Duphaston is an original hormonal drug that is included in the standards of care for pregnant women with miscarriage, multiple pregnancies, and neoplasms. Other indications include endometriosis, irregular menstrual cycles, infertility and miscarriage.
The drug Duphaston is dispensed strictly as prescribed by the doctor and is used on certain days of the cycle. The cost depends on the number of tablets in the package (20 or 28 pieces), and the markup of the pharmacy organization. On average, the price of a package ranges from 530 to 870 rubles.
It is extremely important to coordinate the selection of cheap analogues of Duphaston with a gynecologist due to side effects, the severity of the action of a group of drugs, and the nuances of prescription.
pharmachologic effect
The active component of the drug, dydrogesterone, is an analogue of natural progesterone . Duphaston is a hormonal drug.
Under the influence of this medicine, thermogenesis is not disrupted in a woman’s body, so basal temperature can be measured to determine ovulation. The product does not affect metabolic processes in the body or liver function. Dydrogesterone is very similar in properties and structure to natural progesterone. However, the drug does not provoke the side effects that occur when taking a number of synthetic progesterones. Wikipedia indicates that this drug does not have androgenic, estrogenic, anabolic, thermogenic, or corticoid effects. As a component of hormone replacement therapy for menopause , the drug provides a positive effect of estrogens on the lipid profile blood . But if estrogens have a negative effect on the blood coagulation process, then dydrogesterone has no effect on coagulation.
When taken orally, there is a selective effect of dydrogesterone on the endometrium , which helps prevent the high risk of hyperplasia or carcinogenesis, provoked by increased production of estrogen. The medicine does not have a contraceptive effect. During treatment, the drug does not affect ovulation. Menstruation also continues as usual when taking the medication. A woman can become pregnant with dydrogesterone and maintain pregnancy during treatment with the drug, since no negative effect on the fetus is noted during the treatment process. There is a selective effect on progestin receptors of the uterine mucosa. It does not affect the ovulation of the follicle. There is no masculinizing or virilizing effect.
Since the natural hormone dydrogesterone reduces the level of excitability of the myometrium, under its influence the contractile activity of the uterus decreases. The answer to the question of whether this drug affects weight is clear: taking Duphaston does not contribute to gaining extra pounds.
Thus, dydrogesterone reduces the effect of natural estrogens on the body, therefore it is successfully used for infertility , PMS, recurrent miscarriage, menopause , in women who have already had a frozen pregnancy , etc.
Duphaston or Visanne for endometriosis
Manufacturer: Bayer, Germany
Release form: tablets
Active ingredient: dienogest
For endometriosis, the key element of therapy is taking hormonal drugs, for example, Visanne or Duphaston. The first medication is an expensive German drug from the group of gestagens. Used for a long time once a day. You can start treatment with an analogue on any day of the menstrual cycle.
Duphaston is another imported drug used for endometriosis 2-3 times a day.
What to choose is determined by the attending gynecologist. The patient must be informed whether the medications are affordable and available in city pharmacies.
According to research, Visanne has a number of benefits for endometriosis:
- reduces pelvic pain associated with the disease;
- leads to atrophy of foci with overgrown endometrium, and such areas can be throughout the body (in the kidneys, gastrointestinal tract);
- effectiveness against other symptoms of endometriosis - dysmenorrhea and dyspareunia.
What can replace Duphaston is a question that can only be resolved with a gynecologist. Hormones have a number of side effects (mood changes, headaches, drowsiness, irritability, effects on the bone system, risk of cancer). The choice of an analogue is influenced by the presence of pregnancy and lactation, other medications taken, the patient’s age, and concomitant diseases.
Pharmacokinetics and pharmacodynamics
After oral administration, dydrogesterone is rapidly absorbed from the gastrointestinal tract; after 2 hours the highest concentration of the active component in the blood is observed. The degree of binding to blood proteins is 97%. 56-79% is excreted from the body by the kidneys; a day after administration, about 85% is excreted from the body; the entire excretion process is completely completed after 72 hours. Metabolites are present in urine , mainly in the form of glucuronic acid conjugates .
There is no data on changes in the pharmacokinetics and pharmacodynamics of the active component in people who suffer from kidney disease. Does not accumulate.
Indications for use
Why Duphaston tablets are prescribed depends on the diagnosis and treatment regimen determined by the doctor.
Currently, the following indications for use of the drug are determined:
- Insufficiency of progesterone in the body (in case of infertility associated with insufficiency of the luteal phase, with the threat of miscarriage or habitual loss of the fetus, with dysmenorrhea , menstrual cycle disorders, amenorrhea of secondary origin).
- As part of hormone replacement therapy (during menopause, it is used to neutralize the proliferative effect of estrogens on the mucous membrane of the uterine cavity when using estrogens; during surgical castration).
Thus, tablets are prescribed for dysfunctional uterine bleeding, for polycystic ovary syndrome , for corpus luteum cyst, for endometritis, for uterine fibroids .
What else the medicine is prescribed for, when it is prescribed, and what the dosage should be, you should ask your doctor.
Duphaston®
Before starting treatment with Duphaston® for abnormal uterine bleeding, it is necessary to find out the cause of the bleeding. With prolonged use of the drug, periodic examinations by a gynecologist are recommended, the frequency of which is determined individually, but at least once every six months.
In the first months of treatment for abnormal uterine bleeding, “breakthrough” bleeding or “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 contact your doctor and carry out appropriate additional examination, and, if necessary, do an endometrial biopsy to exclude neoplasms in the endometrium.
If dydrogesterone is prescribed 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 for the treatment of premature menopause. Due to the low absolute risk in younger women, the benefit/risk ratio for them may be more favorable compared with that for older women.
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 performed to identify possible contraindications and conditions requiring precautions.
During treatment, it is recommended to periodically monitor individual tolerance to HRT. The patient should be informed about what changes in the mammary glands she should report to the doctor. (See breast cancer). 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
In women with an intact uterus, the risk of endometrial hyperplasia and cancer increases with long-term estrogen monotherapy.
Cyclic use of progestogens, including dydrogesterone (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
Available evidence suggests that the risk of breast cancer is increased in women treated with estrogen-progestogen HRT, and possibly also with estrogen monotherapy. The level of risk depends on the duration of HRT. The results of the epidemiological study and the WHI (Women's Health Initiative) study confirm an increased risk of developing breast cancer in women taking drugs containing a combination of estrogen and progesterone as part of HRT. The risk increases after about three years of use, but returns to the mean within a few (usually five) years after the end of therapy.
While taking drugs for HRT, especially with combined therapy with estrogens and progestogens, an increase in the density of breast tissue during mammography may be observed, which can make it difficult to diagnose breast cancer.
Ovarian cancer
Ovarian cancer is much less common than breast cancer.
Epidemiological data from a large meta-analysis suggest a small increase in risk for women receiving HRT as estrogen monotherapy or combination therapy with estrogens and progestogens. An increase in this risk becomes apparent with treatment duration of more than five years, and after its cessation the risk gradually decreases over time. Findings from a number of other studies, including the WHI, indicate that combined HRT is associated with a similar or slightly lower risk of ovarian cancer.
Venous thromboembolism
HRT is associated with a 1.3- to 3-fold increase in the 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 established 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 use, advanced age, major surgery, prolonged immobilization, obesity (BMI > 30 kg/m2), pregnancy, the postpartum period, systemic lupus erythematosus and cancer. There is no clear data on the possible role of varicose veins in the development of venous thromboembolism.
If long-term immobilization after surgery is necessary, you should stop taking HRT medications 4-6 weeks before surgery, resuming the drug is possible after the woman has fully recovered her motor activity.
Women with no history of VTE, but with a family history of thrombosis at a young age in close relatives, may be offered screening after detailed counseling about the possible limitations and disadvantages of therapy (screening reveals only some of the hereditary defects of the hemostatic system) .
If thrombophilia associated with thrombosis is detected in family members or if there is a severe defect (for example, deficiency of antithrombin III, protein C, protein S, or a combination of defects), HRT is contraindicated.
If the patient is taking anticoagulants, the benefits/risks of HRT must be carefully assessed. Until a thorough assessment of the factors for the possible development of thromboembolism or the initiation of anticoagulant therapy is completed, HRT drugs are not prescribed. If thrombosis develops after initiation of therapy, HRT should be discontinued.
You should immediately consult a doctor if any of the symptoms indicating a possible thromboembolism appear (painful swelling of the lower extremities, sudden chest pain, shortness of breath, blurred vision).
Coronary heart disease (CHD)
Data obtained from randomized controlled trials indicate a lack of 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 heart disease increases slightly during combined HRT. The absolute risk of developing CHD depends on age. The incidence of CHD associated with HRT use in healthy women near natural menopause is very low, but the risk increases with age.
Ischemic stroke
Combination therapy with estrogens and progestogens or estrogens 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 time of menopause. However, the incidence of stroke varies with age, and the overall risk of stroke in women taking HRT will increase with age.
Excipients
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.
Contraindications
There are contraindications for taking Duphaston.
First of all, you should not take pills if you are highly sensitive to dydrogesterone or other components of the drug, as this can harm the woman’s body.
The tablets should be prescribed with caution to women who have suffered from itching during pregnancy before.
There is no data on the negative effects of dydrogesterone on people who suffer from chronic renal failure
Side effects of Duphaston
During the reception process, some side effects of Duphaston may be observed:
- immune system: hypersensitivity (very rare);
- hematopoietic system: hemolytic anemia (isolated cases);
- nervous system: migraine , headache ;
- hepatobiliary system: minor liver dysfunction, which may cause weakness, jaundice, abdominal pain;
- reproductive system : breakthrough bleeding during administration (rare), prevented by increasing the dosage of the drug; the sensitivity of the mammary glands may increase;
- subcutaneous tissue, skin: itching, urticaria (rare), Quincke's edema (very rare);
- general disorders: peripheral edema (very rare).
If any of the above symptoms occur, you should tell your doctor that this side effect is occurring.
Instructions for use of Duphaston (Method and dosage)
The drug is prescribed according to an individual regimen, both when planning pregnancy and for gynecological diseases. It doesn’t matter how you take it, before or after meals.
Duphaston tablets, instructions for use
The indicated dosage regimens are indicative only. To prescribe a treatment regimen and determine how long the pills can be taken, the doctor must take into account the symptoms of the disease and the phases of the monthly cycle. The daily dose of the medicine should be divided into 2-3 doses, tablets should be taken at equal intervals.
Duphaston for endometriosis is prescribed in a dose of 10 mg of dydrogesterone 2 or 3 times a day. How to take Duphaston for endometriosis depends on the doctor's prescription. You need to take the product from days 5 to 25 of the cycle or do it without a break. It should be borne in mind that only the attending physician can prescribe Duphaston for endometriosis. Reviews from doctors on the Internet or any medical forum with information about treatment should be taken only as information for reference.
Duphaston for conception in case of infertility of progesterone origin is prescribed from the 11th to the 25th day of the monthly cycle. You should definitely find out from a specialist how to take Duphaston for conception. As a rule, treatment lasts for 3-6 months. How to take Duphaston to get pregnant, how much you need to drink to get pregnant, depends on the woman’s diagnosis and the individual characteristics of her body.
If there is a delay after taking the pills and other signs of pregnancy while taking the drug, treatment should continue, and the dose should be equal to that prescribed for a habitual pregnancy loss.
If a woman has a threatened miscarriage or recurrent pregnancy loss , it is advisable to use the medicine only if there is clear evidence of endogenous progesterone deficiency. Women with threatened abortion are advised to take a single dose of 40 mg of dydrogesterone, followed by 10 mg every 8 hours for a week. Then the dose is gradually reduced. But if the threat of miscarriage arises again, the dose is increased. Application can be practiced until the 20th week of pregnancy. But more precisely, your doctor will advise you individually about which week to take the pills during pregnancy.
How to take if there is a threat of miscarriage in the early stages , the doctor determines individually. As a rule, in case of recurrent miscarriage at the stage of pregnancy planning, Duphaston is taken from the 11th to 25th day of the cycle, provided that conception has occurred, the woman continues to receive the same dose. Further, after the 20th week of pregnancy, the dose should be gradually reduced.
Women suffering from PMS are prescribed 10 mg tablets from days 11 to 25, treatment lasts from 3 to 6 months.
Duphaston for delayed menstruation , irregular cycles and other menstrual disorders is prescribed from cycles 11 to 25, 2 times a day, 20 mg. How to induce menstruation with Duphaston depends on the woman’s diagnosis. The doctor prescribes the drug for irregular cycles, determines how to take Duphaston to induce menstruation, how much to drink to induce menstruation. Whether it is possible to induce menstruation with amenorrhea depends on the correct treatment. As a rule, taking Duphaston in this case is combined with taking estrogen . This treatment should be practiced for at least three monthly cycles.
In case of dysfunctional bleeding, the drug is prescribed 10 mg twice a day for 5-7 days, combining the dose with 0.05 mg ethinyl estradiol . In order to prevent the development of bleeding, tablets are prescribed at a dose of 10 mg in the period from 11 to 25 days of menstruation. The dose is combined with 0.05 mg of ethinyl estradiol (1 time per day).
If hormone replacement therapy , it is used in combination with estrogens. Continuous treatment involves taking 10 mg of the drug for 14 days during each monthly cycle. If necessary, the dose can be increased to 20 mg per day.
How to take Duphaston for endometrial hyperplasia depends on what other drugs the doctor prescribes for treatment. As a rule, treatment of endometrial hyperplasia involves taking the drug at a dose of 10 mg from days 16 to 25 of the cycle.
How to take Duphaston for an ovarian cyst also depends on the specialist’s prescription. For ovarian cysts, treatment should continue for at least 3 months.
Treatment of follicular ovarian cyst involves prescribing 10 mg of the drug 2 times a day. ovarian dysfunction is being treated , as well as if multifollicular ovaries .
If a woman misses a Duphaston tablet, then an additional dose should not be taken. You need to continue taking it with the next tablet. For convenience, you can count how many tablets are left in the Duphaston package and monitor the regularity of taking it.
For any diagnosis, you should not start drinking Duphaston without a doctor’s prescription.
Duphaston - instructions for use
The drug is taken 2-3 times a day in the dosage prescribed by the doctor. Features of treatment are determined by the gynecologist depending on the indications, condition and severity of the pathology in the patient.
There is a risk on the tablet. It is intended to make the medicine easier to swallow if you have difficulty swallowing.
Is Duphaston available with a prescription or not? To purchase medication, you need a prescription form issued by a gynecologist. Also, in some areas, the drug is included in the list of drugs available at a discounted rate by prescription.
Take Duphaston before or after meals
The medicine is taken 2-3 times a day in the morning and evening. How to take the tablet - with or after meals - does not affect the effectiveness of Duphaston.
If the patient misses a dose of medication, this must be done as soon as possible. However, if more than 12 hours have passed, you do not need to take the missed dose.
Interaction
With simultaneous administration of inducers of microsomal enzymes ( Rifampicin , Phenobarbital), it is possible to accelerate the metabolism of dydrogesterone and reduce the effect.
There is no evidence of incompatibility with other drugs.
Duphaston and Proginova can be prescribed in parallel, most often when planning pregnancy. Proginova is an estrogen drug.
Duphaston and Clostilbegit are prescribed in combination for the treatment of infertility. Clostilbegit is a non-steroidal anti-estrogen that stimulates ovulation.
Borovaya uterus and Duphaston - the compatibility of these drugs is controversial. There is information that the herbal medicine boron uterus in combination with Duphaston can provoke bleeding.
special instructions
If Duphaston is used in combination with estrogens, caution must be exercised in patients suffering from vascular diseases, heart disease, kidney disease, diabetes mellitus , epilepsy , and migraine. Also carefully prescribed for liver diseases.
If a woman is prescribed a drug for the purpose of hormone replacement therapy, a series of studies must be carried out before starting, and later, regular mammographic examinations . It is important to take into account all contraindications. The doctor must clearly examine the patient's medical history. During HRT, the tolerability of such treatment should be monitored at certain intervals. There is a possibility of breakthrough bleeding in the first months of therapy. If such bleeding also occurs after a course of treatment, the woman needs to undergo an endometrial biopsy to exclude malignant processes.
Duphaston should not be taken by those who suffer from lactase deficiency, galactose deficiency or malabsorption syndrome.
Does not affect the ability to drive a car or operate precision machinery.
If you regularly experience discharge while taking pills, you should tell your doctor about it.
Since Duphaston is a synthetic progesterone , it can replace the natural hormone progesterone, for which Duphaston is prescribed to pregnant women, as well as women during pregnancy planning. How to drink Duphaston to get pregnant is determined by your attending physician. When asked whether this drug suppresses ovulation, experts answer unequivocally in the negative. How this medicine affects ovulation depends on the frequency and duration of its use.
Often women are interested in whether the drug can cause a delay in menstruation , or how to drink to induce menstruation. It should be understood that the regulation of menstruation is ensured by the production of estrogen and progesterone in the body. Often a woman notes that her period has not started if there is a lack of progesterone in the body. If the ovaries do not produce enough progesterone for any reason, a course of Duphaston is prescribed. If your period does not come after taking Duphaston, you should take a pregnancy test . Provided that there are no periods after discontinuation of the drug, and the woman is not pregnant, she should definitely consult a doctor. The reason for scanty periods after the drug may be a lack of estrogen, late ovulation, or changes in the uterus.
It should be borne in mind that when using Duphaston to induce menstruation “for convenience”, without a doctor’s prior prescription, although a woman induces menstruation, she risks disrupting the functions of the hormonal system. As a result, after uncontrolled treatment, a woman sometimes complains that she has heavy periods after taking pills or that her periods take a long time.
Therefore, the answer to the question whether Duphaston can be taken without a doctor’s prescription is clear: this should not be done.
Another question that interests women: do they get better from Duphaston? Namely, does it make you gain weight if you take it for a long time? Since the active substance of the drug is synthetic progesterone, when asked whether it makes you fat, experts answer in the negative.
Duphaston tablets p/o 10 mg No. 20x1
Name
Duphaston.
Release form
Film-coated tablets.
Dosage
10 mg. Quantity per package: 20 pcs.
Manufacturer
Abbott Laboratories
INN
Dydrogesterone.
FTG
Progestogen.
Compound
1 film-coated tablet contains: Active substance: micronized dydrogesterone – 10 mg; Excipients: lactose monohydrate – 111.1 mg, hypromellose 2910 – 2.8 mg, corn starch – 14.0 mg, colloidal anhydrous silicon dioxide – 1.4 mg, magnesium stearate – 0.7 mg; Shell: Opadry white Y-1-7000 (hypromellose 2910, macrogol 400, titanium dioxide (E171)) – 4.0 mg.
Pharmacotherapeutic group
Sex hormones and modulators of the reproductive system. Pregnadiene derivatives. ATX code: G03DB01
Description
A round, biconvex, white, beveled, film-coated tablet with a break line on one side and “155” engraved on both sides of the break line. The purpose of the break line is to break the tablet to make it easier to swallow, but not to divide it into two equal doses.
Pharmacological properties
Pharmacodynamics Duphaston® (dydrogesterone) is a synthetic analogue of progesterone, active when taken orally. Dydrogesterone, when administered orally, selectively acts on the endometrium, thereby preventing the increased risk of developing endometrial hyperplasia and/or estrogen-induced carcinogenesis. Dydrogesterone does not have estrogenic, androgenic, anabolic or glucocorticosteroid activity. When treated with dydrogesterone, the therapeutic effect is achieved without suppressing ovulation. Dydrogesterone makes it possible to conceive and maintain pregnancy during treatment. In postmenopausal women with a preserved uterus, hormone replacement therapy (HRT) with estrogen leads to an increased risk of developing endometrial hyperplasia and endometrial cancer. The addition of a progestogen prevents the development of additional risks. Pharmacokinetics Absorption After oral administration, it is rapidly absorbed from the gastrointestinal tract. The time to reach Tmax is from 0.5 to 2.5 hours. The absolute bioavailability of dydrogesterone at a dose of 20 mg orally (compared with 7.8 mg intravenously) is 28%. The table shows the pharmacokinetic parameters of dydrogesterone (D) and 20α-dihydrodydrogesterone after taking a single dose of 10 mg of dydrogesterone: dydrogesterone dihydrodydrogesterone Cmax (ng/ml) 2.1 53.0 AUCinf (ng h/ml) 7.7 322.0 Distribution With intravenous administration, volume of distribution in in the equilibrium state is about 1400 l. More than 90% of dydrogesterone and dihydrodydrogesterone are bound to plasma proteins. Metabolism After oral administration, dydrogesterone is rapidly metabolized to dihydrodydrogesterone (DHD). The concentration of the main metabolite 20α-dihydrodydrogesterone peaks approximately 1.5 hours after dosing. The concentration of DHD in blood plasma is significantly higher than that of dydrogesterone. The AUC and Cmax ratios of DHD and dydrogesterone are approximately 40 and 25, respectively. T½ of dydrogesterone and DHD averages 5-7 hours and 14-17 hours, respectively. A common characteristic feature of all dydrogesterone metabolites is the preservation of the 4,6-dien-3-one configuration of the original substance and the absence of 17α-hydroxylation, which causes the absence of estrogenic and androgenic activity. Excretion After oral administration of labeled dydrogesterone, an average of 63% of the dose is excreted in the urine. Total plasma clearance – 6.4 l/min. Complete elimination of dydrogesterone occurs after 72 hours. DHD is excreted in the urine mainly in the form of a glucuronic acid conjugate. Dependence of dose and time Pharmacokinetics are linear for both single and repeated use from 2.5 to 10 mg. Comparison of the kinetics of single and multiple doses shows that the pharmacokinetics of dydrogesterone and DHD do not change as a result of repeated dosing. Stable concentrations are achieved after 3 days of treatment.
Indications for medical use
- regulation of the menstrual cycle; - endometriosis; - dysmenorrhea; - infertility caused by luteal insufficiency; — support of the luteal phase when using assisted reproductive technologies (ART); - threatened miscarriage due to progesterone deficiency; - recurrent miscarriage due to progesterone deficiency. Duphaston® can be used in a cyclic mode, in addition to estrogen therapy in women with an intact uterus: - for the prevention of endometrial hyperplasia during the postmenopausal period; - with dysfunctional uterine bleeding; - with secondary amenorrhea.
Directions for use and dosage
Dosage The following treatment regimens for Duphaston are recommended. The dose may be adjusted depending on the severity of the disease and the individual response to treatment. Regulation of the menstrual cycle A cycle duration of 28 days can be achieved by prescribing 1 Duphaston tablet per day from the 11th to the 25th day of the cycle. Endometriosis From 1 to 3 Duphaston tablets per day from the 5th to the 25th day of the cycle or throughout 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. Dysmenorrhea From 1 to 2 Duphaston tablets 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 caused by luteal insufficiency: 1 Duphaston tablet 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 in the same doses as for a recurrent miscarriage. Support of the luteal phase when using assisted reproductive technologies (ART): 1 tablet of Duphaston 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 Duphaston tablets 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 symptoms do not disappear or reappear during treatment, the dose must 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 resumed immediately at the dose that was found to be effective. Habitual miscarriage due to progesterone deficiency: 1 Duphaston tablet per day until the 20th week of pregnancy, followed by a gradual reduction in the dose. Treatment should begin before conception. If symptoms of threatened miscarriage appear during treatment, treatment should be continued as recommended in the case of threatened miscarriage. Dysfunctional uterine bleeding To stop dysfunctional uterine bleeding, 2 tablets of Duphaston are prescribed for 5-7 days. Blood loss is significantly reduced within a few days. Several days after the end of such treatment, withdrawal bleeding will appear, about which the patient must be warned. In order to prevent further bleeding, Duphaston® 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 can be stopped to ensure that the patient's cycle has returned to normal. Secondary amenorrhea 1 or 2 tablets of Duphaston 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 during the postmenopausal period For each 28-day cycle of estrogen therapy, take estrogen only for the first 14 days, and for the next 14 days, in addition to estrogen therapy, take 1 or 2 tablets containing 10 mg of dydrogesterone once a day. If 10 mg of dydrogesterone is prescribed 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 short duration to achieve the therapeutic goal, and the risks for each woman should be periodically reviewed (see section "Precautions for Medical Use"). There are no relevant data on the use of dydrogesterone before menarche. The safety and effectiveness of dydrogesterone in adolescents aged 12-18 years has not been established.
Mode of application
Used internally. When prescribing the drug in higher doses, the daily dose of the drug must be evenly distributed over several doses throughout the day. Adverse Reactions The most commonly reported adverse reactions during clinical trials in patients using dydrogesterone for non-estrogen indications were metrorrhagia, breast tenderness/tenderness, migraine/headache. The following adverse reactions (and their frequency) were observed during clinical trials with dydrogesterone (n=3,483) for non-estrogen indications and were reported spontaneously: Organ System Class Frequent ≥1/100,
Contraindications
- vaginal bleeding, the cause of which has not been established; - treatment to support the luteal phase when using assisted reproductive technologies (ART) should be discontinued if abortion/miscarriage is diagnosed; - presence of severe liver disease or a history of severe liver disease (before normalization of laboratory parameters of liver function); - contraindications to the use of estrogens in combination with progestogens, such as dydrogesterone, for combined hormonal therapy; - established hypersensitivity to dydrogesterone or other components of the drug; - known or suspected malignant tumors that are dependent on sex hormones.
Overdose
Symptoms Dydrogesterone is a drug of very low toxicity. Nausea, vomiting, drowsiness and dizziness are symptoms that could theoretically occur in case of overdose. There are no known cases in which an overdose of dydrogesterone would cause harmful effects. Treatment No specific treatment is necessary. In case of overdose, symptomatic treatment may be considered. Precautions for medical use Before starting treatment with dydrogesterone for dysfunctional uterine bleeding, it is necessary to exclude an organic cause of bleeding. Sometimes, during the first months of treatment, breakthrough bleeding or spotting may occur. If breakthrough bleeding or spotting occurs after a period of taking the drug or continues after the end of treatment, the cause should be determined, including, if necessary, by taking an endometrial biopsy to exclude malignant changes in the endometrium. If any of the following diseases are currently present or worsen while using the drug Duphaston®, you should consider stopping treatment: - unusually severe headache, migraine or symptoms that may suggest cerebral ischemia; - significant increase in blood pressure; - the occurrence of venous thromboembolism. In cases of recurrent or threatened miscarriage, the viability of the embryo or fetus should be monitored during treatment to confirm the progression of pregnancy. Conditions for which monitoring is necessary The following rare conditions are known to be influenced by sex hormones and these conditions may occur or worsen during pregnancy or previous hormonal treatment: cholestatic jaundice, herpes of pregnancy, severe pruritus, otosclerosis or porphyria. Patients with a history of episodes of depression should be closely monitored by a physician. If severe depression recurs, treatment with dydrogesterone should be discontinued. Other conditions Patients with rare hereditary diseases such as galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome should not take Duphaston®. Precautions when using Duphaston for the prevention of endometrial hyperplasia during the postmenopausal period. Pay special attention to the section of the instructions for medical use of the estrogen drug “Precautions for medical use”. Hormone replacement therapy (HRT) is prescribed when symptoms associated with postmenopause negatively affect a woman's quality of life. A thorough assessment of the risks and benefits of each case should be carried out at least annually. HRT is continued as long as the expected benefits outweigh the possible risks. Medical examination/follow-up A complete medical and family history should be obtained before starting or resuming HRT. A medical examination (including examination of the mammary glands and pelvic organs) is carried out to identify possible contraindications and conditions requiring precautions. Dynamic observation is recommended; the frequency and nature of studies are determined individually. Patients should be aware that they should immediately report any changes in the mammary glands to their doctor (see “Breast cancer” below). Breast examinations, including mammography, are carried out in accordance with accepted screening standards and taking into account the clinical indications of each patient. Endometrial hyperplasia and cancer In women with an intact uterus, the risk of endometrial hyperplasia and cancer increases with long-term use of estrogens alone. The risk of developing endometrial cancer with estrogen monotherapy is 2-12 times higher compared to women not using HRT, and depending on the duration of treatment and dose of estrogen. After stopping estrogen, the risk remains high for 10 years. This additional risk can be prevented by combining estrogen treatment with a progestogen, such as dydrogesterone, for at least 12 days of a 28-day cycle. In the first months of treatment with the drug, breakthrough bleeding and spotting from the vagina may occur. If such bleeding appears some time after starting therapy with Duphaston® or continues after stopping treatment, their cause should be established. An endometrial biopsy may be performed to rule out malignancy. Breast cancer All available data indicate an increased risk of breast cancer in women taking estrogen in combination with a progestogen and, possibly, monoestrogen preparations for the purpose of HRT. This risk depends on the duration of therapy. Combined estrogen-progestogen therapy: The randomized, placebo-controlled WHI trial and epidemiological studies have shown an increased risk of breast cancer in women taking combined HRT for 3 years or more. After stopping treatment, the additional risk continues for a maximum of 5 years. When taking combined HRT drugs, the density of the mammographic image increases, which may have a negative impact on the X-ray diagnosis of breast cancer. Ovarian cancer Ovarian cancer is much less common than breast cancer. Epidemiological data from a large meta-analysis have shown a slightly increased risk in women using estrogen alone or estrogen plus progestogen for HRT, which occurs within 5 years of use and decreases with time after discontinuation of use. Some other studies, including the WHI, suggest that the use of combined HRT drugs may be associated with the same or slightly lower risk. Venous thromboembolism HRT is associated with a 1.3-3 times increased risk of developing venous thromboembolism (VTE), that is, deep vein thrombosis and pulmonary thromboembolism. The likelihood of such a complication is higher in the first year of treatment than in subsequent years. Patients with diagnosed thrombophilic conditions have an increased risk of VTE, and HRT may increase this risk. Therefore, HRT is contraindicated in this group of patients. Generally recognized risk factors for the development of VTE are: estrogen use, old age, major surgery, prolonged immobilization, severe obesity (BMI more than 30 kg/m2), pregnancy and the postpartum period, systemic lupus erythematosus, cancer. There is no consensus regarding the possible role of varicose veins in the occurrence of VTE. It is necessary to take measures to prevent VTE in patients in the postoperative period. In cases where prolonged immobilization after surgery is expected, HRT should be stopped 4-6 weeks before surgery. Resumption of treatment is possible only after complete restoration of motor activity. Women who do not have a history of VTE but have a first-degree relative with a history of thrombosis at a young age may be offered screening after careful discussion of its limitations (screening detects only a subset of thrombophilic conditions). HRT is contraindicated if family members have a thrombophilic defect or if the defect is associated with severe disorders (eg, antithrombin, protein S or protein C deficiency or a combination of defects). If the patient is already taking anticoagulant therapy, a careful assessment of the risks and benefits of prescribing HRT is required. If VTE develops while taking HRT, the drug should be discontinued. The patient should know that when the first possible symptoms of VTE appear (painful swelling of the lower extremities, sudden chest pain, shortness of breath), she should immediately contact her doctor. Coronary heart disease (CHD) There is no evidence from randomized clinical trials that HRT (estrogens alone or in combination with progestogens) protects against myocardial infarction in women with or without coronary artery disease. Combined estrogen-progestagen therapy: the relative risk of coronary artery disease during treatment with combined drugs for HRT increases slightly. Since the initial absolute risk of developing coronary heart disease depends significantly on age, the number of additional cases of coronary heart disease in women receiving combined HRT is very low at an age close to the onset of menopause, and increases with age. Ischemic stroke The risk of ischemic stroke with HRT with combined drugs or with estrogen monotherapy increases by 1-1.5 times. The relative risk does not depend on age or duration of menopause. However, the overall risk of stroke in women receiving HRT increases with age, since the baseline absolute risk of stroke varies significantly with age.
Excipients
This medicine contains lactose monohydrate. Patients with rare hereditary disorders (galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome) are not recommended to use this drug.
Use during pregnancy and breastfeeding
Pregnancy It is estimated that more than 9 million women were treated with dydrogesterone during pregnancy. To date, there are no data on the adverse effects of dydrogesterone during pregnancy. There is a study in the literature that found that the use of certain progestogens may be associated with an increased risk of hypospadias. However, since this has not been confirmed in other studies to date, no definite conclusion can be drawn regarding the effect of progestogens on the occurrence of hypospadias. Clinical studies in which a limited number of women were treated with dydrogesterone in early pregnancy did not show any increase in risk. To date, no other epidemiological data are available. The effects that were noted in non-clinical studies of embryofetal and postnatal development were consistent with the pharmacological profile. Adverse effects occurred only when exposed to doses that significantly exceeded the maximum human exposure dose. Dydrogesterone can be used during pregnancy if there are indications for its use. Breastfeeding Period It is not known whether dydrogesterone is excreted into breast milk. The excretion of dydrogesterone into breast milk has not been studied. Data with other progestogens indicate that progestogens and their metabolites pass into breast milk in small quantities. It is unknown whether there is a risk to the baby, so dydrogesterone should not be taken during breastfeeding. Fertility There are no data on the effect of dydrogesterone on decreased fertility. Effect on the ability to drive a car and other mechanisms Dydrogesterone has a slight effect on the ability to drive a car and other mechanisms. In rare cases, dydrogesterone may cause mild drowsiness and/or dizziness, especially during the first few hours after use. In this regard, care must be taken when driving vehicles and operating machinery.
Interaction with other drugs
In vitro data indicate that the main metabolic pathway results in the formation of the main pharmacologically active metabolite, 20α-dihydrodydrogesterone (DHD), which is catalyzed by aldoketo reductase 1C (AKR 1C) in the human cytosol. The following metabolic transformation is carried out by isoenzymes of the cytochrome P450 system (CYPs), almost exclusively by the CYP3A4 isoenzyme, leading to the formation of various minor metabolites. The main active metabolite of DHD is a substrate for metabolic transformation by the CYP3A4 isoenzyme. Therefore, the metabolism of dydrogesterone and DHD may be accelerated by concomitant administration of substances that are inducers of cytochrome 450 enzymes, such as anticonvulsants (eg, phenobarbital, phenytoin, carbamazepine), anti-infectives (eg, rifampicin, rifabutin, nevirapine, efavirenz) and herbal drugs , containing St. John's wort (Hypericum perforatum), sage or ginkgo biloba. Ritonavir and nelfinavir, although known as inhibitors of microsomal metabolism, may act as inducers when taken concomitantly with steroid hormones. Clinically enhanced metabolism of dydrogesterone can lead to a decrease in the clinical effectiveness of therapy and a change in the nature of uterine bleeding. In vitro studies demonstrate that dydrogesterone and DHD do not inhibit or induce CYP enzymes that metabolize drugs.
Storage conditions
Store in original packaging at a temperature not exceeding 30°C in a place protected from light. Keep out of the reach of children.
Best before date
5 years.
Vacation conditions
On prescription.
Package
Film-coated tablets, 10 mg. 20 tablets in a blister made of PVC/aluminum foil. 1 blister in a cardboard box along with instructions for medical use of the drug.
Buy Duphaston tablet p/pl.ob. 10 mg per bl. in pack No. 20x1 in the pharmacy
Price for Duphaston tablet p/pl.ob. 10 mg per bl. in pack №20x1
Instructions for use for Duphaston tablet p/pl.ob. 10 mg per bl. in pack №20х1
Duphaston's analogues
Level 4 ATC code matches:
Lutenil
Any substitute for Duphaston must be approved by your doctor. What can replace this drug depends on the patient’s diagnosis and the individual course of the disease. An analogue in composition is the drug Prajisan , other drugs with a similar effect are Utrozhestan , progesterone in ampoules , etc. The price of Duphaston analogues may be slightly lower.
Utrozhestan or Duphaston - which is better?
A comparison of these drugs indicates that both drugs have similar indications for use. But it’s not difficult to determine what the difference is: Utrozhestan, unlike Duphaston, contains natural progesterone from plant raw materials. Which is better - Duphaston or Utrozhestan - during pregnancy can only be determined individually. But Utrozhestan also has a sedative effect on the body. Sometimes both drugs are prescribed simultaneously during pregnancy.
Which is better: Duphaston or Norkolut?
Norkolut is also used in gynecology. However, it has a different active ingredient – norethisterone. This is a cheaper drug, but you can choose one or another drug only after consulting a doctor.
Prajisan or Duphaston - which is better?
Prajisan is a hormonal drug, an analogue of Duphaston. It has similar indications, but its cost is lower. But still, doctors do not recommend making a decision on replacing funds on your own.
Duphaston or Norkolut – which is better?
Manufacturer: Gedeon Richter, Hungary
Release form: tablets
Active ingredient: norethisterone
Duphaston is an analogue of natural progesterone that promotes the transition of the endometrium to the secretion phase. It is used for menstrual irregularities, infertility, endometriosis, and problems with bearing a fetus during pregnancy.
Norkolut is an imported analogue of Duphaston used for delayed menstruation, endometriosis, endometrial hyperplasia, menopause, and mastodynia. Can be used as a contraceptive to prevent pregnancy. Take 1-2 tablets once a day on certain days of the cycle.
Both drugs - Duphaston and the analogue Norkolut - belong to the group of gestagens. For menstrual irregularities, menopause and endometriosis, both drugs can be used. Duphaston is used during pregnancy.
The cheaper Duphaston substitute Norkolut is used to stop lactation and for contraception.
Duphaston and alcohol
Since the drug often has to be taken over a long period, many women are interested in whether it is possible to drink alcohol while taking Duphaston. There is no information about this in the instructions for the drug. At the same time, many reviews indicate that alcohol was consumed in small quantities. However, doctors warn that combining alcohol and hormonal drugs can negatively affect hormonal levels, liver function and provoke other negative phenomena. In addition, the effectiveness of the product when combined with alcohol is significantly reduced. For those who become pregnant on Duphaston, alcohol is strictly contraindicated.
Duphaston during pregnancy and lactation
The instructions indicate that the drug can be taken during pregnancy. Taking pills during pregnancy is possible in the early stages to prevent miscarriage. Therefore, Duphaston during early pregnancy is prescribed to women who previously suffered from a habitual abortion, or who had a frozen pregnancy. But, as a rule, the doctor recommends that such patients take Duphaston when planning a pregnancy. Whether the drug can be taken, how much to take and how to take Duphaston when planning a pregnancy, the doctor determines after the woman takes tests for progesterone. In the process of discussing the drug Duphaston during pregnancy, reviews from doctors indicate that this drug should be prescribed only after a comprehensive and thorough examination of the patient.
As a rule, during pregnancy planning, the drug is taken for 3-6 months. You need to drink the product from 11 to 25 days. But this scheme is relevant only for women whose monthly cycle is 28 days. The doctor will tell you how much to drink for a different cycle length.
It is also important to know how to stop taking this medicine during pregnancy. Provided that pregnancy occurs while taking the pills, Duphaston should continue to be taken. During gestation, the dosage is 20 mg of the drug per day (in two doses). You should also consider how to properly stop Duphaston during pregnancy. You should definitely consult your doctor about how to reduce the dose and until what week you take the pills. The withdrawal regimen during pregnancy involves taking the drug until the 20th week of pregnancy, but sometimes the period until which time to take the medicine depends on the individual health status of the expectant mother. Some women are advised to stop as early as 16 weeks. But in any case, only a gynecologist should recommend in detail how to cancel Duphaston during pregnancy. You cannot be guided by the advice that other women write on forums or in reviews about the product. After taking and after stopping the drug, it is important to regularly monitor the woman’s condition. During pregnancy, in some cases, Duphaston and Proginova are prescribed simultaneously.
Often pregnant women are interested in how Duphaston affects the body as a whole, in particular, whether they get better from it. It should be noted that weight gain during pregnancy is a physiological process and is not associated with taking pills.
Duphaston or Utrozhestan - which is better?
Manufacturer: Olik Limited, Thailand
Release form: capsules
Active ingredient: progesterone
Synonyms: Iprozhin, Prajisan, Crinon
Duphaston and Utrozhestan are drugs from the estrogen group prescribed during pregnancy or planning pregnancy, with a history of miscarriages or abortions. Both drugs are imported.
Duphaston is a tablet for oral administration based on synthetic estrogen. An analogue of Duphaston during pregnancy, Utrozhestan, is capsules for oral and intravaginal administration containing natural progesterone. When the Duphaston analogue in suppositories is introduced into the vagina, a rapid effect and a lower frequency of side effects are noted.
Both drugs are available by prescription; which analogue to choose is decided by the patient together with the doctor. Determining criteria are gestational age, presence of concomitant diseases (thrombosis, kidney disease), smoking, age, etc.
Reviews about Duphaston
Women taking hormonal pills Duphaston leave positive reviews in most cases. It is often noted online that the medicine helps to get pregnant, that is, it increases the likelihood of conception.
Reviews of Duphaston when planning pregnancy indicate that if you follow the dosage regimen and under the supervision of doctors, you can get the desired result. However, whether this remedy helps you get pregnant in case of infertility depends on whether the diagnosis was made correctly. Women also write on forums that the drug can significantly alleviate symptoms during menopause.
There are also many positive reviews about the use of the drug for endometriosis , for cysts , for polycystic ovary syndrome , for ovarian cysts etc. The drug is often prescribed in combination (for example, with Proginova ’s drugs, etc.).
Women who have treated endometriosis and other diseases with Duphaston sometimes write about side effects. Most often, when taking pills, patients experience the following side effects: nausea , diarrhea , abdominal pain , general weakness, and excess weight .
Many patients, taking the pills during pregnancy, were able to give birth to healthy babies. Reviews of Duphaston for cycle disorders in most cases indicate that after a course of taking pills, the monthly cycle has stabilized. There are also often positive reviews about Duphaston for delayed periods. Experts on the network also often discuss Duphaston. Reviews from doctors for fibroids and other gynecological diseases indicate that experts consider this drug to be effective.
Among other things, it is often discussed online whether Duphaston is hormonal or not. Patients ask questions about whether the pills are hormonal or not, and to specialists. There are many reviews from those who have been helped by taking the pills to get pregnant. On forums, women discuss whether it is possible to get pregnant while taking the drug, whether it affects ovulation, in particular, whether it suppresses ovulation or not. There are often descriptions of individual situations, for example: “I take the drug, but I don’t have my period,” “I drank it for 10 days, but I don’t have my period.”
Women have many questions about taking the drug, which they ask specialists online. People often ask whether it is possible to take Duphaston during menstruation, whether taking it affects the level of hCG , and whether it is possible to gain weight from it.
Duphaston or Prajisan
Manufacturer: Sun Pharmaceutical Industries, India
Release form: capsules
Active ingredient: progesterone
How to replace Duphaston during pregnancy should be discussed with your doctor. The drug of choice is Prajisan capsules, which can be taken orally or administered intravaginally. With the second method of use, there is less likelihood of side effects.
The drugs differ in the active substance - the analogue contains progesterone, Duphaston is a source of the synthetic substance dydrogesterone.
Duphaston price, where to buy
The price of Duphaston tablets is, on average, 520-800 rubles. You can buy Duphaston in a Moscow pharmacy with a doctor's prescription. How much Duphaston costs in pharmacies in Novosibirsk, Omsk, Samara depends on the place of sale, but, on average, the cost of the drug is the same. At the Ozerki pharmacy the cost of the drug is on average 550 rubles.
The price of Duphaston in a Kharkov pharmacy does not differ from the cost in other cities (Kyiv, Odessa, Zaporozhye, Dnepropetrovsk, etc.). On average, in Ukraine the cost of Duphaston 10 mg (pack of 20 pieces) is 390 hryvnia.
- Online pharmacies in RussiaRussia
- Online pharmacies in KazakhstanKazakhstan
ZdravCity
- Duphaston tab.
p/o captivity. 10 mg No. 28 JSC Veropharm 820 rub. order - Duphaston tab. p/o captivity. 10mg No. 20AO Veropharm
RUR 595 order
Pharmacy Dialogue
- Duphaston tablets 10 mg No. 28Abbot
RUR 827 order
- Duphaston tablets 10 mg No. 20Abbot/Veropharm
RUB 629 order
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