General Properties
Estrofem may be used as a supplement to, or substitution for, the ovaries' endogenous oestrogen production. Estrofem causes a decrease in or complete disappearance of oestrogen deficiency symptoms.
Novo Nordisk's specific micronization and formulation ensure an adequate absorption and duration of action, at low doses that are well tolerated.
Indications
Estrofem is indicated for the treatment of the oestrogen deficiency syndrome.
In women with intact uterus use of opposed therapy must be considered.
Contra Indications
Known, suspected, or past history of carcinoma of the breast.
Known or suspected oestrogen dependent neoplasia e.g. endometrial carcinoma.
Acute or chronic liver disease or history of liver disease where the liver function tests have failed to return to normal.
Deep venous thrombosis, thromboembolic disorders, cerebral vascular accident or a past history of these conditions, associated with previous oestrogen use.
Abnormal genital bleeding of unknown aetiology.
Known or suspected pregnancy.
Haemoglobinopathies.
Porphyria.
Dosage and Administration
Estrofem is administered orally, one tablet daily without interruption.
Treatment of hysterectomized women and postmenopausal women may be started on any convenient day. If the patient is menstruating treatment is started on day 5 of bleeding.
Precautions
Physical examination and a complete medical and family history should be taken prior to the initiation of any oestrogen therapy with special reference to blood pressure, palpation of the breasts and the abdomen, and a gynaecological examination.
Patients with intact uterus who are or have previously been treated with unopposed oestrogens should be examined with special care in order to investigate a possible hyperstimilation of the endometrium before commencing Estrofem therapy.
As a general rule, oestrogens should not be prescribed for longer than one year without another physical examination including gynaecological examination being performed.
If abnormal or irregular bleeding occurs during or shortly after therapy diagnostic aspiration biopsy or curettage should be performed to rule out the possibility of uterine malignancy.
As a general rule for hormone replacement therapy (HRT) the lowest dose which alleviates the symptoms should be prescribed and medication should be discontinued as soon as possible.
In patients treated with antihypertensive drugs and hormone replacement therapy (HRT) blood pressure should be monitored regularly.
Patients with epilepsy, migraine, diabetes, asthma or cardiac failure should be carefully controlled as oestrogens may worsen these conditions.
Thromboembolism has been reported in connection with oestrogen replacement therapy but there is no background to believe that the overall incidence is increased.
The indications for immediate withdrawal of therapy are:
It is also advisable to withdraw treatment 4 to 6 weeks before major surgery.
Estrofem has no contraceptive effects.
During the first few months of treatment with Estrofem breast tenderness may occur.
Nausea, headache, and oedema occur rarely. Symptoms are normally transient. Further more , skin reactions have been reported.
Oestrogens interact with liver enzyme inducing drugs with increased metabolism of oestrogens, which may reduce the oestrogen effect interactions are documented for the following liver enzyme inducing drugs:
