POM-V
Prescription Required
Companion Animal
Mometamax Ultra Ear Drops Suspension for Dogs
Active ingredients: Gentamicin, Mometasone Furoate, Posaconazole
Form
Drops
Species
Dogs
Manufacturer
MSD Animal Health UK Limited
VMD MA No.
01708/5062
What it's used for
the acute signs of chronic external otitis of bacterial and fungal origin due to bacteria susceptible to gentamicin, such as , and fungi susceptible to clo...
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Clinical information
Mometamax Ultra Ear Drops Suspension for Dogs — SPC Details
Source: VMD Summary of Product Characteristics (SPC). Last updated 27 Mar 2026.
the acute signs of chronic external otitis of bacterial and fungal origin due to bacteria
susceptible to gentamicin, such as , and fungi
susceptible to clotrimazole, in particular Malassezia pachydermatis.
susceptible to gentamicin, such as , and fungi
susceptible to clotrimazole, in particular Malassezia pachydermatis.
Single treatment.
The recommended dosage is a single dose of 0.8 ml per infected ear.
The maximum clinical response may not be seen until 28 to 42 days after
administration.
Instructions for use:
The veterinary medicinal product should be administered only by veterinarians or by
trained personnel under close veterinary supervision.
Clean and dry the external ear canal before administering the veterinary medicinal
product.
The veterinary medicinal product is preservative-free and should be handled using
clean technique.
Before first use, shake the bottle vigorously for 15 seconds.
Unwrap the syringe with the adapter attached. Remove the cap
from the bottle and insert the adapter by pressing it firmly into
the top of the bottle using the attached syringe. Follow steps 1.
to 5. of the dosing instructions.
1. Invert the bottle and draw up 0.8 ml per ear.
2. Return the bottle to an upright position and remove the
syringe from the adapter.
3. Leave the adapter in place and replace the cap on the bottle.
4. Place the tip of the syringe at the entrance of external ear
and administer the 0.8 ml dose. The applied dose will flow
into the ear canal.
5. After application, the ear can be massaged gently to ensure
distribution of the veterinary medicinal product throughout
the ear canal. Following dosing, the head should be
restrained for approx. 2 minutes to prevent shaking and
dislodging of veterinary medicinal product.
Use a new syringe for each infected ear. Shake the bottle vigorously for 15 seconds
before each use. Remove the cap. Insert the syringe tip into the adapter. Follow
steps 1 to 5 of the dosing instructions.
It is recommended not to repeat ear cleaning for at least 28 days after administration
unless clinically indicated. Care should also be taken to avoid water entering the ear
canal during this period. For this reason, dogs should not be bathed nor allowed to
swim until confirmation of clinical cure 28-42 days after treatment.
Dogs should be re-examined 28-42 days after veterinary medicinal product
administration to assess response to treatment. After confirmation of clinical
resolution, the ears should be cleaned to remove any remaining debris or residual
veterinary medicinal product.
The recommended dosage is a single dose of 0.8 ml per infected ear.
The maximum clinical response may not be seen until 28 to 42 days after
administration.
Instructions for use:
The veterinary medicinal product should be administered only by veterinarians or by
trained personnel under close veterinary supervision.
Clean and dry the external ear canal before administering the veterinary medicinal
product.
The veterinary medicinal product is preservative-free and should be handled using
clean technique.
Before first use, shake the bottle vigorously for 15 seconds.
Unwrap the syringe with the adapter attached. Remove the cap
from the bottle and insert the adapter by pressing it firmly into
the top of the bottle using the attached syringe. Follow steps 1.
to 5. of the dosing instructions.
1. Invert the bottle and draw up 0.8 ml per ear.
2. Return the bottle to an upright position and remove the
syringe from the adapter.
3. Leave the adapter in place and replace the cap on the bottle.
4. Place the tip of the syringe at the entrance of external ear
and administer the 0.8 ml dose. The applied dose will flow
into the ear canal.
5. After application, the ear can be massaged gently to ensure
distribution of the veterinary medicinal product throughout
the ear canal. Following dosing, the head should be
restrained for approx. 2 minutes to prevent shaking and
dislodging of veterinary medicinal product.
Use a new syringe for each infected ear. Shake the bottle vigorously for 15 seconds
before each use. Remove the cap. Insert the syringe tip into the adapter. Follow
steps 1 to 5 of the dosing instructions.
It is recommended not to repeat ear cleaning for at least 28 days after administration
unless clinically indicated. Care should also be taken to avoid water entering the ear
canal during this period. For this reason, dogs should not be bathed nor allowed to
swim until confirmation of clinical cure 28-42 days after treatment.
Dogs should be re-examined 28-42 days after veterinary medicinal product
administration to assess response to treatment. After confirmation of clinical
resolution, the ears should be cleaned to remove any remaining debris or residual
veterinary medicinal product.
Do not use in cases of hypersensitivity to the active substances or to any of the
excipients, to corticosteroids, to other azole antifungal agents and to other
aminoglycosides.
Do not use if the eardrum is perforated.
Do not use in pregnant or breeding animals.
Do not use concurrently with substances known to cause ototoxicity.
Do not use in dogs with generalised demodicosis.
excipients, to corticosteroids, to other azole antifungal agents and to other
aminoglycosides.
Do not use if the eardrum is perforated.
Do not use in pregnant or breeding animals.
Do not use concurrently with substances known to cause ototoxicity.
Do not use in dogs with generalised demodicosis.
Dogs:
No adverse events related to treatment were observed in clinical trials.
Reporting adverse events is important. It allows continuous safety monitoring of a
veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to
either the marketing authorisation holder or the national competent authority via the
national reporting system. See the package leaflet for respective contact details.
No adverse events related to treatment were observed in clinical trials.
Reporting adverse events is important. It allows continuous safety monitoring of a
veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to
either the marketing authorisation holder or the national competent authority via the
national reporting system. See the package leaflet for respective contact details.
Antimicrobial activity can be reduced by low pH and the presence of purulent and/or
inflammatory debris. Ears must be cleaned before administration of the veterinary
medicinal product. Compatibility with ear cleaners has not been demonstrated.
Bacterial and fungal otitis is often secondary to other conditions.. In animals with a
history of recurrent otitis externa, the underlying causes of the condition such as
allergy or anatomical conformation of the ear must be addressed in order to avoid
ineffective treatment with this veterinary medicinal product.
Efficacy of this veterinary medicinal product was not assessed in dogs with atopic or
allergic skin conditions.
Cross-resistance between gentamicin and other members of the aminoglycoside
class has been shown in . Use of the veterinary
medicinal product should be carefully considered when susceptibility testing has
shown resistance to aminoglycosides because its effectiveness may be reduced. Co-
selection for resistance to other classes of antimicrobials is common (see section
4.2).
Special precautions for safe use in the target species:
The safety of the veterinary medicinal product has not been established in dogs less
than 3 months of age or weighing less than 3 kg.
Before the veterinary medicinal product is applied, the external auditory canal must
be examined thoroughly to ensure that the eardrum is not perforated, in order to
avoid the risk of transmission of the infection to the middle ear and to prevent
damage to the cochlear and vestibular apparatus.
Re-evaluate the dog immediately if worsening of clinical signs, hearing loss or signs
of vestibular dysfunction are observed during treatment or if the dog is not showing
signs of improvement by day 14.
Cytology of ear canal is recommended prior to the use of the veterinary medicinal
product to identify a mixed infection.
This antimicrobial combination should only be used where diagnostic testing has
indicated the need for simultaneous administration of each of the active substances.
Use of the veterinary medicinal product should be based on identification and
susceptibility testing of the target pathogens. Ideally, therapy should be based on
epidemiological information and knowledge of susceptibility of the target pathogens
at local/regional level.
Use of the veterinary medicinal product should be in accordance with official, national
and regional antimicrobial policies.
If hypersensitivity to any of the components occurs, treatment should be discontinued
and appropriate therapy instituted.
In case of parasitic otitis, an appropriate acaricidal treatment should be implemented.
Prolonged and intensive use of topical corticosteroids preparation is known to trigger
systemic effects, including suppression of adrenal function (see section 3.10).
Use with precaution in dogs with suspected or confirmed endocrine disorder (i.e.
diabetes mellitus; hypo-thyroid disease, etc).
Ototoxicity may be associated with gentamicin treatment. Experience shows that
geriatric dogs are more at risk of hearing impairment after topical ear product
administration.
Objective hearing assessments were not performed in the pivotal field trial. Dogs with
signs of impaired balance or loss of hearing after administration should be re-
examined.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
The veterinary medicinal product may be slightly irritating to eyes. Accidental eye
exposure may occur when the dog shakes its head during or just after administration.
In case of accidental eye contact, flush the eyes thoroughly with water for 15
minutes. If symptoms develop, seek medical advice and show the package leaflet or
the label to a physician.
Although no potential for skin irritation was indicated by experimental studies, contact
of the veterinary medicinal product with the skin should be avoided. In case of
accidental skin contact, wash the exposed skin with water.
Close contact between the dog and children should be limited in the days following
the treatment due to unknown amount of the veterinary medicinal product possibly
leaking from treated ear/s.
The veterinary medicinal product may be harmful after ingestion. Avoid ingestion of
the veterinary medicinal product including hand-to-mouth exposure. In case of
accidental ingestion, seek medical advice immediately and show the package leaflet
or the label to the physician.
Special precautions for the protection of the environment:
Not applicable.
inflammatory debris. Ears must be cleaned before administration of the veterinary
medicinal product. Compatibility with ear cleaners has not been demonstrated.
Bacterial and fungal otitis is often secondary to other conditions.. In animals with a
history of recurrent otitis externa, the underlying causes of the condition such as
allergy or anatomical conformation of the ear must be addressed in order to avoid
ineffective treatment with this veterinary medicinal product.
Efficacy of this veterinary medicinal product was not assessed in dogs with atopic or
allergic skin conditions.
Cross-resistance between gentamicin and other members of the aminoglycoside
class has been shown in . Use of the veterinary
medicinal product should be carefully considered when susceptibility testing has
shown resistance to aminoglycosides because its effectiveness may be reduced. Co-
selection for resistance to other classes of antimicrobials is common (see section
4.2).
Special precautions for safe use in the target species:
The safety of the veterinary medicinal product has not been established in dogs less
than 3 months of age or weighing less than 3 kg.
Before the veterinary medicinal product is applied, the external auditory canal must
be examined thoroughly to ensure that the eardrum is not perforated, in order to
avoid the risk of transmission of the infection to the middle ear and to prevent
damage to the cochlear and vestibular apparatus.
Re-evaluate the dog immediately if worsening of clinical signs, hearing loss or signs
of vestibular dysfunction are observed during treatment or if the dog is not showing
signs of improvement by day 14.
Cytology of ear canal is recommended prior to the use of the veterinary medicinal
product to identify a mixed infection.
This antimicrobial combination should only be used where diagnostic testing has
indicated the need for simultaneous administration of each of the active substances.
Use of the veterinary medicinal product should be based on identification and
susceptibility testing of the target pathogens. Ideally, therapy should be based on
epidemiological information and knowledge of susceptibility of the target pathogens
at local/regional level.
Use of the veterinary medicinal product should be in accordance with official, national
and regional antimicrobial policies.
If hypersensitivity to any of the components occurs, treatment should be discontinued
and appropriate therapy instituted.
In case of parasitic otitis, an appropriate acaricidal treatment should be implemented.
Prolonged and intensive use of topical corticosteroids preparation is known to trigger
systemic effects, including suppression of adrenal function (see section 3.10).
Use with precaution in dogs with suspected or confirmed endocrine disorder (i.e.
diabetes mellitus; hypo-thyroid disease, etc).
Ototoxicity may be associated with gentamicin treatment. Experience shows that
geriatric dogs are more at risk of hearing impairment after topical ear product
administration.
Objective hearing assessments were not performed in the pivotal field trial. Dogs with
signs of impaired balance or loss of hearing after administration should be re-
examined.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
The veterinary medicinal product may be slightly irritating to eyes. Accidental eye
exposure may occur when the dog shakes its head during or just after administration.
In case of accidental eye contact, flush the eyes thoroughly with water for 15
minutes. If symptoms develop, seek medical advice and show the package leaflet or
the label to a physician.
Although no potential for skin irritation was indicated by experimental studies, contact
of the veterinary medicinal product with the skin should be avoided. In case of
accidental skin contact, wash the exposed skin with water.
Close contact between the dog and children should be limited in the days following
the treatment due to unknown amount of the veterinary medicinal product possibly
leaking from treated ear/s.
The veterinary medicinal product may be harmful after ingestion. Avoid ingestion of
the veterinary medicinal product including hand-to-mouth exposure. In case of
accidental ingestion, seek medical advice immediately and show the package leaflet
or the label to the physician.
Special precautions for the protection of the environment:
Not applicable.
None known.
This veterinary medicinal product does not require any special storage conditions.
1. Invert the bottle and draw up 0.8 ml per ear.
2. Return the bottle to an upright position and remove the
syringe from the adapter.
3. Leave the adapter in place and replace the cap on the bottle.
4. Place the tip of the syringe at the entrance of external ear
and administer the 0.8 ml dose. The applied dose will flow
into the ear canal.
5. After application, the ear can be massaged gently to ensure
distribution of the veterinary medicinal product throughout
the ear canal. Following dosing, the head should be
restrained for approx. 2 minutes to prevent shaking and
dislodging of veterinary medicinal product.
Use a new syringe for each infected ear. Shake the bottle vigorously for 15 seconds
before each use. Remove the cap. Insert the syringe tip into the adapter. Follow
steps 1 to 5 of the dosing instructions.
It is recommended not to repeat ear cleaning for at least 28 days after administration
unless clinically indicated. Care should also be taken to avoid water entering the ear
canal during this period. For this reason, dogs should not be bathed nor allowed to
swim until confirmation of clinical cure 28-42 days after treatment.
Dogs should be re-examined 28-42 days after veterinary medicinal product
administration to assess response to treatment. After confirmation of clinical
resolution, the ears should be cleaned to remove any remaining debris or residual
veterinary medicinal product.
3.10 Symptoms of overdose (and where applicable, emergency procedures and
antidotes)
Auricular administration to puppies at up to 5 times the recommended dose to both
ears on 3 occasions at 2-week intervals was well-tolerated.
All findings were consistent with glucocorticoid administration. Findings in the 3X and
5X overdose groups included mild eosinopenia, lower baseline and ACTH-induced
cortisol levels, lower mean adrenal weights with correlating minimal to mild atrophy of
the adrenal cortex. Minimal to mild atrophy of the epidermis of the external auditory
canal and the epithelium of the external surface of the tympanic membrane
consistent with the
2. Return the bottle to an upright position and remove the
syringe from the adapter.
3. Leave the adapter in place and replace the cap on the bottle.
4. Place the tip of the syringe at the entrance of external ear
and administer the 0.8 ml dose. The applied dose will flow
into the ear canal.
5. After application, the ear can be massaged gently to ensure
distribution of the veterinary medicinal product throughout
the ear canal. Following dosing, the head should be
restrained for approx. 2 minutes to prevent shaking and
dislodging of veterinary medicinal product.
Use a new syringe for each infected ear. Shake the bottle vigorously for 15 seconds
before each use. Remove the cap. Insert the syringe tip into the adapter. Follow
steps 1 to 5 of the dosing instructions.
It is recommended not to repeat ear cleaning for at least 28 days after administration
unless clinically indicated. Care should also be taken to avoid water entering the ear
canal during this period. For this reason, dogs should not be bathed nor allowed to
swim until confirmation of clinical cure 28-42 days after treatment.
Dogs should be re-examined 28-42 days after veterinary medicinal product
administration to assess response to treatment. After confirmation of clinical
resolution, the ears should be cleaned to remove any remaining debris or residual
veterinary medicinal product.
3.10 Symptoms of overdose (and where applicable, emergency procedures and
antidotes)
Auricular administration to puppies at up to 5 times the recommended dose to both
ears on 3 occasions at 2-week intervals was well-tolerated.
All findings were consistent with glucocorticoid administration. Findings in the 3X and
5X overdose groups included mild eosinopenia, lower baseline and ACTH-induced
cortisol levels, lower mean adrenal weights with correlating minimal to mild atrophy of
the adrenal cortex. Minimal to mild atrophy of the epidermis of the external auditory
canal and the epithelium of the external surface of the tympanic membrane
consistent with the
This information is sourced from the official Summary of Product Characteristics (SPC) published by the Veterinary Medicines Directorate (VMD). It is provided for informational purposes only and does not replace professional veterinary advice. Always consult your vet before administering any medication.
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