FUCIDIN TABLET 250 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

SODIUM FUSIDATE

Available from:

DKSH SINGAPORE PTE. LTD.

ATC code:

J01XC01

Dosage:

250 mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

SODIUM FUSIDATE 250 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Laboratoires LEO

Authorization status:

ACTIVE

Authorization date:

1990-08-02

Patient Information leaflet

ADVERSE EFFECTS
Fucidin
®
tablets given orally may cause gastrointestinal
disturbances (dyspepsia, nausea, vomiting) which can
normally be avoided by giving Fucidin
®
tablets with
meals. Reversible increase of transaminases is reported
at daily dosages of 1.5-3 g of Fucidin
®
tablets. Reversible
jaundice has been reported in some patients after
administration of systemic Fucidin
®
, most frequently in
patients receiving intravenous Fucidin
®
in high dosage
and especially in serious Staph. aureus bacteremia. In
some cases, instituting oral therapy may be beneficial.
If the jaundice persists, Fucidin
®
should be withdrawn,
after which the serum bilirubin will return to normal.
Allergic reactions are reported in very few cases.
Musculoskeletal, connective tissue and bone disorders
Frequency not known:
Rhabdomyolysis (examples of signs and symptoms are:
muscle weakness, swelling and pain, dark urine, myoglo-
binuria, elevated serum creatine kinase, acute renal failure,
cardiac arrhythmia). SEE DRUG INTERACTION.
Rhabdomyolysis may be fatal.
Hepatobiliary disorders
Frequency not known:
Cholestasis
Blood and lymphatic system disorders
Leukopenia*
Thrombocytopenia
Pancytopenia
Anaemia
*Haematological disorders affecting the white cell line
(neutropenia, granulocytopenia, agranulocytosis) and more
rarely disorders affecting the other two cell lines have been
reported, either as isolated events or associated. This has
been observed especially in case of treatment duration of
more than 15 days and is reversible upon drug withdrawal.
OVERDOSAGE 
Treatment should be restricted to symptomatic and
supportive measures. Dialysis is of no benefit as the drug
is not significantly dialysed.
PRECAUTIONS
As fusidic acid is metabolized in the liver and excreted
mainly through the bile, periodic liver function tests
should be carried out in patients with liver dysfunction,
abnormalities in the biliary pathway, when fusidic acid is
given in high doses for prolonged periods, or when it is
given in combination with other antibio

Summary of Product characteristics

FUCIDIN®
ANTISTAPHYLOCOCCAL ANTIBIOTIC
BRAND NAME
Fucidin®
ACTIVE INGREDIENTS AND STRENGTH
Tablets: Sodium fusidate
250 mg
PRESENTATION
The tablet is an approximately 7.8 x 16.0 mm white to off-white
greyish marbled film-coated oval
biconvex tablet without embossing.
THERAPEUTIC PROPERTIES
Properties: Fusidic acid is an antibiotic which mode of action is as
inhibitor of the bacterial protein
synthesis resulting in a bactericidal effect. Fusidic acid has a
powerful antibacterial activity against a
number of gram-positive microorganisms. Staphylococci, including the
strains resistant to penicillin,
methicillin or other antibiotics, are particularly susceptible to
fusidic acid. Fusidic acid shows no
cross-resistance to any other antibiotic agent used in clinical
practice. Fucidin® tablets has an
unusually good ability to penetrate tissue and is widely distributed
in the organism. It is of great
clinical importance that Fucidin® tablets provides high
concentrations not only in areas well supplied
with blood, but also in relatively avascular tissue. Concentrations
exceeding the M.I.C. for
Staphylococcus aureus (0.03-0.16 mcg/ml) have been found in pus,
sputum, soft tissue, heart tissue,
bone tissue, synovial fluid, sequestra, burn crusts, brain abscesses,
and intraocularly. Fusidic acid is
metabolized in the liver and mainly excreted through the bile, little
or none being excreted through
the urine.
Fucidin® tablets are generally atoxic and shows no
crosshypersensitivity to other antibiotics in clinical
use which is why Fucidin® tablets also can be used in many cases
where other antibiotics are
contraindicated, e.g. in patients allergic to penicillin or other
antibiotics.
In severe or deep-seated infections and when prolonged therapy is
required, Fucidin® tablets should
generally be given concurrently with other antistaphylococcal
antibiotic therapy to minimize the risk
of resistance development. Fucidin® tablets may be combined with
penicillinasestable penicillins,
cephalosporins, erythromycin, aminoglycoside