Details
Duphaston INDICATIONS
Indication.
- Irregular menstrual cycles;
- endometriosis;
- dysmenorrhea;
- infertility caused by luteal insufficiency;
- support of the luteal phase when using assisted reproductive technologies (ART);
- threatening and habitual miscarriage associated with progesterone deficiency.
Dufaston® can be used as a cyclic addition to estrogen therapy in women with an intact uterus:
- to prevent endometrial hyperplasia during menopause;
- with dysfunctional uterine bleeding;
- with secondary amenorrhea.
APPLICATION
The following dosage regimens are recommended for treatment with Dufaston®. Doses, regimens, and duration of treatment may be adjusted depending on the severity of the disorder and the individual patient's clinical response.
Irregular menstrual cycles
A cycle length of 28 days can be achieved by prescribing 1 tablet of Dufaston® per day from the 11th to the 25th day of the cycle.
Endometriosis
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 per day should be spread evenly throughout the day. It is recommended to prescribe the highest dose at the initial stage of treatment.
Dysmenorrhea
From 1 to 2 Dufaston® tablets per day from the 5th to the 25th day of the cycle. Doses in multiples of 10 mg per day should be spread evenly throughout the day. It is recommended to prescribe the highest dose at the initial stage of treatment.
Infertility caused by luteal insufficiency
1 Dufaston® 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 the treatment during the first months of pregnancy in the same doses as for a normal miscarriage.
Support of the luteal phase when using assisted reproductive technologies (ART)
1 Dufaston® tablet 3 times a day (30 mg per day). Treatment begins on the day of oocyte retrieval and continues for 10 weeks if pregnancy is confirmed.
Threat of miscarriage
Initial dose: 4 Dufaston® tablets at once, then 1 Dufaston® tablet every 8 hours. Doses in multiples of 10 mg per 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 Dufaston® every 8 hours.
After symptoms disappear, the effective dose should be maintained for one week, after which it can be gradually reduced. If symptoms recur, treatment should be immediately resumed at the dose that has been shown to be effective.
Habitual miscarriage
Treatment should be started before conception. 1 Dufaston® tablet per day until the 20th week of pregnancy, after which the dose can be gradually reduced.
If symptoms of threatened abortion appear during treatment, treatment should be continued as described in the case of threatened miscarriage.
Dysfunctional uterine bleeding
To stop bleeding, 2 tablets of Dufaston® are prescribed per day for 5-7 days. Blood loss decreases significantly within a few days. A few days after the end of such treatment, withdrawal bleeding will appear, about which the patient should be warned.
In order to prevent the further occurrence of heavy uterine bleeding, Dufaston® should be prescribed 1 tablet per day from the 11th to the 25th day of the cycle, if necessary - in combination with estrogen for 2-3 cycles. After this, the treatment can be stopped in order to check the normalization of the patient's cycle.
Secondary amenorrhea
From 1 to 2 tablets of the drug Dufaston® per day from the 11th to the 25th day of the cycle to ensure optimal secretory transformation of the endometrium adequately stimulated by endogenous or exogenous estrogen.
To prevent endometrial hyperplasia during menopause
During each 28-day cycle of estrogen therapy, take estrogen alone for the first 14 days, and for the next 14 days take 1 or 2 tablets containing 10 mg of dydrogesterone in addition to estrogen therapy. In the case of a dosage of 10 mg of dydrogesterone 2 times a day, taking tablets should be distributed throughout the day. Withdrawal bleeding usually occurs during the use of dydrogesterone.
The use of combined estrogen and progestagen therapy in postmenopausal women should be limited to the minimum effective dose and shortest duration consistent with the therapeutic goals and risks for each woman, and the appropriateness of such treatment should be periodically reviewed (see "Particulars of use").
Application method
For oral administration.
When using higher doses, the tablets should be evenly distributed throughout the day.
CONTRAINDICATIONS
- Undiagnosed vaginal bleeding;
- existing serious liver diseases or the presence of serious liver diseases in the past, if the indicators of liver function have not normalized;
- contraindications for estrogens should be taken into account if they are used in combination with progestogens such as dydrogesterone;
- established hypersensitivity to the active substance or to any other component of the drug;
- established or suspected progestagen-dependent neoplasms (for example, meningioma).
Luteal maintenance treatment with assisted reproductive technologies (ART) should be discontinued if abortion/miscarriage is diagnosed.
