International generic name
Drug form and composition
Solution for injection. One ampoule of 1 ml contains 10 mg Progesterone (10 mg/ml).
Progesteron is applied in the complex therapy of amenorrhoea; dysfunctional uterine
bleedings; insufficiency or dysfunction of corpus luteum.
Dosage and administration
The preparation is applied parenterally in a dosage regimen according to the
indications and severity of ovarian dysfunction. In secondary amenorrhoea it is
applied intramuscularly in a dose of 5-10 mg daily from 6 to 10 days, before the
expected menstruation. In uterine bleedings it is applied intramuscularly in a dose
of 5-10 mg daily for 6 consecutive days. In insufficiency or dysfunction of corpus
luteum it is applied intramuscularly by 10 mg daily. Usually the therapy continues
two weeks but may be prolonged , if necessary, up to 11 weeks of pregnancy.
Supersensitivity to the preparation; acute and chronic liver diseases; cancer
of breasts and genital system; thrombophlebitis or thromboembolic diseases; unclear
bleedings from urinary and genital tract.
Special warnings and precautions
With due attention, after assessment of the ratio benefit/risk to be applied
to patients with cardiovascular insufficiency, disturbed renal function, liver diseases,
diabetes, asthma, epilepsy, migraine, patients with nervous and psychic diseases,
in anamnesis for passed thromboembolic diseases. Progesteron is not recommended
to be prescribed during pregnancy and lactation.
Progesteron reduces the effect of sulfanylurea antidiabetics, uterotonic drugs,
anabolic steroids, gonadotropic hormones of the anterior part of the hypophysis.
Its effect is reduced by ampicillin, barbiturates, phenytoinum, rifampicin.
During administration of the preparation may be observed nausea, vomiting, diarrhoea,
fluid retention, headache, allergic skin reactions, reduced libido, depression,
irregular uterine bleeding, changes in blood picture.
Progesteron is a natural hormone, synthesized in corpus luteum and placenta.
Uterine and vagina are the target organs for progesteron. Its action is expressed
in the luteal phase of ovarian cycle and during pregnancy. Progesteron acts on estrogen-stimulated
endometrium and transforms it into secretory. This change is necessary to receive
the fertilized ovum and the following implantation of embryo in the early stage.
Continuing secretion is necessary to maintain pregnancy. The contractile response
of myometrium to oxytocin is inhibited. Provokes vagina desquamation. Stimulates
development of secretory alveoli in mammary glands. The increase of basal temperature
is connected with progesterone secretion. By the way of reverse connection, progesteron
inhibits the release of luteinizing hormone.
10 or 50 ampoules of 1ml (10 mg).