Dydrogesterone


Thông tin thuốc gốc
Chỉ định và Liều dùng
Oral
Recurrent miscarriage
Adult: For cases associated with proven progesterone deficiency: 10 mg bid until the 12th or 20th week of pregnancy.

Oral
Endometrial protection during menopausal hormonal replacement therapy, Mild vasomotor symptoms associated with menopause, Moderate vasomotor symptoms associated with menopause, Prophylaxis of postmenopausal osteoporosis
Adult: In combination with continuous estrogen treatment (continuous sequential therapy): 10 mg daily for 14 consecutive days of a 28-day cycle. In combination with cyclical estrogen therapy (cyclic treatment): 10 mg daily for the last 12-14 days of estrogen treatment. Doses may be adjusted to 20 mg daily depending on clinical response (e.g. endometrial biopsy, ultrasound reveal).

Oral
Threatened miscarriage
Adult: For cases associated with proven progesterone deficiency: Initially, up to 40 mg loading dose, followed by 10 mg 8 hourly until symptoms remit.

Oral
Endometriosis
Adult: 10-30 mg daily from day 5-25 of the cycle, or continuously.

Oral
Infertility due to luteal insufficiency
Adult: 10 mg daily from day 14-25 of the cycle for at least 6 months. Alternatively, 10 or 20 mg daily starting on the 2nd half of the menstrual cycle until the 1st day of the next cycle. Maintain treatment for at least 3 consecutive cycles.

Oral
Dysmenorrhoea
Adult: 10 or 20 mg daily from day 5-25 of the cycle.

Oral
Dysfunctional uterine bleeding
Adult: For arresting a bleeding episode: 10 mg bid for 5-7 days. Alternatively, 20 or 30 mg daily may be given for up to 10 days. For continued prevention: 10 or 20 mg daily from day 11-25 of the cycle. Treatment guidelines may vary between countries as some may recommend dydrogesterone to be used in combination with estrogen. Refer to local detailed product information.

Oral
Secondary amenorrhoea
Adult: In combination with estrogen (endogenous or exogenous) to adequately prime the endometrium: 10 or 20 mg daily from day 11-25 of the menstrual cycle.

Oral
Premenstrual syndrome
Adult: 10 mg bid from day 11-25 of the cycle. Alternatively, 10 mg bid starting on the 2nd half of the menstrual cycle until the 1st day of the next cycle; initial treatment day and duration will depend on the individual cycle length.

Oral
Irregular menstrual cycle
Adult: 10 mg bid from day 11-25 of the cycle. Alternatively, 10 or 20 mg daily starting on the 2nd half of menstrual cycle until the 1st day of next cycle; initial treatment day and duration will depend on the individual cycle length.

Oral
Luteal support during assisted reproductive technology
Adult: 10 mg tid starting at the day of oocyte retrieval and continued for 10 weeks if pregnancy is confirmed. Discontinue treatment upon diagnosis of miscarriage or abortion.
Cách dùng
May be taken with or without food.
Chống chỉ định
Known or suspected progestogen dependent neoplasms (e.g. meningioma), undiagnosed abnormal vaginal bleeding; any contraindications associated with estrogen (when dydrogesterone is used in combination with estrogen). Existing or history of serious liver disorders (as long as liver function is not normalised). Lactation.
Thận trọng
Patient with existing or history of depression, porphyria; diabetes, predisposition to cholestasis; herpes gestationis, otosclerosis; known thrombophilic states, risk factors for venous thromboembolism (e.g. SLE, cancer, major surgery, prolonged immobilisation, obesity [BMI >30 kg/m2]). Hepatic impairment. Pregnancy.
Tác dụng không mong muốn
Significant: Breakthrough bleeding and spotting (particularly during the 1st month of therapy); venous thromboembolism (e.g. DVT, pulmonary embolism); increased risk of ischaemic stroke, MI, coronary artery disease, and breast cancer (particularly during combined estrogen-progestogen therapy); CNS effects (e.g. dizziness, drowsiness). Rarely, increased risk of ovarian cancer.
Gastrointestinal disorders: Nausea, vomiting, abdominal pain.
Hepatobiliary disorders: Abnormal hepatic function.
Investigations: Increased weight.
Nervous system disorders: Migraine, headache.
Psychiatric disorders: Depressed mood.
Reproductive system and breast disorders: Menstrual disorders (including metrorrhagia, menorrhagia, amenorrhoea, oligomenorrhoea, dysmenorrhoea, and irregular menstruation), breast tenderness or pain.
Skin and subcutaneous tissue disorders: Rash, pruritus, urticaria.
Thông tin tư vấn bệnh nhân
This drug may cause mild somnolence or dizziness, if affected, do not drive or operate machinery.
Chỉ số theo dõi
Rule out malignancy in all cases of undiagnosed abnormal vaginal bleeding (e.g. endometrial sampling). Screen for complete personal and family medical history prior to initiating and reinstituting hormone replacement therapy. Perform routine physical examination (e.g. breast and pelvic exam, mammogram, blood pressure, Papanicolau smear) periodically before and during treatment.
Tương tác
Increased metabolism with CYP enzyme inducers (e.g. carbamazepine, phenobarbital, phenytoin, rifampicin, efavirenz, nevirapine).
Tương tác với thức ăn
Increased metabolism with St. John's wort, ginkgo biloba, or sage.
Tác dụng
Description:
Mechanism of Action: Dydrogesterone, an orally-active progestogen, is a synthetic retroisomer of progesterone. It produces a complete secretory endometrium in a uterus primed by estrogen, thereby giving protection against the increased risk of endometrium hyperplasia and/or estrogen-induced carcinogenesis. Additionally, it lacks estrogenic, anabolic, androgenic, thermogenic, and corticoid characteristics.
Pharmacokinetics:
Absorption: Rapidly absorbed. Time to peak plasma concentration: 0.5-2.5 hours (dydrogesterone); approx 1.5 hours (DHD). Bioavailability: 28%.
Distribution: Plasma protein binding: >90% (dydrogesterone and DHD).
Metabolism: Rapidly metabolised into 20α-dihydrodydrogesterone (DHD).
Excretion: Via urine (63%, as metabolites). Terminal elimination half-life: 5-7 hours (dydrogesterone); 14-17 hours (DHD).
Đặc tính

Chemical Structure Image
Dydrogesterone

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 9051, Dydrogesterone. https://pubchem.ncbi.nlm.nih.gov/compound/Dydrogesterone. Accessed Nov. 23, 2023.

Bảo quản
Store below 30°C. Protect from moisture.
Phân loại MIMS
Estrogen, progesteron & các thuốc tổng hợp có liên quan
Phân loại ATC
G03DB01 - dydrogesterone ; Belongs to the class of pregnadien derivative progestogens used in progestogenic hormone preparations.
Tài liệu tham khảo
Anon. Dydrogesterone. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 04/02/2022.

Buckingham R (ed). Dydrogesterone. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/02/2022.

Duphaston 10 mg Film-Coated Tablet (Abbott Laboratories Ltd.). MIMS Thailand. http://www.mims.com/thailand. Accessed 04/02/2022.

Duphaston 10 mg Film-Coated Tablets (Abbott Laboratories [M] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 04/02/2022.

Duphaston 10 mg Film-Coated Tablets (Abbott Laboratories [S] Pte Ltd.). MIMS Singapore. http://www.mims.com/singapore. Accessed 04/02/2022.

Duphaston 10 mg Tablets (Abbott Laboratories). MIMS Philippines. http://www.mims.com/philippines. Accessed 04/02/2022.

Thông báo miễn trừ trách nhiệm: Thông tin này được MIMS biên soạn một cách độc lập dựa trên thông tin của Dydrogesterone từ nhiều nguồn tài liệu tham khảo và được cung cấp chỉ cho mục đích tham khảo. Việc sử dụng điều trị và thông tin kê toa có thể khác nhau giữa các quốc gia. Vui lòng tham khảo thông tin sản phẩm trong MIMS để biết thông tin kê toa cụ thể đã qua phê duyệt ở quốc gia đó. Mặc dù đã rất nỗ lực để đảm bảo nội dung được chính xác nhưng MIMS sẽ không chịu trách nhiệm hoặc nghĩa vụ pháp lý cho bất kỳ yêu cầu bồi thường hay thiệt hại nào phát sinh do việc sử dụng hoặc sử dụng sai các thông tin ở đây, về nội dung thông tin hoặc về sự thiếu sót thông tin, hoặc về thông tin khác. © 2024 MIMS. Bản quyền thuộc về MIMS. Phát triển bởi MIMS.com
  • Beritox
  • Duphaston
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in