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drops intilation (Otocerum®)
Otocerum is a cerumenolytic ear drop formulation designed to soften and facilitate the removal of impacted cerumen (earwax) from the external auditory canal.
Otocerum is a cerumenolytic ear drop formulation designed to soften and facilitate the removal of impacted cerumen (earwax) from the external auditory canal. Used for Impacted cerumen (earwax) removal in the external auditory canal.
At a glance
| Generic name | drops intilation (Otocerum®) |
|---|---|
| Sponsor | Hospital Clinic of Barcelona |
| Drug class | Cerumenolytic agent |
| Modality | Small molecule |
| Therapeutic area | Otolaryngology |
| Phase | FDA-approved |
Mechanism of action
The drops contain surfactants and emollients that penetrate and break down the lipid-protein matrix of impacted cerumen, reducing its adhesion to the ear canal wall and making it easier to remove mechanically or allow natural drainage. This non-invasive approach reduces the need for manual cerumen extraction procedures that can cause discomfort or trauma to the delicate ear canal epithelium.
Approved indications
- Impacted cerumen (earwax) removal in the external auditory canal
Common side effects
- Local irritation or itching in the ear canal
- Temporary hearing impairment during treatment
- Allergic contact dermatitis
Key clinical trials
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |