TERBISIL CREAM 1% ww

Krajina: Malajzia

Jazyk: angličtina

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

Aktívna zložka:

Terbinafine Hydrochloride

Dostupné z:

AVERROES PHARMACEUTICALS SDN. BHD.

INN (Medzinárodný Name):

Terbinafine Hydrochloride

Počet v balení:

20gm mcg/mL

Výrobca:

SIU GUAN CHEM. IND.CO.,LTD.

Súhrn charakteristických

TERBISIL CREAM 1% W/W
TERBINAFINE HYDROCHLORIDE 10MG (1%)
PRODUCT DESCRIPTION
A white cream has a slight pear-like and peppermint odor.
COMPOSITION
Each gram of Terbisil Cream contains 10mg of Terbinafine
hydrochloride.
PHARMACODYNAMICS
Terbinafine is an allylamine which has a broad spectrum of antifungal
activity in fungal infections of the
skin. It’s action being fungicidal against dermatophytes, moulds and
certain dimorphous fungi. It has a
fungicidal or fungistatic action on yeasts depending on the species
involved.
Terbinafine interferes with fungal ergosterol biosynthesis at an early
stage. This leads to a deficiency in
ergosterol and to intracellular accumulation of squalene, resulting in
fungal cell death.
Terbinafine acts by inhibiting squalene epoxidase in the fungal cell
membrane. The squalene epoxidase is
not dependent on the
cytochrome
P450 system. Terbinafine does
not have
any
influence
on the
metabolism of hormones or of other medicines.
PHARMACOKINETICS
Less than 5% of the dose is absorbed after topical application in
humans; systemic exposure is thus very
slight.
Biotransformation
results
in
metabolites
with
no
antifungal
activity,
which
is
excreted
predominantly in the urine and the faeces. The elimination half life
is 17 hours. There is no evidence of
accumulation. At the level of the stratum corneum, fungicidal
concentrations of terbinafine can be
measured up to 7 days after the last administration.
INDICATIONS
Terbisil Cream is used for the treatment of
-
Fungal
infections
of
the
skin
caused
by
_Trichophyton_
(eg.
_T. _
_Rubrum_,
_T.Mentagrophytes, _
_T. _
_Verrucosum, T. Violaceum), Microsporum canis_ and _Epidermophyton
floccosum_.
- Yeast infections of the skin, principally those caused by the genus
_Candida_ (eg. _C. albicans_).
- Pityriasis (tinea) versicolor due to _Pityrosporum orbiculare_ (also
known as _Malassezia furfur_).
MODE OF ADMINISTRATION
Terbisil Cream is administered by topically.
RECOMMENDED DOSAGE
_Adults and children from 12 years: _
Cleanse and dry the affected areas