Terbicip 250mg Tablets

Country: Malaysia

Language: English

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

Active ingredient:

TERBINAFINE HYDROCHLORIDE

Available from:

CIPLA MALAYSIA SDN BHD

INN (International Name):

TERBINAFINE HYDROCHLORIDE

Units in package:

28 Tablets

Manufactured by:

CIPLA LTD

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
TERBICIP 250 MG TABLET
Terbinafine Tablets 250 mg
1
WHAT IS IN THIS LEAFLET
1.
What Terbicip tablets are
used for
2.
How Terbicip tablets works
3.
Before you use Terbicip
tablets
4.
How to use Terbicip tablets
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
Terbicip tablets
8.
Product Description
WHAT TERBICIP TABLETS ARE
USED FOR
Terbinafine, the active
ingredient in Terbicip tablets, is
an antifungal medicine.
Terbicip is indicated in the
following conditions:
•
Fungal infections of the
skin, including the treatment
of tinea corporis, tinea
cruris, tinea pedis, and yeast
infections of the skin caused
by the genus Candida (e.g.,
Candida albicans) where
oral therapy is generally
considered appropriate,
owing to the site, severity or
extent of the infection.
•
Tinea capitis
•
Onychomycosis (fungal
infection of the nails) caused
by dermatophyte fungi.
HOW TERBICIP TABLETS WORKS
Terbinafine is an allylamine
which has a broad spectrum of
antifungal activity. At low
concentrations terbinafine is
fungicidal against
dermatophytes, moulds and
certain dimorphic fungi. The
activity versus yeasts is
fungicidal or fungistatic
depending on the species.
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 P450
system.
When given orally, the drug
concentrates in skin at levels
associated with fungicidal
activity.
BEFORE YOU USE TERBICIP
TABLETS
_-_
_ _
_ When you must not use it if _
•
you think you may be
allergic to terbinafine or to
any of the other ingredients
of Terbicip Tablets. (see
section
_Ingredients_
).
•
you have or have had any
liver problems
•
you are breast-feeding
_-_
_ _
_ Before you start to use it _
You should also ask yourself
thes

Summary of Product characteristics

TERBINAFINE TABLETS 250 MG
PACK INSERT:
Enclosed
_For the use only of a Registered Medical Practitioner or a Hospital
or a _
_Laboratory_
TERBICIP
250 MG TABLETS
TERBINAFINE TABLETS 250 MG
COMPOSITION
Each uncoated tablet contains:
Terbinafine Hydrochloride equivalent to
Terbinafine .............................. 250 mg
DESCRIPTION
White, circular, biconvex tablets with ‘TF’ debossed on one side
and
score line on the other side.
DOSAGE FORM
Tablets
PHARMACOLOGY
PHARMACODYNAMICS
Terbinafine is an allyl-amine which has a broad spectrum of antifungal
activity.
At
low
concentrations
terbinafine
is
fungicidal
against
dermatophytes, moulds and certain dimorphic fungi. The activity versus
yeasts is fungicidal or fungistatic depending on the species.
Terbinafine interferes selectively with fungal sterol biosynthesis at
an
early stage through inhibition of the enzyme squalene epoxidase. This
leads to a deficiency in ergosterol and to an intracellular
accumulation of
squalene in the fungal cell membrane. Both the deficiency in
ergosterol
and the accumulation of squalene are responsible for fungal cell
death.
When given orally, the active substance concentrates in skin, hair and
nails
at
levels
associated
with
fungicidal
activity.
Measurable
concentrations of the active substance are still evident 15 – 20
days after
cessation of treatment.
Terbinafine is used for the treatment of fungal infections of the skin
and
nails, which is caused by Trichophyton (e.g. T. rubrum,
T.mentagrophytes,
T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton
floccosum. The following table outlines the range of minimum
inhibitory
concentrations (MIC) against the dermatophytes.
Organism
MIC rang (
μ
g/ml)
Trichophyton rubrun
0.001 – 0.15
Trichophyton mentagrophytes
0.0001 – 0.05
Trichophyton verrucosum
0.001 – 0.006
Trichophyton violaceum
0.001 – 0.1
Microsporum canis
0.0001 – 0.1
Edidermorphyton fluccosum
0.001 – 0.05
Terbinafine exhibits poor efficacy against many yeasts of the Candida
species.
Terbicip 250 mg t