Triozhinal caps. vaginas. 14 pc

Description

Composition
Active substance:
Lyophilized culture of Lactobacillus L. casei rhamnosus Doderleini – 341 mg, which corresponds 1h108 – 2h109 cfu viable lactobacilli (composed of auxiliary substances added prior to lyophilization: potato starch ~ 41% by weight of the lyophilizate of lactose monohydrate ~ 20.6% by weight of lyophilizate MSG ~ 4.5% by weight of lyophilizate, sodium thiosulfate ~ 26.8% by weight of lyophilizate).
Estriol – 0.2 mg
Progesterone – 2.0 mg.
Excipients:
Lactose monohydrate 6.8 mg
Capsule: titanium dioxide (3 mg), gelatin (q.s. to 100 mg).
Description:
Triozhinal® – a combined hormonal preparation for the comprehensive restoration of the epithelium and vaginal flora in women during menopause.
Product form:
Vaginal capsules. 14 capsules in a colorless transparent glass bottle, rubber stoppers of chlorobutyl elastomer; bottle neck with the cork embraced by the protective transparent PVC shrink film. The vial together with instructions for use placed in a cardboard box.
Contraindications
Increased sensitivity to the drug or any of the components of the drug, or suspected breast cancer; estrogen or progesteronzavisimye malignancies or suspicion of them (including endometrial cancer); vaginal bleeding of unknown etiology; untreated endometrial hyperplasia; acute and chronic liver disease (before normalization of liver function tests); porphyria; use of the drug by patients under the age of 18 years; thrombosis (arterial and venous) and thromboembolism in the present and in history (including thrombosis, deep vein thrombosis, pulmonary embolism, myocardial infarction, ischemic or hemorrhagic cerebrovascular accident); pregnancy and lactation, jaundice and / or abnormal liver function; uncontrolled hypertension; congenital or acquired predisposition for arterial thrombosis (e.g., failure of protein C, protein deficiency S, deficiency of antithrombin III, the presence of antibodies to phospholipids (antibodies to cardiolipin, lupus anticoagulant); diabetes from diabetic angiopathy, benign and malignant hepatic neoplasm; expressed or multiple risk factors for thromboembolic events (transient ischemic attack, angina, atrial fibrillation, complicated SHOCK Nia valvular, extended surgery, accompanied by prolonged immobilization, major trauma, obesity with a body mass index over 30 kg / m2).
Carefully
Arterial hypertension; endometriosis; a history of thromboembolic events in family 1st-degree relatives at a relatively young age; risk factors for 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; bronchial asthma; otosclerosis.
Indications
– Atrophic vulvovaginitis, caused by estrogen deficiency. – Preparation of postmenopausal women to planned gynecological surgery to prevent postoperative infectious complications (in the complex therapy).
Interaction with other drugs
While the use of inducers of microsomal liver enzymes (phenobarbital, carbamazepine, phenytoin, rifampin, rifabutin, nevirapine, efavirenz) enhanced the metabolism of sex hormones that can reduce the effectiveness of the drug. Inhibitors of microsomal liver enzymes (ritonavir, nelfinavir) significantly reduced metabolism involving liver microsomal enzymes, but while the use of sex hormones can act as inductors. Formulations Hypericum perforatum can induce estrogen metabolism.
No clinically relevant interactions between registered.
Overdose
Not described.
pharmachologic effect
Pharmacological group:
Estrogen + progestogen + eubiotics.
Pharmacological properties:
Biocoenosis vagina is determined by several factors, particularly concentration, and female sex hormones. The combination of progesterone and estriol in low doses for vaginal administration route has a moderate trophic effect on the vaginal epithelium, contributing to the accumulation of glycogen therein. Accumulation of glycogen formation promotes optimum acidic environment of the vagina (pH 3.8 – 4.2), which provides optimum conditions for the life of sticks Doderlyayna which, in turn, prevents colonization of pathogenic bacteria vagina.
The preparation as one of the active substances is included in the ultra low dose of estriol 0.2 mg. Estriol is the estrogen synthesized in the human body. Once in the bloodstream, it forms a complex with specific receptors (in the uterus, vagina, urethra, breast, liver, hypothalamus, pituitary), stimulates the synthesis of DNA and proteins. Has a selective action, mostly on the cervix, vagina, vulva, causes increased proliferation of the vaginal epithelium and cervical stimulates its blood supply, contributes to the restoration of the epithelium when atrophic changes in premenopausal and menopausal normalizes pH of the vaginal environment, the microflora of the vagina and increases its resistance epithelium to infectious and inflammatory processes that affect the quality and quantity of cervical mucus.
Also the drug as one of the active substances include progesterone in a small dose of 2.0 mg. Progesterone is the hormone of the corpus luteum. By binding to the receptors on the surface of target organ cells, it enters the nucleus, where it activates DNA stimulates RNA synthesis. After preparing the epithelium estriol, progesterone as part Triozhinal® drug contributes to the formation of the intermediate layers of the epithelium and the synthesis of glycogen – the substrate needed to stick caught Doderlyayna.
Local saturation hormones provides vaginal colonization by living chopsticks Doderlyayna – third active drug component, Lactobacillus casei rhamnosus Doderleini – strain, which is known for its resistance to a number of antimicrobials. This creates similar to the physiological environment of the vagina.
Pharmacokinetics:
Absorption occurs quickly estriol: time to reach maximum plasma concentration (TSmax) for intravaginal application is 1-2 hours.
Derivation is performed primarily as metabolites in the kidneys (a few hours after administration and continuing up to 18 hours), 2% is excreted through intestine unchanged.
The maximum concentration (Cmax) of progesterone in blood plasma achieved in 2-6 hours after administration. Progesterone excreted in urine as metabolites, 95% of them are glyukuronkonyugirovannye metabolites, mostly 3-alpha, 5-beta-pregnanediol (pregnandion). These metabolites, which are determined in plasma and urine are similar to the substances formed during physiological secretion of the corpus luteum.
Pregnancy and breast-feeding
It is not recommended to use the drug during pregnancy and lactation.
Conditions of supply of pharmacies
On prescription.
side effects
Allergic reactions (itching and irritation at the injection site); spotting (spotting) from the vagina; extremely rare – the tension of the mammary glands, mammalgia (breast pain); nausea; fluid retention; increased vaginal discharge.
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 noted: heart failure, renal failure, hypertension, epilepsy, migraine, severe liver disease, endometriosis, fibrocystic breast disease, hyperlipoproteinemia and appearance during pregnancy or receiving steroids strong itching or cholestatic jaundice.
Effect on the ability to drive mechanisms and
Triozhinal® does not affect the ability to drive and use machines.
Storage conditions
At a temperature of not higher than 20 ° C.
Keep out of the reach of children.
Dosing and Administration
Vaginally.
Enter the capsule deep into the vagina, moistening with a small amount of water to accelerate dissolution of the drug.
Atrophic vulvovaginitis due to estrogen deficiency:
2 capsules per day for 20 days to alleviate symptoms, followed by 1 capsule per day. The dose is corrected depending on the achieved effect. The duration of drug therapy is determined by the doctor; treatment should not be more than 3 months. If necessary can be repeated courses of the drug therapy.
Preparation of postmenopausal women to planned gynecological surgery to prevent postoperative complications (in the complex therapy): 2 capsules a day for two weeks.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist