WARTEC CREAM podophyllotoxin 1.5mg/g tube

देश: ऑस्ट्रेलिया

भाषा: अंग्रेज़ी

स्रोत: Department of Health (Therapeutic Goods Administration)

सक्रिय संघटक:

podophyllotoxin

थमां उपलब्ध:

GlaxoSmithKline Australia Pty Ltd

INN (इंटरनेशनल नाम):

podophyllotoxin

प्राधिकरण का दर्जा:

Registered

सूचना पत्रक

WARTEC CREAM
®
1
WARTEC CREAM
®
_0.15% w/v podophyllotoxin _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Wartec Cream. It
does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
benefits of you using Wartec Cream
against the risks they expect it may
have for you.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT WARTEC CREAM IS
USED FOR
Wartec Cream contains
podophyllotoxin, a plant extract that
has antiwart properties. It works by
destroying the skin of the wart.
Wartec Cream is used on the skin to
treat warts that are found in the
external genital region (penis or
vulva) or around the anus.
It should not be used to treat warts
that are found inside the anus or
urinary canals of the penis or the
vulva.
These types of warts are commonly
referred to as anogenital or venereal
warts.
They are caused by the Human
Papilloma Virus (HPV). Up to half of
sexually active adults are infected
with HPV but only a small
percentage will show outward signs
of the virus.
Anogenital warts are usually soft and
skin coloured with a fleshy
appearance.
They are contagious and infection
can occur through direct skin-to-skin
contact. In adults, infection
commonly occurs through sexual
contact.
Anogenital warts generally appear
about 3 months after infection
occurs; however they may not show
themselves for over a year.
Wartec Cream is not addictive.
Wartec Cream is only available with
a doctor's prescription.
BEFORE YOU USE
WARTEC CREAM
DO NOT USE WARTEC CREAM IF YOU
HAVE AN ALLERGY TO:

any medicine containing
podophyllotoxin

any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue
or other parts of the

उत्पाद विशेषताएं

1
PRODUCT INFORMATION
WARTEC
®
CREAM
NAME OF THE MEDICINE
WARTEC Cream contains podophyllotoxin as the active ingredient.
CAS number:518-28-5
DESCRIPTION
WARTEC Cream is a white cream for topical use.
WARTEC Cream contains 0.15% w/w podophyllotoxin.
WARTEC Cream also contains purified water, stearyl alcohol, cetyl
alcohol, isopropyl
myristate, liquid paraffin, medium chain triglycerides, butylated
hydroxyanisole (BHA),
steareth-7,
steareth-10,
phosphoric
acid,
methyl
hydroxybenzoate,
propyl
hydroxybenzoate and sorbic acid.
PHARMACOLOGY
Podophyllotoxin is a metaphase inhibitor in dividing cells binding to
at least one binding
site
on
tubulin.
Binding
prevents
tubulin
polymerisation
required
for
microtubule
assembly. At higher concentrations, podophyllotoxin also inhibits
nucleoside transport
through the cell membrane.
The chemotherapeutic action of podophyllotoxin is assumed to be due to
inhibition of
growth and the ability to invade the tissue of the viral infected
cells.
PHARMACOKINETIC PROPERTIES
ABSORPTION / DISTRIBUTION / METABOLISM / EXCRETION
Systemic absorption of podophyllotoxin after topical application of
100 mg of 0.3%
cream or 100 µL of 0.5% solution has been studied (extravaginally in
10 healthy
females (mean age 24 years), and within the preputial cavity in 10
healthy males (mean
age 24 years), each on 2 occasions separated by 8 hours).C
max
was at or below 4.7
ng/mL following all doses and T
max
ranged from 0.5 to 36 hrs; in some subjects
2
concentrations were below the limit of detection. The C
max
and T
max
were comparable
for the 0.3% cream and 0.5% solution in both males and females. It can
be concluded
that systemic absorption of recommended doses of podophyllotoxin cream
or solution is
expected to be low.
In a study, a total of 69 patients received 0.5% podophyllotoxin
(Wartec) solution. The
toxin was not detected in the serum of patients treated with less than
50 µL. Out-
patients who received less than 100 µL gave rise to peak levels of
podophyllotoxin of
≤5.0 ng/mL. In the serum of 7