OESTROGEL GEL

Country: Malaysia

Language: English

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

Active ingredient:

OESTRADIOL

Available from:

SYARIKAT WELLCHEM SDN. BHD.

INN (International Name):

OESTRADIOL

Units in package:

80 gm

Manufactured by:

BESINS MANUFACTURING BELGIUM

Summary of Product characteristics

OESTROGEL ®
TUBE CONTAINING 80 G
_ACTIVE INGREDIENT _
17β-Estradiol……………………………………………………60
mg
Excipient (carbomer, trolamine, ethanol, purified water
q.s.f).…………………………………………………………….100
g
_PHARMACODYNAMICS _
Natural estrogen therapy by the transcutaneous route has the
following advantages:
-
the use of the natural estrogen secreted by the ovary, namely
17beta-estradiol;
-
avoid the first pass effect through the liver which results in the
synthesis of angiotensinogen, very low density lipoproteins and
certain clotting factors which it is thought produce cardiovascular,
thrombo-embolic and metabolic side-effects.
Controlled study conducted with transdermal forms of estrogens
have shown that the effect on prevention of bone loss varies
depending on the patient but is proportional to the dose of estrogens
delivered.
With this gel, at the dose of 2.5g of gel per day, 21 days out of 28,
the effect is obtained in around 89% of the women treated (against
45% under placebo).
_PHARMACOKINETICS _
Percutaneous absorption amounts to approximately 10% of the dose
applied: one ruler (2.5g of gel) corresponds to the absorption of
150ug of estradiol.
There is temporary storage in the horny layer of the epidermis.
From this site, there is slow diffusion into the systemic circulation
via
the capillaries in the dermis.
The plasma concentration of 17beta estradiol obtained in
menopausal women after the administration of one ruler (2.5g of gel)
per day is on average 80 pg/ml, with an estrone/estradiol ratio
similar to of women in genital activity period.
_INDICATIONS _
OESTROGEL is indicated in estrogen deficiency, following the
decrease in ovarian activity:
-vasomotor disorders, hot flushes.
-vaginal atrophy and dryness which may disrupt sexual intercourse.
_ROUTE OF ADMINISTRATION:_ Transdermal
_INTERACTION WITH OTHER MEDICATIONS _
*
Enzyme inducing drugs: anti-convulsants (carbamazepine,
phenobarbital, phenytoin, primidone), barbiturates, griseofu