Expiration date: 11/2025

Vaginal capsules. 1 capsule contains active substance:

the lyophilized culture of Lactobacillus L. casei rhamnosus Doderleini (composed of auxiliary substances added to lyophilization: potato starch ( "41% by weight of lyophilizate), lactose monohydrate (" 20.6% by weight of lyophilizate), monosodium glutamate ( "4.5% by weight of lyophilizate), sodium thiosulfate ( "26.8% by weight of lyophilizate) - 341 mg, which corresponds to at least 1 · 108 - 2 · 109 cfu of viable lactobacilli

estriol 0.2 mg

2 mg progesterone

Excipients: lactose monohydrate - 6.8 mg

Capsule: titanium dioxide - 3 mg Gelatin - q.s. 100 mg

Clinico-pharmacological group: the drug that regulates the balance of vaginal flora, with the estrogen and progestin components

Pharmachologic effect:

Combined preparation for intravaginal use. biocenosis vagina is determined by several factors, and in particular the concentration of female sex hormones. The combination of progesterone and estriol in low doses for vaginal administration route provides a modest trophic effect on the vaginal epithelium, contributing to the accumulation of glycogen therein. The accumulation of glycogen contribute to the formation of the optimal acidic vaginal environment (pH 3.8-4.2), which provides optimal conditions for the life of sticks Doderlyayna, which in turn prevents vaginal colonization by pathogenic bacteria.

The preparation as one of the active substances included in the ultra-low dose of estriol 0.2 mg. Estriol estrogen is synthesized in humans. Once in the bloodstream, is complexed with specific receptors (in the uterus, vagina, urethra, breast, liver, hypothalamus, pituitary), stimulates the synthesis of proteins and DNA. It has a selective action, mainly on the cervix, vagina, vulva, causes increased proliferation of the vaginal epithelium and cervix, stimulates its blood supply, helps to restore the epithelium during its atrophic changes in premenopausal and menopausal, normalize the pH of the vaginal environment, the microflora of the vagina, improves its resistance epithelium to infectious and inflammatory processes that affect the quality and quantity of cervical mucus.

The preparation of the following as active substances include progesterone in a small dose of 2 mg. Progesterone is the hormone of the corpus luteum. By binding to receptors on the surface of cells of target organs, it enters the nucleus, where it activates DNA promotes RNA synthesis. After preparation epithelium estriol, progesterone preparataTriozhinal composition promotes formation of the intermediate layers of the epithelium and glycogen synthesis - substrate necessary to stick Doderlyayna caught.

Local satiety hormones vaginal colonization provides live Doderlyayna sticks - the third active component of the drug Lactobacillus i rhamnosus Doderleini, belonging to the strain, which is known for its resistance to several antimicrobials. This creates similar to the physiological environment of the vagina.

Pharmacokinetics

The absorption of estriol is fast:. Time in plasma Cmax achievements in intravaginal application 1-2 hours Excretion is mainly kidneys as metabolites (a few hours after administration and lasts up to 18 hours), 2% is excreted through the intestine unchanged.

Cmax is achieved in 2-6 hours after administration of progesterone in the blood plasma in the blood plasma. Progesterone is excreted in urine as metabolites, 95% of them are glyukuronkonyugirovannye metabolites, mostly 3-alpha, 5-beta-pregnanediol (pregnandion). These metabolites are determined in plasma and urine are similar to the substances formed at physiological secretions of the corpus luteum.

testimony

• Atrophic vulvovaginitis, caused by estrogen deficiency,
  
• Preparation of postmenopausal women to elective gynecological surgery to prevent postoperative infectious complications (in the complex therapy).
  

dosage

Capsule enter deeply in the vagina, moistening with a small amount of water to accelerate dissolution of the drug.

Atrophic vulvovaginitis due to estrogen deficiency: 1 capsule in the morning and evening for 14 days. If necessary (preservation of those or other symptoms of the disease) therapy may be continued up to 21 days on the advice of a doctor.

The maximum duration of the course should not be more than 21 days.

Preparation of postmenopausal women to elective gynecological surgery to prevent postoperative complications (as part of combination therapy): 1 capsule in the morning and evening for 14 days.

Side effect

Allergic reactions: itching and irritation at the injection site.

Reproductive system: bleeding (spotting) of the vagina, it is extremely rare - the tension of the mammary glands, mammalgia (breast pain), increased vaginal discharge.

Other: nausea, fluid retention.

Contraindications

• Or suspected breast cancer,
  
• Estrogen or progesteronzavisimye malignancies or suspicion on them (including endometrial cancer),
  
• Bleeding from the vagina of unknown etiology,
  
• Untreated endometrial hyperplasia,
  
• Acute and chronic liver disease (up to normalization of liver function tests)
  
• Porphyria
  
• Thrombosis (arterial and venous) and thromboembolism current and history (including thrombosis, deep vein thrombosis),
  
• pulmonary embolism,
  
• Myocardial infarction,
  
• Ischemic or hemorrhagic cerebrovascular disorders,
  
• Jaundice and / or liver dysfunction,
  
• Uncontrolled hypertension,
  
• Congenital or acquired predisposition for arterial thrombosis (eg, protein C deficiency, protein deficiency the S, antithrombin III of failure, the presence of antibodies to phospholipids (cardiolipin antibodies, lupus anticoagulant)
  
• Diabetes with diabetic angiopathy,
  
• Benign or malignant liver tumors,
  
• Expressed or multiple risk factors for thromboembolic events (transient ischemic attack, angina, atrial fibrillation, complicated valvular lesion, expanded surgery, accompanied by prolonged immobilization, major trauma, obesity with a body mass index over 30 kg / m2)
  
• Pregnancy,
  
• Lactation,
  
• Children and teens under 18 years of age,
  
• Hypersensitivity to the drug.
  

Carefully

Hypertension, endometriosis, a history of thromboembolic complications in family 1st-degree relatives at a relatively young age, risk factors, estrogen and progesteronzavisimyh tumors, liver disease (including adenoma), diabetes without diabetic angiopathy, cholelithiasis, migraine or severe headache, systemic lupus erythematosus, endometrial hyperplasia in history, epilepsy, asthma, otosclerosis.

Pregnancy and breast-feeding

Do not use this drug during pregnancy and lactation.

Application for violations of liver function

Carefully.

Use in children

Contraindications to 18 years.

special instructions

It is not recommended to use the drug together with spermicides.

The drug should not be used for contraception.

It is recommended to carry out careful monitoring of the patients who have marked heart failure, renal dysfunction, hypertension, epilepsy, migraine, severe liver disease, endometriosis, fibrocystic breast disease, hyperlipoproteinemia, as well as the appearance during pregnancy or when taking steroids severe itching or cholestatic jaundice.

Effects on ability to drive vehicles and management mechanisms

Triozhinal does not affect the ability to drive and use machines.

Overdose

Not described.

Drug interactions

In an application with inducers of microsomal liver enzymes (phenobarbital, carbamazepine, phenytoin, rifampin, rifabutin, nevirapine, zfavirenz) enhanced the metabolism of sex hormones that may reduce the effectiveness of the drug.

Inhibitors of microsomal liver enzymes (ritonavir, nelfinavir) significantly reduce metabolism involving liver microsomal enzymes, but while the use of sex hormones can act as inducers, drugs St. John's wort may induce the metabolism of estrogens.

No clinically significant interactions of cases have been reported.

Terms and Conditions of storage

The drug should be stored out of reach of children at or above 20 ° C. Shelf life - 3 years.