ODAN-SPOR-HC SUSPENSION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

POLYMYXIN B SULFATE; NEOMYCIN SULFATE; HYDROCORTISONE

Disponible depuis:

ODAN LABORATORIES LTD

Code ATC:

S02CA03

DCI (Dénomination commune internationale):

HYDROCORTISONE AND ANTIINFECTIVES

Dosage:

10000UNIT; 3.5MG; 10MG

forme pharmaceutique:

SUSPENSION

Composition:

POLYMYXIN B SULFATE 10000UNIT; NEOMYCIN SULFATE 3.5MG; HYDROCORTISONE 10MG

Mode d'administration:

OTIC

Unités en paquet:

10ML

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ANTIBACTERIALS

Descriptif du produit:

Active ingredient group (AIG) number: 0305646001; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2015-10-21

Résumé des caractéristiques du produit

PRESCRIBING INFORMATION
INCLUDING PATIENT MEDICATION INFORMATION
PR
ODAN-SPOR-HC
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTIC SUSPENSION,
USP
NEOMYCIN (AS NEOMYCIN SULFATE) 3.5 MG / ML
POLYMYXIN B SULFATES 10 000 UNITS / ML
HYDROCORTISONE 10 MG / ML
ANTIBACTERIAL/ANTI-INFLAMMATORY
ODAN LABORATORIES LTD.
325 Stillview Ave.,
Pointe-Claire, Québec H9R 2Y6
Control No: 226590
Date of Revision:
June 5, 2019
www.odanlab.com
2
PRESCRIBING INFORMATION
PR
ODAN-SPOR-HC NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTIC SUSPENSION,
USP
THERAPEUTIC CLASSIFICATION
ANTIBACTERIAL/ANTI-INFLAMMATORY
ACTION AND CLINICAL PHARMACOLOGY
Corticoids suppress the inflammatory response to a variety of agents
and they may delay healing.
Since corticoids may inhibit the body's defense mechanism against
infection, a concomitant
antimicrobial drug may be used when this inhibition is considered to
be clinically significant in a
particular case.
The anti-infective components in the combination are included to
provide action against specific
organisms susceptible to them. Polymyxin B sulfate and neomycin
sulfate together are considered
active against the following microorganisms: S. aureus, E. coli, H.
influenzæ, Klebsiella-Enterobacter
species, Neisseria species and P. æruginosa. This product does not
provide adequate coverage against
S. marcescens and Streptococci, including S. pneumoniæ.
When used topically, polymyxin B and neomycin are rarely irritating
and absorption from the intact
skin or mucous membrane is insignificant. The incidence of skin
sensitization to this combination has
been shown to be low on normal skin. Since these antibiotics are
seldom used systemically, the patient
is spared sensitization to those antibiotics which might later be
required systemically.
The relative potency of corticosteroids depends on the molecular
structure, concentration, and release
from the vehicle.
INDICATIONS AND CLINICAL USE
For the treatment of superficial bacterial infections of the external
auditory canal caused by organi