PESTOR [Promestrien] 10 mg Soft vaginal capsules

instructions for the medical use of the medicinal product

PESTOR

Tradename

Pestor, Пестор

International non-proprietary name or generic name

Promestriene, Проместриен

Composition

Each capsule contains:

active substance: promestriene 10 mg;

excipients: white petrolatum, sorbitan sesquioleate, perhydrogenated polyisobutene, methylhydroxybenzoate, propylhydroxybenzoate.

Dosage form

Vaginal soft capsules.

Pharmacotherapeutic group

Simple preparations of natural and semi-synthetic estrogens.

Pharmacological properties

Pharmacodynamics

Promestriene is a synthetic estrogen-like agent intended for topical use. By influencing the mucous membrane of the female genital organs, it improves their trophism. When administered intravaginally, it does not have a systemic effect, therefore it does not affect the endometrium, mammary glands and pituitary gland.

Promestriene exhibits a local estrogenic effect on the vaginal mucosa: it promotes the proliferation of the vaginal epithelium.

Pharmacokinetics

When used intravaginally, the capsule interacts with vaginal secretions, breaks down and its components are released. Promestriene does not accumulate in tissues, less than 1% of promestriene is absorbed, its half-life is 24 hours. When administered intravaginally, promestriene does not have a resorptive effect, and there are no systemic hormonal effects.

Indications for use

• for urogenital disorders that are caused by estrogen deficiency (with itching and dryness in the vagina, dyspareunia, recurrent vaginitis, urinary incontinence);

• in postoperative therapy for removal of ovaries;

• to restore the epithelium in the vagina after inflammatory processes;

• for healing after surgical treatment of erosions of the cervical epithelium;

• as post- and preoperative therapy during surgery using intravaginal access;

• to prepare the cervix for childbirth;

• for postpartum restoration of the cervix and vagina.

Contraindications

• hypersensitivity to the components of the drug;

• diagnosed or suspected estrogen-dependent tumors (for example, breast or endometrial cancer);

• untreated endometrial hyperplasia;

• genital bleeding of unknown etiology;

• diagnosed thrombophilic disorders (eg, antithrombin III deficiency, protein C deficiency, protein S deficiency);

• arterial thromboembolism, including a history (for example, angina pectoris, myocardial infarction);

• severe liver disease, including a history of it;

• porphyria.

Method of administration and dosage

Insert 1 capsule (pre-moistened) deep into the vagina for 20 days.

Special instructions and precautions

During treatment you should be under the supervision of a doctor.

If metrorrhagia occurs, it is necessary to determine the cause and provide supportive treatment.

Despite the oiliness, the liquid contained in the capsules is an emulsion and is easily washed off with water.

Unless otherwise directed by a physician, daily vaginal washing is not necessary; external washing with soap and water is sufficient.

In some cases, the use of sanitary napkins may be appropriate.

In the treatment of postmenopausal symptoms, topical estrogen therapy is indicated only in cases where these symptoms negatively affect quality of life. In any case, the benefit/risk ratio must be carefully assessed at least once a year. It is recommended to continue therapy only if the expected benefits of treatment outweigh the possible risks.

Medical examination

Before starting or resuming therapy with topical estrogen, a detailed history of the patient and her family should be obtained. In this case, along with the results of the examination (including examination of the mammary glands and pelvic organs), contraindications and existing risk factors should be taken into account. During treatment, the woman is recommended to undergo periodic medical examinations and examinations, the frequency and nature of which are individual. The woman must be warned about the need to inform the doctor about any changes in the mammary glands. Medical examinations, including mammography, should be carried out in accordance with modern diagnostic approaches and the individual clinical needs of the patient.

Use during pregnancy and breastfeeding

Pestor is not indicated for use during pregnancy. If pregnancy occurs while using the drug, treatment should be stopped immediately.

The drug is not recommended for use during breastfeeding.

Interaction with other medicinal products

Since promestriene is minimally absorbed after vaginal use, clinically significant interactions with other drugs are not expected.

Pestor can inactivate the effect of any spermicide, so their simultaneous use is not recommended.

The drug should not be used when using a latex condom, since oily substances and lubricants containing mineral oils reduce its strength and increase the likelihood of rupture.

Side effect

From the skin and subcutaneous tissue: very rarely local reactions, including irritation, itching, burning.

From the immune system: very rarely allergic reactions.

If any of the side effects indicated in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Overdose

Given the route of administration and the low resorption of promestrin, an overdose is unlikely.

However, an overdose may be accompanied by increased local adverse reactions (irritation, itching, burning) in the vulva area.

Storage conditions

Store at a temperature not exceeding 25°C.

Keep out of the reach of children!

Shelf life

3 years. Do not use after the expiry date stated on the package.

Vacation conditions

Dispensed by prescription.

Release form

5 capsules are packed in an aluminum foil blister. 1 blister along with instructions for use in a cardboard box.