Regulatory product record
CORTOTIC
Product identity, ingredients and source provenance from the regulatory catalogue. Linked clinical evidence has a separate review status.
Product identity
- Brand name
- CORTOTIC
- DIN
- 02545454
- DPD drug code
- 103421
- Regulatory category
- APPROVED_VET_DRUG
- Market status
- MARKETED
- Route(s)
- OTIC
- Pharmaceutical form(s)
- SPRAY
- Ingredients
- HYDROCORTISONE ACEPONATE (0.584 MG)
- Species (DPD record)
- DOGS
- Company
- VIRBAC AH, INC. (DIN owner)
Source and provenance
- Source dataset
- health_canada_dpd_marketed
- Source snapshot date
- Not available in this source
- Source record key
- 103421
- Archive fingerprint (SHA-256)
- 85cc3ce208af3aa57018c3d14d83f90220c436baef7455384b6d48d9774e1c88
Linked clinical reference
Clinical entries are linked through the active molecule. Check their species, formulation, source and review status separately from this product record.
Clinical evidence
Pending clinical review (PROPOSED)Rule-based (RULE_BASED)— applies to the facts and dose entries in this species selection; individual source records retain their own status.
Indications1
EASOTIC Otic Suspension is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).
DogOn-label (ON_LABEL)United States1 source record · View provenance
- Dog · SPL section 34067-9 (INDICATIONS & USAGE SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Dose regimens1
This calculator performs arithmetic only on the sourced dosing field shown for each result — it does not verify the field's accuracy, does not select which field to use for a patient, and does not replace a veterinarian's order. Not for clinical use. Confirm every result against the primary source before dispensing.
Dose calculation
Species: Dog. Results use the source regimens shown below.
- Review the source route shown below.
- Enter patient weight and its unit.
- For volume, optionally enter a matching label concentration.
Source route: Route not specified
Manual verification required — this source did not state a per-weight dose this calculator can compute from.
- Source regimen: Not available in this source
- Source formulation
- Not specified in this source
- Dose basis
- Not specified in this source
Indication: Not specified in this source field
Manual verification required — this source did not state a per-weight dose this calculator can compute from.
SPL section 34068-7 (DOSAGE & ADMINISTRATION SECTION)
Adverse effects149
EFFECTIVENESS In a field study conducted in the United States (see), there were no adverse reactions reported in 145 dogs administered EASOTIC (hydrocortisone aceponate, miconazole nitrate, gentamicin sulfate) Otic Suspension for Dogs. In foreign market experience, reports of hearing loss and application site erythema have been received. In most reported cases, the hearing loss and erythema were transient and resolved with discontinuation of EASOTIC Otic Suspension. CONTACT INFORMATION To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Virbac AH, Inc. at 1-800-338-3659 or us.virbac.com. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or www.fda.gov/reportanimalae.
DogOn-label (ON_LABEL)United States1 source record · View provenance
- Dog · SPL section 34084-4 (ADVERSE REACTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
These are counts of spontaneously reported events, not proven adverse effects, causal relationships, or incidence rates.
Bars compare report counts within each species; they do not show incidence.
More reportsFewer reportsDog
- Loss of hearing294 reports
- Hearing affected145 reports
- Lack of efficacy - NOS77 reports
- Vomiting36 reports
- Deafness27 reports
- Lethargy (see also Central nervous system depression in 'Neurological')22 reports
- Lethargy (see also Central nervous system depression in Neurological)22 reports
- Behavioural disorder NOS20 reports
- Diarrhoea20 reports
- Lack of efficacy (bacteria) - NOS19 reports
- Pinnal erythema19 reports
- Head shake - ear disorder18 reports
Cat
- Application site pain2 reports
- Ataxia2 reports
- Blood in vomit2 reports
- Bloody diarrhoea2 reports
- Decreased appetite2 reports
- Diarrhoea2 reports
- Ear infection NOS2 reports
- Ear pain2 reports
- Hearing affected2 reports
- Hypoglycaemia2 reports
- Lack of efficacy - NOS2 reports
- Vestibular disorder NOS2 reports
Contraindications1
Do not use in dogs with known tympanic membrane perforation. EASOTIC Otic Suspension is contraindicated in dogs with known or suspected hypersensitivity to corticosteroids, imidazole antifungals, or aminoglycoside antibiotics.
DogOn-label (ON_LABEL)United States1 source record · View provenance
- Dog · SPL section 34070-3 (CONTRAINDICATIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Precautions2
Human Warnings : Not for use in humans. Keep this and all drugs out of reach of children. In case of accidental skin contact, wash area thoroughly with soap and water. Avoid contact with eyes. Humans with known or suspected hypersensitivity to hydrocortisone, aminoglycoside antibiotics, or azole antifungals should not handle this product. In case of accidental ingestion by humans, contact a physician immediately. Physicians may contact a Poison Control Center for advice concerning cases of ingestion by humans. Animal Warnings ADVERSE REACTIONS : As a class, aminoglycoside antibiotics are associated with ototoxicity, vestibular dysfunction and renal toxicity. The use of EASOTIC Otic Suspension in a dog with a damaged tympanic membrane can result in damage to the structures of the ear associated with hearing and balance or in transmission of the infection to the middle or inner ear. Immediately discontinue use of EASOTIC OticSuspension if hearing loss or signs of vestibular dysfunction are observed during treatment (see).
DogOn-label (ON_LABEL)United States1 source record · View provenance
- Dog · SPL section 34071-1 (WARNINGS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Do not administer orally. ANIMAL SAFETY Concurrent administration of potentially ototoxic drugs should be avoided. Use with caution in dogs with impaired hepatic or renal function (see). ANIMAL SAFETY Long-term use of topical otic corticosteroids has been associated with adrenocortical suppression and iatrogenic hyperadrenocorticism in dogs (see). The safe use of EASOTIC Otic Suspension in dogs used for breeding purposes, during pregnancy, or in lactating bitches, has not been evaluated.
DogOn-label (ON_LABEL)United States1 source record · View provenance
- Dog · SPL section 42232-9 (PRECAUTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Pharmacokinetics1
Hydrocortisone aceponate is a glucocorticoid with anti-inflammatory effects. Miconazole nitrate is an imidazole antifungal. Gentamicin sulfate is an aminoglycoside antibiotic. In the target animal safety study, hydrocortisone aceponate, miconazole and gentamicin were shown to be systemically absorbed from the ears of healthy dogs (see ANIMAL SAFETY ); increased systemic absorption may be observed in inflamed ears.
DogOn-label (ON_LABEL)United States1 source record · View provenance
- Dog · SPL section 34090-1 (CLINICAL PHARMACOLOGY SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Literature references17
References are linked to this drug. Species applicability is not recorded here, so the species filter does not narrow this list. Imported dates do not retain their original precision; confirm dates in the original citation.
- Hydrocortisone Aceponate for Chronic Otitis: Long-Term Efficacy.
Study summary not available in the imported record. Open the original citation to review the study.
- Effects of the addition of hydrocortisone aceponate to intramammary procaine penicillin for treatment of intramammary infections in dairy cattle.
Study summary not available in the imported record. Open the original citation to review the study.
- Effect of ear cleaning on treatment outcome for canine otitis externa.
Study summary not available in the imported record. Open the original citation to review the study.
- Efficacy and safety of a hydrocortisone aceponate-containing ear spray solution in dogs with erythemato-ceruminous otitis externa: A randomised, multicentric, single-blinded, controlled trial.
Study summary not available in the imported record. Open the original citation to review the study.
- Efficacy and safety of 0.0584% hydrocortisone aceponate topical spray and systemic oclacitinib combination therapy in dogs with atopic dermatitis: a randomized, double-blinded, placebo-controlled trial.
Study summary not available in the imported record. Open the original citation to review the study.
Sources: DailyMed, U.S. National Library of Medicine; PubMed, National Library of Medicine; openFDA, U.S. Food and Drug Administration.