FUCITHALMIC DROPS

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

FUSIDIC ACID

MAH:

AMDIPHARM LIMITED

ATC_code:

S01AA13

INN:

FUSIDIC ACID

dosage:

1%

pharmaceutical_form:

DROPS

composition:

FUSIDIC ACID 1%

administration_route:

OPHTHALMIC

units_in_package:

0.2G

prescription_type:

Prescription

therapeutic_area:

ANTIBACTERIALS

leaflet_short:

Active ingredient group (AIG) number: 0114230001; AHFS:

authorization_status:

CANCELLED POST MARKET

authorization_date:

2017-07-17

SPC

PRODUCT MONOGRAPH
PR
FUCITHALMIC®
Fusidic acid
1% Viscous Eye Drops
Topical Ophthalmic Antibiotic
Amdipharm Limited
Temple Chamber, 3 Burlington Road,
Dublin, Dublin 4, Ireland
Distributed by: Methapharm Inc.
Brantford, Ontario, N3S 7X6
Date of Preparation:
MAY 8, 2014
Control No.: 173659
Variation No.: 0
1
Amdipharm is licensed to use the registered trademark Fucithalmic
®
_ _
_FUCITHALMIC® (fusidic acid) Product Monograph, version _
_ 1.0 (2014.02.03)_
_ _
_ Page 2 of 28_
PR
FUCITHALMIC®
Fusidic acid
1% Viscous Eye Drops
THERAPEUTIC CLASSIFICATION
Topical Ophthalmic Antibiotic
ACTION AND CLINICAL PHARMACOLOGY
FUCITHALMIC Viscous Eye Drops contain the antibiotic fusidic acid. The
antibacterial action of
fusidic acid results from the inhibition of bacterial protein
synthesis. Fusidic acid interferes with amino
acid transfer from aminoacyl-tRNA to protein on the ribosomes. Fusidic
acid may be bacteriostatic or
bactericidal depending on inoculum size. Although bacterial cells stop
dividing almost within two
minutes after contact with the antibiotic _in vitro,_ DNA and RNA
synthesis continue for 45 minutes and 1-
2 hours, respectively. Fusidic acid has a steroid like structure but
does not exhibit any steroid like
pharmacological activity (ie. hormonal or anti-inflammatory effects).
FUCITHALMIC is a 1% microcrystalline suspension of fusidic acid in a
carbomer gel. The sustained
release formulation of FUCITHALMIC provides prolonged contact with the
eye. Pharmacokinetic
studies in humans demonstrated that 1 hour following administration of
a single drop of FUCITHALMIC
into the fornix of the eye, fusidic acid concentrations in lacrimal
fluid ranged between 15.7 to 40
mcg/mL. Fusidic acid concentrations ranged between 1.4 to 5.6 mcg/mL
12 hours after administration.
Median antibiotic levels of 0.3 mcg/mL are maintained for 12 hours in
aqueous humour. Since high
ocular concentrations of fusidic acid are achieved after topical
application of FUCITHALMIC,
standardized susceptibility tests may not be appropriate to pred