Eubiotic + Estriol + Progesterone (Eubiotic + Estriol + Progesterone)

Pharmacodynamics Pharmacokinetics Indications Carefully Contraindications Dosing and Administration Side effects
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Clinical and pharmacological group: & nbsp

"Estrogens, gestagens, their homologues and antagonists"

Included in the formulation
  • Triojinal
    capsules the vagina. 
    Bezen Helskea SA     Belgium
    • АТХ:

    G.02.C.X   Other drugs for use in gynecology

    Pharmacodynamics:

    Combined drug for intravaginal application. The biocenosis of the vagina is determined by a number of factors, in particular, by the concentration of female sex hormones. The combination of progesterone and estriol in low doses with the vaginal route of administration has a moderate trophic effect on the vaginal epithelium, promoting 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 Doderylein wand, which in turn prevents colonization of the vagina by pathogenic bacteria.

    The composition of the drug as one of the active substances is estriol in an ultra low dose of 0.2 mg. Estriol is an estrogen synthesized in the human body. Getting into 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 effect, mainly on the cervix, vagina, vulva, increases the proliferation of the epithelium of the vagina and cervix, stimulates its blood supply, promotes the recovery of the epithelium during its atrophic changes during the periods of premenopause and menopause, normalizes the pH of the vaginal environment, the microflora of the vagina, 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 active substance is progesterone in a small dose of 2 mg. Progesterone is a hormone of the yellow body. Binding to receptors on the surface of cells of target organs penetrates into the nucleus, where activating DNA stimulates RNA synthesis. After preparing the epithelium with estriol, progesterone in the composition of the drug contributes to the formation of intermediate layers of the epithelium and the synthesis of glycogen - the substrate necessary for the Doderylein wand to become familiar.

    Local saturation with hormones ensures colonization of the vagina with live Doderylein rods, the third active ingredient in Lactobacillus casei rhamnosus Doderleini, belonging to a strain that is known for its resistance to a number of antimicrobials.This creates a similar to the physiological environment in the vagina.

    Pharmacokinetics:

    Absorption estriol occurs quickly: the time to reach the maximum concentration in blood plasma for intravaginal application 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 unchanged.

    Maximum concentration in the blood plasma progesterone in blood plasma is achieved in 2-6 hours after administration.

    Progesterone is excreted in the urine in the form of metabolites, 95% of them are glucuron-conjugated metabolites, mainly 3-alpha, 5-beta-pregnanediol (pregnannione). These metabolites, which are determined in the blood plasma and in urine, are similar to substances formed during the physiological secretion of the yellow body.

    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).
    ICD-10

    XIV.N80-N98.N95.2   Postmenopausal atrophic vaginitis

    Contraindications:

    - established or suspected breast cancer;

    - Estrogen- or progesteroid-dependent malignant neoplasms or suspected of them (including endometrial cancer);

    bleeding from the vagina of an unclear etiology;

    - untreated endometrial hyperplasia;

    - acute and chronic liver diseases (before the normalization of indicators of functional liver samples);

    - porphyria;

    - 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 (eg, protein C deficiency, protein S deficiency, antithrombin III deficiency, antibodies to phospholipids (antibodies to cardiolipin, lupus anticoagulant);

    - Diabetes mellitus with diabetic angiopathy;

    - benign and malignant neoplasms of the liver;

    - expressed or multiple risk factors for thromboembolic complications (transient ischemic attacks, angina pectoris, atrial fibrillation,complicated heart valve apparatus lesions; Extended surgical intervention accompanied by prolonged immobilization; extensive trauma; Obesity with a body mass index of more than 30 kg / m2);

    - Pregnancy;

    - lactation period;

    - children and adolescence under 18;

    - Hypersensitivity to the components of the drug.

    Carefully:

    Arterial hypertension, endometriosis, history of thromboembolic complications in relatives of the first 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, endometrial hyperplasia in the anamnesis, epilepsy, bronchial asthma, otosclerosis.

    Pregnancy and lactation:

    The use of the drug during pregnancy and during lactation is contraindicated.

    Dosing and Administration:

    Insert the 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 (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.

    Preparation of 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.

    Side effects:

    Allergic reactions: itching and irritation at the injection site.

    From the side reproductive system: spotting (clotting) from the vagina; extremely rarely - the tension of the mammary glands, mastodynia (pain in the mammary glands); increased vaginal discharge.

    Other: nausea; fluid retention.

    Overdose:

    Not described.

    Interaction:

    With simultaneous use with inductors of microsomal liver enzymes (phenobarbital, carbamazepine, phenytoin, rifampicin, rifabutin, nevirapine, efavirenz) increases the metabolism of sex hormones, 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 simultaneously with sex hormones can act as inducers; preparations of St. John's wort can lead to the metabolism of estrogens.

    Special instructions:

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

    The drug can not be used for contraception.

    It is recommended to carefully monitor patients with heart failure, renal dysfunction, arterial hypertension, epilepsy, migraine, severe liver disease, endometriosis, fibrocystic mastopathy, hyperlipoproteinemia, as well as the appearance of severe itching during pregnancy or when taking steroid medications or cholestatic jaundice.

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