Triogynal vaginal capsules, 14pcs

Composition

1 capsule of vaginal contains:

Active ingredients:

Lyophilized culture of lactobacilli Lactobacillus casei rhamnosus Doderleini 341 mg, which corresponds to the content of viable lactobacilli 1 × 108-2×109 CFU, estriol 0.2 mg, progesterone 2.0 mg.

Excipients 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).

Auxiliary substances:

lactose monohydrate – 6.8 mg.

Capsule shell composition:

titanium dioxide – 3 mg,

gelatin-q. s. up to 100 mg

Pharmacological action

Triojinal is a combination drug for intravaginal use. 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 with the vaginal route of use 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 an optimal acidic environment of the vagina (pH 3.8-4.2), which provides optimal conditions for the vital activity of Doderlein bacillus, which in turn prevents the colonization of the vagina by pathogenic bacteria.

The composition of the drug as one of the active substances includes estriol in an 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, breast, liver, hypothalamus, pituitary gland), stimulates the synthesis of DNA and proteins.

It 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, helps restore the epithelium with its atrophic changes during premenopause and menopause, normalizes the pH of the vaginal environment, the vaginal microflora, increases the resistance of its epithelium to infectious and inflammatory processes, affects the quality and quantity of cervical mucus.

The composition of the drug as the next Active ingredient includes progesterone in a small dose of 2 mg. Progesterone is a hormone of the corpus luteum. Binding to receptors on the surface of target organ cells, it penetrates into the nucleus, where it activates DNA and stimulates RNA synthesis. After the preparation of the epithelium with estriol, progesterone in the preparation Triogynal promotes the formation of intermediate layers of the epithelium and the synthesis of glycogen – the substrate necessary for the Doderlein stick to take root.

Local hormone saturation ensures colonization of the vagina with live Doderlein rods, 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 drugs. This creates a similar physiological environment in the vagina.

Pharmacokinetics

Absorption of estriol occurs quickly: the time to reach Cmax in blood plasma with intravaginal use is 1-2 hours. Excretion is mainly carried out by the kidneys in the form of metabolites (a few hours after ingestion and lasts up to 18 hours),2% is excreted unchanged through the intestine. Cmax in blood plasma of progesterone in blood plasma is reached 2-6 hours after use.

Progesterone is excreted in the urine as metabolites,95% of which are glucuronconjugated metabolites, mainly 3-alpha,5-beta-pregnanediol (pregnandion). These metabolites, which are detected in blood plasma and urine, are similar to substances formed during physiological secretion of the corpus luteum.

Indications

Atrophic vulvovaginitis caused by estrogen deficiency; preparation of postmenopausal patients for elective gynecological operations to prevent postoperative infectious complications (as part of complex therapy).

Use during pregnancy and lactation

It is contraindicated to use the drug during pregnancy and lactation.

Contraindications

-established or suspected breast cancer;- estrogen-or progesterone-dependent malignancies or suspected malignancies (including endometrial cancer);- vaginal bleeding of unclear etiology; – untreated endometrial hyperplasia;- acute and chronic liver diseases (until normalization of liver function tests);- 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 (for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, presence of phospholipid antibodies (cardiolipin antibodies, lupus erythematosus anticoagulant);- diabetes mellitus with diabetic angiopathy;- benign and malignant neoplasms of the liver; – pronounced or multiple risk factors for the development of thromboembolic complications (transient ischemic attacks, angina pectoris, atrial fibrillation, complicated lesions of the valvular apparatus of the heart; extended surgery accompanied by prolonged immobilization; extensive trauma; obesity with a body mass index of more than 30 kg / m2); – pregnancy; – lactation;- children and adolescents under 18 years of age;- hypersensitivity to the components of the drug Triogynal.

With caution:

Arterial hypertension, endometriosis, a history of thromboembolic complications in relatives of the 1st degree of kinship at a relatively young age, risk factors for estrogen-and progesterone – dependent tumors, liver diseases (including adenoma), diabetes mellitus without diabetic angiopathy, cholelithiasis, migraine or severe headache, systemic lupus erythematosus, a history of endometrial hyperplasia, epilepsy, bronchial asthma asthma, otosclerosis.

Side effects

Allergic reactions: itching and irritation at the injection site.

On the part of the reproductive system: bloody discharge (blood smearing) from the vagina; extremely rare-tension of the mammary glands, mastodynia (pain in the mammary glands); increased vaginal discharge.

Other: nausea; fluid retention.

Interaction

When used concomitantly 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; St. John’s wort preparations can induce estrogen metabolism.

No clinically significant cases of interaction were reported.

How to take, course of use and dosage

Insert the Triojinal capsule deep into the vagina, wetting it in a small amount of water to speed up the dissolution of the drug.

Atrophic vulvovaginitis caused by estrogen deficiency: 1 capsule in the morning and evening for 14 days. If necessary (preservation of certain symptoms of the disease), therapy can be continued for up to 21 days on the recommendation of a doctor.

The maximum duration of the course should not exceed 21 days.

Preparation of postmenopausal patients for elective gynecological operations to prevent postoperative complications (as part of complex therapy): take 1 capsule in the morning and evening for 14 days.

Overdose

No data available.

Special instructions

It is not recommended to use the drug together with spermicidal agents.

The drug should not be used for the purpose of contraception.

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

Influence on the ability to drive motor vehicles and manage mechanisms

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

Form of production

Capsules are vaginal.

Storage conditions

At a temperature not exceeding 20 °C.

Shelf

life is 3 years.

Active ingredient

Estriol, Progesterone, Eubiotic

Conditions of release from pharmacies

By prescription

Dosage form

vaginal capsules

Purpose

For women, For adults as prescribed by a doctor, For postmenopausal women

Indications

Inflammation of the female genital organs, Vaginitis