Trioginal caps vag. #14

User manual for Trioginal

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Composition

In one vaginal capsule Trioginal contains active substances: 341 mg of lyophilized culture of lactobacillus lactobacillus casei rhamnosus (GG) Doderleini (equivalent × 108 - 2 × 109 CFU viable lactobacilli), 0.2 mg estriol, 2 mg progesterone.
The composition of the auxiliary inactive substances includes compounds added before the lyophilization process (values ​​are indicated with respect to the weight of the lyophilizate): about 41% potato starch, about 20.6% lactose monohydrate, about 4.5% sodium glutamate, about 26.8% sodium thiosulphate. In general, the capsules include 6.8 mg of lactose monohydrate. The capsule shell is 3 mg titanium dioxide and gelatin (q.s.) up to 100 mg.

Form of issue

Capsules Triojinal are packed in flakonchiki on 14 pieces which are sealed in cardboard packs.

pharmachologic effect

Antimicrobial, anti-inflammatory.

Pharmacodynamics and pharmacokinetics

The use of the combined Trioginal preparation is intravaginal. The complex of progesterone with estriol in low enough doses of the intravaginal route of administration has a moderate trophic effect on the epithelium of the vagina, which contributes to the accumulation of glycogen, and as a result - to achieve optimal acidity of the environment in the vagina (pH 3,8-4,2), which can provide normal conditions for vital functions of the Doderleini wand. This prevents colonization in the vagina of pathogenic bacteria. The effect of the drug is due to its composition of active substances, among which:
    Estriol in very small doses (about 0.2 mg) as estrogen, entering the bloodstream, begins to form a complex with specific receptors located in the tissues of the uterus, vagina, urethra, breast, liver, hypothalamus and pituitary, which stimulates DNA synthesis and different proteins. Due to the selective directional action, there is an increase in proliferation in the epithelium of the vagina, as well as of the cervix, restoration and stimulation of its blood supply during atrophic changes, for example, in the period of premenopause or menopause. This normalizes the pH of the environment and the microflora of the vagina, increasing the resistance of the epithelium to inflammatory processes and the effects of infections, affects the quality and volume of cervical mucus.
    Progesterone in small doses (about 2 mg) - the hormone of the yellow body, is able to bind to receptors located on the surface of the membranes of the cells of target organs, to penetrate into the nucleus and activate DNA to stimulate the synthesis of RNA. As a result, the epithelium prepared by estriol, under the action of progesterone forms an intermediate layer of epithelium and stimulates the synthesis of glycogen, a necessary substrate for the vital functions of Doderleini sticks.
    Doderleini sticks are colonized due to local saturation with hormones. They are known for their resistance to antimicrobials, and the environment in the vagina is created similar to normal - physiological.
Data on the pharmacokinetics of estriol
Absorption occurs quickly: the maximum concentration in the plasma occurs after 1-2 hours. It is excreted mainly by the kidneys in a few hours in the form of metabolites (immediately after ingestion and during the next 18 hours), 2% is eliminated by intestine in unchanged form.
Data on the pharmacokinetics of progesterone
The maximum concentration is reached after 2-6 hours, is excreted in the urine: 95% glucuron-conjugated metabolites, usually 3-α, 5-β-pregnanediol or pregnanodion. These metabolites are similar to substances that are formed as a result of physiological secretion in the yellow body.

Indications for use

    It is used for atrophic vulvovaginitis, which is caused by a deficiency of estrogens;
    Trioginal is a part of complex therapy during the period of postmenopausal preparation for planned operations in gynecology, which is given for preventive purposes in postoperative infectious complications.

Contraindications

    diagnosed breast cancer or suspected of it;
    progesterone- or estrogen-dependent malignant neoplasms, suspected of them (including endometrial cancer);
    the presence of bleeding from the vagina of unexplained etiology;
    healed endometrial hyperplasia;
    acute phase and chronic liver diseases up to complete normalization of liver functional tests;
    porphyria;
    arterial, as well as venous thrombosis, deep vein thrombophlebitis, myocardial infarction, thromboembolism at the time and in the anamnesis, predisposition to them;
    ischemic or hemorrhagic disorders of the brain;
    icteric and other manifestations of liver function disorders;
    uncontrolled condition with arterial hypertension;
    patients with diabetes mellitus with diabetic angiopathy;
    various forms of neoplasm in the liver;
    expressed and multiple risk factors for thromboembolic complications, including: transient ischemic attack, angina pectoris, atrial fibrillation, cardiac valve apparatus lesions;
    operative interventions accompanied by prolonged immobilization;
    extensive injuries;
    Patients with obesity with an index of body weight over 30 kg / m2;
    special groups of patients: pregnant and lactating women, children under 18;
    hypersensitivity to the Trio.

Assign with caution

    with arterial hypertension;
    with systemic lupus erythematosus;
    with epilepsy;
    with endometrial hyperplasia in the anamnesis;
    with bronchial asthma;
    with otosclerosis;
    with endometriosis;
    with thromboembolic complications or history;
    migraines and severe headaches.

Side effects

    Manifestations of allergic reactions: itching, irritation in the area of ​​administration.
    Undesirable reactions arising from the reproductive system: clotting and spotting from the vagina, it is rare enough - mastodynia and mammary gland tension, an increase in the volume of vaginal discharge.
    Among others: fluid retention, a feeling of nausea.

Trioginal, instructions for use (Method and dosage)

Insert the trioginal capsule deeply directly into the vagina, moistening first with a small amount of water to accelerate the dissolution of the drug.

Monotherapy

With atrophic vulvovaginitis due to estrogen deficiency, one capsule should be given in the morning and one evening for 1 week. If necessary and according to the advice of the attending physician - it is possible to extend the course of treatment to a maximum of 3 weeks.

The component of complex therapy

Preparation during the postmenopausal period to the planned gynecological operation, carried out for preventive purposes to prevent postoperative complications: it is necessary to administer 1 capsule in the morning and before bedtime in the evening for 2 weeks.

Overdose

No information was provided.

Interaction

    With inducers of liver enzymes, for example, With Phenobarbital, Carbamazepine, phenytoin, Rifampicin, Rifabutin, Nevirapine, Zfavirenz) - there is an increase in the exchange of sex hormones, leading to a decrease in the effectiveness of the drug.
    With inhibitors of liver enzymes (with Ritonavir, Nelfinavir) - a significant decrease in metabolism in the processes of participating microsomal enzymes of the liver is possible. However - with sex hormones they can act as inducers.
    With the preparations of St. John's wort, an estrogen metabolism can be induced.

Storage conditions

    Temperature regime: up to 20 ° Celsius.
    It is recommended to limit access to children.
Shelf life - up to 36 months.

special instructions

It is not recommended to be used for the purpose of contraception, as well as with various spermicidal agents.

Reviews of Trioginal

Many patients who used the Trioginal suppositories recommend it as a new modern effective drug that helps with endometriosis, vaginal dryness and generally improves the condition of the reproductive system.