Oestradiol Implants

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Oestradiol

Patient Information leaflet

OESTRADIOL IMPLANTS(R)
1
OESTRADIOL IMPLANTS(R)
_Oestradiol hemihydrate_
CONSUMER MEDICINE INFORMATION 
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Oestradiol Implants.
It does not contain all the available
information. 
It does not take the place of talking
to your doctor or pharmacist. 
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Oestradiol
Implants against the benefits they
expect it will have for you. 
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST. 
KEEP THIS INFORMATION WITH THE
PACK. 
You may wish to read it again. 
WHAT OESTRADIOL
IMPLANTS ARE USED FOR
Oestradiol is one of the female
hormones your body makes. During
and after menopause oestrogen
production by your body decreases.
If the ovaries are removed surgically
before menopause, the decrease in
oestrogen production occurs very
abruptly. This decrease may lead to
hot flushes, bone loss, vaginal
irritation, recurrent urinary tract
infections and urinary incontinence.
Oestradiol Implants can be
prescribed for the loss of oestrogen
production by your body. After
insertion under the skin, oestradiol is
slowly released and absorbed into the
blood, thus exerting a uniform action 
over several months. It substitutes
the natural oestrogen production
(oestrogen replacement therapy). 
Oestradiol Implants have no effect on
alertness and concentration as far as
is known. 
A doctor's prescription is required to
obtain this medicine. 
BEFORE YOU HAVE
OESTRADIOL IMPLANTS
INSERTED
_WHEN YOU MUST NOT TAKE IT_
DO NOT HAVE OESTRADIOL IMPLANTS
INSERTED IF: 
*
you are pregnant or think you
may be pregnant
*
you are breastfeeding
*
you have high blood pressure
*
you have or if it is suspected that
you have an oestrogen-dependent
tumour, such as cancer of the
lining of the womb or breast
cancer
*
you have abnormal vaginal
bleeding, which ha

Summary of Product characteristics

 
1
 PRODUCT INFORMATION 

OESTRADIOL IMPLANTS

(I) NAME OF THE MEDICINAL PRODUCT 

Oestradiol Implants
®
 (consisting of oestradiol anhydrous 20 mg, 50 mg or 100 mg) 

C
18
H
24
O
2

_ _272.39 
CAS No. 50-28-2 (anhydrous) 

(II) DESCRIPTION 

Each implant contains 20, 50 or 100 mg of 17
β-oestradiol. Oestradiol implants contain no 
excipients. The implants are white to pale brown, opaque or
translucent cylinders, secured 
by two white wool plugs, in a sealed glass tube with a white
snap-ring. 

The 20 mg implants are approximately 2.15 mm in diameter and 6 mm
long. The 50 mg 
and 100 mg implants are approximately 4.5 mm in diameter and 3 mm and
6 mm long 
respectively. 

(III)  PHARMACOLOGY 

PHARMACODYNAMIC PROPERTIES 
Oestradiol therapy is effective in the treatment of oestrogen
deficiency symptoms 
following natural or surgical menopause in women. Like other
oestrogens, it has a 
stimulating effect on the atrophic tissues of the female urogenital
tract. Oestradiol implants 
change the lipoprotein profile: LDL-C, VLDL-C, total cholesterol and
triglycerides may 
decrease, whereas HDL-C may increase. Oestradiol causes proliferative
changes in the 
endometrium, but hyperplasia can be prevented by addition of a
progestagen. 

With Oestradiol Implants a suppression of both FSH and LH has been
observed. 
Oestradiol Implants have few, if any, adverse effects on liver
function, protein metabolism, 
carbohydrate metabolism, blood pressure and blood clotting factors.
SHBG-binding 
capacity may increase. 

PHARMACOKINETIC PROPERTIES 
After insertion of an implant into the subcutaneous fat the oestradiol
plasma level reaches 
its maximum in a few days and shows a slow and gradual decline for the
life of the 
implant.  As with other oestrogens and progestagens, there are large
inter-individual 
differences in hormone levels, but intra-individual variability
appears to be small. 

2
After repeated implantation, oestradiol levels reach high