Avoxidil Topical Solution 5%wv

البلد: ماليزيا

اللغة: الإنجليزية

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

العنصر النشط:

MINOXIDIL

متاح من:

Abio Marketing Sdn Bhd

INN (الاسم الدولي):

MINOXIDIL

الوحدات في الحزمة:

60 ml

المصنعة من قبل:

SINPHAR PHARM CO LTD

نشرة المعلومات

Consumer Medication Information Leaflet
_(RiMUP)_
Page 1 of 3 pages
AVOXIDIL
TOPICAL SOLUTION 5%W/V
Minoxidil 5%w/v
WHAT IS IN THIS LEAFLET:
a)
What Avoxidil is used for
b)
How Avoxidil works
c)
Before you use Avoxidil
d)
How to use Avoxidil
e)
While you are using Avoxidil
f)
Side effects
g)
Storage and disposal of Avoxidil
h)
Product description
i)
Manufacturer
j)
Product Registration Holder
k)
Date of revision
WHAT AVOXIDIL IS USED FOR
The
name
of
your
medicine
is
Avoxidil
Topical
Solution
5%w/v
(called
‘Avoxidil’
in
this
leaflet).
Avoxidil contains a medicine called
Minoxidil.
Avoxidil is used to treat baldness and
hair
loss
in
men
and
women.
It
stimulates hair growth and stabilize
hair loss in baldness and hair loss.
HOW AVOXIDIL WORKS
Its mechanism of action is not known.
However,
when
applied
topically,
minoxidil
has
been
shown
to
stimulate hair growth in individuals
with problems of baldness and hair
loss.
It takes 4 months or more for hair to
start growing and growth of new hair
will stop upon discontinuation. Pre-
treatment appearance will be restored
within 3-4 months.
BEFORE YOU USE AVOXIDIL
WHEN YOU MUST NOT USE IT.
Do not apply this medicine to other
than your scalp.
Do not use this medicine if you are:

under the age of 18

allergic (hypersensitive) to Minoxidil,
alcohol or propylene glycol.

having hair loss caused by drug
treatment.

having total baldness or complete
loss of all body hair.

having unknown cause of hair loss,
or it is sudden and unexpected.

having
HIGH BLOOD PRESSURE
, even
if it is not being treated.

having any
CONDITION THAT AFFECTS
YOUR SCALP
, including sunburn and
psoriasis.

having a
SHAVED SCALP.

using
CREAMS,
OINTMENTS
OR
LOTIONS
used
to
treat
scalp
conditions

having
any
kind
of
dressing
or
bandage on your scalp.
BEFORE YOU START TO USE IT:
This medicine is for external use only.
Check with your doctor or pharmacist
before taking this medicine:

If
you
are
unsure
whether
your
scalp is normal and healthy.

If you suffer from heart

خصائص المنتج

AVOXIDIL TOPICAL SOLUTION 5 % W/V
COMPOSITION
Each ml contains:
Minoxidil
50 mg
PRODUCT DESCRIPTION
A colorless to light yellowish clear liquid.
INDICATION
Avoxidil Topical Solution 50mg/ml spray is exclusively indicated for
the
treatment of alopecia androgenetica in males and females. Avoxidil
Topical Solution 50mg/ml spray stimulates hair growth and stabilizes
hair loss in patients with alopecia androgenetica.
PHARMACOLOGICAL PROPERTIES
ATC CODE: D11AX01
Pharmacotherapeutic
group:
Dermatological
preparations
containing
minoxidil
PHARMACODYNAMIC PROPERTIES
_MECHANISM OF ACTION: _
The exact mechanism of action of minoxidil in the treatment of
alopecia
androgenetica is not known. However, when applied topically, minoxidil
has been shown to stimulate hair growth in individuals with alopecia
androgenetica.
The onset of hair growth stimulation occurs approximately after 4 or
more
months
of
use
and
is
variable
among
patients.
Upon
discontinuation of Avoxidil Topical Solution 50mg/ml, new hair growth
stops and restoration of pretreatment appearance is expected within 3
-4
months.
PHARMACOKINETIC PROPERTIES
Following topical application, minoxidil is poorly absorbed from
normal
intact skin, with an average of 1.4% (range 0.3-4.5%) of the total
applied
dose ultimately reaching the systemic circulation.
Therefore
a
1
mL
dose
of
Avoxidil
Topical
Solution
50mg/ml,
delivering 50 mg minoxidil to the skin, would result in absorption of
approximately 0.70 mg minoxidil. The effects of concomitant dermal
diseases on absorption are unknown.
Serum
minoxidil
levels
resulting
from
topical
administration
of
minoxidil are governed by the drug’s percutaneous absorption rate.
Following cessation of topical dosing of minoxidil
approximately 95%
of systemically absorbed minoxidil is eliminated within 4 days. The
metabolic biotransformation of minoxidil absorbed following topical
application has not been fully determined.
RECOMMENDED DOSAGE
ROUTE OF ADMINISTRATION
: For external use only.
Use Avoxidil only as directed. Do not apply Avoxid