Ovestin tablets 2mg, No. 30

Atrophy of the mucous membranes of the lower urinary tract due to estrogen deficiency, in particular for the treatment of symptoms such as dyspareunia, vaginal dryness and itching, to prevent recurrent infections of the vagina and lower urinary tract; for the treatment of urinary disorders (eg, increased frequency, dysuria) and moderate urinary incontinence;

Pre- and postoperative treatment for vaginal surgery in the postmenopausal period;

Climacteric disorders such as hot flashes and night sweats;

As an auxiliary diagnostic tool when obtaining an atrophic picture of a cervical smear;

Infertility due to cervical factor.

The drug is administered orally. The daily oral dose should not exceed 8 mg. With atrophy of the lower urinary tract due to estrogen deficiency: 4-8 mg per day for the first 4 weeks, followed by a gradual dose reduction in accordance with the symptoms until a maintenance dose of 1-2 mg per day is reached.
Pre- and postoperative treatment for vaginal surgery in the postmenopausal period: 4-8 mg per day for 2 weeks before surgery, 1-2 mg per day for 2 weeks after surgery.
Treatment of climacteric disorders (hot flashes, night sweats): 4-8 mg per week with a gradual dose reduction. For maintenance therapy, the minimum effective dose should be used.
With infertility due to cervical factor: as a rule, 1-2 mg is prescribed per day from 6 to 15 days of the menstrual cycle. However, in different patients, the daily dose may vary from 1 to 8 mg. The dose should be increased every month until the optimal effect on the cervical mucosa is achieved. If a woman missed the next dose, and the delay was no more than 12 hours, it is necessary to take it as soon as possible. If the delay is more than 12 hours, you should skip one appointment and continue to take the drug at the usual time.
The tablets are taken with water, preferably at the same time of day. The daily dose should be taken in one dose.

Active ingredient: Estriol - 2 mg.
Excipients:
Colloidal anhydrous silicon dioxide, potato starch, magnesium stearate, povidone, lactose monohydrate, distilled water.

Pregnancy, lactation;

Hypersensitivity to the active and (or) excipients of the drug;

Identified or suspected estrogen-dependent tumors (breast cancer, endometrial cancer);

Vaginal bleeding of unknown etiology;

Confirmed venous thromboembolism (deep vein thrombosis, pulmonary thromboembolism) within the past two years;

A history of venous thromboembolism or thrombosis if anticoagulant therapy is not performed;

Diabetes mellitus with angiopathy;

Sickle cell anemia;

Dubin-Johnson syndrome;

Cerebral circulation disorder;

Rotor Syndrome.

Carefully:

Familial hyperlipoproteinemia;

Increased risk of thromboembolic complications;

Systemic lupus erythematosus;

Prolonged immobilization, serious surgical interventions;

Severe liver disease;

History of gallbladder disease (especially cholelithiasis);

Hepatic porphyria;

Severe itching or cholestatic jaundice (including a history of a previous pregnancy);

Pancreatitis;

Endometriosis;

Leiomyoma;

Bronchial asthma;

Arterial hypertension;

Hypercalcemia due to bone metastases of breast cancer;

Herpes during pregnancy;

Epilepsy;

Otosclerosis.

Trade name: OvestinЃ

International non-proprietary name:

Estriol

Dosage form:

pills

Composition of the preparation:
Active substance: Estriol - 2 mg
Excipients:
Colloidal anhydrous silicon dioxide, potato starch, magnesium stearate, povidone, lactose monohydrate, distilled water.

Description:
White round flat tablets with a beveled edge, marked DG over 8, between which there is a dividing line on one side, and ORGANON * on the other side.

Pharmacotherapeutic group:

Estrogens.

Pharmacological properties
Pharmacodynamics
Ovestin contains the natural female sex hormone estriol. In the pre-menopausal and postmenopausal period (natural or surgical), estriol is used to treat symptoms caused by estrogen deficiency. Estriol has a selective effect mainly on the cervix, vagina, vulva and is especially effective for the treatment of urogenital symptoms caused by estrogen deficiency. In cases of atrophy of the vaginal mucosa, estriol causes an increase in the proliferation of the epithelium of the vagina and cervix, stimulates its blood supply, helps to restore the epithelium, normal microflora and physiological pH of the vaginal environment, affects the quality and quantity of cervical mucus. As a result, the resistance of epithelial cells to infection and inflammation increases.
Unlike other estrogens, estriol has a short-term effect, since it is retained for a short time in the nuclei of endometrial cells and, if the recommended dosage regimen is observed, endometrial proliferation should not be expected. In this regard, the cyclic use of progestogens is not necessary, postmenopausal withdrawal bleeding does not occur.

Pharmacokinetics
After oral administration, estriol is rapidly and almost completely absorbed in the gastrointestinal tract. The maximum plasma concentration of unconjugated estriol is reached within 1 hour after ingestion. About 90% of estriol binds to plasma albumin and, unlike other estrogens, estriol hardly binds to sex hormone binding globulin (SHBG). Estriol metabolism consists mainly of conjugation and deconjugation during the intestinal-hepatic circulation. Estriol, the end product of metabolism, is excreted mainly in the urine in conjugated form. Only a small part (± 2%) is excreted in the feces, mainly in the form of unconjugated estriol.

Indications for use:
Atrophy of the mucous membranes of the lower parts of the genitourinary tract, due to estrogen deficiency, in particular, for the treatment of symptoms such as dyspareunia, dryness and itching of the vagina, to prevent recurrent infections of the vagina and lower parts of the genitourinary tract; for the treatment of urinary disorders (eg, increased frequency, dysuria) and moderate urinary incontinence;

Pre- and postoperative treatment for vaginal surgery in the postmenopausal period;

Menopausal disorders such as hot flashes and night sweats; As an auxiliary diagnostic tool when obtaining an atrophic picture of a cervical smear;

Infertility due to cervical factor.

Contraindications:

Pregnancy, lactation;

Hypersensitivity to the active and (or) excipients of the drug;

Identified or suspected estrogen-dependent tumors (breast cancer, endometrial cancer);

Vaginal bleeding of unknown etiology;

Confirmed venous thromboembolism (deep vein thrombosis, pulmonary thromboembolism) within the past two years;

A history of venous thromboembolism or thrombosis if anticoagulant therapy is not performed;

Diabetes mellitus with angiopathy;

Sickle cell anemia;

Dubin-Johnson syndrome;

Cerebral circulation disorder;

Rotor Syndrome.

Carefully:

Familial hyperlipoproteinemia;

Increased risk of thromboembolic complications;

Systemic lupus erythematosus;

Prolonged immobilization, serious surgical interventions;

Severe liver disease;

History of gallbladder disease (especially cholelithiasis);

Hepatic porphyria;

Severe itching or cholestatic jaundice (including a history of a previous pregnancy);

Pancreatitis;

Endometriosis;

Leiomyoma;

Bronchial asthma;

Arterial hypertension;

Hypercalcemia due to bone metastases of breast cancer;

Herpes during pregnancy;

Epilepsy;

Otosclerosis.

Method of administration and dosage
The drug is administered orally. The daily oral dose should not exceed 8 mg. With atrophy of the lower urinary tract due to estrogen deficiency: 4-8 mg per day for the first 4 weeks, followed by a gradual dose reduction in accordance with the symptoms until a maintenance dose of 1-2 mg per day is reached.
Pre- and postoperative treatment for vaginal surgery in the postmenopausal period: 4-8 mg per day for 2 weeks before surgery, 1-2 mg per day for 2 weeks after surgery.
Treatment of climacteric disorders (hot flashes, night sweats): 4-8 mg per week with a gradual dose reduction. For maintenance therapy, the minimum effective dose should be used.
With infertility due to cervical factor: as a rule, 1-2 mg is prescribed per day from 6 to 15 days of the menstrual cycle. However, in different patients, the daily dose may vary from 1 to 8 mg. The dose should be increased every month until the optimal effect on the cervical mucosa is achieved. If a woman missed the next dose, and the delay was no more than 12 hours, it is necessary to take it as soon as possible. If the delay is more than 12 hours, you should skip one appointment and continue to take the drug at the usual time.
The tablets are taken with water, preferably at the same time of day. The daily dose should be taken in one dose.

Side effect
Soreness and tension of the mammary glands, jaundice, nausea, skin rash, increased blood pressure, headache, intermenstrual bloody spotting from the vagina, cervical hypersecretion. Adverse reactions are usually transient, but may also indicate an overdose of the drug.

Overdose
Overdose causes nausea, vomiting and vaginal bleeding.
Treatment is symptomatic.

Interaction with other medicinal products
There were no cases of interaction of the drug Ovestin with other medicinal products. At the same time, there is evidence of an increase in the pharmacological effect of glucocorticosteroids, hypolipidemic agents when used together with estrogens. If necessary, the dose of glucocorticosteroids may be reduced.
Possible weakening of the effects of drugs of male sex hormones, anticoagulants, antidepressants, diuretic, antihypertensive and hypoglycemic drugs.
Barbiturates, antiepileptic drugs (carbamazepine, phenytoin) increase the metabolism of steroid hormones.
Antibiotics (ampicillin, rifampicin), drugs for general anesthesia, narcotic analgesics, anxiolytics, antiepileptic drugs, some antihypertensive drugs, ethanol reduce the effectiveness of estrogens.
Folic acid and thyroid hormone preparations increase the effect of estriol.
Estriol can change the effectiveness of oral anticoagulants, increase the pharmacological effect of succinlicholine, theophylline, foleandomycin.

Special instructions
Before starting hormone replacement therapy, a complete medical examination is required. During treatment, regular examinations (including breast examination, mammography) should be carried out every 6 months in accordance with accepted medical practice. It is necessary to exclude a history of thromboembolism, repeated spontaneous abortions, which indicates thrombophilia. The risk of thromboembolism increases with prolonged immobilization, severe trauma, and surgery. In these cases, it is necessary to temporarily interrupt hormone replacement therapy (4-6 weeks before surgery).
The use of estriol does not lead to an increase in breast density. And it is possible that the use of estriol does not increase the risk of developing breast cancer.
Cases of venous thromboembolism (deep vein thrombosis of the leg, pelvic vein thrombosis, and pulmonary thromboembolism) are more common in women receiving hormone replacement therapy. With regard to the drug Ovestin, such data are not available, therefore it is not known whether its use causes an increase in the incidence of venous thromboembolism. However, it is recommended to follow the directions outlined in the section 'Contraindications'.

Release form
Tablets 2 mg. 30 tablets in a PVC / A1 blister. 1 blister with instructions for use is placed in a cardboard box.

Storage conditions
List B.
At a temperature of 2-30 ? C, protected from light and moisture and out of reach of children.

Shelf life is
5 years.
Do not use after the expiration date indicated on the package.

Terms of dispensing from pharmacies
Prescription.