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Pharmacological action of Duphaston
Analog 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.
As 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 negatively affect the blood coagulation system, dydrogesterone does not affect coagulation parameters. 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 treating with dydrogesterone, the therapeutic effect is achieved without suppressing ovulation or disturbing menstrual function. Dydrogesterone makes conception and pregnancy possible during treatment.
After oral administration, it is rapidly absorbed from the gastrointestinal tract. Cmax in plasma is achieved after 2 hours. Plasma protein binding is 97%.
Metabolized in the liver by hydroxylation.
It is excreted in the urine in the form of metabolites - 56-79%. After 24 hours, approximately 85% is excreted, after 72 hours the process of excretion is practically completed.
Indications of the active substances of the drug Duphaston®
Progesterone deficiency: endometriosis; infertility due to luteal insufficiency; threatening or habitual miscarriage (with progesterone deficiency); premenstrual tension syndrome; dysmenorrhea, irregular menstrual cycle; secondary amenorrhea (in combination therapy with estrogens); dysfunctional uterine bleeding.
HRT: to neutralize the proliferative effect of estrogens on the endometrium in women with disorders caused by natural or surgical menopause with an intact uterus.
Method of application and dosage
The following treatment regimens with Dufaston are recommended. The dose can be adjusted depending on the severity of the disease and on the individual response to treatment.
Regulation of the menstrual cycle
Cycle duration of 28 days can be achieved by prescribing 1 tablet of Dufaston per day from the 11th to the 25th day of the cycle.
From 1 to 3 tablets of Dufaston per day from the 5th to the 25th day of the cycle or during the entire cycle. Doses in multiples of 10 mg / day should be distributed evenly throughout the day. It is recommended to prescribe the maximum dose at the initial stage of treatment.
From 1 to 2 tablets of Duphaston per day from the 5th to the 25th day of the cycle. Doses in multiples of 10 mg / day should be distributed evenly throughout the day. It is recommended to prescribe the maximum dose at the initial stage of treatment.
Infertility due to luteal insufficiency
1 tablet of Dufaston per day from the 14th to the 25th day of the cycle.
This treatment should be continued for a minimum of 6 consecutive cycles. It is recommended to continue therapy during the first month of pregnancy at the same doses as for the usual miscarriage.
Support of the luteal phase with the use of assisted reproductive technologies (ART):
1 tablet of Dufaston three times a day (30 mg per day). Treatment begins on the day of oocyte collection and continues for 10 weeks if pregnancy is confirmed.
Threatened miscarriage due to progesterone deficiency
Initial dose: 4 tablets of Dufaston once, then 1 tablet every 8 hours. Doses, multiples of 10 mg / day, should be evenly distributed throughout the day. It is recommended to prescribe the highest dose at the initial stage of treatment.
If the symptoms do not disappear or reappear during treatment, the dose should be increased by 1 tablet of Duphaston every 8 hours.
After the symptoms disappear, the effective dose must be maintained for 1 week, after which it can be gradually reduced. If symptoms reappear, treatment should be reinstated immediately at a dosage that has proven effective.
Habitual miscarriage due to progesterone deficiency
1 tablet of Duphaston per day until the 20th week of pregnancy, followed by a gradual dose reduction. Treatment should be started before conception. If symptoms of threatened abortion appear during treatment, then treatment should be continued, as recommended in the case of threatened miscarriage.
Dysfunctional uterine bleeding
To stop dysfunctional uterine bleeding, 2 tablets of Dufaston are prescribed for 5-7 days. Blood loss is greatly reduced within a few days. After a few days after the end of such treatment, withdrawal bleeding will appear, which must be warned the patient about.
In order to prevent further bleeding, Dufaston® is prescribed 1 tablet per day from the 11th to the 25th day of the cycle, if necessary in combination with estrogens, for 2-3 cycles. After this, treatment may be discontinued in order to ensure that the patient's cycle is normal.
1 or 2 tablets of Dufaston per day from the 11th to the 25th day of the cycle for optimal secretory transformation of the endometrium, which is adequately prepared by endogenous or exogenous estrogens.
Prevention of endometrial hyperplasia in the postmenopausal period
For each 28-day cycle of estrogen therapy, only estrogen is taken for the first 14 days, and for the next 14 days, in addition to estrogen therapy, 1 or 2 tablets containing 10 mg of dydrogesterone are taken once a day.
In the case of prescribing 10 mg of dydrogesterone 2 times a day, the tablets should be distributed evenly throughout the day. Withdrawal bleeding usually occurs while taking dydrogesterone.
The use of combination therapy with estrogen and progestogen in postmenopausal women should be limited to the minimum effective dose and the short term to achieve the therapeutic goal, and the risks for each woman should be periodically reviewed (see section "Precautions for medical use").
There is no relevant data on the use of dydrogesterone prior to menarche. The safety and efficacy of dydrogesterone in adolescents aged 12-18 years has not been established.
Contraindications to use
Hypersensitivity to dydrogesterone; diagnosed or suspected progestogen-dependent neoplasms (eg, meningioma); bleeding from the vagina of unclear etiology; liver dysfunctions caused by acute or chronic liver diseases at the present time or in history (before the normalization of liver function tests); current or history of malignant liver tumors; period of breastfeeding; current or history of porphyria; age up to 18 years.
When combined with estrogens (HRT): untreated endometrial hyperplasia; arterial and venous thrombosis, thromboembolism at present or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, thrombophlebitis, cerebrovascular disorders of hemorrhagic and ischemic type); revealed 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).
With caution: in depression, currently ; conditions that previously appeared or worsened during a previous pregnancy or previous use of sex hormones, such as cholestatic jaundice, herpes during pregnancy, severe pruritus, otosclerosis.When
using dydrogesterone in combination with estrogens, care must be taken if there are risk factors for the development of thromboembolic conditions such as angina pectoris, prolonged immobilization, severe obesity (body BMI over 30 kg / m2),advanced age, extensive surgery, systemic lupus erythematosus, carcinoma, patients receiving anticoagulant therapy, endometriosis, myoma of the uterus; Nali a history of endometrial hyperplasia; liver adenoma; diabetes mellitus with or without vascular complications; arterial hypertension; bronchial asthma; epilepsy; a history of migraine or severe headache; gallstone disease; chronic renal failure; if you have a history of risk factors for the development of estrogen-dependent tumors (for example, 1st-line relatives with breast cancer).
Application during pregnancy and lactation
During pregnancy, it is possible to use it according to indications in recommended doses.
Dydrogesterone is excreted in breast milk, therefore it is contraindicated during breastfeeding.
Application for violations of liver function
Use is contraindicated for violations of liver function due to acute or chronic liver diseases at the present time or in history (until the normalization of liver function tests); with malignant liver tumors at the present time or in history.
Application for impaired renal function Use with
caution in patients with impaired renal function.
Use in children
Use in children and adolescents under the age of 18 is contraindicated, due to the lack of data on efficacy and safety in this age category.
Use in elderly patients
Use with caution in elderly patients due to the risk of venous thromboembolism.
Before starting treatment with dihydrosterone with abnormal uterine bleeding, it is necessary to find out the cause of the bleeding. With prolonged use of dihydrosterone, periodic examinations by a gynecologist are recommended, the frequency of which is determined individually, but at least once every 6 months. During the first months of treatment for abnormal uterine bleeding, breakthrough bleeding or spotting bleeding may occur. If "breakthrough" bleeding or spotting spotting occurs after a certain period of taking dihydrosterone or continues after a course of treatment, you should consult your doctor and conduct an appropriate additional examination, if necessary, do an endometrial biopsy to exclude neoplasms in the endometrium.
HRT should be prescribed for the treatment of 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.
Medical examination. 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 precautionary measures.
During treatment, it is recommended to periodically monitor the individual tolerance of HRT.
Endometrial hyperplasia and cancer. In women with an intact uterus, the risk of endometrial hyperplasia and cancer increases with prolonged estrogen monotherapy. Cyclic use of progestogens, incl. dydrogesterone (for at least 12 days of a 28-day cycle), or the use of a sequential combined HRT regimen in women with a preserved uterus, may prevent the increased risk of endometrial hyperplasia and cancer with estrogen monotherapy.
Mammary cancer. The available data indicate that the risk of breast cancer is increased in women who received HRT with estrogen-progestogen drugs, and, possibly, with estrogen monotherapy. The level of risk depends on the duration of HRT. While taking medications 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. Ovarian cancer is much less common than breast cancer. There is evidence of a slight increase in risk for women receiving HRT in the form of estrogen monotherapy or combination therapy with estrogens and progestogens. An increase in this risk becomes evident with the duration of therapy for more than 5 years, and after its termination, the risk gradually decreases over time.
Venous thromboembolism. HRT is associated with a 1.3-3-fold increased risk of venous thromboembolism (VTE), i.e. deep vein thrombosis or pulmonary embolism. The likelihood is highest in the first year of HRT than in subsequent years. Patients with diagnosed 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 the occurrence of venous thromboembolism include estrogen, old age, holding a major surgery, prolonged immobilisation, obesity (BMI> 30 kg / m2),pregnancy, postpartum period, systemic lupus erythematosus, cancer. There are no unambiguous data on the possible role of varicose 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, resuming their intake is possible after the woman's motor activity is fully restored.
If thrombophilia associated with thrombosis is detected in family members or if there is a severe defect (for example, lack of antithrombin III, protein C, protein S, or a combination of defects), HRT is contraindicated.
If the patient is taking anticoagulants, it is necessary to carefully assess the benefits / risks of HRT. Until a thorough assessment of the factors for the possible development of thromboembolism is completed or the initiation of anticoagulant therapy, HRT drugs are not prescribed. If thrombosis develops after starting therapy, HRT should be discontinued.
It is necessary to urgently consult a doctor in case of any of the symptoms indicating possible thromboembolism (soreness or swelling of the lower extremities, sudden chest pain, shortness of breath, blurred vision).
Coronary artery disease (CHD). There is evidence that there is no protective effect against the development of myocardial infarction in women with and without coronary artery disease, 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. The absolute risk of CAD depends on age. The number of cases of ischemic heart disease against the background of the use of HRT is less in healthy women at an age close to the onset of natural menopause, but it increases in subsequent years.
Ischemic stroke. Combination therapy with estrogens and progestogens or estrogens alone is associated with a 1.5-fold increased risk of ischemic stroke. The relative risk does not change with age and does not depend on the time of menopause. However, the incidence of stroke varies with age, and the overall risk of stroke in women receiving HRT will increase with age.
Effects on the ability to drive vehicles and use mechanisms
Care should be taken 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).
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 metabolism of dydrogesterone and reduce its effect.
Ritonavir and nelfinavir, as strong inhibitors of enzymes of the cytochrome system, when used together with steroids, have enzyme-inducing properties.
From the hematopoietic system: rarely - hemolytic anemia.
From the nervous system: often - migraine / headache; infrequently - dizziness; rarely, drowsiness.
From the side of the psyche: infrequently - depressed mood.
From the digestive system: often - nausea; infrequently - vomiting.
Liver and biliary tract: disordersinfrequently - liver dysfunction (with jaundice, asthenia or malaise, abdominal pain).
Allergic reactions: infrequently - allergic dermatitis (eg, rash, itching, urticaria); rarely - Quincke's edema, hypersensitivity reactions.
Reproductive system disorders: often - menstrual irregularities (including metrorrhagia, menorrhagia, oligo- / amenorrhea, dysmenorrhea and irregular menstrual cycle); tenderness / tenderness of the mammary glands; rarely - swelling of the mammary glands.
Others: infrequently - an increase in body weight; rarely - edema, an increase in the size of progestogen-dependent neoplasms (for example, meningioma).