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Active substance

Polymyxin B

Favourites

Polypeptide antibiotic. Registered in Georgia: 2 veterinary products. Forms: ear drops.

Dose and use

Doses

We have no dose with a cited source for this substance yet.

Before use

Safety information

Known Contraindications

  • Critical
    Do not use if hypersensitive to polymyxin B.
Latin name
Polymyxin B
Georgian name
პოლიმიქსინი B
Authorisation status
Authorised veterinary medicine
An authorised veterinary medicine containing this substance exists. Whether a particular use is on-label depends on the species and the indication - see each dose rule.
Registered in Georgia
2 of 2 forms
Products
Otimix Plus, Ototop
Controlled in Georgia
No
Checked against the narcotics law, Annex 1, lists I-IV, and Order No. 22/n.
Verified on: 18 Oct 2026
All forms and registration2

Registration in Georgia and abroad: the register, number, validity and source are behind (i).

Otimix Plus, Ear drops

miconazole nitrate 23 mg/ml + polymyxin B sulfate 5500 IU/ml + prednisolone acetate 5 mg/ml, ear drops, suspension for dogs and cats
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 Label-concordant topical treatment of limited dermatitis caused by susceptible bacterial/fungal organisms in dogs, with primary dermatosis management
6.6/10
Situational / acceptable
vetman assessment

Otimix Plus

miconazole nitrate 23 mg/ml + polymyxin B sulfate 5500 IU/ml + prednisolone acetate 5 mg/ml, ear drops, suspension for dogs and cats
Assessed clinical scopeDog · Label-concordant topical treatment of limited dermatitis caused by susceptible bacterial/fungal organisms in dogs, with primary dermatosis management · On the skin
Care settingVeterinary skin diagnosis with cytology/culture where indicated, clipping and limited-area twice-daily application with lick prevention and planned recheck
vetman score 6.6/10 Situational / acceptable
Evidence confidence: Low Georgia: Yes, veterinary · Verified on 22 Oct 2026

A plausible labelled option for culture-compatible limited infected dermatitis, but direct skin-outcome evidence is thin and steroid/AMEG-B exposure makes empirical or prolonged use unattractive.

Regulatory and scientific credibility8.0/10

The exact 15 ml dog/cat product has a current national EU regulator record, transparent exact instruction and Georgian registration; it is a generic of an established same-strength combination. Exact independent Otimix outcome/pharmacovigilance data and multi-country dossier breadth are limited.

Clinical efficacy6.0/10

The label and component spectrum support susceptible limited dermatitis, but direct modern canine outcomes for this fixed combination are sparse and broad empirical triple therapy is not justified. Primary allergic/parasitic disease and resistant organisms can defeat apparent short-term improvement.

Safety and tolerability6.0/10

Limited-area short-course exposure is usually manageable, but prednisolone can cause local immunosuppression, epidermal thinning, delayed healing and systemic adrenal effects with extensive, occluded, highly perfused or ingested use. Antimicrobial resistance and hypersensitivity remain.

Clinical practicality6.0/10

Ready-to-use drops and twice-daily limited-area application are workable, but clipping, gloves, full coverage, lick prevention and recheck are required; persistent fungal disease must transition away from steroid, making open-ended home continuation inappropriate.

Full-course cost-effectiveness-

Current Georgian full-course price and pack-wastage data were unavailable; price is excluded from the denominator.

Important safety and use flags

  • Use only on a diagnosed limited susceptible dermatitis. Do not apply to an undiagnosed wound, extensive/ulcerated skin or under an impermeable dressing without a specific monitored plan.
  • Perform cytology and use culture/susceptibility when indicated. Polymyxin B is AMEG category B: reserve it for cases where category C/D antimicrobials are not expected to work; consider cross-resistance with colistin and other imidazoles.
  • Clip as needed, shake, cover the lesion with a few drops twice daily and rub with a gloved hand, generally no more than 14 days. Recheck cure and the underlying disease.
  • Long or extensive corticosteroid exposure can cause local immunosuppression, secondary infection, epidermal thinning, delayed healing, telangiectasia/bleeding and systemic adrenal effects; licking and occlusion increase exposure.
  • For persistent fungal disease beyond the short labelled course, continue with a corticosteroid-free preparation if still indicated; do not prolong prednisolone merely because inflammation rebounds.
  • Otimix Plus is only adjunctive when Otodectes cynotis coexists with susceptible secondary infection. Diagnose and treat mites with an appropriate acaricide and manage all in-contact animals/environment as indicated.
  • Do not use with hypersensitivity to miconazole, polymyxin B, prednisolone or excipients. Pregnancy/lactation safety is unestablished; use only after veterinarian benefit–risk assessment.
  • Treat the primary cause—commonly allergy, parasites, foreign body, conformation or endocrine disease—or recurrence is likely. Steroid-driven relief does not prove microbial eradication.
  • Shake well and prevent dropper contact with ear, skin or fingers. Wear gloves, wash hands and avoid eye/skin contact or ingestion; pregnant or breastfeeding handlers should use particular caution.
  • Store below 25°C and discard three months after first opening. Document opening date, course, organism/susceptibility basis and recheck result; do not keep using a contaminated communal bottle.
Assessment sources
  1. Otimix Czech label2026
  2. Otimix exact instruction2026
  3. Surolan VMD control2025
  4. Surolan Canada control2018
  5. MSD pyoderma2026
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.
Dog Label-concordant treatment of external otitis caused by susceptible bacterial/fungal organisms in dogs, with intact tympanum and cause-directed management
6.9/10
Situational / acceptable
vetman assessment

Otimix Plus

miconazole nitrate 23 mg/ml + polymyxin B sulfate 5500 IU/ml + prednisolone acetate 5 mg/ml, ear drops, suspension for dogs and cats
Assessed clinical scopeDog · Label-concordant treatment of external otitis caused by susceptible bacterial/fungal organisms in dogs, with intact tympanum and cause-directed management · Into the ear
Care settingVeterinary otoscopy/cytology, intact tympanum confirmation, cleaning and susceptibility-led selection; instructed twice-daily application with massage and planned clinical/cytological recheck
vetman score 6.9/10 Situational / acceptable
Evidence confidence: Medium Georgia: Yes, veterinary · Verified on 22 Oct 2026

An evidence-supported but stewardship-restricted triple ear drop for susceptible external otitis with an intact tympanum. It is useful when diagnostics fit, not a default for every inflamed ear.

Regulatory and scientific credibility8.0/10

The exact 15 ml dog/cat product has a current national EU regulator record, transparent exact instruction and Georgian registration; it is a generic of an established same-strength combination. Exact independent Otimix outcome/pharmacovigilance data and multi-country dossier breadth are limited.

Clinical efficacy7.5/10

Multiple controlled trials of the same three-active combination support canine otitis efficacy, but cure is not universal and modern trials show suitable alternatives can match or outperform it. Activity depends on actual susceptibility, cleaning and correction of primary disease.

Safety and tolerability5.5/10

An intact tympanum is a hard prerequisite because polymyxin B is potentially ototoxic; very rare deafness is reported and steroid/antimicrobial exposure can mask or select persistent infection. Local/systemic corticosteroid effects, hypersensitivity and pregnancy uncertainty remain.

Clinical practicality6.5/10

Three to five drops twice daily for 7–14 days is familiar and feasible after cleaning, but requires reliable home adherence, massage, dropper hygiene and recheck. Otoscopy/intact-tympanum confirmation and AMEG-B susceptibility justification add necessary clinical work.

Full-course cost-effectiveness-

Current Georgian full-course price and pack-wastage data were unavailable; price is excluded from the denominator.

Important safety and use flags

  • Never use unless otoscopy confirms an intact tympanum. Polymyxin B is potentially ototoxic; perforation, suspected middle-ear disease, new vestibular signs or hearing change requires stopping and immediate reassessment.
  • Perform cytology and use culture/susceptibility when indicated. Polymyxin B is AMEG category B: reserve it for cases where category C/D antimicrobials are not expected to work; consider cross-resistance with colistin and other imidazoles.
  • Clean the external canal, shake well, apply 3–5 drops twice daily and massage the base. Treat at least 7–10 and no more than 14 days, with clinical and cytological recheck rather than stopping on appearance alone.
  • Long or extensive corticosteroid exposure can cause local immunosuppression, secondary infection, epidermal thinning, delayed healing, telangiectasia/bleeding and systemic adrenal effects; licking and occlusion increase exposure.
  • Very rare deafness is reported, especially in older dogs. Stop for new hearing loss, head tilt, nystagmus, ataxia or severe pain and investigate otitis media/interna.
  • Otimix Plus is only adjunctive when Otodectes cynotis coexists with susceptible secondary infection. Diagnose and treat mites with an appropriate acaricide and manage all in-contact animals/environment as indicated.
  • Do not use with hypersensitivity to miconazole, polymyxin B, prednisolone or excipients. Pregnancy/lactation safety is unestablished; use only after veterinarian benefit–risk assessment.
  • Treat the primary cause—commonly allergy, parasites, foreign body, conformation or endocrine disease—or recurrence is likely. Steroid-driven relief does not prove microbial eradication.
  • Shake well and prevent dropper contact with ear, skin or fingers. Wear gloves, wash hands and avoid eye/skin contact or ingestion; pregnant or breastfeeding handlers should use particular caution.
  • Store below 25°C and discard three months after first opening. Document opening date, course, organism/susceptibility basis and recheck result; do not keep using a contaminated communal bottle.
Assessment sources
  1. Otimix Czech label2026
  2. Otimix exact instruction2026
  3. Surolan VMD control2025
  4. Surolan Canada control2018
  5. Canine otitis phase III2005
  6. Canine combination trial1991
  7. Burow versus Surolan2021
  8. MSD otitis externa2026
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.
Cat Label-concordant topical treatment of limited dermatitis caused by susceptible bacterial/fungal organisms in cats, with primary dermatosis management
6.2/10
Situational / acceptable
vetman assessment

Otimix Plus

miconazole nitrate 23 mg/ml + polymyxin B sulfate 5500 IU/ml + prednisolone acetate 5 mg/ml, ear drops, suspension for dogs and cats
Assessed clinical scopeCat · Label-concordant topical treatment of limited dermatitis caused by susceptible bacterial/fungal organisms in cats, with primary dermatosis management · On the skin
Care settingVeterinary skin diagnosis with cytology/culture where indicated, clipping and limited-area twice-daily application with lick prevention and planned recheck
vetman score 6.2/10 Situational / acceptable
Evidence confidence: Low Georgia: Yes, veterinary · Verified on 22 Oct 2026

A weakly evidenced feline skin option whose fixed antibiotic-antifungal-steroid mix, grooming exposure and imprecise lesion dose justify narrow, reassessed use only.

Regulatory and scientific credibility8.0/10

The exact 15 ml dog/cat product has a current national EU regulator record, transparent exact instruction and Georgian registration; it is a generic of an established same-strength combination. Exact independent Otimix outcome/pharmacovigilance data and multi-country dossier breadth are limited.

Clinical efficacy5.5/10

The feline dermatitis indication is regulator-supported, but direct outcome evidence is very limited and grooming increases exposure. Cytology/culture and diagnosis of the primary dermatosis are essential; short-term steroid improvement does not prove infection cure.

Safety and tolerability5.5/10

Skin exposure plus grooming/ingestion increases local and systemic corticosteroid uncertainty in cats. Immunosuppression, delayed healing, secondary infection, resistance and hypersensitivity require a limited area, short course and lick prevention.

Clinical practicality5.5/10

Twice-daily lesion coverage, clipping and lick prevention are difficult in many cats, while an imprecise “few drops” skin dose complicates consistent exposure. Gloves, recheck and switching away from steroid for persistent fungal disease add burden.

Full-course cost-effectiveness-

Current Georgian full-course price and pack-wastage data were unavailable; price is excluded from the denominator.

Important safety and use flags

  • Use only on a diagnosed limited susceptible dermatitis. Do not apply to an undiagnosed wound, extensive/ulcerated skin or under an impermeable dressing without a specific monitored plan.
  • Perform cytology and use culture/susceptibility when indicated. Polymyxin B is AMEG category B: reserve it for cases where category C/D antimicrobials are not expected to work; consider cross-resistance with colistin and other imidazoles.
  • Clip as needed, shake, cover the lesion with a few drops twice daily and rub with a gloved hand, generally no more than 14 days. Recheck cure and the underlying disease.
  • Long or extensive corticosteroid exposure can cause local immunosuppression, secondary infection, epidermal thinning, delayed healing, telangiectasia/bleeding and systemic adrenal effects; licking and occlusion increase exposure.
  • For persistent fungal disease beyond the short labelled course, continue with a corticosteroid-free preparation if still indicated; do not prolong prednisolone merely because inflammation rebounds.
  • Otimix Plus is only adjunctive when Otodectes cynotis coexists with susceptible secondary infection. Diagnose and treat mites with an appropriate acaricide and manage all in-contact animals/environment as indicated.
  • Do not use with hypersensitivity to miconazole, polymyxin B, prednisolone or excipients. Pregnancy/lactation safety is unestablished; use only after veterinarian benefit–risk assessment.
  • Treat the primary cause—commonly allergy, parasites, foreign body, conformation or endocrine disease—or recurrence is likely. Steroid-driven relief does not prove microbial eradication.
  • Shake well and prevent dropper contact with ear, skin or fingers. Wear gloves, wash hands and avoid eye/skin contact or ingestion; pregnant or breastfeeding handlers should use particular caution.
  • Store below 25°C and discard three months after first opening. Document opening date, course, organism/susceptibility basis and recheck result; do not keep using a contaminated communal bottle.
Assessment sources
  1. Otimix Czech label2026
  2. Otimix exact instruction2026
  3. Surolan VMD control2025
  4. Surolan Canada control2018
  5. MSD pyoderma2026
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.
Cat Label-concordant treatment of external otitis caused by susceptible bacterial/fungal organisms in cats, with intact tympanum and cause-directed management
6.6/10
Situational / acceptable
vetman assessment

Otimix Plus

miconazole nitrate 23 mg/ml + polymyxin B sulfate 5500 IU/ml + prednisolone acetate 5 mg/ml, ear drops, suspension for dogs and cats
Assessed clinical scopeCat · Label-concordant treatment of external otitis caused by susceptible bacterial/fungal organisms in cats, with intact tympanum and cause-directed management · Into the ear
Care settingVeterinary otoscopy/cytology, intact tympanum confirmation, cleaning and susceptibility-led selection; instructed twice-daily application with massage and planned clinical/cytological recheck
vetman score 6.6/10 Situational / acceptable
Evidence confidence: Low Georgia: Yes, veterinary · Verified on 22 Oct 2026

A regulator-supported feline option, but independent feline outcomes are limited and repeated handling plus ototoxicity/stewardship constraints make it conditional.

Regulatory and scientific credibility8.0/10

The exact 15 ml dog/cat product has a current national EU regulator record, transparent exact instruction and Georgian registration; it is a generic of an established same-strength combination. Exact independent Otimix outcome/pharmacovigilance data and multi-country dossier breadth are limited.

Clinical efficacy6.5/10

The exact label includes cats and mixed-species Otodectes plus limited feline reports support the same combination, but independent feline bacterial/fungal otitis outcomes are sparse. The product is only adjunctive for ear mites and susceptibility/primary disease remain decisive.

Safety and tolerability5.5/10

An intact tympanum is a hard prerequisite because polymyxin B is potentially ototoxic; very rare deafness is reported and steroid/antimicrobial exposure can mask or select persistent infection. Local/systemic corticosteroid effects, hypersensitivity and pregnancy uncertainty remain.

Clinical practicality6.0/10

The same small-volume twice-daily regimen is feasible, but many cats resist ear handling for 7–14 days. Safe restraint, cleaning, massage, dropper hygiene, cytological recheck and intact-tympanum confirmation create a meaningful adherence and welfare burden.

Full-course cost-effectiveness-

Current Georgian full-course price and pack-wastage data were unavailable; price is excluded from the denominator.

Important safety and use flags

  • Never use unless otoscopy confirms an intact tympanum. Polymyxin B is potentially ototoxic; perforation, suspected middle-ear disease, new vestibular signs or hearing change requires stopping and immediate reassessment.
  • Perform cytology and use culture/susceptibility when indicated. Polymyxin B is AMEG category B: reserve it for cases where category C/D antimicrobials are not expected to work; consider cross-resistance with colistin and other imidazoles.
  • Clean the external canal, shake well, apply 3–5 drops twice daily and massage the base. Treat at least 7–10 and no more than 14 days, with clinical and cytological recheck rather than stopping on appearance alone.
  • Long or extensive corticosteroid exposure can cause local immunosuppression, secondary infection, epidermal thinning, delayed healing, telangiectasia/bleeding and systemic adrenal effects; licking and occlusion increase exposure.
  • Very rare deafness is reported, especially in older dogs. Stop for new hearing loss, head tilt, nystagmus, ataxia or severe pain and investigate otitis media/interna.
  • Otimix Plus is only adjunctive when Otodectes cynotis coexists with susceptible secondary infection. Diagnose and treat mites with an appropriate acaricide and manage all in-contact animals/environment as indicated.
  • Do not use with hypersensitivity to miconazole, polymyxin B, prednisolone or excipients. Pregnancy/lactation safety is unestablished; use only after veterinarian benefit–risk assessment.
  • Treat the primary cause—commonly allergy, parasites, foreign body, conformation or endocrine disease—or recurrence is likely. Steroid-driven relief does not prove microbial eradication.
  • Shake well and prevent dropper contact with ear, skin or fingers. Wear gloves, wash hands and avoid eye/skin contact or ingestion; pregnant or breastfeeding handlers should use particular caution.
  • Store below 25°C and discard three months after first opening. Document opening date, course, organism/susceptibility basis and recheck result; do not keep using a contaminated communal bottle.
Assessment sources
  1. Otimix Czech label2026
  2. Otimix exact instruction2026
  3. Surolan VMD control2025
  4. Surolan Canada control2018
  5. Dog cat Otodectes trial2000
  6. Feline Malassezia cases2000
  7. MSD otitis externa2026
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
Miconazole23 mg/ml Polymyxin B5500 IU/ml Prednisolone5 mg/ml
Formulation Type
Ear drops
Administration route
Into the ear, On the skin
Manufacturer
Bioveta a.s. · Czechia
Registration
Georgia Yes, veterinary
Veterinary (National Food Agency)
In the register: ოტიმიქსი პლუსი
Verified on: 22 Oct 2026
 EU Yes, veterinary
№ CZ 96/053/23-C
Verified on: 22 Oct 2026
 UK No
Verified on: 22 Oct 2026
 US No
Verified on: 22 Oct 2026
Controlled in Georgia
No
Checked against the narcotics law, Annex 1, lists I-IV, and Order No. 22/n.
Verified on: 18 Oct 2026
Information not fully verified Shake well. Otitis: after cytology/otoscopy, cleaning and confirmation of intact tympanum, apply 3–5 drops into the affected external canal twice daily and massage; continue a few days after signs resolve, at least 7–10 and at most 14 days. Dermatitis: clip as needed, cover the lesion with a few drops twice daily and rub with a gloved hand, usually no more than 14 days; persistent fungal treatment should continue without corticosteroid. Recheck clinical and cytological cure.

Ototop, Ear drops

miconazole nitrate 23 mg/ml + prednisolone acetate 5 mg/ml + polymyxin B sulfate 5500 IU/ml, ear drops and cutaneous suspension
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 Label-concordant topical treatment of limited dermatitis caused by susceptible bacterial/fungal organisms in dogs, with primary dermatosis management
6.7/10
Situational / acceptable
vetman assessment

Ototop

miconazole nitrate 23 mg/ml + prednisolone acetate 5 mg/ml + polymyxin B sulfate 5500 IU/ml, ear drops and cutaneous suspension
Assessed clinical scopeDog · Label-concordant topical treatment of limited dermatitis caused by susceptible bacterial/fungal organisms in dogs, with primary dermatosis management · On the skin
Care settingVeterinary skin diagnosis with cytology/culture where indicated, clipping and limited-area twice-daily application with lick prevention and planned recheck
vetman score 6.7/10 Situational / acceptable
Evidence confidence: Medium Georgia: Yes, veterinary · Verified on 22 Oct 2026

A plausible labelled option for culture-compatible limited infected dermatitis, but direct skin-outcome evidence is thin and steroid/AMEG-B exposure makes empirical or prolonged use unattractive.

Regulatory and scientific credibility8.5/10

The exact dog/cat product has a current regulator leaflet, valid multi-country EU DCP, transparent three-pack identity, national-register corroboration and Georgian registration. The established same-strength combination has independent controls, although direct independent Ototop outcome data remain limited.

Clinical efficacy6.0/10

The label and component spectrum support susceptible limited dermatitis, but direct modern canine outcomes for this fixed combination are sparse and broad empirical triple therapy is not justified. Primary allergic/parasitic disease and resistant organisms can defeat apparent short-term improvement.

Safety and tolerability6.0/10

Limited-area short-course exposure is usually manageable, but prednisolone can cause local immunosuppression, epidermal thinning, delayed healing and systemic adrenal effects with extensive, occluded, highly perfused or ingested use. Antimicrobial resistance and hypersensitivity remain.

Clinical practicality6.0/10

Ready-to-use suspension and twice-daily thin-film application are workable, but clipping, gloves, full coverage, lick prevention and recheck are required; persistent fungal disease must transition away from steroid, making open-ended home continuation inappropriate.

Full-course cost-effectiveness-

Current Georgian full-course price and pack-wastage data were unavailable; price is excluded from the denominator.

Important safety and use flags

  • Use only on a diagnosed limited susceptible dermatitis. The exact label prohibits extensive lesions, poorly healing or fresh wounds and viral skin infections; avoid occlusion or an undiagnosed lesion.
  • Perform organism identification and susceptibility testing when possible. Polymyxin B is AMEG category B: prefer an effective lower-category option; known polymyxin B or miconazole resistance excludes use.
  • Clip and clean as needed, shake, apply a thin film twice daily and rub in, normally no more than 14 days. Persistent signs may require 2–3 weeks only with repeated examination and diagnostic verification; no numeric skin drop count is stated.
  • Long or extensive corticosteroid exposure can cause local immunosuppression, secondary infection, epidermal thinning, delayed healing, telangiectasia/bleeding and systemic adrenal effects; licking and occlusion increase exposure.
  • For persistent fungal disease beyond the short labelled course, continue with a corticosteroid-free preparation if still indicated; do not prolong prednisolone merely because inflammation rebounds.
  • Ototop is only adjunctive when Otodectes cynotis coexists with susceptible secondary infection. Diagnose and treat mites with an appropriate acaricide and manage all in-contact animals/environment as indicated.
  • Do not use with hypersensitivity to miconazole, polymyxin B, prednisolone, related corticosteroids/azoles or excipients. Pregnancy/lactation safety is unestablished; use only after veterinary benefit–risk assessment and avoid mammary-gland application.
  • Treat the primary cause—commonly allergy, parasites, foreign body, conformation or endocrine disease—or recurrence is likely. Steroid-driven relief does not prove microbial eradication.
  • Shake well and prevent dropper contact with ear, skin or fingers. Wear gloves, wash hands and avoid eye/skin contact or ingestion; pregnant or breastfeeding handlers should use particular caution.
  • Do not mix with another veterinary medicine because compatibility studies are absent. Store below 25°C and discard six months after first opening; document opening date, course, susceptibility basis and recheck result.
Assessment sources
  1. Ototop current regulator leaflet2025
  2. Ototop EU identity2026
  3. Surolan VMD control2025
  4. Surolan Canada control2018
  5. Surolan FDA control2026
  6. MSD pyoderma2026
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.
Dog Label-concordant treatment of external otitis caused by susceptible bacterial/fungal organisms in dogs, with intact tympanum and cause-directed management
7.1/10
Good
vetman assessment

Ototop

miconazole nitrate 23 mg/ml + prednisolone acetate 5 mg/ml + polymyxin B sulfate 5500 IU/ml, ear drops and cutaneous suspension
Assessed clinical scopeDog · Label-concordant treatment of external otitis caused by susceptible bacterial/fungal organisms in dogs, with intact tympanum and cause-directed management · Into the ear
Care settingVeterinary otoscopy/cytology, intact tympanum confirmation, cleaning and susceptibility-led selection; instructed twice-daily application with massage and planned clinical/cytological recheck
vetman score 7.1/10 Good
Evidence confidence: Medium Georgia: Yes, veterinary · Verified on 22 Oct 2026

An evidence-supported but stewardship-restricted triple ear drop for susceptible external otitis with an intact tympanum. It is useful when diagnostics fit, not a default for every inflamed ear.

Regulatory and scientific credibility8.5/10

The exact dog/cat product has a current regulator leaflet, valid multi-country EU DCP, transparent three-pack identity, national-register corroboration and Georgian registration. The established same-strength combination has independent controls, although direct independent Ototop outcome data remain limited.

Clinical efficacy7.5/10

Multiple controlled trials of the same three-active combination support canine otitis efficacy, but cure is not universal and modern trials show suitable alternatives can match or outperform it. Activity depends on actual susceptibility, cleaning and correction of primary disease.

Safety and tolerability5.5/10

An intact tympanum is a hard prerequisite because polymyxin B is potentially ototoxic; very rare deafness is reported and steroid/antimicrobial exposure can mask or select persistent infection. Local/systemic corticosteroid effects, hypersensitivity and pregnancy uncertainty remain.

Clinical practicality6.5/10

Three to five drops twice daily for 7–14 days is familiar and feasible after cleaning, but requires reliable home adherence, massage, dropper hygiene and recheck. Otoscopy/intact-tympanum confirmation and AMEG-B susceptibility justification add necessary clinical work.

Full-course cost-effectiveness-

Current Georgian full-course price and pack-wastage data were unavailable; price is excluded from the denominator.

Important safety and use flags

  • Never use unless otoscopy confirms an intact tympanum. Polymyxin B is potentially ototoxic; perforation, suspected middle-ear disease, new vestibular signs or hearing change requires stopping and immediate reassessment.
  • Perform organism identification and susceptibility testing when possible. Polymyxin B is AMEG category B: prefer an effective lower-category option; known polymyxin B or miconazole resistance excludes use.
  • Clean the external canal, shake well, apply 3–5 drops (0.035 ml/drop) twice daily and massage. Continue uninterrupted for several days after complete clinical resolution, at least 7 and at most 14 days; veterinary confirmation of cure is required before stopping.
  • Long or extensive corticosteroid exposure can cause local immunosuppression, secondary infection, epidermal thinning, delayed healing, telangiectasia/bleeding and systemic adrenal effects; licking and occlusion increase exposure.
  • Very rare deafness is reported, especially in older dogs. Stop for new hearing loss, head tilt, nystagmus, ataxia or severe pain and investigate otitis media/interna.
  • Ototop is only adjunctive when Otodectes cynotis coexists with susceptible secondary infection. Diagnose and treat mites with an appropriate acaricide and manage all in-contact animals/environment as indicated.
  • Do not use with hypersensitivity to miconazole, polymyxin B, prednisolone, related corticosteroids/azoles or excipients. Pregnancy/lactation safety is unestablished; use only after veterinary benefit–risk assessment and avoid mammary-gland application.
  • Treat the primary cause—commonly allergy, parasites, foreign body, conformation or endocrine disease—or recurrence is likely. Steroid-driven relief does not prove microbial eradication.
  • Shake well and prevent dropper contact with ear, skin or fingers. Wear gloves, wash hands and avoid eye/skin contact or ingestion; pregnant or breastfeeding handlers should use particular caution.
  • Do not mix with another veterinary medicine because compatibility studies are absent. Store below 25°C and discard six months after first opening; document opening date, course, susceptibility basis and recheck result.
Assessment sources
  1. Ototop current regulator leaflet2025
  2. Ototop EU identity2026
  3. Surolan VMD control2025
  4. Surolan Canada control2018
  5. Surolan FDA control2026
  6. Canine otitis phase III2005
  7. Canine combination trial1991
  8. Burow versus Surolan2021
  9. MSD otitis externa2026
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.
Cat Label-concordant topical treatment of limited dermatitis caused by susceptible bacterial/fungal organisms in cats, with primary dermatosis management
6.3/10
Situational / acceptable
vetman assessment

Ototop

miconazole nitrate 23 mg/ml + prednisolone acetate 5 mg/ml + polymyxin B sulfate 5500 IU/ml, ear drops and cutaneous suspension
Assessed clinical scopeCat · Label-concordant topical treatment of limited dermatitis caused by susceptible bacterial/fungal organisms in cats, with primary dermatosis management · On the skin
Care settingVeterinary skin diagnosis with cytology/culture where indicated, clipping and limited-area twice-daily application with lick prevention and planned recheck
vetman score 6.3/10 Situational / acceptable
Evidence confidence: Low Georgia: Yes, veterinary · Verified on 22 Oct 2026

A weakly evidenced feline skin option whose fixed antibiotic-antifungal-steroid mix, grooming exposure and imprecise lesion dose justify narrow, reassessed use only.

Regulatory and scientific credibility8.5/10

The exact dog/cat product has a current regulator leaflet, valid multi-country EU DCP, transparent three-pack identity, national-register corroboration and Georgian registration. The established same-strength combination has independent controls, although direct independent Ototop outcome data remain limited.

Clinical efficacy5.5/10

The feline dermatitis indication is regulator-supported, but direct outcome evidence is very limited and grooming increases exposure. Cytology/culture and diagnosis of the primary dermatosis are essential; short-term steroid improvement does not prove infection cure.

Safety and tolerability5.5/10

Skin exposure plus grooming/ingestion increases local and systemic corticosteroid uncertainty in cats. Immunosuppression, delayed healing, secondary infection, resistance and hypersensitivity require a limited area, short course and lick prevention.

Clinical practicality5.5/10

Twice-daily thin-film coverage, clipping and lick prevention are difficult in many cats, while the absence of a numeric skin volume requires careful lesion-based application. Gloves, recheck and switching away from steroid for persistent fungal disease add burden.

Full-course cost-effectiveness-

Current Georgian full-course price and pack-wastage data were unavailable; price is excluded from the denominator.

Important safety and use flags

  • Use only on a diagnosed limited susceptible dermatitis. The exact label prohibits extensive lesions, poorly healing or fresh wounds and viral skin infections; avoid occlusion or an undiagnosed lesion.
  • Perform organism identification and susceptibility testing when possible. Polymyxin B is AMEG category B: prefer an effective lower-category option; known polymyxin B or miconazole resistance excludes use.
  • Clip and clean as needed, shake, apply a thin film twice daily and rub in, normally no more than 14 days. Persistent signs may require 2–3 weeks only with repeated examination and diagnostic verification; no numeric skin drop count is stated.
  • Long or extensive corticosteroid exposure can cause local immunosuppression, secondary infection, epidermal thinning, delayed healing, telangiectasia/bleeding and systemic adrenal effects; licking and occlusion increase exposure.
  • For persistent fungal disease beyond the short labelled course, continue with a corticosteroid-free preparation if still indicated; do not prolong prednisolone merely because inflammation rebounds.
  • Ototop is only adjunctive when Otodectes cynotis coexists with susceptible secondary infection. Diagnose and treat mites with an appropriate acaricide and manage all in-contact animals/environment as indicated.
  • Do not use with hypersensitivity to miconazole, polymyxin B, prednisolone, related corticosteroids/azoles or excipients. Pregnancy/lactation safety is unestablished; use only after veterinary benefit–risk assessment and avoid mammary-gland application.
  • Treat the primary cause—commonly allergy, parasites, foreign body, conformation or endocrine disease—or recurrence is likely. Steroid-driven relief does not prove microbial eradication.
  • Shake well and prevent dropper contact with ear, skin or fingers. Wear gloves, wash hands and avoid eye/skin contact or ingestion; pregnant or breastfeeding handlers should use particular caution.
  • Do not mix with another veterinary medicine because compatibility studies are absent. Store below 25°C and discard six months after first opening; document opening date, course, susceptibility basis and recheck result.
Assessment sources
  1. Ototop current regulator leaflet2025
  2. Ototop EU identity2026
  3. Surolan VMD control2025
  4. Surolan Canada control2018
  5. Surolan FDA control2026
  6. MSD pyoderma2026
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.
Cat Label-concordant treatment of external otitis caused by susceptible bacterial/fungal organisms in cats, with intact tympanum and cause-directed management
6.7/10
Situational / acceptable
vetman assessment

Ototop

miconazole nitrate 23 mg/ml + prednisolone acetate 5 mg/ml + polymyxin B sulfate 5500 IU/ml, ear drops and cutaneous suspension
Assessed clinical scopeCat · Label-concordant treatment of external otitis caused by susceptible bacterial/fungal organisms in cats, with intact tympanum and cause-directed management · Into the ear
Care settingVeterinary otoscopy/cytology, intact tympanum confirmation, cleaning and susceptibility-led selection; instructed twice-daily application with massage and planned clinical/cytological recheck
vetman score 6.7/10 Situational / acceptable
Evidence confidence: Low Georgia: Yes, veterinary · Verified on 22 Oct 2026

A regulator-supported feline option, but independent feline outcomes are limited and repeated handling plus ototoxicity/stewardship constraints make it conditional.

Regulatory and scientific credibility8.5/10

The exact dog/cat product has a current regulator leaflet, valid multi-country EU DCP, transparent three-pack identity, national-register corroboration and Georgian registration. The established same-strength combination has independent controls, although direct independent Ototop outcome data remain limited.

Clinical efficacy6.5/10

The exact label includes cats and mixed-species Otodectes plus limited feline reports support the same combination, but independent feline bacterial/fungal otitis outcomes are sparse. The product is only adjunctive for ear mites and susceptibility/primary disease remain decisive.

Safety and tolerability5.5/10

An intact tympanum is a hard prerequisite because polymyxin B is potentially ototoxic; very rare deafness is reported and steroid/antimicrobial exposure can mask or select persistent infection. Local/systemic corticosteroid effects, hypersensitivity and pregnancy uncertainty remain.

Clinical practicality6.0/10

The same small-volume twice-daily regimen is feasible, but many cats resist ear handling for 7–14 days. Safe restraint, cleaning, massage, dropper hygiene, clinical recheck and intact-tympanum confirmation create a meaningful adherence and welfare burden.

Full-course cost-effectiveness-

Current Georgian full-course price and pack-wastage data were unavailable; price is excluded from the denominator.

Important safety and use flags

  • Never use unless otoscopy confirms an intact tympanum. Polymyxin B is potentially ototoxic; perforation, suspected middle-ear disease, new vestibular signs or hearing change requires stopping and immediate reassessment.
  • Perform organism identification and susceptibility testing when possible. Polymyxin B is AMEG category B: prefer an effective lower-category option; known polymyxin B or miconazole resistance excludes use.
  • Clean the external canal, shake well, apply 3–5 drops (0.035 ml/drop) twice daily and massage. Continue uninterrupted for several days after complete clinical resolution, at least 7 and at most 14 days; veterinary confirmation of cure is required before stopping.
  • Long or extensive corticosteroid exposure can cause local immunosuppression, secondary infection, epidermal thinning, delayed healing, telangiectasia/bleeding and systemic adrenal effects; licking and occlusion increase exposure.
  • Very rare deafness is reported, especially in older dogs. Stop for new hearing loss, head tilt, nystagmus, ataxia or severe pain and investigate otitis media/interna.
  • Ototop is only adjunctive when Otodectes cynotis coexists with susceptible secondary infection. Diagnose and treat mites with an appropriate acaricide and manage all in-contact animals/environment as indicated.
  • Do not use with hypersensitivity to miconazole, polymyxin B, prednisolone, related corticosteroids/azoles or excipients. Pregnancy/lactation safety is unestablished; use only after veterinary benefit–risk assessment and avoid mammary-gland application.
  • Treat the primary cause—commonly allergy, parasites, foreign body, conformation or endocrine disease—or recurrence is likely. Steroid-driven relief does not prove microbial eradication.
  • Shake well and prevent dropper contact with ear, skin or fingers. Wear gloves, wash hands and avoid eye/skin contact or ingestion; pregnant or breastfeeding handlers should use particular caution.
  • Do not mix with another veterinary medicine because compatibility studies are absent. Store below 25°C and discard six months after first opening; document opening date, course, susceptibility basis and recheck result.
Assessment sources
  1. Ototop current regulator leaflet2025
  2. Ototop EU identity2026
  3. Surolan VMD control2025
  4. Surolan Canada control2018
  5. Surolan FDA control2026
  6. Dog cat Otodectes trial2000
  7. Feline Malassezia cases2000
  8. MSD otitis externa2026
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
Miconazole23 mg/ml Prednisolone5 mg/ml Polymyxin B5500 IU/ml
Formulation Type
Ear drops
Administration route
Into the ear, On the skin
Registration
Georgia Yes, veterinary
Veterinary (National Food Agency)
In the register: ოტოტოპი
Verified on: 22 Oct 2026
 EU Yes, veterinary
№ DCP DE/V/0321/001; PL 3001/20; LT/2/20/2602/001–003
Verified on: 22 Oct 2026
 UK No
Verified on: 22 Oct 2026
 US No
Verified on: 22 Oct 2026
Controlled in Georgia
No
Checked against the narcotics law, Annex 1, lists I-IV, and Order No. 22/n.
Verified on: 18 Oct 2026
Information not fully verified Shake well. Otitis: after examination, intact-tympanum confirmation and cleaning, apply 3–5 drops (0.035 ml/drop) into the external canal twice daily and massage; continue uninterrupted for several days after complete clinical resolution, at least 7 and at most 14 days, with veterinary confirmation of cure. Skin: clip/clean as needed, apply and rub in a thin film twice daily, normally up to 14 days; persistent signs may require 2–3 weeks only with repeated examination and diagnostic verification, and ongoing antifungal treatment should use no glucocorticoid when appropriate.

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