Marbodex Ear Drops 10 ml / Marbofloxacin, Clotrimazole, Dexamethasone/


Marbodex Aural Ear Drops Suspension for Dogs.

Target species

Dogs

Indications for use

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.
The product should be used based on susceptibility testing of isolated bacteria.

Contraindications

Do not use in dogs suffering from perforation of the tympanic membrane.
Do not use in case of hypersensitivity to the active substances or to any of the excipients.

Special warnings The external ear canal should be meticulously cleaned and dried before treatment.

Bacterial and fungal otitis is often secondary in nature. The underlying cause should be identified and treated.

Special precautions for use

Special precautions for use in animals
For external use only.  Auricular use. 
Avoid contact with eyes in animals. In case of accidental contact, rinse thoroughly with water.

Heavy reliance on a single class of antibiotics may result in the induction of resistance in a bacterial population. It is prudent to reserve the fluoroquinolones for the treatment of clinical conditions which have responded poorly or are expected to respond poorly, to other classes of antibiotics.
Before treating with the product, the integrity of the tympanic membrane must be verified.
Official and local antimicrobial policies should be taken into account when the product is used. 

Quinolone class drugs have been associated with cartilage erosions in weight-bearing joints and other forms of arthropathy in immature animals of various species. The use of the product in young animals is not recommended.

Special precautions to be taken by the person administering the medicinal products to animals
Wash hands carefully after applying the product.
Avoid contact with eyes. In the event of accidental eye contact, rinse with clean water.
People with known hypersensitivity to fluoro(quinolones) and other compounds in the product should avoid contact with the veterinary medicinal product.

Adverse reactions (frequency and seriousness)

Usual adverse reactions associated with corticosteroid drugs may be observed (changes in biochemical and haematological parameters, such as an increase of alkaline phosphatase, and of aminotransferase, some limited neutrophilia).
Prolonged and intensive use of topical corticosteroid preparations is known to trigger local and systemic effects, including suppression of adrenal function, thinning of the epidermis and delayed wound healing.
On rare occasions, the use of this product may be associated with deafness, mainly in elderly dogs and mostly of a transient nature.

Use during pregnancy, lactation

Do not administer to pregnant or lactating bitches.

Interaction with other medicinal products and other forms of interaction

None known

Amount(s) to be administered and administration route

Auricular use.
One drop of the preparation contains 71µg marbofloxacin, 237µg clotrimazole and 23.7µg dexamethasone acetate.

Shake well for 1 minute before use.
Apply ten drops into the ear once daily for 7 to 14 days.
After application, the base of the ear may be massaged briefly and gently to allow the preparation to penetrate to the lower part of the ear canal.

After 7 days of treatment, the veterinary surgeon should evaluate the necessity to extend the treatment an other week.

When the product is intended for use in several dogs, use one cannula per dog.

Overdose (symptoms, emergency procedures, antidotes), if necessary

Changes in biochemical and haematological parameters (such as increase of alkaline phosphatase, aminotransferase, some limited neutrophilia, eosinopenia, lymphopenia) are observed with three fold the recommended dosage; such changes are not serious and will reverse once the treatment has stopped.

Withdrawal period

Not applicable.


PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: corticosteroids and antiinfectives in combination 
ATC vet code: QS02CA06

Pharmacodynamic properties

The preparation combines three active ingredients:

Marbofloxacin is a synthetic bactericidal agent belonging to the fluoroquinolone family that acts by inhibiting DNA gyrase. It exhibits a broad spectrum of activity against Gram-positive bacteria (e.g. Staphylococcus intermedius) and against Gram-negative organisms (Pseudomonas aeruginosa, Escherichia coli and Proteus mirabilis).

For Marbofloxacin:
European literature reports of microbiological susceptibility data (collected from 1994 – 2012) involving hundreds of canine and feline pathogens susceptible to marbofloxacin are outlined.

Microorganism MIC (µg/ml)
Staph pseudintermedius 0.125-1
Pseudomonas 0.12-1

Susceptibility breakpoints have been determined as ? 1 µg/ml for sensitive, 2 µg/ml for intermediate and ? 4 µg/ml for resistant bacterial strains.
Marbofloxacin is not active against anaerobes, yeast or fungi. Resistance to fluoroquinolones occurs by chromosomal mutation with three mechanisms: decrease of the bacterial wall permeability, expression of efflux pump or mutation of enzymes responsible for molecule binding.

Clotrimazole is an anti-fungal agent that belongs to the imidazole family and which acts by causing changes in membrane permeability, allowing intracellular compounds to leak from the cell and thus inhibiting cellular molecular synthesis. It exhibits a wide spectrum of activity and is aimed, in particular, at Malassezia pachydermatis. 

For Clotrimazole: 
Susceptibility breakpoints have been determined as ? 25 µg/ml for sensitive fungal strains.

Dexamethasone acetate is a synthetic glucocorticoid exhibiting anti-inflammatory and anti-pruritic activity.

Pharmacokinetic particulars

Pharmacokinetics studies in dogs at the therapeutic dosage have shown that: Marbofloxacin plasma concentrations peak at 0.06 µg/ml on the 14th day of treatment. Marbofloxacin bonds weakly to plasma proteins (< 10% in dogs) and is eliminated slowly, mainly in the active form, over 2/3 in urine and over 1/3 in faeces. Clotrimazole absorption is extremely poor (plasma concentration < 0.04 µg/ml). Dexamethasone acetate plasma concentration reaches 1.25 ng/ml on the 14th day of treatment. Dexamethasone resorption is not increased by the inflammatory process induced by otitis.

PHARMACEUTICAL PARTICULARS

List of excipients

Propyl gallate (E310)
Sorbitan oleate
Silica, hydrophobic colloidal
Triglycerides, medium-chain

Incompatibilities

Not applicable

Shelf-life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after first opening the immediate packaging: 3 months.

Special precautions for storage

Do not store above 30°C.

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