LAMISIL CREAM 1%

국가: 말레이시아

언어: 영어

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

유효 성분:

Terbinafine Hydrochloride

제공처:

GLAXOSMITHKLINE CONSUMER HEALTHCARE SDN. BHD.

INN (International Name):

Terbinafine Hydrochloride

패키지 단위:

15 gm; 7.5 gm

Manufactured by:

GSK Consumer Healthcare SARL

환자 정보 전단

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
LAMISIL CREAM 1%
®
Terbinafine hydrochloride (1%w/w)
1
WHAT IS IN THIS LEAFLET
1.
What Lamisil Cream is used for
2.
How Lamisil Cream Works
3.
Before you use Lamisil Cream
4.
How to use Lamisil Cream
5.
While using Lamisil Cream
6.
Side effects
7.
Storage and Disposal of Lamisil
Cream
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT LAMISIL CREAM IS USED FOR
Lamisil Cream is used to treat the
topical fungal infections below:
•
athlete’s
foot
(tinea
pedis)
–
especially
when
it
occurs
between the toes
•
dhobie (jock) itch (tinea cruris) –
itchy
rash
with
a
clear
border
which often occurs on the groin
and inner thigh area.
•
ringworm
(tinea
corporis)
–
circular patches of red rash which
may appear scaly
•
skin candidiasis (intertrigo or
•
sweat rash) – redness, itching and
scaling in folded areas of skin
which are wet with perspiration.
•
pityriasis
(tinea)
versicolor
-
scaly patches that become white
areas
due
to
loss
of
skin
pigmentation.
HOW LAMISIL CREAM WORKS
Lamisil Cream is an antifungal, and
works by killing the fungi causing
your skin problem.
BEFORE YOU USE LAMISIL CREAM
_When you must not use it _
•
Do NOT use in children under 12
years of age.
•
Do NOT use to treat fungal nail
infection (inside and under the
nail), with discoloration of the
nails and change in nail texture
(thick,
flaky).
Please
see
your
doctor for appropriate treatment
for this type of infection
•
Do NOT use Lamisil Cream:
-
If
you
are
allergic
(hypersensitive)
to
terbinafine
hydrochloride or any of the other
ingredients
of
this
medicine
(listed in Product Description).
_IMPORTANT INFORMATION ABOUT SOME _
_OF THE INGREDIENTS OF LAMISIL CREAM _
Lamisil Cream contains
•
cetyl alcohol and stearyl alcohol:
may cause local skin reactions
(e.g. contact dermatitis).
_PREGNANCY, _
_BREAST-FEEDING _
_AND _
_FERTILITY _
If you are pregnant or breast-feeding,
think you might be pregnant or are
planning to have a baby, a

제품 특성 요약

SYMPTOMS AND TREATMENT OF OVERDOSE
The low systemic absorption of topical terbinafine renders overdosage
extremely
unlikely during cutaneous use.
Accidental ingestion of one 30 g tube of cream, which contains 300 mg
terbinafine
base, is comparable to ingestion of one Terbinafine 250 mg tablet
(adult oral unit
dose).
Symptoms/signs of overdose following ingestion of terbinafine may
include
headache, nausea, epigastric pain and dizziness.
Further management should be as clinically indicated or as recommended
by the
national poisons centres where available.
In case of accidental oral ingestion, the alcohol content (9.4%
W/W)
has to be
considered.
PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: Antifungal for topical use.
ATC CODE
ATC code: D01AE15
MECHANISM OF ACTION
Terbinafine interferes specifically with fungal sterol biosynthesis at
an early step.
This leads to a deficiency in ergosterol and to an intracellular
accumulation of
squalene, resulting in fungal cell death. Terbinafine acts by
inhibition of squalene
epoxidase in the fungal cell membrane. The enzyme squalene epoxidase
is not
linked to the cytochrome P-450 system. Terbinafine does not influence
the
metabolism of hormones or other drugs.
Terbinafine is an allylamine which has a broad spectrum of antifungal
activity in
fungal infections of the skin caused by dermatophytes such as
_Trichophyton _
(e.g.
_T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum),
Microsporum canis _
and
_Epidermophyton floccosum. _
At low concentrations terbinafine is fungicidal
against dermatophytes, moulds and certain dimorphic fungi. The
activity against
yeasts is fungicidal (e.g.
_Malassezia futfui') or _
fungistatic, depending on the
species.
PHARMACOKINETIC PROPERTIES
ABSORPTION
Less than 5% of the dose is absorbed after topical application to
humans; systemic
bioavailability is therefore very low. A similar
dermato-pharmacokinetic profile of
cutaneous solution, spray and gel to cream was observed in
pharmacokinetic
studies.
DISTRIBUTI