INDICATIONS
a. Atrophy of the lower urogenital tract related to oestrogen deficiency,
particularly –
For the treatment of vaginal complaints such as dyspareunia,
dryness and itching.
For the prevention of recurrent infections of the vagina and
lower urinary tract.
In the management of micturition complaints (such as
frequency and dysuria) and mild urinary incontinence.
b. Pre- and postoperative therapy in postmenopausal women
undergoing vaginal surgery.
c. Climacteric complaints such as hot flushes and night sweating.
d. A diagnostic aid in case of a doubtful atrophic cervical smear.
e. Infertility due to cervical hostility.
DOSAGE & ADMINISTRATION
It is important that the total daily dose is taken at one time. It may be taken
with or without food.
Atropy of the lower urogenital tract
4-8 mg/day for the first weeks, followed by a gradual reduction, based on
relief of symptoms, until a maintenance dosage (e.g. 1-2 mg/day) is
reached.
Pre- and postoperative therapy in postmenopausal women undergoing
vaginal surgery
4-8 mg/day in the 2 weeks before surgery; 1-2 mg/day in the 2 weeks after
surgery.
Climacteric complaints such as hot flushes and night sweating
4-8 mg/day during the first weeks, followed by a gradual reduction. For
maintenance therapy the lowest effective dosage should be used.
A diagnostic aid in case of a doubtful atrophic cervical smear
2-4 mg/day for 7 days before taking the next smear.
Infertility due to cervical hostility
In general 1-2 mg/day on days 6-15 of the menstrual cycle. However, for
some patients dosages as low as 1mg/day are sufficient, whereas others
may need up to 8 mg/day. Therefore, the dosage should be increased each
month until an optimal effect on the cervical mucus is obtained.
OVERDOSAGE
Symptoms that may occur in the case of an acute overdosage are nausea,
vomiting and possibly withdrawal bleeding in females. No specific
antidote is known. If necessary, a symptomatic treatment should be
instituted.
CONTRAINDICATIONS
Pregnancy, Known or suspected estrogen-dependent tumours,
undiagnosed vaginal bleeding, untreated endometrial hyperplasia, known
or suspected breast cancer.
Warnings
During prolonged treatment with estrogens, periodic medical
examinations are advisable. With vaginal infections, a concomitant specific
treatment is recommended. In order to prevent endometrial stimulation,
the daily dose should not exceed 8 mg nor should this maximum dose be
used for longer than several weeks. Patients with any of the following
conditions should be monitored: A history of latent or overt cardiac failure,
fluid retention due to renal dysfunction, hypertension, epilepsy or
migraine (or a history of these conditions), severe liver disorders,
endometriosis, fibrocystic mastopathy, porphyria, hyperlipoproteinaemia, a
history during pregnancy or previous use of steroids of severe pruritus,
cholestatic jaundice or herpes gestationis. Estrogen is reported to increase
the risk of endometrial carcinoma in postmenopausal women. Use with
precaution in gallbladder disorders, hypercalcemia, additional progestin,
hypercoagulability, urethral bleeding and mastodynia.
USE IN LACTATION
Use FemastinTM in breastfeeding women only if really needed, as estriol is
excreted in the milk and it may decrease the quality and quantity of the
milk production.
ADVERSE DRUG REACTIONS
Breast tension or pain, nausea, spotting, fluid retention and cervical
hypersecretion may occasionally occur and be indicative of too high
dosage. Headache, hypertension, leg cramps and vision disturbances are
seldom observed. In general, most of these adverse reactions disappear
after the 1st week of treatment.
Breast enlargement, vaginal candidiasis, change in vaginal bleeding
pattern, vomiting, stomach cramps, cholestatic jaundice, chloasma or
melasma, erythema multiforme, erythema nodosum, hemorrhagic
eruption, mental depression, chorea, increasing or decreasing body
weight, edema, changes in libido.
DRUG INTERACTIONS
There are strong indications that estrogens, estriol included, can increase
the pharmacologic effects of certain corticosteroids. If necessary, the
dosage of the corticosteroid should be reduced. There are also some
indications, mainly obtained with other estrogens or oral contraceptives,
that concurrent use of estriol with activated charcoal, barbiturates,
hydantoin
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