Dydrogesterone | Duphastone | Orally active progesterone

Dydrogesterone | Duphastone

Dydrogesterone | Duphastone

This medicine is also known as Duphaston which is the registered trademark. 

Pharmacotherapeutic group: Genitourinary system and sex hormones

Dydrogesterone is an orally active progestogen which produces a complete secretory endometrium in an oestrogen primed uterus thereby providing protection for oestrogen induced increased risk for endometrial hyperplasia and / or carcinogenesis. It is indicated in all cases of endogenous progesterone deficiency.

Indication

Hormonal replacement therapy: Is indicated to counteract the effects of unopposed oestrogen on the endometrium  (inner lining of the uterus) in hormonal replacement therapy for women with disorders  due to naturally or surgically induced menopause with an intact uterus.

Progesterone deficiencies such as

  • Treatment of dysmenorrhea (painful menstruation)
  • Treatment of endometriosis (growth of uterine tissues outside the uterus with associated symptoms)
  • Treatment of secondary amenorrhea (cessation of menstruation)
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  • Treatment of irregular cycles
  • Treatment of dysfunctional uterine bleeding
  • Treatment of premenstrual syndrome
  • Treatment of threatened and habitual abortion, associated with proven progesterone deficiency
  • Treatment of infertility due to luteal (ovarian yellow body) insufficiency 

Dosage and administration

Always take the medicine as prescribed. If you have any question ask your doctor or pharmacist. If you forget to take your tablet(s), do not take a double dose to compensate for it. If you require further information, please ask your doctor or pharmacist for advice

For hormonal replacement therapy

In combination with continuous oestrogen therapy, take one tablet daily for 14 consecutive days of 28 day cycle. In combination with cyclical oestrogen therapy take one tablet daily during the last 12 to 14 days of oestrogen therapy For doctor: if endometrial biopsies or ultrasound reveal inadequate progestronal response, 20 mg dydrogesterone should be prescribed

Posology for specific indications

Dysmenorrhea (painful menstruation): Take one tablet twice daily from day 5 to day 25 of the cycle

Endometriosis: Take one tablet two or three times daily from day 5 to day 25 of the cycle or continuously as prescribed by the doctor.

Dysfunctional bleeding (to stop bleeding): Take one tablet twice daily for five to seven days

Dysfunctional bleeding (to prevent bleeding): Take one tablet twice daily for from day 11 to day 25 of the cycle

Amenorrhea: Your doctor should prescribe an oestrogen along with dydrogesterone. Then take the oestrogen once daily from day 1 to day 25 of the cycle or continuously (as prescribed by the doctor)

Irregular cycle: Take one tablet twice daily from day 11 to day 25 of the cycle

Premenstrual syndrome: Take one tablet twice from day 11 to day 25 of the cycle

Threatened abortion: Take four tablets at once, then one tablet every eight hours until symptoms abate

Habitual abortion: Take one tablet twice daily until the twentieth week of pregnancy.

Infertility due to luteal insufficiency: Take one tablet daily from 14 to 25 of the cycle. Continue the treatment for at least six consecutive cycles.

Contraindications

•  Hypersensitive (allergic) to the active substance or to any of the excipients

•  Have a known or suspected progestogen dependent neoplasm

• Have undiagnosed vaginal bleeding

• Are using this medicine to prevent hyperplasia, specifically if you are also taking oestrogens

Interactions

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without prescription

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Effect on ability to drive and use machines

Dydrogesterone has no or negligible influence on the ability to dive and use machines

Undesirable effects

• Hypersensitivity  

• Migraines  

• Abnormal hepatic function

• Allergic dermatitis

• Angioedema

• Metrorrhagia

• Breast pain

• Depressed mood

• Breast swelling

References
https://www1.ndmctsgh.edu.tw/pharm/pic/medinsert/005DUP05E.pdf
https://en.wikipedia.org/wiki/Dydrogesterone
https://www.indiamart.com/proddetail/duphastone-10-mg-21772428330.html
https://www.practo.com/medicine-info/duphaston-tablet-45731
https://data.health.gov.il/drugs/alonim/Duphaston_dr_1410193172635.pdf
http://www.hpra.ie/img/uploaded/swedocuments/~db5_Oe1473cc1ea6248bca768c3611a6d293b-2151419-28082014144118-635448336793226250.pdf
https://data.health.gov.il/drugs/alonim/Duphaston_dr_1410193172635.pdf
https://www.who.int/medicines/publications/druginformation/issues/WHO-DI-22-2.pdf?ua=1

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