International generic name

Progesterone

Drug form and composition

Solution for injection. One ampoule of 1 ml contains 10 mg Progesterone (10 mg/ml).

Indications

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.

Contraindications

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.

Drug interactions

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.

Adverse reactions

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.

Pharmacological mechanisms

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.

Supplied

10 or 50 ampoules of 1ml (10 mg).

Expiry

2 years.