Estrovagin - instructions for use, dose, side effects, contraindications

The preparation contains estriol - an analog of the natural female hormone. Estriol It is used to treat conditions and symptoms caused by estrogen deficiency in women before and after menopause (both natural and surgical).

Estriol has a specific colpos and urotropic activity, therefore it is especially effective in the treatment of urogenital disorders.

Has a selective effect, mainly on the cervix, vagina, vulva, stimulates blood supply, promotes the development and recovery of the epithelium of the vagina and cervix with its atrophic changes in the periods of premenopause and menopause, normalizes the pH of the vaginal environment, the microflora of the vagina, increases the resistance of its epithelium to infectious and inflammatory processes, affects the quality and quantity of cervical mucus.

Unlike other estrogens, estriol interacts with structures sensitive to it for a short time, no more than 2-4 hours. Thanks to this, when taking the recommended daily dose - once a day - the proliferation of the endometrium does not occur. Consequently, there is no need for a cyclic supplemental administration of progestogens, and there are no withdrawal bleeding in the postmenopausal period.

Pharmacokinetics:

The time to reach the maximum concentration with intravaginal application is 1-2 hours. Absorption through atrophically altered vaginal mucosa is intensified during the first 3-4 months of use, after reconstitution of the structure, the absorption decreases.

Excretion is carried out mainly by the kidneys in the form of metabolites (several hours after ingestion and lasts up to 18 hours), 2% is excreted through the intestine unchanged.

Indications:- Replacement hormone therapy (HRT) with atrophy of the mucous membrane of the lower sections of the genito-urinary tract caused by a deficiency of estrogens.

- Pre-and postoperative therapy in postmenopausal women, who or a vaginal operation has already been performed.

- With a diagnostic purpose for unclear results of cytological examination of the cervical epithelium against the background of atrophic changes.

Contraindications:Hypersensitivity, established (including in history) or suspected breast cancer, estrogen-dependent malignant neoplasms or suspected of them (including endometrial cancer), vaginal bleeding of unclear etiology, untreated endometrial hyperplasia, anterior idiopathic or present in the Currently, venous thromboembolism (deep vein thrombosis, pulmonary embolism), active or recently transferred arterial thromboembolism (including angina pectoris, myocardial infarction),acute liver disease or the presence of liver disease in history until the liver function indicators return to normal, porphyria, pregnancy, lactation.

Carefully:

Leiomyoma or endometriosis, history of thromboembolism or risk factors its development, risk factors for estrogen-dependent tumors, for example, 1 sta hereditary stain for breast cancer, arterial hypertension, benign liver tumors (including liver adenoma), jaundice (including a history in pregnancy), liver failure, diabetes mellitus with or without vascular complications, cholelithiasis, Migraine or severe headache, systemic lupus erythematosus, endometrial hyperplasia in anamnesis, epilepsy, bronchial asthma, otosclerosis, familial hyperlipoproteinemia, impaired renal function, cardiovascular failure.

Pregnancy and lactation:

The drug estrovagin® is contraindicated during pregnancy and lactation.

In case of pregnancy during drug therapy treatment must be canceled.

Dosing and Administration:Vaginally, before going to sleep.

Atrophy of the mucous membrane of the lower sections of the urogenital tract - 0, 5 mg / day, daily for the first 2 weeks, then gradually reduce the dose, based on the symptomatology, to 0. 5 mg / day 2 times a week;

pre- and postoperative therapy in postmenopausal women - 0.5 mg / day for 2 weeks before or after surgery;

as a diagnostic tool - 0.5 mg through day for a week before taking the next smear.

In case the next dose of the drug was missed, you should take it immediately. However, if it was found only on the day of taking the next dose, you should continue taking the drug in the usual way, without making up the missed dose. Do not use two doses in one day.

Side effects:

Itching and irritation at the injection site, tension and tenderness of the mammary glands.

Also can be noted: acyclic spotting, bleeding "breakthrough", metrorrhagia.

When carrying out HRT in combination with gestagens, the following side effects can be observed, the relationship of which with estriol is not proved: benign and malignant estrogen-dependent tumors, incl. breast and endometrial cancer; venous thromboembolism, incl. deep veins of the lower leg and pelvis, pulmonary veins; myocardial infarction; stroke; diseases of the gallbladder (especially bile-stone disease); Chloasma; erythema multiforme; erythema nodosum; vascular purpura; dementia.

Overdose:Overdose is unlikely.

Symptoms: nausea, vomiting, bloody youdivision from the vagina.

Treatment: symptomatic. There is no specific antidote.

Interaction:Inductors of microsomal oxidation (phenobarbital, carbamazepine, phenytoin, rifampicin, rifabutin, nevirapine, efavirenz) increase the metabolism of estrogens; powerful inhibitors (ritonavir, nelfinavir) significantly inhibit metabolism.

St John's wort preparations can induce estrogen metabolism, which can lead to a decrease in their clinical effectiveness.

Estriol enhances the action of lipid-lowering drugs, weakens the effects of male sex hormones, anticoagulants, antidepressants, diuretic, hypotensive and hypoglycemic drugsresources.

Medicines for general anesthesia, narcoticsanalgesics, anxiolytics, certain antihypertensive drugs, ethanol reduce the effectiveness of estrogens.

Folic acid and preparations of thyroid hormones increase the effect of estriol.

Special instructions:

With prolonged treatment with estrogens, systematic medical examinations are shown. Before the beginning of admission and every 4-6 months of treatment, a thorough general medical and gynecological examination, including examination of the mammary glands, should be carried out.

Estrogens can cause fluid retention, so patients with impaired renal function and cardiovascular insufficiency must be under careful control of the doctor.

Effect on the ability to drive transp. cf. and fur:Does not affect.

Form release / dosage:Vaginal suppositories, 0.5 mg.

Packaging:

5 pieces per contour cell pack.

Two contour packs together with instructions for use put in a pack of cardboard.

Storage conditions:

In a dry, dark place at a temperature of 2 to 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after expiry date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-000720

Date of registration:29.09.2011

Date of cancellation:2016-09-29

The owner of the registration certificate:ALTAYVITAMINS, CJSC ALTAYVITAMINS, CJSC Russia

Manufacturer: & nbsp

ALTAYVITAMINS, CJSC Russia

Representation: & nbspALTAYVITAMINS, CJSCALTAYVITAMINS, CJSC

Information update date: & nbsp02.10.2015

Illustrated instructions

Instructions

Estrovagin® (Estrovagin®)