Fungiconazol 400 mg Tablets for Dogs
Active ingredient: Ketoconazole
Form
Tablet
Species
Manufacturer
Dechra Regulatory B.V.
VMD MA No.
50406/4028
What it's used for
Treatment of acute superficial dermatitis caused by mixed infections with Pseudomonas aeruginosa or susceptible to marbofloxacin and susceptible to ketocon...
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Fungiconazol 400 mg Tablets for Dogs — SPC Details
Source: VMD Summary of Product Characteristics (SPC). Last updated 27 Mar 2026.
Pseudomonas aeruginosa or susceptible to
marbofloxacin and susceptible to ketoconazole. The
indication is limited to focal skin infections (e.g. hot spots, intertrigo, superficial
folliculitis).
corresponds to 1 tablet per 40 kg body weight daily.
It is recommended to sample the animal once a month during treatment and to stop
antifungal administration after two negative cultures. When mycological follow up is
not possible, treatment should be continued for an adequate period of time to ensure
mycological cure. If lesions persist after 8 weeks of treatment, medication should be
re-evaluated by the responsible veterinarian.
To be administered preferably together with food, in order to maximise
absorption.
Tablets can be divided into halves or quarters to ensure accurate dosing. Put the
tablet on a flat surface, with its scored side facing up and the convex (rounded) side
facing the surface.
Halves: With the tip of the thumbs, exert a slight vertical pressure on both sides of the
tablet to break it into halves.
Quarters: With the tip of a thumb, exert a slight vertical pressure on the middle of the
tablet to break it into quarters.
To ensure a correct dosage, body weight should be determined as accurately as
possible.
Revised May 2025
AN: 00699/2024 & 00705/2024
Do not use in cases of hypersensitivity to the active substance or to any of the
excipients.
Revised May 2025
AN: 00699/2024 & 00705/2024
Rare
(1 to 10 animals / 10,000
animals treated):
Neurological signs
a
(e.g. Ataxia, Tremor)
Apathy
a
, Anorexia
a
Hepatic toxicosis
a
Vomiting
a
, Diarrhoea
a
Very rare
(<1 animal / 10,000 animals
treated, including isolated
reports):
Endocrine system disorder (anti-androgenic
effects
b,c
, anti-glucocorticoid effects
b
)
a
May be observed at standard doses.
b
Transient. Ketoconazole inhibits the conversion of cholesterol to steroid hormones
such as testosterone and cortisol in a dose dependent and time-dependent manner.
c
See also section Special precautions for safe use in the target species for effects in
male breeding 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 its local representative or the national
competent authority via the national reporting system. See the package leaflet for
respective contact details.
azoles.
Special precautions for safe use in the target species:
Use of the 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 farm level, or at local/regional level.
Use of the product should be in accordance with official, national and regional
antimicrobial policies.
Treatment with ketoconazole suppresses testosterone concentrations and increases
progesterone concentrations and may affect breeding effectiveness in male dogs
during and for some weeks after treatment.
Treatment of dermatophytosis should not be limited to treatment of the infected
animal(s). It should also include disinfection of the environment, since spores can
survive in the environment for long periods of time. Other measures such as frequent
vacuuming, disinfection of grooming equipment and removal of all potentially
contaminated material that cannot be disinfected will minimize the risk of re-infection
or spread of infection.
Combination of systemic and topical treatment is recommended.
In case of long term treatment administration, liver function should be closely
monitored. If clinical signs suggestive of liver dysfunction develop, treatment should
be discontinued immediately. As the tablets are flavoured, they should be stored in a
safe place out of the reach of animals.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
Accidental ingestion should be avoided. Keep the blister in the outer carton to
prevent access by children. Part (half/quarter) tablets should be stored in the original
blister and be used for the next administration. In case of accidental ingestion, seek
medical advice immediately and show the package leaflet or the label to the
physician.
People with known hypersensitivity to ketoconazole should avoid contact with the
veterinary medicinal product. Wash hands after use.
Special precautions for the protection of the environment:
Not applicable.
Other precautions:
Dermatophytes mentioned in the indication have zoonotic potential with risk of
transmission to humans. Maintain good personal hygiene (washing hands after
Revised May 2025
AN: 00699/2024 & 00705/2024
handling the animal and avoiding direct contact with animal). If signs of skin lesions
occur, contact your physician.
or proton pump inhibitors (e.g. omeprazole) as the absorption of ketoconazole may
be modified (absorption requires an acid environment).
Ketoconazole is a substrate and potent inhibitor of cytochrome P450 3A4 (CYP3A4).
It may decrease the elimination of drugs metabolized by CYP3A4, thereby altering
their plasma concentrations. This may result in increased plasma concentrations of
e.g. cyclosporine, macrocyclic lactones (ivermectin, selamectin, milbemycin),
midazolam, cisapride, calcium-channel blocking agents, fentanyl, digoxin,
macrolides, methylprednisolone or coumarine anticoagulants. The increased plasma
levels of drugs mentioned above can prolong the duration of effects as well as side
effects.
Revised May 2025
AN: 00699/2024 & 00705/2024
On the other hand, inducers of cytochrome P450 may increase the rate of
metabolism of ketoconazole, e.g. barbiturates or phenytoin can increase the rate of
metabolism of ketoconazole, resulting in a decreased bioavailability, hence a
decreased efficacy.
Ketoconazole may decrease theophylline serum concentrations.
Ketoconazole inhibits the conversion of cholesterol to cortisol and may thus affect
trilostane / mitotane dosing in dogs concurrently being treated for
hyperadrenocorticism.
It is not known to what extent these interactions are relevant for dogs and cats, but in
the absence of data, co-administration of the veterinary medicinal product and these
drugs should be avoided.
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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Related Conditions
Other Products Containing Ketoconazole
These products share the same active ingredient and may be suitable alternatives. Always consult your vet.
Alternative options to consider
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