Item nanme:Dydrogesterone Tablets Item character:The goods is white
Indication: Didrogesterone can be used to treat diseases caused by endogenous progesterone deficiency, such as
Dysmenorrhea
Endometriosis
Secondary amenorrhea
Irregular menstrual cycle
Functional uterine bleeding
Premenstrual Syndrome
Predictive or habitual abortion due to progesterone deficiency
Infertility due to corpus luteum insufficiency.
Item specifications:10mg*20tab/box
Usage and dosage:dysmenorrhea
Didrogesterone tablets (10 mg in didrogesterone) are given orally twice a day from the 5th to 25th days of the menstrual cycle.
Endometriosis
From the 5th to 25th days of the menstrual cycle, desdrogesterone is given orally 2-3 times a day, one tablet of desdrogesterone at a time (10 mg in desdrogesterone).
Functional hemorrhage
Dose of hemostasis
Didrogesterone tablets (10 mg in didrogesterone) were taken orally twice a day for 5-7 days in a row.
Dose to prevent bleeding
From the 11th to 25th days of the menstrual cycle, oral desdrogesterone tablets (10 mg in desdrogesterone) are given twice a day.
Amenorrhoea
From day 1 to day 25 of the menstrual cycle, take estradiol once a day.From the 11th to 25th days of the menstrual cycle, the combination of didrogesterone was given twice a day, one tablet at a time (10 mg in didrogesterone).
Premenstrual Syndrome
From the 11th to 25th day of the menstrual cycle, oral desdrogesterone twice a day, one tablet at a time (10 mg in desdrogesterone).
Irregular menstruation
From the 11th to 25th days of the menstrual cycle, oral desdrogesterone twice a day, one tablet at a time (10 mg in desdrogesterone).
threatened abortion
The initial dose was 4 oral tablets of desdrogesterone (40 mg in desdrogesterone) at one time, followed by 1 tablet of desdrogesterone (10 mg in desdrogesterone) every 8 hours until symptoms disappeared.
Habitual Abortion
Didrogesterone is given orally twice a day, one tablet at a time (10 mg in didrogesterone) until the 20th week of pregnancy.
Infertility due to endogenous progesterone deficiency
On days 14 to 25 of the menstrual cycle, oral desdrogesterone tablets (10 mg in desdrogesterone) were given daily.Treatment should last at least six consecutive cycles and should be continued in the first few months of pregnancy, with reference to the treatment dose for habitual abortion or as directed by your doctor.
Adverse reactions Predictive or habitual abortion due to progesterone deficiency
Infertility due to corpus luteum insufficiency.
Adverse reactions reported in clinical trials and/or marketing of desdrogesterone are as follows:
Other adverse reactions related to desdroprogesterone with unknown frequency after marketing:
[u] Benign, malignant and unspecified tumors (including cysts and polyps) [/u]
Progesterone-dependent increase in tumor size (e.g., meningioma) (see contraindications).
[u] Mental disorders [/u]
Depression, stress
[u] Other [/u]
Vomiting, altered libido
[u] Reproductive and breast diseases [/u]
Swelling breasts
Adverse reactions related to estrogen-progesterone therapy were also observed.
Breast cancer
Endometrial hyperplasia, endometrial cancer
Sex hormone dependent tumors (malignant/benign)
Venous Thrombosis
Myocardial infarction, cardiovascular events
Taboo: - Anyone who is known to be allergic to the active ingredients of this product or any excipient.
-Progesterone-dependent tumors are known or suspected.
- Unknown vaginal bleeding;
-If used to prevent endometrial hyperplasia (in women who use estrogen), contraindications to the combination of estrogen and progesterone (e.g., desdrogesterone) are seen.
-Serious dysfunction: liver tumors (present or past), Dubin Johnson syndrome, Potor syndrome, jaundice;
- Diseases or symptoms that occur or worsen during pregnancy or when sex hormones are used, such as severe pruritus, obstructive jaundice, herpes gravidarum, porphyria, and otosclerosis;
Matters needing attention: Before initiating drogesterone for the treatment of abnormal bleeding, the cause of bleeding should be identified.
Occasional changes in liver function, sometimes accompanied by clinical symptoms, occur during desdroprogesterone treatment.Therefore, patients with acute liver disease or a history of liver disease and normal liver function should use drogesterone with caution.The drug should be discontinued once severe liver damage occurs.
Breakthrough bleeding may occur in a small number of patients.
[u] Situation to be monitored [/u]
Patients should be closely monitored if the following conditions are present, have occurred, and/or worsen during pregnancy and prior hormone therapy.It should be considered that these conditions may recur or worsen during treatment with desdroprogesterone, in particular;
1. Porphyria
2. Depression
[u] Other cases [/u]
You have galactose intolerance.Patients with rare genetic disorders such as Lapp lactase deficiency or glucose-galactose malabsorption should not take this drug.
Warnings and precautions when local drogesterone is used to prevent endometrial hyperplasia in women using estrogen;
Note: Hormone replacement therapy (HRT) should only be used when symptoms of estrogen deficiency in postmenopausal women are adversely affected by the warning in the information on estrogen medication products.Careful assessment of the benefits and risks of HRT is done regularly (at least once a year), and HRT treatment can only be continued if the benefits outweigh the disadvantages.
Medical Examination/Follow-up
A complete medical history, including family history, should be set before starting hormone replacement therapy (HRT) or when it is reused after interruption.Physical examination (including gynecological and breast examination) must be performed under the guidance of medical history, contraindications and warnings.During treatment, it is recommended to adjust the frequency and content of periodic examinations according to individual circumstances.Women should be advised to report any breast changes to their doctor.
Regular breast examinations, including mammograms, should be based on current guidelines for healthy women and combined with the medical needs of individual women.
Endometrial Hyperplasia
Long-term estrogen use without the addition of progesterone increases the incidence of endometrial hyperplasia and endometrial cancer in women with retained uterus.The combination of estrogen and progesterone (e.g., desdrogesterone) for at least 12 days during each menstrual cycle may largely prevent this risk.
Breakthrough bleeding and drip-like bleeding may occur occasionally in the first few months of treatment. If breakthrough bleeding and drip-like bleeding occur after a period of treatment or persist after treatment has stopped, the cause of bleeding should be investigated and endometrial biopsy can be performed to exclude the possibility of endometrial malignancy.Further examination should be performed when abnormal vaginal bleeding occurs.
Mammary cancer
A randomized placebo-controlled study, the Women's Health Advocacy Study (WHI) and several epidemiological studies, including the Millions of Women's Study (MWS), showed that women who had taken estrogen, estrogen-progesterone combination, or tibolone as hormone replacement therapy for many years had a relatively increased risk of breast cancer.For all HRTs, this risk occurs in the first few years of use and increases with the duration of treatment. The risk decreases to pre-treatment levels within a few years (up to 5 years) after discontinuation.MWS showed that women treated with conjugated estrogen (CEE) or estradiol (E2) had a higher relative risk of breast cancer when progesterone was added.This risk was not associated with the dosing regimen (sequential or continuous use of progesterone) or the type of progesterone used.
Venous Thromboembolism
Hormone replacement therapy is associated with a higher relative risk of venous thromboembolism (VTE) (i.e., deep venous thrombosis or pulmonary embolism).A randomized controlled study and some epidemiological studies found that HRT users had a 2-3-fold increased risk of VTE compared with women who did not use VTE.
In the first year of HRT treatment, the incidence of VTE was higher than that of subsequent treatment periods.
the general risk factors for VTE are:
Positive personal history;
Family history was positive.
Severe obesity (body mass index > 30kg/m2);
Systemic lupus erythematosus (SLE).
There is no consensus on the possible role of varices in VTE.
The incidence of VTE increased in patients with a previous history of VTE recurrence or a definite tendency to thrombosis.Hormone replacement therapy further increases this risk.Previous personal or exact family history of VTE or recurrent spontaneous abortion should be investigated to exclude the tendency to thrombosis.HRT is disabled in these patients unless a complete assessment of thrombotic factors has been completed or anticoagulation therapy has been initiated.The advantages and disadvantages of HRT for women who have undergone anticoagulation therapy must be carefully evaluated.
Long-term inactivity. The likelihood of venous thromboembolism increases temporarily during severe trauma or major surgery.Postoperative prophylactic measures must be taken to prevent postoperative venous thromboembolism in all patients.If long-term inactivity is expected after elective surgery (especially abdominal or lower extremity plastic surgery), preoperative HRT interruption for 4-6 weeks must be considered and restarted after complete recovery of activity.
If venous thromboembolism occurs after initiation of treatment, the drug must be discontinued.Patients must be informed that they should contact their doctor immediately if possible symptoms of thrombosis occur (e.g., one-leg swelling, sudden chest pain, and shortness of breath).
coronary heart disease
Randomized controlled trials did not provide evidence that continuous combination of conjugated estrogen and medroxyprogesterone acetate was beneficial to the risk of coronary heart disease.Two large clinical studies (WHI and HERS [Heart and Estrogen/Progesterone Replacement Therapy Study]) have shown that the risk of cardiovascular disease in the first year of treatment may increase and that, in general, no beneficial effect is observed.
Cerebrovascular Accident (CVA)
A large randomized clinical trial in healthy women {WHI Study} reported that continuous combination of conjugated estrogen and medroxyprogesterone acetate increased the risk of ischemic CVA (a secondary end point of this study).
Didrogesterone has no or negligible effect on driving and operating the machine.
Medication for pregnant and lactating women: It is estimated that about 35 million women have been treated with desdrogesterone.Although it is difficult to estimate the number of pregnancies, it is estimated that approximately 9 million pregnant women have fetal exposure to gestational progesterone (Note: This higher pregnancy exposure is due to gestational-related indications in many countries).According to the spontaneously reported surveillance system, there is no evidence to date that desdrogesterone cannot be used during pregnancy.There are no other epidemiological data on the use of desdrogesterone.
However, a recent case-control study in the United States (surveying 502 children with hypospadias and 1286 healthy control children) showed that mothers who used progesterone (mainly progesterone) shortly before or during the first trimester of pregnancy had at least a twofold increased risk of having a second or third degree of hypospadias in their boys (OR2.2, 95% CI 1.0-5.0).The causal relationship between the two is unclear because progesterone use during pregnancy may be a potential risk factor for hypospadias.The risk of hypospadias caused by desdrogesterone is unknown.
However, due to the major metabolic differences between rats and humans, animal studies have not been carried out to demonstrate human pregnancy, embryo/fetus, or postpartum development.The potential risks to the human body are unknown.
Limited animal safety data suggest that desdrogesterone has a delayed delivery effect, consistent with its progesterone activity.
The secretion of drogesterone is common in breast milk of lactating women.Risks to breastfed children cannot be excluded.Didrogesterone should not be used during breastfeeding.
There is no evidence that desdroprogesterone causes a decrease in fertility at the therapeutic dose.
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