DEXORYL EAR DROPS OILY SUSPENSION

Land: Malaysia

Språk: engelska

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

Aktiva substanser:

DEXAMETHASONE ACETATE; GENTAMYCIN SULPHATE; TIABENDAZOLE/THIABENDAZOLE

Tillgänglig från:

PET ARCADE SDN BHD

INN (International namn):

DEXAMETHASONE ACETATE; GENTAMYCIN SULPHATE; TIABENDAZOLE/THIABENDAZOLE

Enheter i paketet:

10.00 mcg/mL

Tillverkad av:

VIRBAC

Produktens egenskaper

_COMPOSITION_
Gentamycin (as sulfate) ...300 mg
Thiabendazole .....................4 g
Dexamethasone (as acetate) 90.3 mg
_DESCRIPTION_
DEXORYL is creamy-white suspension packed in 10g vials provided with a
cannula
for easy administration.
_PHARMACODYNAMICS_
DEXORYL ear drops is an oily suspension associating Gentamycin
sulfate, an
antibiotic of the aminoglycoside family, Thiabendazole, an imidazole
with antifungal
and anti-parasitic properties and finally, Dexamethasone a
glucocorticoid anti-
inflammatory agent. The combination of those 3 compounds is justified
by the
etiology of otitis externa.
The primary causes being external factors such as parasites or trauma
further
complicated by bacterial or mycotic infections.
Gentamycin, belonging to the aminoglycoside family is a broad spectrum
bactericidal antibiotic, orientated against such germs as _Proteus
mirabilis_, positive-
indole _Proteus_, _Proteus vulgaris_, _Proteus morganii_, _Aerobacter_
and _Pseudomonas_
_aeruginosa_. Aminoglycosides are especially effective against rapidly
multiplying
organisms. They are lethal to susceptible bacteria mainly by binding
to bacterial
ribosomes and impairing the protein biosynthesis.
Thiabendazole is an anti-fungal and anti-parasitic compound of the
imidazole family.
It acts by inhibiting the endogenous respiration with the primary site
of action being
the terminal electron transport system.
Dexamethasone is a glucocorticoid anti-inflammatory compound inducing
a
microvascular dilation. The migration of polymorphonuclear WBC is
reduced. The
adherence to vascular endothelium and diapedesis are inhibited.
_PHARMACOKINETICS_
Considering the topical administration of the preparation in the
middle ear, only few
pharmacokinetic data were developed.
Gentamycin is primarily eliminated as the unchanged drug in the urine.
Dexamethasone : metabolism occurs primarily in the liver. It is
primarily eliminated
in the urine and a lower fraction is excreted in the bile & feces.
Thiabendazole : after administration per os, gastrointestinal