Description
Latin name
Trioginal
Release form
vaginal capsules
Packaging
14 capsules.
Pharmacological action
Triozhinal – a combined preparation for intravaginal use. 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 with the vaginal route of administration 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 life of Doderlein sticks, which in turn prevents the 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. Once in the bloodstream, it forms a complex with specific receptors (in the uterus, vagina, urethra, mammary gland, liver, hypothalamus, pituitary gland), stimulates the synthesis of DNA and proteins. It has a selective effect, mainly on the cervix, vagina, vulva, causes an increase in the proliferation of the epithelium of the vagina and cervix, stimulates its blood supply, helps restore the epithelium during 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 of the active substances includes progesterone in a small dose of 2 mg. Progesterone is a corpus luteum hormone. Contacting the receptors on the surface of the cells of target organs, it penetrates into the nucleus, where, by activating DNA, it stimulates RNA synthesis. After preparing the epithelium with estriol, the progesterone in the composition of the Triozhinal preparation promotes the formation of intermediate layers of the epithelium and the synthesis of glycogen, a substrate necessary for the Doderlein stick to take root.
Local hormone saturation provides colonization of the vagina by live Doderlein bacilli, the third active component of 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
Absorption of estriol occurs quickly: the time to reach Cmax in plasma with intravaginal administration is 1-2 hours.
Excretion is carried out mainly by the kidneys in the form of metabolites (several hours after administration and lasts up to 18 hours), 2% is excreted through the intestines into unchanged form.
Cmax in blood plasma progesterone in plasma is achieved 2-6 hours after administration.
Progesterone is excreted in the urine as metabolites, 95% of them are glucuronconjugated metabolites, mainly 3-alpha, 5-beta-pregnanediol (pregnandion). These metabolites, which are determined in blood plasma and in urine, are similar to substances formed during physiological secretion of the corpus luteum.
Indications
Atrophic vulvovaginitis due to estrogen deficiency preparation of postmenopausal patients for elective gynecological surgery to prevent postoperative infectious complications (as part of complex therapy).
Contraindications
Established deficiency of DPD (dihydropyrimidine dehydrogenase), as well as for other fluoropyrimidines
, concomitant use of sorivudine and its structural analogues such as brivudine
severe renal failure / min <30 min 109 / l and / or platelet count < 100 109 / l if there are contraindications to one of the combination therapy drugs, Xeloda ® pregnancy should not be prescribed breastfeeding period child age (efficacy and safety have not been established) hypersensitivity to capecitabine or any other components of the drug hypersensitivity to fluorouracil or in cases of the development of unexpected or severe adverse reactions to treatment with fluoropyrimidine derivatives in history. With caution: the drug should be prescribed for coronary heart disease, moderate renal failure, liver failure, simultaneous use with coumarin-type oral anticoagulants, hereditary lactase deficiency, lactose intolerance, glucose-galactose malabsorption, patients over the age of 60. Contraindications established or suspected breast cancer estrogen- or progesterone-dependent malignancies or suspected malignant neoplasms (including endometrial cancer) vaginal bleeding of unknown etiology untreated endometrial hyperplasia liver disease normal and normal liver disease test liver) 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 dysfunction jaundice and / or impaired liver function uncontrolled arterial hypertension, congenital proteinosis, congenital malignancy, or III, the presence of 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 valvular heart disease 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 adolescents under 18 hypersensitivity to the components of the drug Triozhinal. With caution Arterial hypertension, endometriosis, 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 disease (including adenoma), diabetes mellitus without diabetic angiopathy , cholelithiasis, migraine or severe headache, systemic lupus erythematosus, a history of endometrial hyperplasia, epilepsy, bronchial asthma, otosclerosis. Use during pregnancy and lactation The use of the drug during pregnancy and lactation is contraindicated. composition 1 capsule vaginal contains: Active substances: lyophilized culture of lactobacilli Lactobacillus casei rhamnosus Doderleini 341 mg, which corresponds to the content of viable lactobacilli 1 Ã 108 – 2 Ã 109 CFU, estriol 0.2 mg, progesterone 2.0 mg srdlpp ~ 41% by weight of lyophilisate), lactose monohydrate (~ 20.6% by weight of lyophilisate), sodium glutamate (~ 4.5% by weight of lyophilisate), sodium thiosulfate (~ 26.8% by weight of lyophilisate). Dosage and administration Introduce the Trioginal capsule deep into the vagina, by 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 (preservation of certain symptoms of the disease), therapy can be continued up to 21 days on the recommendation of a doctor. The maximum course duration should not be more than 21 days. Preparation of postmenopausal patients for planned gynecological operations for the prevention of 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 reproductive system: spotting (vomiting) from the vagina is extremely rare – tension of the mammary glands, mastodynia (pain in the mammary glands), increased discharge from the vagina. Other: nausea fluid retention. Drug Interaction When co-administered with inducers of microsomal enzymes of the liver (phenobarbital, carbamazepine, phenytoin, rifampicin, rifabutin, nevirapine, zfavirenz), the metabolism of sex hormones can increase, and the metabolism of sex hormones can be increased. Inhibitors of microsomal liver enzymes (ritonavir, nelfinavir) significantly reduce metabolism with the participation of microsomal liver enzymes, but when used with sex hormones can act as inducers of St. John’s wort drugs can induce estrogen metabolism. No clinically relevant cases of interaction have been reported. Overdose No data available. Storage conditions The drug should be stored out of the reach of children at a temperature not exceeding 20 ° C. The Expiration of is 3 years. Eubiotics dosage form dosage form capsules vaginal bi’os Industrie, France, Russia biosynthesis
