Duphaston 10mg tablets 20, Dydrogesterone
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Active substance: dydrogesterone 10 mg.
Excipients: lactose monohydrate - 111.1 mg, hypromellose - 2.8 mg, corn starch - 14 mg, silicon dioxide colloidal - 1.4 mg, magnesium stearate - 0.7 mg.
Shell composition: opadrai white Y-1-7000 (hypromellose, polyethylene glycol 400, titanium dioxide (E171)) - 4 mg.
Analogue of natural progesterone. Dydrogesterone in its molecular structure, chemical and pharmacological properties is very close to natural progesterone. Due to the fact that dydrogesterone is not a derivative of testosterone, it does not have the side effects characteristic of most synthetic progestogens, the so-called "androgenic" progestogens. Dydrogesterone does not have estrogenic, androgenic, anabolic, glucocorticoid and thermogenic activity.
Being a progestogenic component of HRT in menopause, dydrogesterone helps to maintain the beneficial effect of estrogens on the lipid profile of the blood. However, unlike estrogens, which usually adversely affect the blood coagulation system, dydrogesterone does not affect coagulation rates. Does not adversely affect carbohydrate metabolism and liver function. Dydrogesterone when administered orally selectively affects the endometrium, thereby preventing an increased risk of endometrial hyperplasia and / or carcinogenesis in conditions of excess estrogen. It is indicated in all cases of endogenous progesterone deficiency.
Dydrogesterone has no contraceptive effect. When treated with dydrogesterone, the therapeutic effect is achieved without suppressing ovulation or impaired menstrual function. Dydrogesterone makes it possible to conceive and maintain pregnancy during treatment.
Indications for use
For the treatment of conditions characterized by progesterone deficiency, such as:
- infertility caused by luteal insufficiency;
- threatening or habitual abortion associated with an established progesterone deficiency;
- premenstrual syndrome;
- irregular menstruation;
- secondary amenorrhea;
- dysfunctional uterine bleeding.
Hormone replacement therapy
To neutralize the proliferative effect of estrogens on the endometrium as part of hormone replacement therapy in women with disorders caused by natural or surgical menopause with intact uterus.
- hypersensitivity to dydrogesterone or other components of the drug;
- diagnosed or suspected progestogen-dependent neoplasms (for example, meningioma);
- bleeding from the vagina of unclear etiology;
- violations of liver function caused by acute or chronic liver diseases at present or in the anamnesis (before the normalization of liver function tests);
- malignant liver tumors currently or in the anamnesis;
- galactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome;
- the period of breastfeeding;
- porphyria, currently or in the anamnesis;
- age up to 18 years, due to the lack of data on efficacy and safety in girls- adolescents under 18 years of age;
- spontaneous abortion (miscarriage) or failed miscarriage with luteal phase support in assisted reproductive technologies (ART).
When combined with estrogens
When used as indicated, hormone replacement therapy (HRT):
- untreated endometrial hyperplasia;
- arterial and venous thrombosis, thromboembolism at present or in the anamnesis (including deep vein thrombosis, pulmonary embolism, myocardial infarction, thrombophlebitis, cerebrovascular disorders of hemorrhagic and ischemic type);
- identified predisposition to venous or arterial thrombosis (resistance to activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (antibodies to cardiolipin, lupus anticoagulant).
- depression, currently or in the anamnesis;
- conditions that have previously appeared or worsened during a previous pregnancy or previous intake of sex hormones, such as cholestatic jaundice, herpes during pregnancy, severe skin itching, otosclerosis.
When using dydrogesterone in combination with estrogens, caution should be exercised in the presence of risk factors for thromboembolic conditions, such as angina pectoris, prolonged immobilization, severe forms of obesity (body BMI more than 30 kg / m2), advanced age, extensive surgical interventions, systemic lupus erythematosus, cancer; in patients receiving anticoagulant therapy; with endometriosis, uterine fibroids; the presence of endometrial hyperplasia in the anamnesis; liver adenoma; diabetes mellitus with or without vascular complications; arterial hypertension; bronchial asthma; epilepsy; migraine or severe headache pain in the anamnesis; cholelithiasis; chronic renal failure; if there is a history of risk factors for the development of estrogen-dependent tumors (for example, relatives of the 1st line of kinship with breast cancer).
Use in pregnancy and lactation
The drug can be used during pregnancy.
Dydrogesterone is excreted in mother's milk.
Breastfeeding while taking Duphaston® is not recommended.
Before starting treatment with Duphaston® for abnormal uterine bleeding, it is necessary to find out the cause of bleeding. With prolonged use of the drug, periodic examinations by a gynecologist are recommended, the frequency of which is established individually, but at least once every six months. In the first months of treatment of abnormal uterine bleeding, "breakthrough" bleeding or "spotting" spotting may occur. If "breakthrough" bleeding or "spotting" spotting occurs after a certain period of taking the drug or continues after a course of treatment, you should consult your doctor and conduct an appropriate additional examination, if necessary, make an endometrial biopsy to exclude neoplasms in the endometrium.
In the case of prescribing dydrogesterone in combination with estrogens for the purpose of hormone replacement therapy (HRT), you should carefully read the contraindications and special instructions associated with the use of estrogens.
HRT should be prescribed to treat menopausal symptoms that adversely affect the patient's quality of life. The benefit/risk ratio of HRT should be assessed annually. Therapy should be continued until the potential benefit outweighs the potential risk.
There is limited data on the risks associated with HRT in the treatment of premature menopause. Due to the low absolute risk in young women, the benefit/risk ratio for them may be more favorable compared to that of older women.
Before starting the use of a combination of dydrogesterone and estrogen (for HRT), a complete individual and family history should be collected. An objective examination (including examination of the pelvic organs and mammary glands) should be carried out in order to identify possible contraindications and conditions requiring precautions.
During treatment, it is recommended to periodically monitor the individual tolerance of HRT. The patient should be informed about what changes in the mammary glands she should inform the doctor. Studies including mammography should be carried out in accordance with generally accepted screening, taking into account individual characteristics and the clinical picture.
Hyperplasia and endometrial cancer
At of women with intact uterus, the risk of hyperplasia and endometrial cancer increases with prolonged estrogen monotherapy.
Cyclic use of progestogens, including dydrogesterone (at least for 12 days of a 28-day cycle), or the use of a sequential combined HRT regimen in women with a preserved uterus can prevent an increased risk of hyperplasia and endometrial cancer with estrogen monotherapy.
Evidence suggests that the risk of breast cancer is increased in women who received HRT with estrogen-progestogenic drugs, and possibly with estrogen monotherapy. The level of risk depends on the duration of HRT. The results of the epidemiological study and the WHI study (Women's Health Initiative study) confirm an increased risk of breast cancer in women taking medications containing a combination of estrogen and progesterone within HRT. The risk increases after about 3 years of use, while returning to the average value within a few (usually five) years after the end of therapy.
Against the background of taking drugs for HRT, especially with combination therapy with estrogens and progestogens, there may be an increase in breast tissue density during mammography, which can complicate the diagnosis of breast cancer.
Ovarian cancer is much less common than breast cancer.
Epidemiological data from large-scale meta-analysis indicate a slight increase in risk for women receiving HRT as estrogen monotherapy or estrogen and progestogen combination therapy. An increase in this risk becomes apparent with a duration of therapy of more than 5 years, and after its termination, the risk gradually decreases. over time. The results of a number of other studies, including WHI, indicate that combined HRT is associated with a similar or slightly lower risk of developing ovarian cancer.
HRT is associated with a 1.3-3-fold increase in the risk of venous thromboembolism (VTE), i.e. deep vein thrombosis or pulmonary embolism. The probability is higher in the first year of HRT than in subsequent ones. Patients diagnosed with thrombophilia have an increased risk of developing venous thromboembolism, and HRT may increase the risk. For this reason, HRT is contraindicated in such patients.
Risk factors for venous thromboembolism include estrogen intake, old age, extensive surgery, prolonged immobilization, obesity (BMI >30 kg / m2), pregnancy, postpartum period, systemic lupus erythematosus and cancer. Unambiguous data on the possible role of varicose veins there are no veins in the development of venous thromboembolism.
If long-term immobilization is necessary after surgical interventions, you should stop taking drugs for HRT 4-6 weeks before the operation, the resumption of taking the drug is possible after the full restoration of the woman's motor activity.
Women with no history of VTE cases, but indicating the presence in the family history of cases of thrombosis at a young age in the next of kin, after a detailed consultation on possible limitations and shortcomings of therapy, can be offered screening (during screening, only a part of the hereditary defects of the hemostasis system is detected).
In case of detection of thrombophilia associated with thrombosis in family members or in the case of a severe defect (for example, insufficiency of antithrombin III, protein C, protein S, or a combination of defects), HRT is contraindicated.
If the patient takes anticoagulants, the benefit/risk of prescribing HRT should be carefully assessed. Until the completion of a thorough assessment of the factors of the possible development of thromboembolism or the beginning of anticoagulant therapy, drugs for HRT are not prescribed. If thrombosis develops after the start of therapy, HRT should be canceled.
It is necessary to urgently consult a doctor in case of any of the symptoms indicating a possible thromboembolism (soreness or swelling of the lower extremities, sudden pain in the chest, shortness of breath, visual impairment).
Ischemic heart disease (CHD)
Data obtained in randomized controlled trials indicate that there is no protective effect on the development of myocardial infarction in women with and without chD receiving HRT in the form of combination therapy with estrogens and progestogens or estrogen monotherapy.
The relative risk of developing coronary artery disease increases slightly during combined HRT. Absolute risk the occurrence of coronary artery disease depends on age. The number of cases of coronary artery disease against the background of the use of HRT is less in healthy women at an age close to the onset of natural menopause, however, it increases in subsequent years.
Combination therapy with estrogens and progestogens or estrogen alone is associated with a 1.5-fold increase in the risk of ischemic stroke. The relative risk does not change with age and does not depend on the timing of menopause. However, the incidence of stroke depends on age, and the overall risk of stroke in women receiving HRT will increase with age.
The drug contains lactose monohydrate. Patients with rare hereditary diseases, such as galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome, should not take the drug.
Influence on the ability to drive vehicles and drive Mechanisms
Duphaston® has a negligible effect on the ability to drive vehicles and mechanisms. Caution should be exercised when driving vehicles and mechanisms, given the possibility of adverse reactions from the nervous system (mild drowsiness and / or dizziness, especially in the first hours of admission).
Data obtained in vitro show that the main pathway of formation of the main pharmacologically active metabolite of DGD is carried out under the catalytic action of aldo-keto reductase 1C (AKR1 C) in the cytosol of human cells. Then, inside the cytosol, metabolic transformation of cytochrome P450 isoenzymes occurs, mainly with the help of CYP3A4, resulting in the formation of several secondary metabolites.
The substrate for transformation with the isoenzyme CYP3A4 is the main active metabolite of DGD. Metabolism of dydrogesterone and DGD can be accelerated by the combined use of substances that are inducers of enzymes of the cytochrome 450 system, such as anticonvulsants (for example, phenobarbital, phenytoin, carbamazepine), antibacterial and antiviral drugs (for example, rifampicin, rifabutin, nevirapine, efavirenz) and herbal preparations containing, for example, St. John's wort perforated. Ritonavir and nelfinavir, known as strong inhibitors of cytochrome enzymes, when combined with steroids, on the contrary, have ferment-inducing properties.
From a clinical point of view, increasing the metabolism of dydrogesterone can reduce its effectiveness.
The results of in vitro studies show that dydrogesterone and DGD in clinically significant concentrations do not inhibit or induce cytochrome system enzymes that metabolize drugs.
Dosage and Administration
Preparation taken orally.
The fault line is intended only to simplify the breaking of the tablet and the convenience of swallowing, and not to divide it into equal doses.
The duration of therapy and dose can be adjusted taking into account the individual clinical response of the patient and the severity of the pathology within the dosage regimen of the drug presented below:
Endometriosis: 10 mg 2-3 times / day from the 5th to the 25th day of the menstrual cycle or continuously.
Infertility (due to insufficiency of the luteal phase): 10 mg / day from the 14th to the 25th day of the cycle. Treatment should be carried out continuously for at least six consecutive cycles. In the first months of pregnancy, it is recommended to continue treatment according to the scheme described with a habitual miscarriage.
Threatening miscarriage: 40 mg once, then 10 mg every 8 hours until symptoms disappear.
Habitual miscarriage: 10 mg 2 times / day up to the 20th weeks of pregnancy, followed by a gradual decrease in dose.
Premenstrual syndrome: 10 mg 2 times / day from the 11th to the 25th day of the menstrual cycle.
Dysmenorrhea: 10 mg 2 times / day from the 5th to the 25th day of the menstrual cycle.
Irregular menstruation: 10 mg 2 times / day from the 11th to the 25th day of the menstrual cycle.
Secondary amenorrhea: estrogenic drug 1 time / day from the 1st to the 25th day of the cycle along with 10 mg of the drug Duphaston® 2 times / day from the 11th to the 25th day of the menstrual cycle.
Dysfunctional uterine bleeding (to stop bleeding): 10 mg 2 times / day for 5 or 7 days.
Dysfunctional uterine bleeding (to prevent bleeding): 10 mg 2 times / day from the 11th to the 25th day of the menstrual cycle.
HRT in combination with estrogens: with a continuous sequential regimen - 10 mg of dydrogesterone per day for 14 consecutive days within 28-day cycle. With a cyclic regimen of therapy (when estrogens are used in 21-day courses with 7-day breaks) - 10 mg of dydrogesterone per day for the last 12-14 days of estrogen intake. If a biopsy or ultrasound indicates an insufficient response to a progestogenic drug, the daily dose of dydrogesterone should be increased to 20 mg.
If the patient missed the pill, it should be taken as early as possible, within 12 hours after the usual time of admission. If more than 12 hours have passed, the missed tablet should not be taken, and the next day you need to take the pill at the usual time. Skipping the drug may increase the likelihood of "breakthrough" bleeding or "spotting" spotting.
Support of the luteal phase in the process of using auxiliary methods of reproduction: 10 mg 3 times / day, starting from the day of egg retrieval and up to 10 weeks of pregnancy (if pregnancy is confirmed). If the patient missed taking the pill, this pill should be taken as early as possible and consult a doctor.
The use of dydrogesterone to menarche is not indicated. The safety and efficacy of dydrogesterone in adolescent girls aged 12 to 18 years has not been established. Currently available limited data do not allow for recommendations on the dosage regimen in patients of this age group.
Data on cases of drug overdose are limited. Dydrogesterone was well tolerated after oral administration (the maximum described daily dose was 360 mg).
Symptoms: theoretically possible clinical manifestations of an overdose of the drug - nausea, vomiting, dizziness and drowsiness.
Treatment: there is no specific antidote, treatment should be symptomatic.
From the side of the hematopoietic system: rarely - hemolytic anemia.
From the nervous system: often - migraine / headache; infrequently - dizziness; rarely - drowsiness.
From the side of the psyche: infrequently - depressive mood.
From the digestive system: often - nausea; infrequently - vomiting.
From the liver and biliary tract: infrequently - impaired liver function (with jaundice, asthenia or malaise, abdominal pain).
Allergic reactions: infrequently - allergic dermatitis (eg, rash, itching, urticaria); rarely - Quincke's edema, hypersensitivity reactions.
From the reproductive system: often - menstrual disorders (including metrorrhagia, menorrhagia, oligo-/amenorrhea, dysmenorrhea and irregular menstrual cycle); soreness / sensitivity of the mammary glands; rarely - swelling of the mammary glands.
Other: infrequently - an increase in body weight; rarely - edema, increase in the size of progestogen-dependent neoplasms (for example, meningioma).
In a dark place at a temperature of 0 to 30 ° C.
Out of the reach of children.
- Dosage form
- 10 mg
- Number of tablets
- INN Russian
- Russian title