Posatex Ear Drops Suspension for Dogs
Active ingredients: Mometasone Furoate Monohydrate, Orbifloxacin, Posaconazole
Form
Drops
Species
Manufacturer
MSD Animal Health UK Limited
VMD MA No.
01708/5059
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Prescription required
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Posatex Ear Drops Suspension for Dogs — SPC Details
Source: VMD Summary of Product Characteristics (SPC). Last updated 27 Mar 2026.
posaconazole.
The external ear canal should be meticulously cleaned and dried before treatment.
Excess hair around the treatment area should be cut.
Shake well before use.
Dogs weighing less than 2 kg, apply 2 drops to the ear once a day.
Dogs weighing 2 - 15 kg, apply 4 drops to the ear once a day.
Dogs weighing 15 kg or more, apply 8 drops to the ear once a day.
Treatment should continue for 7 consecutive days.
After application, the base of the ear may be massaged briefly and gently to allow
the veterinary medicinal product to penetrate the lower part of the ear canal.
Posatex is a viscous suspension. The inherent viscosity will result in a reduced
delivery volume compared to the fill volume (see section 5.4).
Do not use in cases of hypersensitivity to the active substances, to any of the
excipients, to corticosteroids, to other azole antifungal agents or to other
fluoroquinolones.
Do not use during the whole or part of the pregnancy.
Common
(1 to 10 animals / 100 animals treated):
Pinnal erythema
Uncommon
(1 to 10 animals / 1,000 animals treated):
Impaired hearing
1
Mild
Usually temporary and primarily in geriatric dogs.
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.
be identified and treated.
Special precautions for safe use in the target species:
Heavy reliance on a single class of antibiotic may result in the induction of resistance
in a bacterial population. It is prudent to reserve fluoroquinolones for the treatment of
clinical conditions, which have responded poorly or are expected to respond poorly
to other classes of antibiotics.
Use of the veterinary medicinal product should be based on identification and
susceptibility testing of the target pathogen(s). If this is not possible, therapy should
be based on epidemiological information and knowledge of susceptibility of the target
pathogens at local/regional level.
Use of the product should be in accordance with official, national and regional
antimicrobial policies.
An antibiotic with a lower risk of antimicrobial resistance selection (lower AMEG
category) should be used for first line treatment where susceptibility testing suggests
the likely efficacy of this approach.
Narrow spectrum antibiotic therapy with a lower risk of antimicrobial resistance
selection should be
used for first line treatment where susceptibility testing suggests the likely efficacy of
this approach
Quinolone class veterinary medicinal products have been associated with cartilage
erosions in weightbearing joints and other forms of arthropathy in immature animals
of various species. Therefore, do not use in animals less than 4 months of age.
Prolonged and intensive use of topical corticosteroids preparation is known to trigger
local and systemic effects, including suppression of adrenal function, thinning of the
epidermis and delayed healing. See section 3.10.
Before the veterinary medicinal product is applied, the external auditory canal must
be examined thoroughly to ensure that the ear drum 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.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
Wash hands carefully after applying the veterinary medicinal product. Avoid skin
contact. In case of accidental exposure, rinse the affected area with copious
quantities of water.
Special precautions for the protection of the environment:
Not applicable.
Administration of the recommended dose (4 drops per ear) 5 times daily for 21
consecutive days to dogs weighing 7.6 to 11.4 kg bodyweight caused a slight
decrease in serum cortisol response after adrenocorticotropic hormone (ACTH)
administration in an ACTH stimulation test. Discontinuation of treatment will result in
a complete return to normal adrenal response.
3.11 Special restrictions for use and special conditions for use, including
restrictions on the use of antimicrobial and antiparasitic veterinary
medicinal products in order to limit the risk of development of resistance
Not applicable.
3.12 Withdrawal periods
Not applicable.
4.
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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