Dydrogesterone
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Drug Status
Government Approvals
UK(BNF)
WHO Essential Medicine
NO
Known Teratogen
NO
Pharmaceutical Class
None
Controlled Drug Substance
NO
Dydrogesterone
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Click HereSummary
Dydrogesterone is used to treat conditions like dysmenorrhoea (painful menstruation), endometriosis (a condition where tissue similar to the lining of the uterus is found outside the uterus), irregular menstrual cycles, and premenstrual syndrome. It's also used in hormone replacement therapy to counteract estrogen's effects on the endometrium.
Dydrogesterone is an orally active progestogen. It works by causing full secretory transformation of the estrogen-activated endometrium. This action significantly reduces the increased risk of endometrial hyperplasia or cancer caused by estrogens.
Dydrogesterone is taken orally. The dosage varies depending on the condition being treated. For dysmenorrhoea and irregular menstrual cycles, it's usually 10 mg twice a day from day 5 to 25 of the cycle. For endometriosis, it's 10 mg two to three times daily from day 5 to 25 of the cycle or continuously. For premenstrual syndrome, it's 10 mg twice a day from day 12 to 26 of the cycle.
Common side effects of Dydrogesterone include headache, migraine, nausea, menstrual disorders, and breast pain or tenderness. Serious adverse effects may include increased size of progestogen-dependent tumors, liver function abnormalities, and hypersensitivity reactions.
Dydrogesterone should not be used in patients with known or suspected progestogen-dependent tumors, unexplained vaginal bleeding, severe liver diseases, thrombophlebitis, and thromboembolic diseases. It should not be used in pregnancy or while breastfeeding without medical advice.
Indications and Purpose
How does Dydrogesterone work?
Dydrogesterone is an orally active progestogen that causes full secretory transformation of the estrogen-activated endometrium. This action significantly reduces the increased risk of endometrial hyperplasia or carcinogenesis induced by estrogens. It does not have estrogenic, androgenic, thermogenic, anabolic, or corticoid effects, making it a targeted treatment for progesterone insufficiencies.
How does one know if Dydrogesterone is working?
The benefit of dydrogesterone is evaluated through clinical response and symptom relief in conditions like dysmenorrhoea, endometriosis, and pre-menstrual syndrome. Regular follow-up examinations and medical history reviews are recommended to assess the effectiveness and safety of the treatment. Adjustments in dosage or treatment duration may be made based on the severity of symptoms and individual patient response.
Is Dydrogesterone effective?
Dydrogesterone is an orally active progestogen that effectively causes full secretory transformation of the estrogen-activated endometrium. This action significantly reduces the increased risk of endometrial hyperplasia or carcinogenesis induced by estrogens. Clinical trials have shown that dydrogesterone is effective in relieving symptoms of dysmenorrhoea, premenstrual syndrome, dysfunctional uterine bleeding, and irregular cycles, with effects comparable to those in adults.
What is Dydrogesterone?
Dydrogesterone is a progestogen used to treat conditions like dysmenorrhoea, endometriosis, irregular menstrual cycles, and pre-menstrual syndrome. It is also used in hormone replacement therapy to counteract estrogen's effects on the endometrium. Dydrogesterone works by causing full secretory transformation of the estrogen-activated endometrium, reducing the risk of endometrial hyperplasia or carcinogenesis.
What is Dydrogesterone used for?
Dydrogesterone is indicated for treating progesterone insufficiencies, such as dysmenorrhoea, endometriosis, irregular menstrual cycles, and pre-menstrual syndrome. It is also used in hormone replacement therapy for non-hysterectomised women with menopause symptoms and in managing dysfunctional bleeding or secondary amenorrhoea when used with estrogen.
Directions for Use
For how long do I take Dydrogesterone?
The duration of dydrogesterone use depends on the condition being treated. For example, in the treatment of dysmenorrhoea, it is used from day 5 to 25 of the menstrual cycle. For hormone replacement therapy, it is used during the last 14 days of each 28-day cycle. The treatment duration should be adjusted according to the severity of symptoms and clinical response, as advised by a healthcare professional.
How do I take Dydrogesterone?
Dydrogesterone is taken orally, and it is recommended to take the daily dose at the same time each day, either in the morning or evening. When taking two tablets daily, one should be taken in the morning and one in the evening. There are no specific food restrictions mentioned, but taking the medication with food may help reduce nausea.
How should I store Dydrogesterone?
Dydrogesterone does not require special storage conditions. However, it should be kept in its original packaging to protect it from moisture and light. It is important to store the medication out of reach of children and to dispose of any unused product in accordance with local requirements or return it to the pharmacy to prevent environmental contamination.
What is the usual dose of Dydrogesterone?
For adults, the dosage of dydrogesterone varies based on the condition being treated. For dysmenorrhoea, it's 10 mg twice a day from day 5 to 25 of the cycle. For endometriosis, it's 10 mg two to three times daily from day 5 to 25 of the cycle, or continuously. For irregular menstrual cycles, it's 10 mg twice a day from day 11 to 25 of the cycle. For pre-menstrual syndrome, it's 10 mg twice a day from day 12 to 26 of the cycle. The dosage may be increased if necessary. There is no relevant use for dydrogesterone before menarche, and the safety and efficacy in adolescents aged 12-18 years have not been established.
Warnings and Precautions
Can Dydrogesterone be taken safely while breastfeeding?
There are no data on the excretion of dydrogesterone in breast milk, but experience with other progestogens suggests they pass into breast milk in small amounts. The risk to the baby is unknown, so it is recommended not to take dydrogesterone while breastfeeding unless advised by a healthcare professional.
Can Dydrogesterone be taken safely while pregnant?
Dydrogesterone is not authorized for use during pregnancy. Although more than 10 million pregnancies have been exposed to dydrogesterone without evidence of harmful effects, some progestogens are associated with an increased risk of hypospadias. Due to confounders, no definitive conclusion can be drawn. It is important to consult a healthcare professional before using dydrogesterone during pregnancy.
Can I take Dydrogesterone with other prescription drugs?
Dydrogesterone's metabolism may be increased when used with substances that induce CYP enzyme activity, such as anticonvulsants (e.g., phenobarbital, phenytoin, carbamazepine) and certain antibiotics (e.g., rifampicin, rifabutin). Herbal preparations like St John's wort may also affect its metabolism. These interactions can lead to reduced effectiveness of dydrogesterone, so it's important to inform healthcare providers of all medications being taken.
Who should avoid taking Dydrogesterone?
Important warnings for dydrogesterone include hypersensitivity to the active substance, known or suspected progestogen-dependent tumors, unexplained vaginal bleeding, and severe liver diseases. It is contraindicated in patients with thrombophlebitis and thromboembolic diseases. Patients should be monitored for conditions like porphyria, depression, and liver function abnormalities. Dydrogesterone should not be used in pregnancy or while breastfeeding without medical advice.
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