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Otoxolan

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Marbofloxacin + Clotrimazole + Dexamethasone · Krka

1 form: ear drops. No registration in force in Georgia.

Forms and doses0 of 1 in force in Georgia

The dose from the product's label, by species and weight. Check the label of the pack you use.

Form Species Dose Frequency Georgia
3 mg/ml + 10 mg/ml + 1 mg/ml, Ear drops · Dog Dog 10 drops
Shake for 30 seconds, then apply 10 drops into the affected ear once daily for 7–14 days. Reassess after 7 days. Confirm that the tympanic membrane is intact before use. Do not use during pregnancy, lactation, or in young growing animals unless specifically justified.
 · once daily, 7–14 days		 once daily, 7–14 days Georgia No
Not registered in Georgia
Veterinary (National Food Agency)
Verified on: 15 Oct 2026
Details: pack, label wording, sources, registration

Otoxolan 3 mg/ml + 10 mg/ml + 1 mg/ml, Ear drops

ear drops suspension, for dogs
vetman assessment
vetman’s 10-point assessment brings together a product’s regulatory credibility, clinical efficacy, safety and practicality. Cost-effectiveness is assessed only when reliable data are available. It is informational and does not replace a veterinarian’s clinical judgment for an individual patient.
Dog
7.4/10
Good
vetman assessment

Otoxolan

3 mg/ml + 10 mg/ml + 1 mg/ml, ear drops suspension, for dogs
Assessed clinical scopeDog · Label-concordant treatment of canine otitis externa caused by marbofloxacin-susceptible bacteria and clotrimazole-susceptible fungi, especially Malassezia pachydermatis, with concurrent control of inflammation · Into the ear
Care settingVeterinary diagnosis and selection after otoscopy and cytology; outpatient administration after cleaning and drying, with day-7 veterinary reassessment and investigation of the underlying cause.
vetman score 7.4/10 Good
Evidence confidence: Medium Georgia: No · Verified on 15 Oct 2026

A good authorised generic option with regulator-accepted equivalence to Aurizon, but without an independent exact-product outcome trial. Use only after otoscopy and cytology, reserve the fluoroquinolone appropriately and reassess before extending beyond seven days.

Regulatory and scientific credibility8.5/10

Otoxolan has current exact EU/EEA and GB veterinary authorisations, regulator-hosted product information and a public generic dossier accepting qualitative and physicochemical equivalence to Aurizon. It is not registered in the checked Georgian or US registers.

Clinical efficacy7.0/10

The regulator accepted equivalent efficacy claims to Aurizon from matching composition and physicochemical characteristics; the reference combination has comparative canine evidence for bacterial/fungal otitis and Malassezia-associated inflammation. There is no independent exact-product outcome trial, and success still depends on cytology, susceptibility where indicated and control of the underlying cause.

Safety and tolerability7.0/10

Topical exposure is much lower than systemic treatment, but the intact tympanic membrane must be confirmed. Rare mostly transient deafness, local irritation and corticosteroid-related skin thinning, delayed healing, laboratory changes or adrenal suppression are possible; avoid pregnancy/lactation and unnecessary use in growing dogs.

Clinical practicality7.0/10

Ten drops once daily for 7-14 days is manageable, but the viscous suspension requires 30 seconds of shaking, dropper filling, a separate dropper per dog, prior cleaning/drying and veterinary reassessment at day 7. The fixed ten-drop dose and three-month in-use shelf life are practical but not long-acting.

Full-course cost-effectiveness-

Price was not assessed and is excluded from the overall score.

Important safety and use flags

  • Perform otoscopy and verify an intact tympanic membrane before every course. Do not use with a perforated or unvisualised tympanum; stop and reassess urgently for head tilt, nystagmus, ataxia, hearing change or other vestibular signs.
  • Cytology is required in every otitis externa case and should be repeated at recheck. Sample before cleaning; identify and manage allergy, foreign body, parasites, conformation, endocrine disease, otitis media or another primary/perpetuating cause rather than repeatedly suppressing secondary infection.
  • Marbofloxacin is an EMA AMEG Category B fluoroquinolone. Do not use this combination prophylactically or as a routine first choice; use a lower-category topical option when likely effective and document why a fluoroquinolone is required. Culture and susceptibility are especially important with rods, chronic/recurrent disease or poor response.
  • Do not use when resistance to marbofloxacin or clotrimazole is known, or with hypersensitivity to fluoroquinolones, azole antifungals, corticosteroids or excipients. Failure despite correct administration requires diagnosis and susceptibility review, not automatic repetition or prolongation.
  • Avoid use in young growing dogs unless the exceptional need clearly outweighs the risk. Quinolones are associated with weight-bearing cartilage injury and arthropathy in immature animals.
  • Do not use during pregnancy or lactation. Record reproductive status before treatment and choose a suitable alternative for pregnant, breeding or nursing animals.
  • Clean and dry the external canal before dosing, shake the suspension as directed, instil exactly ten drops once daily and massage the ear base gently. Reassess at day 7 before extending to 14 days; use a separate cannula/dropper for each dog and do not continue beyond the labelled course.
  • Rare, usually transient deafness is reported, mainly in older dogs. Establish baseline hearing and neurologic status when relevant; stop and reassess promptly for reduced hearing, pain, marked erythema, vestibular signs or worsening discharge.
  • Prolonged or intensive topical corticosteroid exposure can cause skin thinning, delayed healing, biochemical/haematological changes and adrenal suppression. Avoid duplicate otic/systemic corticosteroids without review and investigate persistent inflammation rather than extending treatment.
  • Avoid skin and eye contact, wash hands after administration and keep the applicator uncontaminated. People hypersensitive to fluoroquinolones, azole antifungals or corticosteroids should avoid handling; seek medical advice after accidental ingestion or persistent exposure symptoms.
Assessment sources
  1. VMD SPC 20242024
  2. Otoxolan VMD assessment2016
  3. Canine otitis phase III comparison2005
  4. Canine Malassezia otitis comparison2006
  5. AIDAP canine otitis guideline2022
  6. AAHA allergic otitis guideline2023
  7. Recurrent canine otitis review2023
  8. EMA AMEG fluoroquinolone category2019
Assessed: 22 Oct 2026The overall score uses 25/25/25/15/10 weights. An unassessed price is excluded and the remaining weights are proportionally renormalised.
Composition / strength
Marbofloxacin3 mg/ml Clotrimazole10 mg/ml Dexamethasone0.9 mg/ml
Formulation Type
Ear drops
Administration route
Into the ear
Manufacturer
Krka · Slovenia
Registration
Georgia No
Not registered in Georgia
Veterinary (National Food Agency)
Verified on: 15 Oct 2026
 EU Yes, veterinary
Verified on: 15 Oct 2026
 UK Yes, veterinary
Verified on: 15 Oct 2026
 US No
Verified on: 15 Oct 2026
Controlled in Georgia
No
Checked against the narcotics law, Annex 1, lists I-IV, and Order No. 22/n.
Verified on: 16 Oct 2026
DoseSpeciesWeightRouteFrequencySource
10 drops
Shake for 30 seconds, then apply 10 drops into the affected ear once daily for 7–14 days. Reassess after 7 days. Confirm that the tympanic membrane is intact before use. Do not use during pregnancy, lactation, or in young growing animals unless specifically justified.
 Dog Any weight Into the ear once daily, 7–14 days
VMD SPC 2024
Official product label (SPC), VMD, UK
Approved by the UK Veterinary Medicines Directorate (VMD) as part of the product's authorisation. It applies to that product as authorised there.
Otoxolan Ear Drops, Suspension for Dogs - UK SPC
VMD Product Information Database, 2024
Active substance doses, with sources
Active substance Marbofloxacin
Dose calculatorCalculates the active-substance amount; it is not a prescription.
PatientSpecies and weight will be filled in automatically in other calculators.
Selected dose
Dose Species Indication Route Frequency Source
2 mg/kg Dog, Cat Bacterial Infection; Skin and Soft Tissue Infection By mouth / Subcutaneous once daily
VMD SPC 2025
Official product label (SPC), VMD, UK
Approved by the UK Veterinary Medicines Directorate (VMD) as part of the product's authorisation. It applies to that product as authorised there.
Marbocyl P 5 mg Tablet for Dogs and Cats - Summary of Product Characteristics
UK Veterinary Medicines Directorate, Product Information Database, 2025
VMD Marbocyl SA SPC
Official product label (SPC)
Approved by a medicines regulator as part of the product's authorisation. It applies to that product as authorised there.
Marbocyl SA 200 mg powder and solvent for solution for injection - Summary of Product Characteristics
UK Veterinary Medicines Directorate, Product Information Database, 2025
2.75–5.5 mg/kg Dog, Cat Bacterial Infection By mouth once daily
FDA 2019
Official product label (SPC), FDA, US
Approved by the US Food and Drug Administration (FDA) as part of the product's authorisation. It applies to that product as authorised there.
Zeniquin (marbofloxacin) Tablets - FDA-approved animal drug label, NADA 141-151
US Food and Drug Administration, via DailyMed, 2019
5.5 mg/kg Dog Skin and Soft Tissue Infection By mouth once daily
ISCAID 2025
Guideline or consensus statement
Recommendations agreed by a panel of veterinary specialists after reviewing the evidence. They guide practice and do not authorise a product.
Antimicrobial use guidelines for canine pyoderma by the International Society for Companion Animal Infectious Diseases (ISCAID)
Veterinary Dermatology, 2025
2 mg/kg Dog Skin and Soft Tissue Infection Subcutaneous Single dose
VMD Marbocyl SA SPC
Official product label (SPC)
Approved by a medicines regulator as part of the product's authorisation. It applies to that product as authorised there.
Marbocyl SA 200 mg powder and solvent for solution for injection - Summary of Product Characteristics
UK Veterinary Medicines Directorate, Product Information Database, 2025
Active substance Dexamethasone
Dose calculatorCalculates the active-substance amount; it is not a prescription.
PatientSpecies and weight will be filled in automatically in other calculators.
Selected dose
Dose Species Indication Route Frequency Source
0.05–0.2 mg/kg Dog Inflammation By mouth once daily in the morning
VMD SPC 2025
Official product label (SPC), VMD, UK
Approved by the UK Veterinary Medicines Directorate (VMD) as part of the product's authorisation. It applies to that product as authorised there.
Dexacortone 0.5 mg and 2.0 mg Chewable Tablets for Dogs and Cats - Summary of Product Characteristics
UK Veterinary Medicines Directorate, 2025
0.1 mg/kg Dog, Cat Allergic Reaction Intramuscular as needed
VMD SPC 2025
Official product label (SPC), VMD, UK
Approved by the UK Veterinary Medicines Directorate (VMD) as part of the product's authorisation. It applies to that product as authorised there.
Dexadreson 2 mg/ml Solution for Injection - Summary of Product Characteristics
UK Veterinary Medicines Directorate, 2025
0.05–0.2 mg/kg Cat Inflammation By mouth once daily in the evening
VMD SPC 2025
Official product label (SPC), VMD, UK
Approved by the UK Veterinary Medicines Directorate (VMD) as part of the product's authorisation. It applies to that product as authorised there.
Dexacortone 0.5 mg and 2.0 mg Chewable Tablets for Dogs and Cats - Summary of Product Characteristics
UK Veterinary Medicines Directorate, 2025

Clotrimazole: No dose supported by a publicly verifiable source yet

Known Contraindications

  • Critical Dexamethasone
    Do not use corticosteroids, topically or systemically, while a corneal ulcer is present. They slow healing of the corneal epithelium and can increase collagenase activity, which may turn the ulcer into a melting ulcer.
    Sources: MSD Vet Manual
  • Critical Dexamethasone
    Do not use dexamethasone in animals with diabetes mellitus or hyperadrenocorticism unless specifically required and closely monitored.
    Sources: VMD SPC · VMD
  • Critical Dexamethasone
    Do not use in animals with diabetes mellitus or hyperadrenocorticism.
    Sources: VMD SPC · VMD
  • Critical Dexamethasone
    Do not use dexamethasone in animals with osteoporosis because corticosteroids increase protein catabolism and can reduce bone mass.
    Sources: VMD SPC · VMD
  • Critical Dexamethasone
    Do not use dexamethasone in animals with cardiac or renal dysfunction, including congestive heart failure, unless specifically required and closely monitored.
    Sources: VMD SPC · VMD
  • Critical Dexamethasone
    the product should not be used in animals suffering from diabetes, chronic nephritis, renal disease, congestive heart failure, osteoporosis and in viral infections during the viraemic stage
    Sources: VMD SPC · VMD
  • Critical Dexamethasone
    Do not use in animals with cardiac or renal dysfunction.
    Sources: VMD SPC · VMD
  • Critical Dexamethasone
    Do not use in animals with gastro-intestinal ulceration.
    Sources: VMD SPC · VMD
  • Critical Dexamethasone
    Do not use dexamethasone in animals with glaucoma.
    Sources: VMD SPC · VMD
  • Critical Dexamethasone
    Do not use systemic dexamethasone in animals with burns unless specifically indicated and closely monitored.
    Sources: VMD SPC · VMD
  • Critical Dexamethasone
    Do not use dexamethasone during pregnancy because early exposure can cause fetal abnormalities and late exposure can induce abortion or premature parturition.
    Sources: VMD SPC · VMD
  • Critical Dexamethasone
    Known hypersensitivity to dexamethasone, another corticosteroid, or any excipient is a contraindication.
    Sources: VMD SPC · VMD
  • Critical Dexamethasone
    Do not use in animals with viral or mycotic infections.
    Sources: VMD SPC · VMD
  • Warning Dexamethasone
    Use with particular caution in an immunocompromised patient because corticosteroids delay wound healing and can exacerbate an existing infection.
    Sources: VMD SPC · VMD
  • Warning Dexamethasone
    Corticoids such as dexamethasone should be used with caution in patients with hypertension.
    Sources: VMD SPC · VMD
  • Warning Dexamethasone
    Since glucocorticosteroids are known to slow growth, use in young animals (under 7 months of age) should be based on a benefit/risk assessment by the attending veterinarian.
    Sources: VMD SPC · VMD
  • Warning Dexamethasone
    Do not use concomitantly with attenuated alive vaccine dexamethasone should not be used in combination with vaccines or within two weeks after vaccination
    Sources: VMD SPC · VMD
  • Caution Dexamethasone
    Due to the long duration of effect of dexamethasone alternate day therapy is not an adequate way to allow the hypothalamic-pituitary-adrenal axis to recover.
    Sources: VMD SPC · VMD
  • Caution Dexamethasone
    Use cautiously in geriatric or debilitated animals because corticosteroids increase protein catabolism. Prolonged treatment can cause cushingoid changes, including fat redistribution, muscle weakness and atrophy, and osteoporosis.
    Sources: VMD SPC · VMD
  • Critical Marbofloxacin
    Do not use in animals hypersensitive to fluoroquinolones or any product component. Do not use where quinolone resistance is confirmed; cross-resistance among fluoroquinolones is almost complete.
    Sources: VMD SPC · VMD · FDA
  • Critical Marbofloxacin (Dog)
    Age limits differ by product: one label prohibits use in dogs younger than 12 months and in slow-growing large breeds younger than 18 months; another uses 8 months for small/medium breeds, 12 months for large breeds, and 18 months for giant breeds. Fluoroquinolones can erode articular cartilage in growing dogs.
    Sources: VMD SPC · VMD · FDA
  • Warning Marbofloxacin
    Use with caution in dogs or cats with epilepsy because fluoroquinolones can cause neurological adverse effects. Overdose may cause acute neurological disturbances requiring symptomatic management.
    Sources: VMD SPC · VMD
  • Warning Marbofloxacin
    Safety in pregnant dogs and cats has not been established. Use only after a benefit-risk assessment. Studies in pregnant rats and rabbits found no adverse effects, but target-species studies are lacking; this means unassessed, not proven safe.
    Sources: VMD SPC · VMD
  • Warning Marbofloxacin
    Safety during lactation in dogs and cats has not been established. Use only after a benefit-risk assessment; the reviewed labels provide pregnancy data but no separate lactation statement.
    Sources: FDA

Known Drug Interactions

  • Contraindicated Robenacoxib + Dexamethasone
    Do not give robenacoxib together with other non-steroidal anti-inflammatory drugs or glucocorticoids because adverse gastrointestinal and renal effects may increase.
    Recommendation: Do not use these drugs together. Allow a treatment-free interval of at least 24 hours after the previous anti-inflammatory drug, extending it when required by that drug’s pharmacokinetics.
  • Major warning Marbofloxacin + Aminophylline
    Theophylline metabolism is inhibited by... enrofloxacin, and marbofloxacin
    Recommendation: Reduce the aminophylline dose during concomitant use. Signs of toxicity include vomiting, excitation, tachyarrhythmia, and seizures.
    Sources: MSD Vet Manual
  • Major warning Meloxicam + Dexamethasone
    The concomitant use of this veterinary medicinal product with non-steroidal anti-inflammatory drugs may exacerbate gastrointestinal tract ulceration.
    Recommendation: Avoid concurrent administration. Observe an appropriate washout period when switching. If both are essential, provide gastroprotection and monitor gastrointestinal signs closely.
    Sources: VMD SPC · VMD
  • Major warning Carprofen + Dexamethasone
    Do not give other non-steroidal anti-inflammatory drugs or glucocorticoids concurrently with carprofen or within 24 hours of treatment because gastrointestinal ulceration or perforation may occur.
    Recommendation: Consider appropriate washout times when switching from one NSAID to another or when switching from corticosteroid use to NSAID use.
    Sources: FDA
  • Major warning Dexamethasone + Insulin glargine
    Glucocorticoids, progestogens, and certain endocrinopathies can have an antagonistic effect on insulin activity. Glucocorticoid and progestogen use should be avoided.
    Recommendation: Avoid the combination. If the glucocorticoid cannot be discontinued within 2 weeks, the insulin dose may need to be increased; monitor glycaemia.
    Sources: FDA · AAHA
  • Major warning Dexamethasone + Insulin human
    Glucocorticoids, progestogens, and certain endocrinopathies can have an antagonistic effect on insulin activity. Glucocorticoid and progestogen use should be avoided.
    Recommendation: Avoid the combination. If the glucocorticoid cannot be discontinued within 2 weeks, the insulin dose may need to be increased; monitor glycaemia.
    Sources: FDA · AAHA
  • Major warning Marbofloxacin + Sucralfate
    Sucralfate, antacids, and mineral supplements containing iron, aluminium, calcium, magnesium, zinc, or other divalent or trivalent cations can reduce quinolone absorption and bioavailability. The magnitude is drug-specific; marbofloxacin is covered by a direct product warning.
    Recommendation: Avoid concurrent oral administration. If both medicines are necessary, separate sucralfate or the cation-containing product from the quinolone by at least 2 hours and monitor clinical response.
    Sources: VMD SPC · VMD · FDA · ACVIM · JVIM
  • Major warning Marbofloxacin + Theophylline
    Fluoroquinolones can increase serum theophylline concentrations. When marbofloxacin and theophylline are used together, monitor theophylline closely because its therapeutic range is narrow and toxicity may occur.
    Recommendation: If concomitant use is necessary, monitor serum theophylline and be prepared to reduce its dose. Alternatively, choose another antibiotic.
    Sources: VMD SPC · VMD
  • Minor warning Furosemide + Dexamethasone
    The risk of hypokalaemia may be increased if dexamethasone is administered together with potassium depleting diuretics.
    Recommendation: Monitor serum potassium. Hypokalaemia also increases cardiac glycoside toxicity.
    Sources: VMD SPC · VMD
  • Minor warning Dexamethasone + Torasemide
    The risk of hypokalaemia may be increased if dexamethasone is administered together with potassium depleting diuretics.
    Recommendation: Monitor serum potassium.
    Sources: VMD SPC · VMD

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