Triozhinal

General characteristics. Structure:

The lyophilized culture of lactobacilli of L. casei rhamnosus Doderleini of 341 mg that соотв. to keeping of viable lactobacilli 1×108 - 2×109, WHICH
Acting substances:
- estriol of 0.2 mg
- progesterone of 0.2 mg
Excipients: lactoses monohydrate of 6.8 mg.
Structure of a cover of the capsule: titanium dioxide of 3 mg, gelatin (q.s. to 100 mg).
The excipients added before lyophilizing: potato starch (~ 41% of the mass of lyophilisate), lactoses monohydrate (~ 20.6% of the mass of lyophilisate), sodium glutamate (~ 4.5% of the mass of lyophilisate), Natrium thiosulfuricum (~ 26.8% of the mass of lyophilisate).

Pharmacological properties:

The combined drug for intravaginalny use. The biocenosis of a vagina is defined by a number of factors, in particular and concentration of female sex hormones. The combination of progesterone and estriol in low doses at a vaginal way of introduction has moderate trophic effect on a vagina epithelium, promoting accumulation of a glycogen in it. Accumulation of a glycogen promotes formation of optimum acid medium of a vagina (рН 3.8-4.2) which provides optimal conditions for life activity of a stick of Doderlyayn which in turn interferes with colonization of a vagina pathogenic bacteriums.

Estriol in a midget dose of 0.2 mg is a part of drug as one of active agents. Estriol is the estrogen synthesized in a human body. Getting to a blood stream, forms a complex with specific receptors (in a uterus, a vagina, an urethra, a mammary gland, a liver, a hypothalamus, a hypophysis), stimulates synthesis of DNA and proteins. Possesses the selection action, it is preferential on a neck of uterus, a vagina, a vulva, causes strengthening of proliferation of an epithelium of a vagina and neck of uterus, stimulates its blood supply, promotes recovery of an epithelium at its atrophic changes during the periods of a premenopauza and menopause, normalizes рН the vulval environment, vagina microflora, increases the resilience of its epithelium to infectious and inflammatory processes, exerts impact on quality and amount of cervical slime.

Progesterone in a small dose of 2 mg is a part of drug as the following from active agents. Progesterone is hormone of a yellow body. Contacting receptors on a surface of cells of target organs, gets into a kernel where, activating DNA, stimulates RNA synthesis. After preparation of an epithelium estriol, progesterone as a part of drug Triozhinal promotes formation of medines of an epithelium and synthesis of a glycogen - the substrate necessary in order that Doderlyayn's stick got accustomed.

Local saturation by hormones provides colonization of a vagina with live sticks of Doderlyayn - the third active component of the drug Lactobacillus casei rhamnosus Doderleini, belonging to a strain which is known for the resistance to a number of antimicrobic drugs. At the same time an environment in a vagina is created similar with physiological.

Pharmacokinetics. Absorption of estriol happens quickly: time of achievement of Cmax in a blood plasma at intravaginalny use of 1-2 h.

Removal is carried out generally by kidneys in the form of metabolites (in several hours after reception and proceeds to 18 h), 2% are removed through intestines in not changed look.
Cmax in a progesterone blood plasma in a blood plasma is reached in 2-6 h after introduction.

Progesterone is removed with urine in the form of metabolites, 95% from them are made by glyukuronkonjyugirovanny metabolites, generally 3 alpha, 5 - beta pregnandiol (прегнандион). The specified metabolites which are defined in a blood plasma and in urine are similar to the substances which are formed at physiological secretion of a yellow body.

Indications to use:

— the atrophic vulvovaginitis caused by deficit of estrogen;
— training of patients in a postmenopause to planned gynecologic operations with the purpose of prevention of postoperative infectious complications (as a part of complex therapy).

Route of administration and doses:

To enter the capsule deeply into a vagina, having moistened it in a small amount of water for drug dissolution acceleration.
The atrophic vulvovaginitis caused by deficit of estrogen: on 1 capsule in the morning and in the evening within 14 days. If necessary (preservation of these or those symptoms of a disease) therapy can be continued up to 21 days according to the recommendation of the doctor.
The maximum duration of a course should not make more than 21 day.
Training of patients in a postmenopause to planned gynecologic operations with the purpose of prevention of postoperative complications (as a part of complex therapy): on 1 capsule in the morning and in the evening within 14 days.

Features of use:

Use of drug together with spermicidal means is not recommended.
Drug cannot be used for the purpose of contraception.
It is recommended to carry out careful observation of patients at whom heart failure, a renal failure, arterial hypertension, epilepsy, migraine, a serious illness of a liver, endometriosis, a fibrous and cystous mastopathy, a giperlipoproteinemiya, and also emergence are noted during pregnancy or at reception of steroid drugs of a severe itch or cholestatic jaundice.

Influence on ability to driving of motor transport and to control of mechanisms
Triozhinal does not influence ability to manage vehicles and mechanisms.

Side effects:

Allergic reactions: an itch and irritation in an injection site.
From reproductive system: bloody allocations (krovomazany) of a vagina; extremely seldom - tension of mammary glands, a mastodynia (mammary gland pain); increase in allocations from a vagina.
Others: nausea; liquid delay.

Interaction with other medicines:

At simultaneous use with inductors of microsomal enzymes of a liver (phenobarbital, carbamazepine, Phenytoinum, rifampicin, рифабутин, not Virapinum, зфавиренз) metabolism of sex hormones amplifies that can lead to decrease in efficiency of drug.

Inhibitors of microsomal enzymes of a liver (ритонавир, нелфинавир) considerably reduce metabolism with participation of microsomal enzymes of a liver, but at simultaneous use with sex hormones can work as inductors; drugs of the St. John's Wort which is made a hole can induce metabolism of estrogen.

Clinically significant cases of interaction are not registered.

Contraindications:

— the established or suspected breast cancer;
— estrogen - either progesteronzavisimy malignant new growths or suspicion on them (including endometrial cancer);
— bleedings from a vagina of not clear etiology;
— uncured hyperplasia of an endometria;
— acute and chronic diseases of a liver (before normalization of indicators of functional trials of a liver);
— porphyria;
— fibrinferments (arterial and venous) and thromboembolisms now and in the anamnesis (including thrombosis, thrombophlebitis of deep veins);
— thromboembolism of a pulmonary artery;
— myocardial infarction;
— ischemic or hemorrhagic cerebrovascular disturbances;
— jaundice and/or abnormal liver function;
— uncontrollable arterial hypertension;
— the inborn or acquired predisposition to arterial fibrinferments (for example, insufficiency of a protein With, insufficiency of a protein of S, insufficiency of antithrombin III, existence of antibodies to phospholipids (antibodies to cardiolipin, lupoid anticoagulant);
— a diabetes mellitus with a diabetic angiopatiya;
— high-quality and malignant new growths of a liver;
— the expressed or multiple factors of risk of development of tromboembolic episodes (the tranzitorny ischemic attacks, stenocardia, fibrillation of auricles, the complicated defeats of the valve device of heart; the expanded operative measure which is followed by a long immobilization; extensive injury; obesity with an index of body weight more than 30 kg/sq.m);
— pregnancy;
— lactation period;
— children's and teenage age up to 18 years;
— hypersensitivity to drug components.

With care
Arterial hypertension, endometriosis, existence in the anamnesis of tromboembolic episodes at relatives of the 1st degree of relationship at rather young age, risk factors it is oestrogenic - and progesteronzavisimy tumors, a liver disease (including adenoma), a diabetes mellitus without diabetic angiopatiya, a cholelithiasis, migraine or a heavy headache, a system lupus erythematosus, an endometria hyperplasia in the anamnesis, epilepsy, bronchial asthma, an otosclerosis.

Use of drug TRIOZhINAL at pregnancy and feeding by a breast
Use of drug at pregnancy and in the period of a lactation is contraindicated.

Use at abnormal liver functions
With care.

Use for children
It is contraindicated up to 18 years.

Overdose:

It is not described.

Storage conditions:

Drug should be stored in the place, unavailable to children, at a temperature not above 20 °C.

Issue conditions:

According to the recipe

Packaging:

Capsules are vaginal: 14 pieces.