FLUNCO 200 CAPSULE

Land: Malaysia

Språk: engelska

Källa: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktiva substanser:

FLUCONAZOLE

Tillgänglig från:

IMEKS PHARMA SDN. BHD.

INN (International namn):

FLUCONAZOLE

Enheter i paketet:

100Capsule Capsules; 50Capsule Capsules; 1Capsule Capsules

Tillverkad av:

T.O. CHEMICALS (1979) LTD.

Bipacksedel

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
FLUNCO
® 200 CAPSULE
Fluconazole (200 mg)
_ _
1
WHAT IS IN THE LEAFLET
1.
What Flunco is used for
2.
How Flunco works
3.
Before you use Flunco
4.
How to use Flunco
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Flunco
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of Revision
WHAT FLUNCO
IS USED FOR
Fluconazole is classified as an antifungal
medication. It is used to treat a wide range of
fungal/yeast infections. You may be given
Flunco under the following circumstances:
• Internal infections caused by the fungus,
_Cryptococcus_
–
_cryptococcal_
meningitis, and
infections at other sites i.e. skin and lungs.
• Internal infections caused by the fungus,
_Candida_
– it invades via the bloodstream to
infect different organs including the visceral
coverings of these organs. (lungs, intestine,
heart, urinary tract)
• Genital Candidiasis – fungal infection of
the vagina or penis.
• Prevention of infection in
immunocompromised patient to curb
infections.
HOW FLUNCO
WORKS
Flunco is an antifungal agent that alters the
cell membrane of fungus. This alteration
inhibits the replicative effect of fungus in
turn preventing the increase of fungal
reproduction.
BEFORE YOU USE FLUNCO_ _
_ _
-
_When you must not use it_
Do not use Flunco if you:
• have any allergic tendencies or in the past
developed hypersensitive reactions to
fluconazole or any of the ingredients stated
in this leaflet.
• are afflicted by any liver disease, or if you
have an abnormal liver function test on your
recent blood test.
• have ever had severe skin reactions such as
Steven-Johnson Syndrome and toxic
epidermal necrolysis after treatment with any
antibiotics.
• are pregnant
• are breast-feeding
-
_Before you start to use it _
Tell your doctor if you:
• have any liver disease or if you have
recently learnt that you had an abnormal
liver blood profile
• had any drug related allergies in the past
-
_Taking other medicines _
Info

Produktens egenskaper

FLUNCO 200
Each capsule contains fluconazole 200mg.
DESCRIPTION
White powder filled in violet-white cap no. 0, bearing the letter
“FLUNCO 200”.
PROPERTIES
Fluconazole is a triazole antifungal drug. It is a highly selective
inhibitor
of
cytochrome
P-450
dependent
enzyme
(14-alpha-
desmethylase) resulting in impairment of ergosterol synthesis in
fungal cell membranes. The subsequent loss of normal sterols
correlates with the accumulation of 14 alpha-methyl sterols in
fungi
and
may
be
responsible
for
the
fungistatic
activity
of
fluconazole.
Fluconazole is active against _Blastomyces dermatitides, Candida _
spp.,_ _
_Coccidioides _
_immitis, _
_Cryptococcus _
_neoformans, _
_Epidermophyton _
spp.,_ _
_Histoplasma _
_capsulatum, _
_Microsporum _
spp.,_ _and_ Trichophyton _spp.
In common with other azole antifungal agents, most fungi show a
higher apparent sensitivity to fluconazole _in vivo _than _in vitro._
Fluconazole is well-absorbed following oral administration and is
not affected by concomitant food intake. The plasma levels or
systemic bioavailability from oral route are over 90% of the level
achieved
from
the
intravenous
route.
Mean
peak
plasma
concentrations of 6.72
µ
g/ml have been reported in healthy
subjects
following
a
400mg
oral
dose.
Peak
plasma
concentrations (C
max
) are reached within 1 to 2 hours of oral
administration. Peak plasma concentrations and AUC’s increase
proportionally to doses over a range of 50 to 400mg.
Multiple dosing lead to increases in peak plasma concentrations.
Steady state concentrations are reached in 6 to 10 days but it
may be attained on day 2 if a loading dose of twice the usual
daily dose is given on day 1.
Fluconazole is widely distributed and the apparent volume of
distribution is close to that of total body water. Concentration in
breast
milk,
joint
fluid,
saliva,
sputum,
vaginal
fluids
and
peritoneal fluid are similar to those achieved in plasma. However,
concentrations in the cerebrospinal fluid range from 50 to 90% of
plasma
concentrations,
even
in
the
absence