Dydrogesterone


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Dysmenorrhoea 10 or 20 mg/day from day 5-25 of menstrual cycle. Endometriosis 10-30 mg/day from day 5-25 of menstrual cycle or continuously for the entire cycle. Dysfunctional uterine bleeding Arrest of bleeding episode: 20 or 30 mg/day for up to 10 days. Continuous treatment: 10 or 20 mg/day during the 2nd half of the menstrual cycle, initial treatment and duration depends on cycle length. Secondary amenorrhoea 10 or 20 mg/day for 14 days during the 2nd half of the assumed cycle. Premenstrual syndrome 10 mg bid starting on the 2nd half of the menstrual cycle until the 1st day of the next cycle, initial treatment and duration depends on the cycle length. Irregular menstrual cycle 10 or 20 mg/day starting on the 2nd half of menstrual cycle until 1st day of next cycle, initial treatment and duration depends on the cycle length. Threatened miscarriage Initial: up to 40 mg followed by 20 or 30 mg/day until symptoms remit. Recurrent miscarriage 10 mg bid until the 12th week of pregnancy. Infertility due to luteal insufficiency 10 or 20 mg/day starting on the 2nd half of menstrual cycle until the 1st day of the next cycle. Maintain treatment for at least 3 consecutive cycles. Endometrial protection during menopausal hormonal replacement therapy In addition to oestrogen: Continuous therapy: 10 mg/day for the last 14 days of every 28-day cycle. Cyclic therapy: 10 mg/day for the last 12-14 days of oestrogen therapy; may be adjusted to 20 mg/day depending on clinical response.
Dosage Details
Oral
Recurrent miscarriage
Adult: 10 mg bid until the 12th week of pregnancy.

Oral
Infertility due to luteal insufficiency
Adult: 10 or 20 mg daily starting on the 2nd half of 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 menstrual cycle.

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

Oral
Threatened miscarriage
Adult: Initially, up to 40 mg followed by 20 or 30 mg daily until symptoms remit.

Oral
Endometrial protection during menopausal hormonal replacement therapy
Adult: In addition to oestrogen dose: Continuous sequential therapy: 10 mg daily for the last 14 days of every 28-day cycle. Cyclic therapy: 10 mg daily for the last 12-14 days of oestrogen therapy; may be adjusted to 20 mg daily depending on the clinical response.

Oral
Dysfunctional uterine bleeding
Adult: Arrest of bleeding episode: 20 or 30 mg daily given for up to 10 days. Continuous treatment: 10 or 20 mg daily during the 2nd half of the menstrual cycle, initial treatment and duration will depend on cycle length.

Oral
Secondary amenorrhoea
Adult: 10 or 20 mg daily for 14 days during the 2nd half of the assumed cycle.

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

Oral
Premenstrual syndrome
Adult: 10 mg bid starting on the 2nd half of the menstrual cycle until the 1st day of the next cycle, initial treatment and duration will depend on the cycle length.
Administration
May be taken with or without food.
Contraindications
Known or suspected progestogen dependent neoplasms (e.g. meningioma), undiagnosed vaginal bleeding. Presence or history of serious liver disorders. Coadministration with oestrogen when oestrogen is used for prevention of endometrial hyperplasia.
Special Precautions
Patient with porphyria, herpes gestationis, otosclerosis, severe pruritus, history of depression. Hepatic impairment. Pregnancy and lactation.
Adverse Reactions
Significant: Bleeding and spotting, venous thromboembolism, menstrual disorders (e.g. metrorrhagia, menorrhagia, amenorrhoea, oligomenorrhoea, dysmenorrhoea and irregular menstruation), breast tenderness or pain, abnormal LFT.
Gastrointestinal disorders: Nausea, vomiting.
Investigations: Weight increased.
Nervous system disorders: Migraine, headache, dizziness.
Psychiatric disorders: Depressed mood.
Skin and subcutaneous tissue disorders: Rash, pruritus, urticaria.
Potentially Fatal: Increased risk of breast cancer or rarely, ovarian cancer (when combined with oestrogen).
Patient Counseling Information
This drug may cause mild somnolence or dizziness, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor liver function values. Perform breast examination.
Drug Interactions
Increased metabolism with concomitant use of CYP3A4 inducers (e.g. carbamazepine, phenobarbital, rifampicin, efavirenz).
Food Interaction
Increased metabolism with St John’s wort, ginkgo biloba or sage.
Action
Description: Dydrogesterone is a progestogen which has structures related to progesterone. It produces a complete secretory endometrium in a uterus primed by oestrogen, providing protection against increased risk of endometrium hyperplasia and/or carcinogenesis. Dydrogesterone lacks oestrogenic, anabolic, androgenic, thermogenic and corticoid characteristics.
Pharmacokinetics:
Absorption: Rapidly absorbed. Time to peak plasma concentration: 0.5-2.5 hours. Absolute bioavailability: 28%.
Metabolism: Completely metabolised mainly to 20α-dihydrodydrogesterone (DHD).
Excretion: Via urine mainly as conjugated glucuronic acid (average of 63%). Mean terminal half-life: 5-7 hours (dydrogesterone); 14-17 hours (DHD).
Chemical Structure

Click on icon to see table/diagram/image
Storage
Store below 25°C. Protect from light.
ATC Classification
G03DB01 - dydrogesterone ; Belongs to the class of pregnadien derivative progestogens used in progestogenic hormone preparations.
Disclaimer: This information is independently developed by MIMS based on Dydrogesterone from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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