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Pharmacological properties

lactobacilli acidophili are one of the dominant species of flora in the vagina of a healthy woman. lactobacilli have a protective function in the vagina. they ferment the glycogen of the vaginal epithelium to lactic acid. acidic medium (pH 3.8–4.5), which is formed as a result, creates unfavorable conditions for the colonization and development of pathogenic microorganisms and provides optimal conditions for the propagation of lactobacilli. in addition to lactic acid, lactobacilli produce hydrogen peroxide and bacteriocins, which also inhibit the development of pathogenic microorganisms.

Estriol is an endogenous estrogen hormone that selectively affects the vagina and does not affect the endometrium. Estriol contained in Gynoflora provides proliferation of the vaginal epithelium. The proliferating and mature epithelium is a physiological barrier and contains glycogen, a nutrient substrate for Lactobacilli. With hormonal disorders that occur more often in older women, as well as inflammatory processes in the vagina, the vaginal epithelium is damaged and the amount of glycogen decreases. Exogenous estriol, even at a low dose, restores the proliferating and mature epithelium and provides a supply of glycogen for the nutrition of Lactobacilli.

Violation or destruction of the physiological vaginal flora mainly occurs due to local or systemic treatment with anti-infective agents, serious systemic diseases, improper hygiene and vaginal infections. In a non-physiological vaginal environment, the amount of Lactobacilli may decrease or they may even disappear, their protective function is not realized.

The therapeutic effect of Gynoflora is manifested in the restoration of vaginal microflora by introducing exogenous Lactobacilli and improving the condition of the vaginal epithelium by introducing exogenous estriol. As a result, physiological balance in the vagina and vaginal epithelium are restored. Lactobacillus acidophilus and estriol act locally, exclusively in the vagina.

Lactose, which is contained in vaginal tablets as an excipient, can also be fermented by Lactobacilli to lactic acid. Reproduction of Lactobacilli and recolonization of the vagina by these bacteria begin after the first use of the drug.

Pharmacokinetics As soon as the vaginal tablet interacts with the vaginal secretion, it begins to break down, lyophilized bacteria and estriol are released. Experimental in vitro studies have shown that Lactobacilli restore their metabolism and reduce the pH of the vagina within a few hours.

Positive estrogenic effects caused by estriol appear quickly, and throughout the course of treatment (6-12 days), the state of proliferating and mature vaginal epithelium gradually improves.

After a 12-day use of vaginal tablets (at the end of Ginoflor treatment 1 time per day), the peak level of unbound estriol in blood plasma was not increased compared to the main level.

No accumulation of estriol was detected during the 12-day treatment. The concentration of unbound estriol in blood plasma after repeated use of Gynoflora was within the normal boundaries of the endogenous level of the hormone in the blood plasma. Estriol therapy does not affect the plasma concentration of estrone and estradiol, since estriol is the final product of their metabolism.

Due to the low dose (0.03 mg), local application and the limited duration of treatment (6-12 days), estriol does not accumulate and systemic effects of estrogen are unlikely.

Indications

Restoring the vaginal flora of lactobacillus after local and / or systemic treatment with anti-infective or chemotherapeutic agents; atrophic vaginitis due to estrogen deficiency during menopause and postmenopause or concomitant treatment during systemic hormone replacement therapy; mild to moderate cases of bacterial vaginosis and candidiasis, vaginal discharge of unknown origin (fluor vaginalis), in which the use of anti-infection therapy is not necessary; preventive treatment of recurrent vaginal infections.

Application

Restoration of lactobacillus flora after local and / or systemic treatment with anti-infective or chemotherapeutic agents, fluor vaginalis (vaginal discharge), vaginal infections: 1-2 vaginal tablets daily for 6-12 days. vaginal tablets must be administered deep into the vagina in the evening before bedtime. it is better to do this while lying on your back, slightly bending your legs at the knees.

Treatment should be suspended for the duration of menstruation, and then continued again.

Atrophic vaginitis, vaginal discharge (Fluor vaginalis) in the postmenopausal period: 1 vaginal tablet daily for 12 days, then a maintenance dose is applied - 1 vaginal tablet 1-2 times a week. Regular use of Gynoflora with atrophic changes in the vaginal epithelium is necessary for the prevention of atrophic vaginitis.

Treatment of recurrent vaginal infections: the recommended dose is 1 vaginal tablet daily for 12 days.

Contraindications

Hypersensitivity to active substances or any of the excipients of the drug; malignant neoplasms (estrogen-dependent malignant tumors) of the breast, uterus or vagina; endometriosis (suspected or diagnosed); vaginal bleeding of unknown origin; girls before puberty.

Side effects

General disorders and conditions at the injection site. after applying gynoflora for a short time, a slight burning sensation or heat may occur.

When using the drug, local allergic reactions are possible, including rash, hyperemia, pain, swelling, itching, in people with hypersensitivity, the development of generalized allergic reactions is not excluded.

If Gynoflor was accidentally taken orally, no undesirable effects should be expected.

special instructions

Gynoflor contains components that may not completely dissolve, the remains of the tablet can sometimes be found on underwear. this does not affect the effectiveness of the drug. with significant dryness of the vagina, the tablet should be moistened with a small amount of ordinary water before administration, which will contribute to its dissolution.

During pregnancy and breastfeeding. Gynoflor can be used during pregnancy and lactation. Like other medicines, Gynoflor is prescribed with caution in the first trimester of pregnancy. Research data does not indicate an undesirable effect of estriol and Lactobacillus acidophilus on pregnancy or the health of the fetus / newborn.

Children. The drug can not be used in girls who have not reached puberty.

The ability to influence the reaction rate when driving vehicles or other mechanisms. Does not affect.

Interactions

Lactobacillus acidophilus is susceptible to numerous anti-infective agents (topical or systemic use). concomitant treatment with such agents can cause a decrease in the effectiveness of gynoflora.

Overdose

Not noted.

Storage conditions

In the original packaging, in the refrigerator (2–8 ° C). storage of gynoflora at room temperature for 1–2 weeks does not reduce its effectiveness.

Tags: Estriol