FUCIDIN FILM COATED TAB 250MG TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

FUSIDATE SODIUM

Available from:

LEO PHARMA INC

ATC code:

J01XC01

INN (International Name):

FUSIDIC ACID

Dosage:

250MG

Pharmaceutical form:

TABLET

Composition:

FUSIDATE SODIUM 250MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

OTHER MISCELLANEOUS ANTIBACTERIAL AGENTS*

Product summary:

Active ingredient group (AIG) number: 0114229002; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2009-06-05

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
FUCIDIN®
Sodium fusidate
Film Coated Tablets, 250 mg
Antibiotic
LEO Pharma Inc.
Thornhill, Ontario
L3T 7W8
www.leo-pharma.com/canada
Date of Revision:
FEBRUARY 16, 2010
Submission Control No: 134282
®Registered trademark of LEO Pharma A/S used under license by LEO
Pharma Inc., Thornhill, ON
LEO®
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NAME OF DRUG
PR
FUCIDIN®
Sodium fusidate
Film Coated Tablets, 250 mg
THERAPEUTIC CLASSIFICATION
Antibiotic
ACTION
The antibacterial action of fusidic acid results from the inhibition
of bacterial protein synthesis.
The drug interferes with amino acid transfer from aminoacyl-tRNA to
proteins undergoing
biosynthetic process on the ribosomes. 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.
(13,37,38,45)
CLINICAL PHARMACOLOGY
Fusidic
acid
is
active
against
a
wide
range
of
gram
positive
organisms,
particularly
staphylococci.
(2,10)
Other species against which fusidic acid exerts high clinical activity
include
Streptococci, (including Pneumococci) and Corynebacteria.
(2,10,14)
Fusidic acid is virtually inactive against most gram negative
bacteria. The differences in activity
against gram negative and gram positive organisms are believed to be
due to a difference in cell
LEO®
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wall permeability.
Mammalian cells are much less susceptible to inhibition of protein
synthesis by FUCIDIN
(fusidic acid) than sensitive bacterial cells. These differences are
believed to be due primarily to a
difference in cell wall permeability.
No cross-resistance has been observed to date between FUCIDIN and
other antibiotics presently
in clinical use.
CLINICAL PHARMACOKINETICS
FUCIDIN (fusidic acid) has a somewhat steroid like structure but does
not exhibit any steroid
like pharmacological activity (ie. hormonal or anti-infl