Otoxolan Ear Drops, Suspension for Dogs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Clotrimazole, Dexamethasone Acetate, Marbofloxacin

Available from:

Krka d.d., Novo Mesto

ATC code:

QS02CA06

INN (International Name):

Clotrimazole, Dexamethasone Acetate, Marbofloxacin

Pharmaceutical form:

Ear drops, suspension

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Dogs

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

2016-12-23

Summary of Product characteristics

Revised: March 2022
AN: 00137/2021 & 00139/2021
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Otoxolan Ear Drops, Suspension for Dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of suspension contains:
ACTIVE SUBSTANCES:
Marbofloxacin
3.0 mg
Clotrimazole
10.0 mg
Dexamethasone acetate
1.0 mg
(equivalent to Dexamethasone
0.9 mg)
EXCIPIENTS:
Propyl gallate (E310)
1.0 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Ear drops, suspension.
Off yellow, opalescent, viscous suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of otitis externa of both bacterial and fungal origin
respectively due to
bacteria sensitive to marbofloxacin, and fungi especially _Malassezia
pachydermatis_
sensitive to clotrimazole.
4.3
CONTRAINDICATIONS
Do not use in dogs suffering from perforation of the tympanic
membrane.
Do not use in cases of hypersensitivity to the active substances, to
other azole
antifungal agents or to any other fluoroquinolones or to any of the
excipients.
Do not use in animals, where resistance of causative agents to
marbofloxacin and/or
clotrimazole is known.
See section 4.7.
Revised: March 2022
AN: 00137/2021 & 00139/2021
Page 2 of 6
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Bacterial and fungal otitis is often secondary in nature. The
underlying cause should
be identified and treated.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Before treating with the product, the integrity of the tympanic
membrane must be
verified.
Use of the product should be based on susceptibility testing of the
bacteria and/or
fungi isolated from the animal. If this is not possible, therapy
should be based on
local (regional) epidemiological information about susceptibility of
the target
pathogens.
Official and local antimicrobial policies should be taken in to
account when the
veterinary medicinal product is used.
Heavy reliance on a single class of antibiotic m