SANDOZ CORTIMYXIN OINTMENT

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

POLYMYXIN B (POLYMYXIN B SULFATE); BACITRACIN (BACITRACIN ZINC); NEOMYCIN (NEOMYCIN SULFATE); HYDROCORTISONE

Available from:

SANDOZ CANADA INCORPORATED

ATC code:

S01CA03

INN (International Name):

HYDROCORTISONE AND ANTIINFECTIVES

Dosage:

10000UNIT; 400UNIT; 3.5MG; 10MG

Pharmaceutical form:

OINTMENT

Composition:

POLYMYXIN B (POLYMYXIN B SULFATE) 10000UNIT; BACITRACIN (BACITRACIN ZINC) 400UNIT; NEOMYCIN (NEOMYCIN SULFATE) 3.5MG; HYDROCORTISONE 10MG

Administration route:

OPHTHALMIC

Units in package:

3.5GM

Prescription type:

Prescription

Therapeutic area:

ANTIBACTERIALS

Product summary:

Active ingredient group (AIG) number: 0405634002; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2019-08-01

Summary of Product characteristics

PRESCRIBING INFORMATION
PR
SANDOZ CORTIMYXIN
OTIC SOLUTION
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTIC SOLUTION USP
PR
SANDOZ CORTIMYXIN OPHTHALMIC OINTMENT
NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC,
AND HYDROCORTISONE OPHTHALMIC OINTMENT USP
ANTI-INFLAMMATORY – ANTIBACTERIAL
Sandoz Canada Inc.
Date of Preparation: December 17, 1996
110 Rue de Lauzon
Date of Revision: January 29, 2019
Boucherville, QC, Canada
J4B 1E6
Control No 216573
PR
SANDOZ CORTIMYXIN
Sandoz Cortimyxin Page 2 of 13
OTIC SOLUTION
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTIC SOLUTION USP
PR
SANDOZ CORTIMYXIN OPHTHALMIC OINTMENT
NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC,
AND HYDROCORTISONE OPHTHALMIC OINTMENT USP
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, bacitracin 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
r