Instructions for Trioginal vaginal capsules 14 pieces
Release form Trioginal:
Vaginal capsules Trioginal are opaque, gelatinous, size "0", white with a yellowish tinge; the contents of the capsules are a powder of light yellow with a brownish shade.
14 pcs. - bottles of colorless glass (1) - packs of cardboard.
Composition Trioginal:
1 caps.
lyophilized culture of lactobacilli L. casei rhamnosus Doderleini at least 2 × 107 CFU
estriol 0.2 mg
progesterone 2 mg
Excipients Trioginal:
lactose monohydrate - 6.8 mg, components of a protective drying medium (potato starch (~ 41% of the lyophilisate mass), lactose monohydrate (~ 20.6 % of the mass of the lyophilisate), sodium glutamate (~ 4.5% of the mass of the lyophilisate), sodium thiosulfate (~ 26.8% of the mass of the lyophilisate)).
The composition of the capsule shell: titanium dioxide - 3 mg, gelatin - qs up to 100 mg.
Pharmaco-therapeutic group Trioginal:
Estrogen + gestagen + eubiotic.
Pharmacological properties Trioginal:
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 for 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 vital activity of Doderlein's 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, 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, promotes the restoration of the epithelium during its atrophic changes during periods of premenopause and menopause, normalizes the pH of the vaginal environment, vaginal microflora, 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 of the active substances includes progesterone in a small dose of 2 mg. Progesterone is a hormone of the corpus luteum. By binding to receptors on the surface of cells of target organs, it penetrates into the nucleus, where, by activating DNA, it stimulates RNA synthesis. After preparation of the epithelium with estriol, progesterone in the composition of Trioginal promotes the formation of intermediate layers of the epithelium and the synthesis of glycogen, the substrate necessary for Doderlein's bacillus to take root.
Local saturation with hormones ensures the colonization of the vagina with living Doderlein sticks, the third active component of Lactobacillus casei rhamnosus Doderleini, a strain that is known for its resistance to a number of antimicrobial drugs Trioginal. This creates a similar physiological environment in the vagina.
Indications for use Trioginal:
atrophic vulvovaginitis due to estrogen deficiency;
pre- and postoperative therapy for gynecological operations in postmenopausal women.
Mode of application Trioginal:
The drug is used intravaginally. The capsule should be inserted deep into the vagina, moistened with a small amount of water to accelerate the dissolution of the drug.
With atrophic vulvovaginitis caused by estrogen deficiency, 2 caps are used. 1 time / day for 20 days until symptoms are relieved, then 1 caps / day. The dose of the drug is adjusted depending on the effect achieved. The duration of drug therapy is determined by the doctor, but should not be more than 3 months. If necessary, it is possible to repeat the courses of therapy.
When carrying out pre- and postoperative therapy for gynecological operations in postmenopausal women, 2 caps are used. 1 time / day for 2 weeks before surgery and within 2 weeks after surgery.
Contraindications Trioginal:
Established, history, or suspected breast cancer
diagnosed or suspected estrogen- or progesterone-dependent malignant neoplasms (for example, endometrial cancer);
vaginal bleeding of unknown etiology;
untreated endometrial hyperplasia;
congenital or acquired predisposition to arterial or venous thrombosis (resistance to activated protein C; deficiency of protein C, protein S or antithrombin III; hyperhomocysteinemia; the presence of antibodies to phospholipids (antibodies to cardiolipin, lupus anticoagulant);
thrombosis (venous and arterial) and thromboembolism at present or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke);
conditions preceding thrombosis (including transient ischemic attacks, angina pectoris) at present or in history;
liver disease in the acute stage or a history of liver disease (before the normalization of liver function tests);
porphyria;
age under 18;
pregnancy;
lactation period (breastfeeding);
hypersensitivity to active substances or to any of the auxiliary components of the drug.
With caution
It is necessary to use the drug Trioginal with caution (under the close supervision of a physician) if any of the following diseases or conditions are present, or they were noted earlier and / or worsened during a previous pregnancy or previous sex hormone treatment:
leiomyoma (uterine fibroids) or endometriosis;
a history of endometrial hyperplasia;
risk factors for the development of thromboembolic complications;
risk factors for estrogen- and progesterone-dependent tumors, for example, 1st degree of heredity for breast cancer;
arterial hypertension;
benign liver tumors (eg, liver adenoma);
diabetes mellitus with or without diabetic angiopathy;
cholelithiasis;
migraine or severe headache;
systemic lupus erythematosus;
epilepsy;
bronchial asthma;
familial hyperlipoproteinemia;
pancreatitis;
renal failure;
otosclerosis.
Side effects Trioginal
Allergic reactions: itching and irritation at the injection site.
On the part of the reproductive system: spotting spotting from the vagina; extremely rare - breast tension, mastodynia (pain in the mammary glands); increased vaginal discharge.
Others: nausea; fluid retention.
special instructions Trioginal:
The drug Trioginal should not be used for contraception.
It is necessary to cancel the use of the drug Trioginal and consult a doctor when a migraine-like headache appears for the first time or when an unusual severe headache recurs; the first signs of phlebitis, such as local redness, swelling and pain in the lower limb, or thromboembolic symptoms (sudden chest pain, shortness of breath); when pregnancy occurs; when jaundice appears; significant increase in blood pressure and acute visual impairment.
It is recommended to use the drug with caution under close medical supervision in patients with risk factors for thromboembolic complications, which include: old age, major surgical interventions, prolonged immobilization, obesity (BMI> 30 kg / m2), pregnancy, postpartum period, systemic lupus erythematosus, cancer.
If Trioginal is prescribed for preparation for planned gynecological operations, the issue of thrombosis prevention should be considered.
If the vagina is dry, the vaginal capsule may not dissolve. To prevent such cases, before administration, the capsule should be moistened with a small amount of plain water - this will facilitate faster dissolution. The vaginal capsule is best inserted in the supine position with the knees slightly bent.
Drug interactions Trioginal:
It is not recommended to use the drug together with spermicidal agents.
With simultaneous use with inducers of microsomal liver enzymes (phenobarbital, carbamazepine, phenytoin, rifampicin, rifabutin, nevirapine, efavirenz), the metabolism of sex hormones increases, which can lead to a decrease in the effectiveness of the drug.
Inhibitors of liver microsomal enzymes (ritonavir, nelfinavir) significantly reduce metabolism with the participation of liver microsomal enzymes, but when used simultaneously with sex hormones, they can act as inducers; St. John's wort preparations can induce estrogen metabolism.