Ovestin, vaginal suppositories 0.5 mg 15 pcs

Pharmacotherapeutic group: natural and synthetic estrogens.
ATH code: G03CA04

Pharmacological properties

Pharmacodynamics
.
The active ingredient of the drug is estriol – an analogue of the natural female hormone estriol. It replenishes estrogen deficiency in postmenopausal women and relieves postmenopausal symptoms. Estriol is most effective in the treatment of urinary and reproductive tract disorders (e.g. atrophic vaginitis). In atrophy of lower urinary and genital tract mucosa, estriol induces normalization of vaginal, cervical and urethral epithelium, thus contributing to restoration of normal vaginal microflora and pH. As a result, the resistance of the epithelium of the urinary and genital tracts to infection and inflammation increases; mucosal dryness and itching in the vagina, pain during intercourse, the possibility of vaginal and urinary tract infections decreases. Therapy with estriol promotes normalization of urination and prevents urinary incontinence.
Unlike other estrogens, estriol has a short period of action (it is retained in the nuclei of endometrial cells for a short period of time). It is assumed that a single daily dose does not cause endometrial proliferation. Therefore, no cyclic progestagen administration is required and no “withdrawal” bleeding occurs.

Pharmacokinetics

Absorption
Intravaginal administration of estriol provides optimal bioavailability at the site of action. Estriol is absorbed and enters the general bloodstream, which is manifested by a rapid increase in the plasma concentration of unbound estriol. After intravaginal administration at a dose of 0.5 mg the maximum concentration of estriol in plasma (100 pg/ml) is observed 1-2 hours after administration.

Distribution
In plasma 90% of estriol is bound to albumin. Unlike other estrogens, it almost does not bind to sex hormone-binding globulin.

Metabolism
The metabolism of estriol consists mainly of conversion to conjugated and unconjugated states by intestinal and hepatic recirculation.

Elimination
Estriol, being the end product of metabolism, is mainly excreted by the kidneys in bound form. Only a small part (about 2%) is excreted through the intestine, mostly as unbound estriol. The elimination half-life of estriol is about 6-9 hours.

Indications

Active ingredient

Composition

How to take, the dosage

Interaction

Special Instructions

Synopsis

Contraindications

Side effects

Classification by organ and system

Frequency of occurrence

Indesirable reactions

Disorders of metabolism and nutrition

Infrequent

Fluid retention

Gastrointestinal disorders

Gastrointestinal disorders

Infrequent

Nausea

Genital and mammary disorders

Infrequent

Breast pain, breast pain, acyclic bloody discharge, cervical discharge

General disorders and disorders at the injection site

/p>

Infrequent

Itching and irritation at the site of administration

Frequency unknown

Flu-like symptoms

Age range

(years)

Incidence per 1,000 women who took placebo for more than 5 years (placebo group)

Relative risk (95% CI)

Additional cases per 1,000 patients receiving ZGT for 5 years

Peroral estrogen monotherapy*

50-59

7

1.2 (0.6-2.4)

1 (- 3-10)

* Study in women who underwent hysterectomy

Age range

(years)

Incidence per 1,000 women taking placebo for 5 years (placebo group)

/p>

Relative risk (95% CI)

Additional cases per 1,000 patients receiving ZGT for 5 years

/p>

50-59

8

1.3 (1.1-1.6)

3 (1-5)

*Ischemic and hemorrhagic strokes were not distinguished.

Overdose

Pregnancy use

Similarities