Trioginal vaginal capsules №14

Release form, composition
Triozhinalny vaginal capsules
1 caps:
- freeze-dried culture of lactobacilli L. casei rhamnosus Doderleini 341 mg, which is equivalent. the content of viable lactobacilli 1 × 108 - 2 × 109 CFU
- estriol 0.2 mg
- Progesterone 0.2 mg
Excipients: lactose monohydrate 6.8 mg.
The composition of the shell of the capsule: titanium dioxide 3 mg, gelatin (q.s. up to 100 mg).
Pharmaceutical action:The biocenosis of the vagina 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 the 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 Trioginal as one of the active substances includes estriol in 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 to restore the epithelium during its atrophic changes during the premenopause and menopause, normalizes the pH of the vaginal environment, the vaginal microflora, promotes vaginal fluids, menopause and menopause, normalizes the pH of the vaginal environment, vaginal microflora, promotes the vaginal fluids, menopause and menopause epithelium to infectious and inflammatory processes, affects the quality and quantity of cervical mucus.
The composition of the drug as the next active ingredient is progesterone in a small dose of 2 mg. Progesterone is a yellow body 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 the preparation of the epithelium with estriol, progesterone in the composition of the Trioginal drug promotes the formation of intermediate layers of the epithelium and the synthesis of glycogen, the substrate necessary for the Doderlein's stick to take root.
Local hormone saturation provides colonization of the vagina with Doderlein live chopsticks - the third active ingredient of Lactobacillus casei rhamnosus Doderleini, belonging to a strain that is known for its resistance to a number of antimicrobial agents. This creates a similar physiological environment in the vagina.
Pharmacokinetics:Absorption of estriol occurs quickly: the time to reach Cmax in the blood plasma with intravaginal application of 1-2 hours.Excretion is carried out mainly by the kidneys in the form of metabolites (several hours after ingestion and lasts up to 18 hours), 2% is excreted through the intestine in unchanged form.
Cmax in plasma of progesterone in plasma is reached 2-6 hours after administration. Progesterone is excreted in the urine as metabolites, 95% of which are glucuron-conjugated metabolites, mainly 3-alpha, 5-beta-pregnandiol (pregnandion). These metabolites, which are determined in the blood plasma and urine, are similar to substances formed during the physiological secretion of the corpus luteum.
Indications:- atrophic vulvovaginitis due to estrogen deficiency;
- preparation of postmenopausal patients for planned gynecological operations to prevent postoperative infectious complications (as part of complex therapy).
Category of action on the fetus:It is not recommended to use the drug Trioginal during pregnancy and lactation.
Contraindications:- established or suspected breast cancer;
- 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 diseases of the liver (until normalization of indicators of liver function tests);
- porphyria;
- use of the drug by patients under the age of 18 years;
- Thrombosis (arterial and venous) and thromboembolism at present and in history (including thrombosis, deep vein thrombophlebitis);
- pulmonary embolism;
- myocardial infarction;
- ischemic or hemorrhagic cerebrovascular disorders);
- pregnancy;
- lactation period;
- jaundice and / or abnormal 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 of the liver;
- severe or multiple risk factors for thromboembolic complications (transient ischemic attacks, angina pectoris, atrial fibrillation, complicated valvular heart disease; extended surgery, accompanied by prolonged immobilization; extensive trauma; obesity with a body mass index of more than 30 kg / m2);
- hypersensitivity to the drug or to any of the components of the Trioginal drug.
Carefully
Arterial hypertension, endometriosis, with a history of thromboembolic complications in relatives of the 1st degree of relationship, 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, endometrial hyperplasia in history, epilepsy, bronchial asthma, otosclerosis.
Dosing:Insert the capsule deep into the vagina, wetting 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 (the 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 Trioginal in the morning and evening for 14 days.
Side effect:Allergic reactions (itching and irritation at the injection site); bleeding from the vagina; extremely rarely - the tension of the mammary glands, mastodinia (pain in the mammary glands); nausea; fluid retention, increased vaginal discharge.
Interaction:When used simultaneously with inducers of microsomal liver enzymes (phenobarbital, Carbamazepine, phenytoin, rifampicin, rifabutin, nevirapine, zfavirenz), 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 with the participation of microsomal liver enzymes, but when used simultaneously with sex hormones can act as inducers; Hypericum perforatum drugs can induce estrogen metabolism.
No clinically significant interaction reported.
Special instructions:The use of the drug Trioginal 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 kidney function, arterial hypertension, epilepsy, migraine, severe liver disease, endometriosis, fibrocystic mastopathy, hyperlipoproteinemia, and the appearance of strong itch during pregnancy or when taking steroid drugs or cholestatic jaundice.
Influence on ability to drive motor transport and control mechanisms
Trioginal does not affect the ability to drive vehicles and mechanisms.