ESTROFEM 1mg

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

Oestradiol hemihydrate

Prieinama:

Novo Nordisk Pharmaceuticals Pty Ltd

Klasė:

Medicine Registered

Prekės savybės

Product Information 
EstPI 8.doc 

Page 1 of 16 

PRODUCT INFORMATION 

 ESTROFEM
®

NAME OF THE MEDICINE 

Oestradiol (as hemihydrate) 

DESCRIPTION 

Estrofem is an oestrogen preparation comprising 28 tablets. Each
tablet contains 1mg or 2mg 
17β-oestradiol.  The oestrogen component of Estrofem substitutes
for the loss of endogenous 
oestrogen production due to natural or surgical menopause in
hysterectomised women. 

Active ingredients: oestradiol - chemical name:
estra-1,3,5(10)-triene-3,17β-diol (as 
hemihydrate). Oestradiol is a white or almost white crystalline
powder which is practically 
insoluble in water and soluble in acetone.  Oestradiol has 5 chiral
centres.  The molecular 
formula is C
18
H
24
O
2
. Oestradiol hemihydrate has a molecular weight of 281.39. 

STRUCTURE 

Oestradiol hemihydrate 

CAS no.: 35380-71-3 

Excipients: lactose, maize starch, hydroxypropylcellulose, talc,
magnesium stearate, 
hypromellose, titanium dioxide (E171), propylene glycol (red 1
mg tablets only), Macrogol 
400 (blue 2 mg tablets only), colouring - red 1mg - iron oxide red
(E172); blue 2mg - indigo 
carmine (E132). Estrofem does not contain clinically significant
amounts of gluten. 
PHARMACOLOGY 
’½H
2
O’ 
Product Information 
EstPI 8.doc 

Page 2 of 16 

PHARMACOKINETICS 

Micronised oestradiol is rapidly and efficiently absorbed from the
gastrointestinal tract 
following oral administration.  Peak plasma concentrations of
oestradiol occur 4-6 hours after 
tablet ingestion.  Thereafter elimination is slow and oestradiol
levels are maintained above 
baseline for 24 hours. The steady state plasma level of oestradiol
ranges between 70-100 
pg/mL. Oestradiol has a half-life of approximately 14-16 hours. In the
bloodstream more than 
90% of oestradiol is bound to plasma proteins. Some oestradiol is
converted to oestrone in 
the intestinal mucosa before absorption into the portal vein.  During
passag