Regulatory product record
EASOTIC
Product identity, ingredients and source provenance from the regulatory catalogue. Linked clinical evidence has a separate review status.
Owner information handout
Plain-language medication information to review with the owner. Open the handout to print it or download a PDF.
Product identity
- Brand name
- EASOTIC
- DIN
- 02424576
- DPD drug code
- 90925
- Regulatory category
- APPROVED_VET_DRUG
- Market status
- MARKETED
- Route(s)
- OTIC
- Pharmaceutical form(s)
- SUSPENSION
- Ingredients
- GENTAMICIN (GENTAMICIN SULFATE) (1.5 MG), HYDROCORTISONE ACEPONATE (1.1 MG), MICONAZOLE NITRATE (17.4 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
- 90925
- 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.
Indications4
Serious gram-negative aerobic infections / staphylococci when safer drugs lack susceptibility or empiric coverage is urgent (sepsis, soft tissue/orthopedic, bacteremia)
DogCatExtra-label (EXTRA_LABEL)2 source records · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 567–569; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 353–354 — Indications table · Not applicable · Extra-label (EXTRA_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Original excerpt: Serious gram-negative aerobic infections / staphylococci when safer drugs lack susceptibility or empiric coverage is urgent (sepsis, soft tissue/orthopedic, bacteremia) — FDA-approved parenteral (dogs/cats); often extra-label by regimen
- Cat · Plumb's Veterinary Drug Handbook, 7th ed., p. 567–569; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 353–354 — Indications table · Not applicable · Extra-label (EXTRA_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Original excerpt: Serious gram-negative aerobic infections / staphylococci when safer drugs lack susceptibility or empiric coverage is urgent (sepsis, soft tissue/orthopedic, bacteremia) — FDA-approved parenteral (dogs/cats); often extra-label by regimen
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 567–569; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 353–354 — Indications table · Not applicable · Extra-label (EXTRA_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Brucellosis combination protocol (with minocycline/doxycycline)
DogExtra-label (EXTRA_LABEL)1 source record · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 567–569; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 353–354 — Indications table · Not applicable · Extra-label (EXTRA_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Original excerpt: Brucellosis combination protocol (with minocycline/doxycycline) — Extra-label
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 567–569; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 353–354 — Indications table · Not applicable · Extra-label (EXTRA_LABEL) · Pending clinical review (PROPOSED) · Rule-based
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 regimens7
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.
Select a species above to calculate a dose.
Adverse effects552
Nephrotoxicity — worse than amikacin — Tubular necrosis; usually reversible if stopped early
Other speciesNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Other species · Plumb's Veterinary Drug Handbook, 7th ed., p. 567–569; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 353–354 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Ototoxicity — leans VESTIBULAR (vs amikacin's auditory) — May be irreversible
CatNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Cat · Plumb's Veterinary Drug Handbook, 7th ed., p. 567–569; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 353–354 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Neuromuscular blockade — Myasthenia gravis risk
Other speciesNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Other species · Plumb's Veterinary Drug Handbook, 7th ed., p. 567–569; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 353–354 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
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
- Deafness2,101 reports
- Loss of hearing623 reports
- Temporary deafness489 reports
- Partial deafness384 reports
- Loss of hearing346 reports
- Vomiting343 reports
- PR-EAR(S), LESION(S)321 reports
- Lack of efficacy - NOS298 reports
- Loss of hearing294 reports
- Lethargy (see also Central nervous system depression in 'Neurological')208 reports
- Diarrhoea192 reports
- Emesis187 reports
Cat
- Ataxia34 reports
- Anorexia29 reports
- Deafness29 reports
- Vomiting24 reports
- Death by euthanasia22 reports
- Head tilt - ear disorder17 reports
- Depression15 reports
- Lack of efficacy - NOS15 reports
- Weight loss15 reports
- Lethargy (see also Central nervous system depression in 'Neurological')13 reports
- Vestibular disorder NOS13 reports
- Lack of efficacy - NOS13 reports
Monitoring1
Urine sediment + BUN/creatinine q2–3 days; serum levels if extended therapy (peak/trough); hearing/vestibular watch in cats
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 567–569; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 353–354 — Monitoring Parameters · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
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
Precautions7
Gentamicin assay artifact: beta-lactams falsely lower stored-sample levels — freeze samples, draw at beta-lactam trough.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 567–569; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 353–354 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Same risk set as amikacin: renal disease, neonate/geriatric, dehydration/fever/sepsis, working dogs, sighthounds (reduce dose); rabbits contraindicated
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 567–569; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 353–354 — Contraindications & Warnings table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Gentamicin = vestibular ototoxicity; amikacin = auditory — either can do both, but the exam leans this way. Cats: vestibular sensitivity.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 567–569; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 353–354 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Once-daily dosing logic identical to amikacin (peaks drive kill; low troughs spare the kidney) — exceptions: neutropenia (q8h), renal impairment (extend interval + TDM).
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 567–569; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 353–354 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Brucellosis protocol: gentamicin 5 mg/kg SC q24h weeks 1 & 4 + minocycline (or doxycycline) 25 mg/kg PO q24h × 4 weeks, repeated courses with serologic monitoring.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 567–569; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 353–354 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Interactions5
Loop/osmotic diuretics (furosemide, torsemide, mannitol) — ↑ nephro/ototoxicity
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 567–569; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 353–354 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Other nephrotoxins (amphotericin B, cisplatin, polymyxin B, vancomycin) — Additive renal injury
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 567–569; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 353–354 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Cephalosporins — Possible additive nephrotoxicity (historical, cephaloridine/cephalothin era)
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 567–569; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 353–354 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Beta-lactams — Synergy (Pseudomonas) — separate in vitro mixing; in-vivo inactivation in renal failure
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 567–569; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 353–354 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Neuromuscular blockers/anesthetics — Potentiated blockade
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 567–569; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 353–354 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Pharmacokinetics3
Class PK — As amikacin: extracellular distribution, renal elimination unchanged, negligible oral absorption
Other speciesNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Other species · Plumb's Veterinary Drug Handbook, 7th ed., p. 567–569; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 353–354 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Half-life — Short (~1–2 h small animals), prolonged in renal failure
Other speciesNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Other species · Plumb's Veterinary Drug Handbook, 7th ed., p. 567–569; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 353–354 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
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
Pregnancy / lactation considerations1
Category C / class C — last resort; fetal ototoxicity possible; milk passage.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 567–569; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 353–354 — Pregnancy & Lactation · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Literature references40
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.
- Comparative evaluation of nephrotoxicity and antibacterial activity of free and liposomal gentamicin in rats: Biochemical, molecular and histopathological analysis.
Study summary not available in the imported record. Open the original citation to review the study.
- Carvacrol potentiates gentamicin against Staphylococcus aureus via disrupting bacterial respiratory bioenergetics.
Study summary not available in the imported record. Open the original citation to review the study.
- Shelter dogs and cats as a one health interface for phenotypic and genomic surveillance of antimicrobial-resistant Enterococcus Spp. in the United Arab Emirates.
Study summary not available in the imported record. Open the original citation to review the study.
- Nitrendipine synergizes with multiple antibiotics against methicillin-resistant Staphylococcus aureus by disrupting membrane homeostasis.
Study summary not available in the imported record. Open the original citation to review the study.
- Antimicrobial prophylaxis regimens in joint replacement surgery: Susceptibility and PK/PD target attainment.
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; Plumb DC. Plumb's Veterinary Drug Handbook. 7th ed. PharmaVet Inc; 2011.