1 vaginal capsule contains:
lyophilized culture of lactobacilli Lactobacillus casei rhamnosus Doderleini 341 mg, which corresponds to the content of viable lactobacilli 1 × 108 - 2 × 109 CFU, estriol 0.2 mg, progesterone 2.0 mg.
Excipients added before lyophilization:
potato starch (~ 41% by weight of lyophilisate),
lactose monohydrate (~ 20.6% by weight of lyophilisate),
sodium glutamate (~ 4.5% by weight of lyophilisate),
sodium thiosulfate (~ 26.8% by weight of lyophilisate).
lactose monohydrate - 6.8 mg.
The composition of the capsule shell:
titanium dioxide - 3 mg,
gelatin - qs up to 100 mg.
Triozhinal is a combined preparation for intravaginal use. Vaginal biocenosis is determined by a number of factors, in particular, the concentration of female sex hormones. The combination of progesterone and estriol in low doses during the vaginal route of administration has a moderate trophic effect on the vaginal epithelium, contributing to the accumulation of glycogen in it. The accumulation of glycogen contributes to the formation of an optimal acidic environment of the vagina (pH 3.8-4.2), which provides optimal conditions for the life of the Doderlein stick, which in turn prevents the colonization of the vagina by pathogenic bacteria.
The composition of the drug as one of the active substances includes estriol in an ultra-low dose of 0.2 mg. Estriol is an estrogen synthesized in the human body. Once in the bloodstream, it forms a complex with specific receptors (in the uterus, vagina, urethra, mammary gland, liver, hypothalamus, pituitary gland), stimulates the synthesis of DNA and proteins.
It has a selective effect, mainly on the cervix, vagina, vulva, causes increased proliferation of the epithelium of the vagina and cervix, stimulates its blood supply, helps restore the epithelium during its atrophic changes during premenopause and menopause, normalizes the pH of the vaginal environment, the vaginal microflora, increases its resistance epithelium to infectious and inflammatory processes, affects the quality and quantity of cervical mucus.
The composition of the drug as the next of the active substances includes progesterone in a small dose of 2 mg. Progesterone is a corpus luteum hormone. By binding to receptors on the surface of target organ cells, it penetrates into the nucleus, where, by activating DNA, it stimulates RNA synthesis. After preparing the epithelium with estriol, the progesterone in the composition of the Triozhinal preparation promotes the formation of intermediate layers of the epithelium and the synthesis of glycogen, the substrate necessary for the Doderlein stick to take root.
Local hormone saturation provides colonization of the vagina with live Doderlein sticks, the third active component of the drug Lactobacillus casei rhamnosus Doderleini, belonging to a strain that is known for its resistance to several antimicrobials. This creates a similar to the physiological environment in the vagina.
Estriol absorption occurs rapidly: the time to reach Cmax in plasma with intravaginal administration is 1-2 hours. Excretion is carried out mainly by the kidneys in the form of metabolites (several hours after administration and lasts up to 18 hours), 2% is excreted unchanged through the intestine. Cmax in blood plasma of progesterone in blood plasma is achieved 2-6 hours after administration.
Progesterone is excreted in the urine in the form of metabolites, 95% of them are glucuronconjugated metabolites, mainly 3-alpha, 5-beta-pregnanediol (pregnandion). These metabolites, which are determined in blood plasma and in urine, are similar to substances formed during physiological secretion of the corpus luteum.
Atrophic vulvovaginitis due to estrogen deficiency; preparation of postmenopausal patients for planned gynecological operations in order to prevent postoperative infectious complications (as part of complex therapy).
Pregnancy and lactation
The use of the drug during pregnancy and during lactation is contraindicated.
- estrogen- or progesterone-dependent malignant neoplasms or suspicion of them (including endometrial cancer);
- bleeding from the vagina of unknown etiology;
- untreated endometrial hyperplasia;
- acute and chronic liver diseases (until the normalization of liver function tests);
- thrombosis (arterial and venous) and thromboembolism at present and in the anamnesis (including thrombosis, deep vein thrombophlebitis);
- pulmonary embolism;
- myocardial infarction;
- Ischemic or hemorrhagic cerebrovascular disorders;
- jaundice and / or impaired liver function;
- uncontrolled arterial hypertension;
- congenital or acquired predisposition to arterial thrombosis (for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, the presence of antibodies to phospholipids (antibodies to cardiolipin, lupus anticoagulant);
- diabetes mellitus with diabetic angiopathy;
- benign and malignant neoplasms;
- expressed or multiple risk factors for the development of thromboembolic complications (transient ischemic attacks, angina pectoris, atrial fibrillation, complicated lesions of the valvular apparatus of the heart; extended surgical intervention, accompanied by prolonged immobilization; extensive trauma; obesity with a body mass index of more than 30 kg / m2);
- lactation period;
- children's and teenage age up to 18 years;
- Hypersensitivity to the components of the drug Triozhinal .
Arterial hypertension, endometriosis, a history of thromboembolic complications in relatives of the 1st degree of kinship at a relatively young age, risk factors for estrogen- and progesterone-dependent tumors, liver disease (including adenoma), diabetes mellitus without diabetic angiopathy, cholelithiasis, migraine or severe headache, systemic lupus erythematosus, a history of endometrial hyperplasia, epilepsy, bronchial asthma, otosclerosis.
Allergic reactions: itching and irritation at the injection site.
From the reproductive system: spotting (blood clotting) from the vagina; extremely rarely - tension of the mammary glands, mastodynia (pain in the mammary glands); increased vaginal discharge.
Other: nausea; fluid retention.
With the simultaneous use of microsomal liver enzymes (phenobarbital, carbamazepine, phenytoin, rifampicin, rifabutin, nevirapine, zfavirenz) with inducers, the metabolism of sex hormones increases, which can lead to a decrease in the effectiveness of the drug.
Inhibitors of microsomal liver enzymes (ritonavir, nelfinavir) significantly reduce metabolism involving microsomal liver enzymes, but when used with sex hormones can act as inducers; Hypericum perforatum preparations can induce estrogen metabolism.
No clinically significant cases of interaction have been reported.
How to take, course of administration and dosage
Insert the Triozhinal capsule deep into the vagina, moistening it in a small amount of water to accelerate the dissolution of the drug.
Atrophic vulvovaginitis due to estrogen deficiency: 1 capsule in the morning and evening for 14 days. If necessary (preservation of certain symptoms of the disease), therapy can be continued up to 21 days on the recommendation of a doctor.
The maximum duration of the course should not be more than 21 days.
Preparing postmenopausal patients for planned gynecological operations to prevent postoperative complications (as part of complex therapy): 1 capsule in the morning and evening for 14 days.
The use of the drug with spermicidal agents is not recommended.
The drug can not be used for contraception.
It is recommended to carefully monitor patients who have heart failure, impaired renal function, arterial hypertension, epilepsy, migraine, severe liver disease, endometriosis, fibrocystic mastopathy, hyperlipoproteinemia, and the appearance of severe itching during pregnancy or when taking steroid drugs or cholestatic jaundice.
Influence on the ability to drive vehicles and control mechanisms
Triozhinal does not affect the ability to drive vehicles and mechanisms.
Capsules are vaginal.