Triojinal (Trioginal)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceEubiotic + Estriol + ProgesteroneEubiotic + Estriol + Progesterone
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  • Triojinal
    capsules the vagina. 
    Bezen Helskea SA     Belgium
    • Dosage form: & nbspVaginal capsules.
    Composition:

    Composition (per 1 capsule)

    Active components:

    Lyophilized culture of lactobacilli L. casei rhamnosus Doderleini (in the composition of auxiliary substances added before lyophilization: potato starch (~ 41% by weight of lyophilizate), lactose monohydrate (~ 20.6% by weight of lyophilizate), sodium glutamate (~ 4.5% by weight of lyophilizate), sodium thiosulfate ^ 26.8% by weight of lyophilizate) - 341 mg, which corresponds to 1 × 108 - 2x109 CFU viable lactobacilli.

    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)

    Pharmacotherapeutic group:Estrogen + progestogen + eubiotic
    ATX: & nbsp

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

    Pharmacodynamics:

    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 Dodderlein 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 excess of a small 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 2.0 mg. Progesterone is a hormone of the yellow body. By binding to receptors on the surface of the cells of target organs, it penetrates into the nucleus, where, by activating DNA, it stimulates the synthesis of RNA. After preparing the epithelium with estriol, progesterone as part of the preparation TRIOJINAL promotes the formation of intermediate layers of epithelium and the synthesis of glycogen - a substrate necessary for the adoption of Dodderlein's wand. Local saturation with hormones ensures the 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 a number of antimicrobial agents. This creates a similar to the physiological environment in the vagina.

    Pharmacokinetics:

    The absorption of estriol occurs quickly: the time to reach the maximum concentration in the blood plasma (TCmax) with intravaginal application 1-2 hours. Excretion is carried out mainly by kidneys in the form of metabolites (several hours after admission and lasts up to 18 hours), 2 % is excreted through the intestine in an unchanged form.

    The maximum concentration in the blood plasma (Cmax) of progesterone in the blood plasma is achieved 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 blood plasma and in urine, are analogous 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).

    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 (up to the normalization of indicators of functional liver tests), porphyria, the use of the drug by patients under the age of 18, thromboses (arterial and venous) and thromboembolism in a good time and a history (including thrombosis,deep vein thrombophlebitis; pulmonary embolism; myocardial infarction; ischemic or hemorrhagic cerebrovascular disorders), pregnancy and lactation, jaundice and / or impaired liver function, uncontrolled hypertension, congenital or acquired predisposition to arterial thrombosis (eg, protein C deficiency, protein deficiency S, antithrombin III deficiency, antibodies to phospholipids (antibodies to cardiolipin, lupus anticoagulant), diabetes mellitus with diabetic angiopathy, benign and malignant neoplasms Efficacy, expressed or multiple risk factors for thromboembolic complications (transient ischemic attacks, angina pectoris, atrial fibrillation, complicated cardiac valve disorders, extensive surgery accompanied by prolonged immobilization, extensive trauma, obesity with body mass index of more than 30 kg / m2).

    Carefully:

    Arterial hypertension, endometriosis, with a 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 (incl.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:

    It is not recommended to use the drug during pregnancy and lactation.

    Dosing and Administration:

    The route of administration is intravaginal. 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:

    2 capsules per day for 20 days until relief of symptoms, then 1 capsule per day. The dose of the drug is corrected depending on the affect achieved. The duration of therapy with the drug is determined by the doctor; treatment should not be more than 3 months.

    If necessary, repeat the course of therapy with the drug.

    Preparation of postmenopausal patients for cyan gynecological operations to prevent postoperative complications (as part of complex therapy):

    2 capsules per day for two weeks.

    Side effects:

    Allergic reactions (itching and irritation at the injection site); bloody discharge (clotting) from the vagina; extremely rarely - the tension of the mammary glands, mastodynia (pain in the mammary glands); nausea; fluid retention, increased vaginal discharge.

    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.

    Clinically significant cases of interaction have not been reported.

    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, and the appearance during pregnancy or with the use of steroid drugs of a strong itching or cholestatic jaundice.

    Effect on the ability to drive transp. cf. and fur:

    TRIOJINAL does not affect the ability to drive vehicles and mechanisms.

    Form release / dosage:Vaginal capsules.
    Packaging:

    For 14 capsules in a colorless transparent glass bottle, sealed with a stopper of chlorobutyl elastomer; The neck of the bottle with the stopper is covered with a protective transparent shrink film made of PVC. The bottle together with the instruction for use is placed in a cardboard box.

    Storage conditions:

    At a temperature not exceeding 20 ° C Keep out of the reach of children.

    Shelf life:3 years. Do not use after expiry date.
    Terms of leave from pharmacies:On prescription
    Registration number:LP-001342
    Date of registration:09.12.2011
    The owner of the registration certificate:Bezen Helskea SABezen Helskea SA Belgium
    Manufacturer: & nbsp
    Representation: & nbspBEZEN HELSKEA ENG LLCBEZEN HELSKEA ENG LLCRussia
    Information update date: & nbsp21.10.2015
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