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Otosynalar®
Otosynalar is a topical corticosteroid-antibiotic combination that reduces inflammation and treats bacterial infection in the ear canal.
Otosynalar is a topical corticosteroid-antibiotic combination that reduces inflammation and treats bacterial infection in the ear canal. Used for Acute otitis externa (swimmer's ear), Bacterial infection of the external ear canal with inflammation.
At a glance
| Generic name | Otosynalar® |
|---|---|
| Sponsor | Laboratorios Osorio de Moraes Ltda. |
| Drug class | Topical corticosteroid-antibiotic combination |
| Modality | Small molecule |
| Therapeutic area | Otolaryngology / Dermatology |
| Phase | Phase 3 |
Mechanism of action
The formulation combines a corticosteroid (typically neomycin and dexamethasone or similar agents) to suppress inflammatory response and reduce swelling in otitis externa, paired with an antibiotic component to address bacterial infection. This dual action addresses both the infectious and inflammatory components of ear canal disease.
Approved indications
- Acute otitis externa (swimmer's ear)
- Bacterial infection of the external ear canal with inflammation
Common side effects
- Local irritation or sensitization
- Allergic contact dermatitis
- Secondary infection
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 |