TERBINAFINE ARW terbinafine (as hydrochloride) 250 mg tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
01-12-2017
Summary of Product characteristics
(SPC)
01-12-2017
Public Assessment Report
(PAR)
27-11-2017
Active ingredient:
terbinafine hydrochloride, Quantity: 281.28 mg
Available from:
Arrotex Pharmaceuticals Pty Ltd
INN (International Name):
terbinafine hydrochloride
Pharmaceutical form:
Tablet, uncoated
Composition:
Excipient Ingredients: hypromellose; colloidal anhydrous silica; sodium starch glycollate type A; microcrystalline cellulose; magnesium stearate
Administration route:
Oral
Units in package:
42
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
? Treatment in adults of ringworm (tinea corporis, tinea cruris and tinea pedis) due to infection caused by dermatophytes such as Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum, where oral therapy is considered appropriate owing to the site, severity or extent of the infection, and the infection is not responsive to topical therapy. ? Onychomycosis in adults (fungal infection of the nail) caused by dermatophyte fungi.
Product summary:
Visual Identification: White to off-white, uncoated biconvex, bevelled edge tablet, engraved 'TER' and '250' with a break line on one side and plain on the other; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius
Authorization status:
Licence status A
Authorization date:
2014-03-20
Patient Information leaflet
Terbinafine tablets CMI v1.0
1
TERBINAFINE AMNEAL TABLETS
_terbinafine _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Terbinafine AMNEAL
tablets. It does not contain information
about other forms of Terbinafine
AMNEAL that are available without a
prescription from your pharmacy.
It does not contain all the available
information about Terbinafine AMNEAL
tablets. It does not take the place of
talking to your doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. Some more recent
information on the medicine may be
available.
YOU SHOULD ENSURE THAT YOU SPEAK TO
YOUR PHARMACIST OR DOCTOR TO OBTAIN
THE MOST UP TO DATE INFORMATION ON
THE MEDICINE.
Those updates may contain important
information about the medicine and its
use of which you should be aware.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you taking this medicine against the
benefits they expect it will provide.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT TERBINAFINE AMNEAL
TABLETS ARE USED FOR
Terbinafine AMNEAL tablets are used
to treat:
• fungal infections of the finger nails
and toe nails
• tinea (ringworm) infections of the groin
and body
• tinea infections of the feet, commonly
called "athlete's foot." These
infections are caused by a group of
fungi called dermatophytes
Terbinafine, the active ingredient in
Terbinafine AMNEAL tablets, works by
killing the dermatophytes.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it for
another reason.
Terbinafine AMNEAL tablets are only
available with a doctor's prescription.
This medicine is not addictive.
There is not enough information to
recommend the use of this medicine in
children.
BEFORE YOU TAKE TERBINAFINE
AMNEAL TABLETS
_WHEN YOU MUST NOT TAKE IT _
_ _
DO NOT TAKE TERBINAFIN
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Summary of Product characteristics
Terbinafine AMNEAL PI v0.1 1
TERBINAFINE AMNEAL TABLETS
PRODUCT INFORMATION
NAME OF THE MEDICINE
Active ingredient:
terbinafine hydrochloride
Chemical name:
(E)-N)-(6,6-dimethyl-2-hepten-4-ynyl)-N-methyl-1-
naphthalenemethanamine hydrochloride
CAS number:
78628-80-5
Molecular formula:
C
21
H
26
ClN
Molecular weight:
327.90
DESCRIPTION
Terbinafine hydrochloride is a white to off-white, finely crystalline
powder. It is soluble in isopropyl
alcohol (> 70 mg/mL at 25°C) and ethanol (> 70 mg/mL at 25°C), and
slightly soluble in water (6.3
mg/mL at 25°C).
Each Terbinafine AMNEAL tablet contains terbinafine hydrochloride
equal to 250 mg terbinafine
base.
Each tablet also contains magnesium stearate, hypromellose, sodium
starch glycollate,
microcrystalline cellulose and colloidal anhydrous silica.
PHARMACOLOGY
PHARMACODYNAMICS
Pharmacotherapeutic group: Oral antifungal agent, ATC Code: D01B A02
Terbinafine is an allylamine with antifungal activity mainly against
dermatophytes, including
Trichophyton (e.g.
_T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum),
Microsporum canis_
,
and
_Epidermophyton floccosum. _
_ _
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
Terbinafine AMNEAL PI v0.1 2
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 and nails at levels
associated with antifungal
activity.
PHARMACOKINETICS
ABSORPTION:
Following oral administration, terbinafine is well absorbed (>70%) and
the bioavailability of
terbinafine hydrochloride from terbinafine tablets as a result of
first-pass metabolism is
approximately 40%. A single oral dose of 250 mg terbinafine results in
peak plasma concentration
(C
max
) of 0.83 microgram/mL within two hours of administration. The
absorption
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