Triozhinal, vaginal capsules 14 pcs

Trioginal is a combination drug for intravaginal use. The vaginal biocenosis is determined by a number of factors, in particular the concentration of female sex hormones. The combination of progesterone and estriol in low doses at the vaginal route of administration has a moderate trophic effect on the vaginal epithelium, contributing to the accumulation of glycogen in it. Accumulation of glycogen contributes to the formation of an optimal acidic vaginal environment (pH 3.8-4.2) which provides optimal conditions for the activity of bacillus Döderlein, which in turn prevents colonization of the vagina by pathogenic bacteria.

Estriol is one of the active ingredients of the drug, at an ultra-low dose of 0.2 mg. Estriol is an estrogen synthesized in the human body. On entering the bloodstream, it forms a complex with specific receptors (in the uterus, vagina, urethra, mammary gland, liver, hypothalamus and pituitary gland) and 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 in its atrophic changes in the periods of premenopause and menopause, normalizes the pH of the vaginal environment and vaginal microflora, increases the resistance of its epithelium to infectious and inflammatory processes, and affects the quality and quantity of cervical mucus.

The next active ingredient of the drug is progesterone in a low dose of 2 mg. Progesterone is a hormone of the corpus luteum. It binds to receptors on the surface of target organ cells and penetrates into the nucleus, where, by activating DNA, it stimulates RNA synthesis. After preparation of the epithelium with estriol, progesterone in the composition of Triojinal promotes the formation of intermediate layers of the epithelium and the synthesis of glycogen, the substrate necessary for Döderlein bacillus to take root.

Local hormone saturation ensures colonization of the vagina by live Doderlein bacilli, the third active ingredient of Lactobacillus casei rhamnosus Doderleini, which belongs to a strain known to be resistant to a number of antimicrobial drugs. This creates a physiological-like environment in the vagina.

Pharmacokinetics

Absorption of estriol is rapid: time to reach Cmax in blood plasma with intravaginal use 1-2 hours. Excretion is mainly by the kidneys as metabolites (several hours after intake and lasts up to 18 hours), 2% is excreted unchanged in the intestine. Cmax in plasma progesterone 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 (pregnandione). These metabolites, which are determined in plasma and urine, are similar to substances produced during physiological secretion of the corpus luteum.

Indications

Atrophic vulvovaginitis due to oestrogen deficiency; preparation of postmenopausal patients for elective gynecological surgery in order to prevent postoperative infectious complications (in the complex therapy).

Active ingredient

Composition

1 vaginal capsule contains:

Active ingredients:

Lyophilized culture of Lactobacillus casei rhamnosus Doderleini 341 mg, corresponding to a viable lactobacillus content of 1×108 to 2×109 CFU, estriol 0.2 mg, progesterone 2.0 mg.

Auxiliary substances added before lyophilization:

Potato starch (~41% of the 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).

Ancillary substances:

Lactose monohydrate – 6.8 mg.

Capsule shell composition:

Titanium dioxide – 3 mg,

Gelatin – q.s. to 100 mg.

How to take, the dosage

Inject the capsule Triojinal deep into the vagina, moistening it with a little water to speed up the dissolution of the drug.

Atrophic vulvovaginitis due to estrogen deficiency: 1 capsule in the morning and evening for 14 days. If it is necessary (the preservation of some or other symptoms of the disease) the therapy can be continued up to 21 days upon the doctor’s recommendation.

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

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

Interaction

In concomitant use with inducers of microsomal liver enzymes (phenobarbital, carbamazepine, phenytoin, rifampicin, rifabutin, nevirapine, zfavirenz) the metabolism of sex hormones is increased, which may lead to a decrease in the drug effectiveness.

Liver microsomal enzyme inhibitors (ritonavir, nelfinavir) significantly reduce metabolism involving liver microsomal enzymes, but when combined with sex hormones may act as inducers; St. John’s wort preparations may induce estrogen metabolism.

No clinically significant cases of interaction have been reported.

Special Instructions

The use of the drug together with spermicides is not recommended.

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

. Careful monitoring is recommended in patients with heart failure, impaired renal function, arterial hypertension, epilepsy, migraine, severe liver disease, endometriosis, cystic fibrosis, hyperlipoproteinemia, and occurrence of severe itching or cholestatic jaundice during pregnancy or while taking steroid drugs.

Impact on driving and operating machinery

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

Contraindications

Side effects

Allergic reactions: itching and irritation at the injection site.

Reproductive system disorders:bloody discharge (bleeding) from the vagina; extremely rare – tightness of the mammary glands, mastodynia (pain in the mammary glands); increased discharge from the vagina.

Others: nausea; fluid retention.

Pregnancy use

The drug is contraindicated in pregnancy and lactation.