotic treatment.
Q2: Can Audax cure otitis externa? A: It may relieve pain and inflammation, but it does not constitute definitive antimicrobial treatment when bacterial infection requires antimicrobial therapy.
Q3: Can Audax be used if the eardrum is perforated? A: No. Perforated tympanic membrane is listed as a contraindication in the regulatory product information.
Q4: Can Audax be used with ear antibiotics? A: Potentially, when clinically appropriate, because Audax can provide symptomatic relief while an antimicrobial addresses the infection.
Q5: Does Audax contain a local anesthetic such as benzocaine? A: No. Its analgesic effect is attributed to choline salicylate.
Q6: Does Audax have antimicrobial activity? A: The older manufacturer description claimed that it had an antimicrobial spectrum. However, this claim was not sufficiently substantiated in the authoritative regulatory documents reviewed.
Q7: Can Audax be used for earwax? A: Yes, this is a documented use. It can soften earwax and assist its removal.
Q8: Can Audax be used in pregnancy? A: The available regulatory documents are inconsistent. Pregnant patients should use Audax only after professional assessment.
Q9: Can Audax be used while breastfeeding? A: Professional assessment is appropriate based on local product information.
Q10: Can Audax be used in babies? A: The reviewed patient leaflet states that it should not be used in children under 1 year of age unless advised by a doctor.
Q11: What should I do if the pain does not improve? A: Persistent or worsening pain should be medically assessed rather than treated indefinitely.
Q12: Can Audax cause systemic salicylate toxicity? A: Significant systemic toxicity is unlikely with correct short-term otic administration, but excessive exposure or accidental ingestion is concerning.
22. References
- Health Products Regulatory Authority (HPRA). Audax Ear Drops Solution – Summary of Product Characteristics. Revision dated 11 June 2019.
- Health Products Regulatory Authority (HPRA). Audax Ear Drops – Patient Information Leaflet. February 2019.
- Health Products Regulatory Authority (HPRA). Audax Ear Drops Solution Choline Salicylate 20% w/v Glycerol 12.6% w/v – regulatory product information.
- Egyptian Health Council. Clinical Guideline: Acute Otitis Externa. Last update: 28 April 2024.
- American Academy of Otolaryngology–Head and Neck Surgery. Clinical Practice Guideline: Acute Otitis Externa.
- Cochrane Database of Systematic Reviews. Ear drops for the removal of ear wax.
- Choline Salicylate Analysis: Chemical Stability and Degradation Product Identification. Scientific literature describing choline salicylate pharmacology.
- Pharco Pharmaceuticals. Official corporate information and manufacturer details.
- Mundipharma. Official corporate information.