AURIZON EAR DROP

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

CLOTRIMAZOLE; DEXAMETHASONE ACETATE; MARBOFLOXACIN

Available from:

Gladron Chemicals Sdn Bhd

INN (International Name):

CLOTRIMAZOLE; DEXAMETHASONE ACETATE; MARBOFLOXACIN

Units in package:

10.00 mcg/mL; 20.00 mcg/mL

Manufactured by:

Vetoquinol

Summary of Product characteristics

EAR DROPS, OILY SUSPENSION.
HOMOGENOUS, BEIGE TO YELLOW SUSPENSION
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ML OF AURIZON CONTAINS:
Marbofloxacin . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . 3 mg
Clotrimazole Ph.Eur
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . 10 mg
Dexamethasone acetate . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . 1.0 mg
(equivalent to dexamethasone . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . 0.9 mg)
LIST OF EXCIPIENTS:_ Propyl gallate, sorbitan oleate, colloidal
silica,_
_medium-chain triglycerides_
The product does not contain an antimicrobial preservative.
ATC VET CODE: QS02CA06
PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMIC PROPERTIES :
The preparation combines three active ingredients :
- MARBOFLOXACIN, 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_).
- CLOTRIMAZOLE, 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_.
- DEXAMETHASONE ACETATE, a synthetic glucocorticoid exhibiting
anti-inflammatory and
anti-pruritic activity.
PHARMACOKINETIC PROPERTIES :
Pharmacokinetics studies in dogs at the therapeutic dosage have shown
that plasma
concentrations of marbofloxacin 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, 2/3 in urine and 1/3 in faeces.
Clotrimazole absorption is
extremely poor (plasma concentration <0.04 µg/ml)