What Is Progesterone Deficiency?

Dydroxyprogesterone tablets, the indication is Dydroxyprogesterone can be used to treat diseases caused by insufficient endogenous progesterone, such as dysmenorrhea endometriosis secondary amenorrhea irregular menstrual cycle dysfunction Uterine bleeding Premenstrual syndrome Threatened or habitual abortion due to progestin deficiency Infertility due to luteal deficiency.

Drug Name: Dydrogesterone tablets

Drug type: Prescription drugs, medicines for medical workers' injuries
Use classification: Progestins

Dydrogesterone tablets ingredients

Chemical name: 9, 10-Pregna-4, 6-diene-3, 20-dione9, 10-pregnane-4, 6-diene-3, 20-dione Chemical structural formula:

Molecular formula: C ₂₁ H ₂₈ O ₂
Molecular weight: 321.85

Dydrogesterone Tablet Properties

This product is a white film-coated tablet that appears white after removal of the coating.

Dydrogesterone tablets indications

Didroxyprogesterone can be used to treat diseases caused by insufficient endogenous progesterone, such as dysmenorrhea endometriosis secondary amenorrhea irregular menstrual cycle dysfunctional uterine bleeding premenstrual syndrome pregnancy Threat induced abortion or habitual abortion due to hormone deficiency Infertility caused by luteal deficiency.

Didroxyprogesterone Tablets Specifications

10mg

Didroxyprogesterone tablets dosage

Dysmenorrhea: From the 5th to the 25th day of the menstrual cycle, 1 tablet of dydrogesterone (10 mg based on dydrogesterone) is taken orally twice a day.
Endometriosis < br From the 5th to the 25th day of the menstrual cycle, dydrogesterone is taken orally 2-3 times a day, 1 tablet of dydrogesterone (10 mg based on dydrogesterone). .
Dose for hemorrhage of functional bleeding < br 1 tablet of dydrogesterone (10 mg based on dydrogesterone) orally, 2 times a day for 5-7 days.
Dose for preventing bleeding < br From the 11th to the 25th day of the menstrual cycle, take 1 tablet of dydrogesterone (10 mg based on dydrogesterone) orally twice daily.
Amenorrhea: From the 1st to 25th days of the menstrual cycle, take estradiol once daily. From 11 to 25 days of the menstrual cycle, combined with dydrogesterone, 1 tablet 2 times a day (10 mg based on dydrogesterone).
Premenstrual syndrome From the 11th to 25th days of the menstrual cycle, dydrogesterone is taken orally twice a day, 1 tablet each time (10 mg based on dydrogesterone).
Irregular menstruation From the 11th to the 25th days of the menstrual cycle, dydrogesterone is taken orally twice a day, 1 tablet each (10 mg based on drogesterone).
Threatened abortion < br The initial dose is 4 oral dydrogesterone (40 mg based on dydrogesterone), followed by 1 tablet of dydrogestrel every 10 hours (10 mg based on dydrogesterone) ), Until the symptoms disappear.
Habitual abortion < br Oral dydrogesterone 2 times daily, 1 tablet each (10 mg based on dydrogesterone), until the 20th week of pregnancy.
Infertility due to endogenous progesterone deficiency <br On the 14th to 25th days of the menstrual cycle, 1 tablet of dydrogesterone (10 mg based on dydrogesterone) is taken orally daily. Treatment should continue for at least 6 consecutive cycles. It is recommended that this method be used continuously in the first few months of pregnancy. The dose should be based on the treatment dose of habitual abortion or as prescribed by your doctor.

Adverse effects of dydrogesterone tablets

The adverse reactions reported in clinical trials and / or marketing use of dydrogesterone are as follows:
Other adverse reactions related to dydrogesterone after marketing and unknown frequency:
[u] Benign, malignant, and unspecified tumors (including cysts and polyps) [/ u]
Increase in the size of progesterone-dependent tumors (eg, meningiomas) (see [Contraindications]).
[u] mental illness [/ u]
Depression, stress [u] Others [/ u]
Vomiting, altered libido [u] reproductive and breast diseases [/ u]
Breast swelling <br Adverse reactions related to estrogen-progestin treatment can also be found in [Notes]:
· Breast cancer · Endometrial hyperplasia, endometrial cancer · Sex hormone-dependent tumors (malignant / benign)
· Venous thrombosis · Myocardial infarction, cardiovascular accident

Didroxyprogesterone tablets contraindications

-People who are allergic to the active ingredients of this product or any excipients.
-Known or suspected progestin-dependent tumors.
-Unexplained vaginal bleeding;
-If used to prevent endometrial hyperplasia (women using estrogen), see Contraindications for the combination of estrogen and progestin (such as dydrogesterone).
-Severe dysfunction: liver tumors (current or past), Dubin Johnson syndrome, Potor syndrome, jaundice;
-Illnesses or symptoms that develop or worsen during pregnancy or with sex hormones, such as severe pruritus, obstructive jaundice, herpes during pregnancy, porphyria and otosclerosis;

Precautions for dydrogesterone tablets

Before starting dydrogesterone for abnormal bleeding, the cause of the bleeding should be determined.
Changes in liver function occasionally occur during dydrogesterone treatment, sometimes with clinical symptoms. Therefore, dydrogesterone should be used with caution in patients with acute liver disease or a history of liver disease and liver function has not returned to normal. This drug should be discontinued in the event of severe liver damage.
Breakthrough bleeding may occur in a small number of patients.
[u] Situations to be monitored [/ u]
Patients should be closely monitored if the following conditions are present, have occurred, and / or have worsened during pregnancy and previous hormonal therapy. Consideration should be given to the possibility that these conditions may recur or worsen during treatment with dydrogesterone, especially;
1. Porphyria Depression [u] Other conditions [/ u]
Suffering from galactose intolerance. Patients with Lapp lactase deficiency or rare genetic disorders of glucose-galactose malabsorption should not take this medicine.
Local warnings and precautions when using droprogesterone for "preventing endometrial hyperplasia in women using estrogen";
Note: See also the warnings in the product information for estrogen drugs when treating estrogen deficiency symptoms in postmenopausal women. Hormone replacement therapy (HRT) should only be used when symptoms adversely affect quality of life. Careful assessment of the benefits and risks of HRT is performed regularly (at least annually), 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 taken before hormone replacement therapy (HRT) is started, or when it is reapplied after interruption. Physical examination (including gynecology and breast examination) must be performed under the guidance of medical history, contraindications and warnings. It is recommended to adjust the frequency and content of regular inspections during treatment according to personal circumstances. Female patients should be advised to report any changes to their breasts.
Periodic breast examinations (including mammograms) should be performed in accordance with the requirements of current guidelines applicable to healthy women and in combination with the medical needs of individual female patients.
Endometrial hyperplasia < br Long-term application of estrogen without the addition of progestin will increase the incidence of endometrial hyperplasia and endometrial cancer in women with uterus. The combination of estrogen and progesterone (such as dydrogesterone) for at least 12 days during each menstrual cycle may largely prevent this risk.
In the first few months of treatment, breakthrough bleeding and spotting bleeding may occasionally occur. If breakthrough bleeding and spotting bleeding occur after a period of treatment or continue after treatment has stopped, the cause of the bleeding should be investigated and the uterus can be performed Endometrial biopsy to rule out the possibility of endometrial malignancy. When abnormal vaginal bleeding occurs, further examination should be done.
Breast Cancer < br A randomized placebo-controlled study, the Women's Health Advocacy Study (WHI) and some epidemiological studies (including the Million Women's Study (MWS)) show that: Female patients who have been combined or treated with tibolone as a hormone replacement therapy for many years have a relatively increased risk of breast cancer. For all HRTs, this risk occurs during the first few years of use and increases with the duration of administration, and within a few years (up to 5 years) after discontinuation, the risk drops to pre-treatment levels. MWS indicates that women treated with conjugated estrogen (CEE) or estradiol (E2) have a higher relative risk of breast cancer when progestin is added. This risk is independent of the dosing regimen (sequential or continuous progestin) and the type of progestin.
Venous thromboembolism <br /> Hormone replacement therapy is associated with a higher relative risk of developing venous thromboembolism (VTE) (ie, deep vein thrombosis or pulmonary embolism). A randomized controlled study and some epidemiological studies have found that the risk of VTE in HRT users is 2-3 times higher compared to women who do not use VTE.
In the first year of HRT treatment, the incidence of VTE is higher than the subsequent treatment period.
The general risk factors for VTE are:
Positive personal history;
Positive family history;
Severe obesity (body mass index> 30kg / m ² );
Systemic lupus erythematosus (SLE).
There is no consensus on the possible role of varicose veins in VTE.
Increasing the incidence of VTE in patients with a previous history of VTE recurrence or a true tendency to thrombosis. Hormone replacement therapy will further increase this risk. Individuals with a previous personal or exact family history of VTE or recurrent spontaneous abortion must first be investigated to rule out the tendency to thrombosis. HRT is disabled in these patients unless a complete assessment of thrombotic factors has been completed or anticoagulation has been performed. Careful assessment of the advantages and disadvantages of HRT treatment must be performed on women who have been treated with anticoagulation.
Prolonged inactivity. The possibility of venous thromboembolism temporarily increases during severe trauma or major surgery. All postoperative patients must pay close attention to postoperative precautions to prevent postoperative venous thromboembolism. If long-term inactivity after elective surgery (especially abdominal or lower extremity plastic surgery) is anticipated, HRT must be discontinued 4-6 weeks before surgery and HRT should be restarted after the patient has fully recovered activity.
If venous thromboembolism occurs after starting treatment, the drug must be discontinued. Patients must be informed that they should contact their doctor immediately if there are possible symptoms of thrombosis (eg, one-leg pain, sudden chest pain, and shortness of breath).
Coronary heart disease < br Randomized controlled studies have not provided evidence that continuous estrogen combined with medroxyprogesterone acetate is beneficial for the risk of coronary heart disease. Two large clinical studies (WHI and HERS [Heart and Estrogen / Progestin Replacement Therapy Study]) have shown that the risk of cardiovascular disease incidence may increase during the first year of treatment and generally have no beneficial effects.
Cerebrovascular accident (CVA)
A large randomized clinical trial in healthy women {WHI study) reported that a continuous combination of estrogen combined with medroxyprogesterone acetate increased the risk of ischemic CVA (the secondary end point of this study).
Dydrogesterone has no or negligible effect on the ability to drive and operate machines.

Didroxyprogesterone tablets for pregnant and lactating women

It is estimated that approximately 35 million women have been treated with dydrogesterone. Although it is difficult to estimate the number of pregnancies, it is estimated that approximately 9 million pregnant women have fetuses exposed to dydrogesterone (Note: This higher pregnancy exposure is due to the fact that dydrogesterone has pregnancy-related indications in many countries). According to a spontaneously reported monitoring system, there is no evidence to date that dydrogesterone cannot be used during pregnancy. There are no other epidemiological data on dydrogesterone use.
However, a recent case-control study in the United States (investigating 502 children with hypospadias and 1,286 healthy controls) showed that mothers who used progesterone (mainly progesterone) shortly before or early in pregnancy had Boys are at least twice as likely to have second- or third-degree hypospadias (OR2.2, 95% CI 1.0-5.0). The cause-and-effect relationship between the two is unknown, as the reason for the need for progesterone during pregnancy may be a potential risk factor for hypospadias. The risk of dydrogesterone causing hypospadias is unknown.
However, due to major metabolic differences between rats and humans, animal studies have not been performed to prove pregnancy, embryo / fetal or postnatal development in humans. The potential risks to the human body are unknown.
Limited animal safety data indicate that dydrogesterone has a delay in childbirth, consistent with its progestin activity.
The secretion of dydrogesterone in the milk of lactating women. The risk to breastfeeding children cannot be ruled out. Dydroxyprogesterone should not be used during breastfeeding.
There is no evidence that dydrogesterone reduces fertility at therapeutic doses.

Didroxyprogesterone tablets for children

Due to insufficient information on safety and effectiveness, this product is not recommended for children under 18 years of age.

Didroxyprogesterone tablets for the elderly

There are insufficient data to treat women over 65 years of age.

Didroxyprogesterone tablets drug interactions

Interaction studies have not been performed.

Didroxyprogesterone tablets overdose

There are no reports of sequelae of overdose of dydrogesterone. Dydrogesterone is extremely toxic, and overdose can cause symptoms such as nausea, vomiting, drowsiness, and dizziness. Existing data on overdose in humans are limited. After oral administration of dydrogesterone (the maximum daily human dose is 360mg), it is well tolerated. There is no specific antidote for symptomatic treatment. The above information is also used for overdose in children.

Didroxyprogesterone tablets pharmacology and toxicology

Pharmacological effects:
Dydroxyprogesterone is an oral progestin that allows the endometrium to enter the full secretory phase, thereby preventing endometrial hyperplasia and the risk of canceration caused by estrogen. Didroxyprogesterone can be used for various diseases with endogenous progestin deficiency.
Didroxyprogesterone has no estrogen, androgen, and adrenal hormone effects.
Didydrogesterone does not produce heat and has no effect on lipid metabolism.

Pharmacokinetics of Didroxyprogesterone Tablets

Oral-labeled dydrogesterone was excreted in the urine with an average of 63% and completely cleared from the body within 72 hours. Dydrogesterone is completely metabolized in the body. The main metabolite is DHD (20-dihydrogesterone), which is mostly measured in the urine as glucuronide. The structure of all metabolites maintains the configuration of 4,6-diene-3-one without 17-hydroxylation, which determines that this product is free of estrogen and androgenesis.
After oral administration of dydrogesterone, the plasma DHD concentration was higher than the concentration of dydrogesterone in plasma. The ratios of DHD to dydrogesterone AUC and C _max were 40 and 25, respectively.
Didroxyprogesterone was rapidly absorbed after oral administration, and the dydrogesterone and DHD peaked ( _Tmax ) at 0.5 and 2.5 hours, respectively.
The average final half-lives of dydrogesterone and DHD are 5-7 hours and 14-17 hours, respectively.
Unlike endogenous progesterone, dydrogesterone is not excreted in the urine as pregnanediol. Therefore, the production of endogenous progesterone can still be determined based on the excretion of pregnanediol in urine.

Storage of dydrogesterone tablets

15 -30 , store in a dry place.

Dydrogesterone Tablets Packaging

Aluminum-plastic blister pack, 20 pieces / box.

Dydrogesterone tablets expiration date

Sixty months.

The standard of dydrogesterone tablets

Import drug registration standard JX20010415 ^[1]