Florexa Cream 13.9%

Country: Jordan

Language: English

Source: JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

Active ingredient:

Eflornithine Hydrochloride 13.9 %

Available from:

بيلا للصناعات الدوائية - Pella Pharmaceuticals Co.Ltd

ATC code:

D11AX16

INN (International Name):

Eflornithine Hydrochloride 13.9 %

Dosage:

13.9%

Units in package:

30 g

Manufactured by:

Pella Pharmaceuticals Co.Ltd (الاردن)

Product summary:

25.48 :سعر الجمهور + الضريبة

Patient Information leaflet

FLOREXA
®
Eflornithine HCl 13.9%
Cream
COMPOSITION
Each 1 g contains: Eflornithine hydrochloride139 mg.
Excipients:
Ceteareth-25,
Cetostearyl
alcohol,
Lanolin,
Glyceryl
monostearate, mineral oil, Cetyl alcohol, Methyl Paraben, Emulsifying
wax, Dimethicone, and Purified Water.
PROPERTIES
FLOREXA
is a prescribed medication applied to the skin for the reduction
of unwanted facial hair in women.
There are no studies examining the inhibition of the enzyme ornithine
decarboxylase (ODC) in human skin following the application of topical
eflornithine. However, there are studies in the literature that
report the
inhibition of ODC activity in skin following oral eflornithine. It is
postulated that topical eflornithine hydrochloride irreversibly
inhibits
skin
ODC
activity.
This
enzyme
is
necessary
in
the
synthesis
of
polyamines.
Animal
data
indicate
that
inhibition
of
ornithine
decarboxylase
inhibits
cell
division
and
synthetic
functions,
which
affect the rate of hair growth. Eflornithine hydrochloride Cream 13.9%
has been shown to retard the rate of hair growth in non-clinical and
clinical studies.
INDICATIONS
FLOREXA
is indicated for the reduction of unwanted facial hair in women.
FLOREXA
has only been studied on the face and adjacent involved areas
under the chin of affected individuals. Usage should be limited to
these
areas of involvement.
CONTRAINDICATIONS
Eflornithine
HCl
is
contraindicated
in
patients
with
a
history
of
sensitivity to any components of the preparation.
Children less than 12 years of age shouldn’t use
FLOREXA
.
PRECAUTIONS
FOR EXTERNAL USE ONLY.
Transient stinging or burning may occur when applied to abraded or
broken skin.
PREGNANCY AND LACTATION
Because there are no adequate and well-controlled studies in pregnant
women, the risk/benefit ratio of using eflornithine HCl in women
with
unwanted facial hair who are pregnant should be weighed carefully with
serious consideration for either not implementing or discontinuing use
of
FLOREXA
.
It is not known whether or not eflornithine hydrochl