hovid-Ketoconazole Tablet 200 mg

País: Malásia

Língua: inglês

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

Ingredientes ativos:

KETOCONAZOLE

Disponível em:

HOVID BERHAD

DCI (Denominação Comum Internacional):

KETOCONAZOLE

Unidades em pacote:

30 Tablet Tablets; 100 Tablet Tablets

Fabricado por:

HOVID BERHAD

Folheto informativo - Bula

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
HOVID-KETOCONAZOLE 200MG TABLET
_® _
Ketoconazole (200 mg)
Page no.1
WHAT IS IN THIS LEAFLET
1. What _hovid-Ketoconazole 200mg _
_Tablet_ is used for
2. How _hovid-Ketoconazole 200mg _
_Tablet_ works
3. Before you use _hovid-_
_Ketoconazole 200mg Tablet _
4. How to use _hovid-Ketoconazole _
_200mg Tablet_
5. While you are using _hovid-_
_Ketoconazole 200mg Tablet_
6. Side effects
_7._ Storage and Disposal of _hovid-_
_Ketoconazole 200mg Tablet _
8. Product Description
9. Manufacturer
10._ _Product Registration Holder
11. Date of revision
12. Serial Number
WHAT _HOVID-KETOCONAZOLE 200MG _
_TABLET _IS USED FOR
Ketoconazole_ _should be used only
when other effective antifungal
therapy is not available. It is used for
the treatment of systemic fungal
infections (e.g. blastomycosis,
coccidioidomycosis, histoplasmosis,
chromomycosis, and
paracoccidioidomycosis).
Ketoconazole should not be used for
fungal meningitis because it does not
penetrate well into the central nervous
system (CNS).
HOW _HOVID-KETOCONAZOLE 200MG _
_TABLET_ WORKS
Ketoconazole is an antifungal agent
which will disrupt production of
fungal cell membrane components,
therefore damaging and changing its
permeability. This results in loss of
essential cell elements and buildup of
toxicity in fungal cells and will lead
to the death of fungal cells.
Ketoconazole works effectively
against Candida albicans.
BEFORE YOU USE _HOVID-KETOCONAZOLE _
_200MG TABLET_
_-When you must not use it _
In patients with acute porphyria,
acute or chronic liver disease, or
allergic to other azole antifungals
(itraconazole, fluconazole,
miconazole). Ketoconazole should
not be taken together with
terfenadine, astemizole and cisapride.
Ketoconazole is not recommended
during pregnancy. Nursing mothers
should stop breast-feeding when
beginning and throughout treatment
with ketoconazole for 24 to 48 hour
thereafter as it is excreted in breast
milk and may increase the possibility
of kernicterus in the nursing infant.
Ketoconazole s

Características técnicas

DESCRIPTION
Round, white uncoated tablet, bevel-edged, shallow convex
faces, “HD” and break-bar embossed on one face.
COMPOSITION
Each tablet contains: Ketoconazole 200 mg/tablet.
PHARMACODYNAMICS
Fungistatic; may be fungicidal, depending on concentration;
inhibits biosynthesis of ergosterol or other sterols, damaging
the fungal cell membrane and altering its permeability; as a
result, loss of essential intracellular elements may occur; also
inhibits biosynthesis of triglycerides and phospholipids by
fungi; in addition, inhibits oxidative and peroxidative enzyme
activity, resulting in intracellular buildup of toxic concentrations
of hydrogen peroxide, which may contribute to deterioration of
subcellular
organelles
and
cellular
necrosis.
In
Candida
albicans, inhibits transformation of blastospores into invasive
mycelial form.
PHARMACOKINETICS
Readily absorbed orally in normal patients and it is excreted
as metabolites and unchanged drug chiefly in the faeces;
some is excreted in the urine.
INDICATIONS
•
hovid-Ketoconazole 200 Tablet should be used only when
other
effective
antifungal
therapy
is
not
available
or
tolerated and the potential benefits are considered to
outweight the potential risks.
•
hovid-Ketoconazole
200
Tablet
are
indicated
for
the
treatment of the following systemic fungal infections in
patients who have failed or who are intolerant to other
therapies:
blastomycosis,
coccidioidomycosis,
histoplasmosis,
chromomycosis,
and
paracoccidioidomycosis.
•
hovid-Ketoconazole 200 Tablet should not be used for
fungal meningitis because it penetrates poorly into the
cerebrospinal fluid.
CONTRAINDICATIONS
•
It is contraindicated in patients with acute or chronic liver
disease or with a known hypersensitivity to the drug.
•
It
is
also
contraindicated
when
co-administered
with
terfenadine, astemizole and cisapride.
WARNING AND PRECAUTIONS
•
Ketoconazole was considered to be unsafe in patients with
acute
porphyria
because
it
has
been
shown
to
be
porphyrinogenic in animals or in vitro systems.
•